The Use of Compulsory Licenses in EU Countries to Facilitate Access to Medicines

7/26/2019 The Use of Compulsory Licenses in EU Countries to Facilitate Access to Medicines

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Table of content

This document provides a framework note on Compulsory licenses (CLs) use in Europe (in English and in French), followed by the legal provisions dedicated to CLs in the 28 laws ofthe Member States, with commentary (legal text mostly in English, comments in English).

Framework note on Compulsory Licenses in Europe ................................................................ 4

Note de cadrage sur les licences obligatoires en Europe ........................................................... 7

Austria ...................................................................................................................................... 10

Belgium (legal provisions in French) ....................................................................................... 13

Bulgaria .................................................................................................................................... 25

Croatia ...................................................................................................................................... 28

Cyprus ...................................................................................................................................... 38

Czech Republic ........................................................................................................................ 44

Denmark ................................................................................................................................... 45

Estonia ...................................................................................................................................... 48

Finland ...................................................................................................................................... 51

France (legal provisions in French) .......................................................................................... 54

Germany ................................................................................................................................... 58

Greece ....................................................................................................................................... 60

Hungary .................................................................................................................................... 64

Ireland ....................................................................................................................................... 67

Italia .......................................................................................................................................... 76

Latvia ........................................................................................................................................ 80

Lithuania ................................................................................................................................... 82

Luxembourg (legal provisions in French) ................................................................................ 86

Malte ......................................................................................................................................... 90

Netherlands ............................................................................................................................... 93

Poland ....................................................................................................................................... 98

Portugal .................................................................................................................................. 101

Romania ................................................................................................................................. 106

Slovak Republic ..................................................................................................................... 109

Slovenia .................................................................................................................................. 112

Spain ......................................................................................... Error! Bookmark not defined.

Sweden ................................................................................................................................... 126

United Kingdom ..................................................................................................................... 129



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Framework note on Compulsory Licenses in Europe

The new drugs against hepatitis C are the first case of mobilization of public opinions across

Europe about outraging drug prices and problems of access and rationing. But other caseswill follow, concerning other diseases, because it illustrates a trend that will not be reversed simply by invoking better negotiations with the pharmaceutical industry.One of the few efficient actions that government could undertake is to use the legal provisioneach one has in its patent law – compulsory licenses (CL) – to withhold the exclusive rights ofthe patents and allow generic local production or importation.This note exposes how the call for governments to use CL could be framed by civil society inorder to address the crisis with Hepatitis C medicines (and possibly some of the cancer drugsextremely expensive). It also gathers the legal provisions on compulsory licenses in the 28

Member States of the European Union, providing some comments on aspects of these provisions that are peculiar, particularly useful in the context of the issue of CLs to allow

access to medicines, or on the contrary restrictive.

Legal context

A compulsory license is legal provision provided for in article 31 of the Trade-Related Aspectsof Intellectual Property Rights Agreement (TRIPS) of the WTO.

It allows a sovereign State to authorize a third party or a state entity to use a patent without theauthorization of the patent holder. To put it simply, it suspends the monopoly rights the nationalauthority (the patent office) gave to the patent holder when it granted the patent1. However, itdoes not break or cancel the patent itself.

Just like patents, compulsory licenses can theoretically apply to any "invention" and be used inany field of technology. In the pharmaceutical field, they can apply to patents on products ormanufacturing processes. There are already some experiences of uses of compulsory licensesin the field of health in Europe.2

Compulsory licensing is often referred to as one of the "flexibilities" of the TRIPS agreementas it introduces the possibility to limit or override exclusive rights. It was brought to the publicattention in the context of the conflicts in international institutions over access to medicines forthe treatment of HIV infections (AIDS) in the 1990s and at the beginning of the 2000s.Countries from the global South obtained the adoption of a declaration at the WTO called

"Declaration on the TRIPS agreement and public health" (also known as the “Dohadeclaration”), which clarified that " Each member has the right to grant compulsory licensesand the freedom to determine the grounds upon which such licenses are granted ".3

1 In the case of Europe, there are both national patent offices and the European Patent Office (EPO). Peoplewilling to request a patent can go either to the national or European patent office.

2 For examples of compulsory licensing uses, see KEI Research Note: Recent European Union CompulsoryLicenses. March 1, 2014. 3 See the declaration: http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

http://keionline.org/sites/default/files/Annex_B_European_Union_Compulsory_Licenses_1Mar2014_8_5x11_0.pdf




http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm








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These licenses are called "compulsory" precisely because they are imposed by the nationalauthorities (as opposed to voluntary licenses that are granted by the patent holder). But, as inthe case of voluntary licensing, royalties have to be paid to the patent owner.4

The possibility of compulsory licenses exists in all EU laws. The use of this provision by

individual States is determined by the conditions and specificities set in the national law. National law prescribes how compulsory licenses can be granted: on what ground a compulsorylicenses can be granted, when a request can be put to the authorities, whether it is via a simpleadministrative decision or by a court decision, who is the Minister in charge who has the powerto grant a license, etc. Depending on the language, the legal tradition or even the purpose of thelicense, different names are used in national laws to refer to compulsory licenses: non voluntarylicenses, non-contractual licenses, licenses d'office, licenses for government uses, licenses tothe public sector, Crown use licenses, etc.

There are differences in the provisions of the different Member States of the EU. Some lawsare more flexible or open than others, some, on the contrary, are more restrictive than the

standards established by the WTO.

A compulsory license is only valid on the territory of the country where it was granted and primarily aims at responding to the needs of the national market.

The use of compulsory licenses to respond to accessibility problems in Europe

The issue of accessibility to recent medicines against deadly diseases is raising as a problem ina growing number of EU countries.

The launching of sofosbuvir a new treatment against hepatitis C open up a public debate onthe excessive prices and their impact on accessibility. This medicine is sold in Europe by the pharmaceutical company Gilead that owns the patent on it between €20.000 and €50.000 per

patient for a 12-weeks course. The price of the treatment – that is a combination of 2 or 3medicines, including sofosbuvir – can exceed 70.000€ per month, which is unacceptable both

from a moral and an economic point of view.

But hepatitis C treatment is not an isolated case. It illustrates a trend. For the last 10 years, the price of new medicines has increased dramatically. Similar problems arise with differenttypes of drugs against severe diseases, for instance cancers, with prices for the medicinesalone (not including delivery or care regimens) coming close to or exceed €100.000 euros per

patient per year. Such prices represent insurmountable burden on social security systems inEurope and progressively lead governments to rationing policies. This is true in countries thatare facing heavy financial and economic crisis, but it is also the case in the biggest economiesin the EU (as it is in the US).

In such situations, governments should use compulsory licenses. These are textbook caseswhere instead of cutting back the right to health of EU citizens, governments should use theexisting legal tools in their laws to balance the impact of patent rights of multinationals.Granting compulsory licenses would allow them to authorize local production or importation

4 See the guidelines about the payment of royalties published by the World Health Organisationhttp://www.who.int/hiv/amds/WHOTCM2005.1_OMS.pdf

http://www.who.int/hiv/amds/WHOTCM2005.1_OMS.pdf





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of generic versions of the medicines patients’ needs. The reintroduction of competition on themarket would bring the prices down in a very significant way.

Researchers showed that the cost to produce and sell new hepatitis C treatments could be lessthan €150 for a combination (Hill, 20145, 2016). Generic producers in different countries are

producing some of these treatments already (India, Egypt, Morocco, Argentina, Thailand,etc). The prices are dropping constantly; at the end of January 2016 the lowest price forsofosbuvir was USD108 for a 3 months treatment6. Between €150 and €50.000, compulsory

licenses would allow to reach a price that is acceptable and that health systems can cover.Meanwhile, the owner of the patent would get royalties, as prescribed by the law: a

percentage of the sales of the generic product. It is a better option for public interest thatgovernment use their sovereign rights to ensure access than to have individuals trying to findsolution at their level (as people are doing now in Australia or the UK, getting access toIndian generics through buyers' clubs7).

*When there is a patent monopoly on essential medicines and it is impossible to find an

agreement with the patent holder on a reasonable price, governments have the responsibilityto use the available legal tools to authorize the production, importation and marketing ofgeneric versions. The European commission should assist the Member States in doing so.Breaking the trend of extremely high prices using compulsory license would rebalance therelationship and negotiations between governments and industries. It would also be a way to

bring multinationals to be more reasonable about what they ask.

5 See: http://www.hepcoalition.org/advocate/advocacy-tools/article/minimum-costs-to-produce-

hepatitis?lang=en6 See: https://testandtreathepatitisc.files.wordpress.com/2014/11/31-jan-2016-indian-generic-sofosbuvir.pdf7 See, for instance, Fix HepC: http://fixhepc.com/



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Note de cadrage sur les licences obligatoires en Europe

Les nouveaux traitements contre l'hépatite C sont le premier cas de mobilisation de l'opinion public à travers l'Europe à propos de prix scandaleux et de problèmes d'accès et derationnement. Mais il y en aura d'autres, pour d'autres pathologies, parce que cela illustreune tendance, qui ne pourra être inversée simplement en invoquant de meilleuresnégociations avec l'industrie pharmaceutique.

L'un des rares actions efficaces que les gouvernements puissent entreprendre est d'utiliserune disposition légale dont chacun dispose dans sa loi – les licences obligatoires – pour

suspendre les droits exclusifs accordés par le brevet et permettre l'importation ou la production locale de générique.Cette note expose de quelle façon les demandes de recours aux licences obligatoires peuventêtre formulées par la société civile de façon à répondre à la crise suscitée par les

médicaments contre l'hépatite C (et possiblement de certains anticancéreux extrêmementcouteux). Elle rassemble également les dispositions légales des 28 États membres de l'Unioneuropéenne en matière de licences obligatoires, assorties de commentaires sur des élémentsau sein de ces dispositions qui sont singuliers, particulièrement utiles dans le cadre del'octroi de licence obligatoire pour permettre l'accès aux médicaments ou au contraire trèsrestrictifs.

Contexte légal

Une licence obligatoire est une disposition légale prévue par l'article 31 de l'accord sur les

aspects des droits de propriété intellectuelle liées au commerce (ADPIC) de l'Organisationmondiale du commerce (OMC).

Elle permet à un État souverain d'autoriser un tiers ou une entité étatique à utiliser un brevetsans l'accord du détenteur de brevet. En d'autres termes, elle suspend les droits de monopoleque l'autorité nationale (office des brevets) a donné au détenteur de brevet en lui accordantcelui-ci. Cependant, elle n'enfreint pas ni n'annule le brevet.

Comme c'est le cas des brevets, les licences obligatoires peuvent s'appliquer à n'importe queltype d'invention, dans n'importe quel champ technologique. Dans le domaine pharmaceutique,elles peuvent s'appliquer à des brevets sur des produits ou sur un processus de fabrication. Il

existe déjà quelques exemples d'utilisation des licences obligatoires dans le domaine de la santéen Europe.8

Les licences obligatoires sont souvent désignées comme des "flexibilités" de l'accord ADPIC parce qu'elles introduisent la possibilité de limiter ou d'outrepasser des droits exclusifs. Cetteoption a attiré l'attention publique dans le cadre des conflits au niveau des institutionsinternationales sur l'accès aux médicaments contre le sida à la fin des années 1990 et au débutdes années 2000. Les pays du Sud ont alors obtenu l'adoption d'une déclaration à l'OMC appelée"ADPIC et santé publique" (aussi connue comme "la déclaration de Doha"), qui clarifie le fait

8 For examples of compulsory licensing use, see KEI Research Note: Recent European Union CompulsoryLicenses. March 1, 2014.









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que "chaque État a le droit d'octroyer des licences obligatoires et la liberté de déterminer surquelles bases ces licences sont octroyées".9

Ces licences sont appelées "obligatoires" précisément par ce qu'elles sont imposées par lesautorités nationales (par opposition aux licences volontaires qui sont accordées par le détenteurde brevet). Mais, comme dans le cas de licences volontaires, des redevances sont payées audétenteur de brevet.10

La possibilité des licences obligatoires existe dans toutes les lois européennes. L'utilisation decette disposition par les États individuels est déterminée par des conditions et des spécificités

prévues par la loi nationale. Celle-ci établit de quelle façon une licence obligatoire peut êtreaccordée : sur quelles bases, dans quelles circonstances une demande peut être posée auprèsdes autorités, s'il s'agit d'une simple décision administrative ou de la décision d'une cour, quiest le ministre qui a le pouvoir d'accorder une licence obligatoire, etc. Selon les langues, les

traditions juridiques ou l'objectif de la licence différents noms sont utilisés dans les loisnationales pour se référer aux licences obligatoires : licences non volontaires, licence noncontractuelles, licences d'office, licences pour l'usage gouvernemental, licences pour le secteur

public, licences d'utilisation par la Couronne, etc.

Il existe des différences entre les dispositions des différents États membres de l'UE. Certaineslois sont plus flexibles et ouvertes que d'autres, ou au contraire, plus restrictives que lesstandards établis par l'OMC.

Une licence obligatoire n'est valide que sur le territoire du pays où elle a été accordée et sert principalement à répondre au besoin du marché national.

L'utilisation des licences obligatoires pour répondre à des problèmes d'accessibilité en Europe

La question de l'accessibilité à des médicaments récents contre des pathologies mortellesémerge comme un problème dans un nombre croissant de pays européens.

Le lancement du sofosbuvir, un nouveau traitement contre l'hépatite C, a ouvert un débat publicsur les prix excessifs des médicaments et leur impact sur l'accessibilité. Ce médicament estvendu en Europe par la firme pharmaceutique Gilead qui en détient les brevets entre 20 000 €

et 50 000 € par patient pour 12 semaines de traitement. Le prix du traitement – une combinaisonde 2 ou 3 médicaments dont le sofosbuvir – peut dépasser 70 000 € par mois, ce qui est

inacceptable tant moralement qu'économiquement.

Mais le traitement contre l'hépatite C n'est pas un cas isolé. Il illustre une tendance. Durant les10 dernières années, le prix des nouveaux médicaments a augmenté dramatiquement. Des

problèmes similaires émergent avec différents types de médicaments contre des maladiesgraves, par exemple des cancers, avec un prix par médicament (indépendamment des autrescouts des soins) proche ou supérieur à 100 000€ par patient e t par an. De tels prix représententune charge insurmontable pour les systèmes de sécurité sociale en Europe et conduit

9 Voir le texte de la déclaration : https://www.wto.org/french/thewto_f/minist_f/min01_f/mindecl_trips_f.htm10 Voir les recommandations sur le paiement des redevances publiées par l'Organisation mondiale de la santé(OMS) : http://www.who.int/hiv/amds/WHOTCM2005.1_OMS.pdf







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progressivement les gouvernements à des politiques de rationnement. Ceci est vrai dans les pays faisant face à de fortes crises financières et économiques, mais aussi aux plus grandeséconomies européennes (comme c'est aussi le cas aux États-Unis).

Dans de telles situations, les gouvernements devraient avoir recours aux licences obligatoires.

Il s'agit de cas d'école où au lieu de rogner sur les droits à la santé des citoyens européens, lesgouvernements devraient utiliser les outils juridiques existant dans leurs lois pourcontrebalancer l'impact des droits des brevets des multinationales. Accorder des licencesobligatoires leur permettrait d'autorité la production locale ou l'importation de versionsgénériques des médicaments dont les malades ont besoin. La réintroduction d'une compétitionsur le marché permettrait alors de faire baisser les prix très significativement.

Des chercheurs ont montré que le cout de production et de vente des nouveaux traitementscontre l'hépatite C pouvait être de moins de 150€ pour une combinaison (Hill, 201411, 2016).Des producteurs de génériques dans différents pays produisent déjà certains de cesmédicaments (Inde, Égypte, Maroc, Argentine, Thaïlande, etc.). Les prix baissent en

permanence ; à la fin du mois de janvier 2016 le prix le plus bas pour le sofosbuvir était de 108$US pour trois mois de traitements12. Entre 150€ et 50 000€, les licences obligatoires pourraient permettre d'atteindre un prix acceptable que les systèmes de santé puissent couvrir. Dans lemême temps, le détenteur du brevet recevrait des redevances, comme prescrit par la loi : un

pourcentage des ventes du produit générique. L'utilisation par les États de leurs droitssouverains est une meilleure option pour servir l'intérêt général et assurer l'accès auxmédicaments que de voir les individus essayer de trouver des solutions à leur niveau (commeles gens le font actuellement en Australie ou au Royaume-Uni, par exemple, en accédant auxgénériques indiens au travers de buyers' clubs13).

*

Lorsqu'il y a un monopole du aux brevets sur des médicaments essentiels et qu'il est impossiblede trouver un accord avec le détenteur du brevet sur un prix raisonnable, les gouvernements ontla responsabilité d'utiliser les outils légaux existant pour autoriser la production locale oul'importation et la mise sur le marché de génériques. La Commission européenne devrait assisterles États membres dans cette voie. Rompre la tendance qui conduit à avoir des prix extrêmementélevés en utilisant les licences obligatoires rééquilibrerait la relation et les négociations entreles gouvernements et les industriels. Ce serait un moyen d'amener les multinationales à devenir

plus raisonnables vis-à-vis de ce qu'elles exigent.

11 See: http://www.hepcoalition.org/advocate/advocacy-tools/article/minimum-costs-to-produce-

hepatitis?lang=en12 See: https://testandtreathepatitisc.files.wordpress.com/2014/11/31-jan-2016-indian-generic-sofosbuvir.pdf13 See, for instance, Fix HepC: http://fixhepc.com/



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Austria

Current law: Patents Act 1970 (as last amended by Federal Law Gazette (BGBl) I No.135/2009) See: http://www.patentamt.at/Media/PatG_englisch.pdf

Provisions CommentsCompulsory Licenses36.(1) If a patented invention cannot be exploited withoutviolating an invention patented with a better priority(earlier patent), the patentee of the later patent shall beentitled to a non-exclusive license to the earlier patent,if the invention protected by the later patent constitutes

an important technical progress of considerableeconomic significance compared with the invention protected by the earlier patent.If such a license is granted, the patentee of the earlier

patent shall also be entitled to a non-exclusive license tothe later patent.

(2) If a plant breeder cannot acquire or exploit a plantvariety right without infringing an invention patentedwith a better priority (earlier patent), he shall be entitledto a non-exclusive license to the patent, if the plant

variety constitutes a significant technological progressof considerable economic interest compared with theinvention protected by patent, and if such a license isrequired to exploit the plant variety to be protected.

(3) If the owner of a patent concerning a biotechnological invention is granted a non-exclusivelicense to a plant variety protected by a plant varietyright granted with a better priority (earlier plant varietyright), because he cannot exploit the biotechnologicalinvention without infringing an earlier plant variety

right, the owner of the earlier plant variety right shall beentitled to a non-exclusive license to the later patent toexploit the protected invention.

(4) If a patented invention is not worked to anadequate extent in Austria – working of the inventionmay also be effected by imports – and if the patenteehas not under taken everything necessary for suchworking, anyone shall be entitled to a non-exclusivelicense to work the patent for the purposes of his

business, unless the patentee proves that the workingof the invention in Austria cannot reasonably be

• The text states explicitly thatworking of the invention coversimportation.• A CL as defined by section 36 (4)can only be granted “four years

from the filing of the application orthree years from the announcement



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expected at all or on a larger scale than actuallyeffected due to the difficulties opposing such working.

(5) If the grant of a license to a patented invention is inthe public interest, anyone shall be entitled to a non-

exclusive license to the invention for purposes of his business. The respective entitlement of the federaladministrative authorities, however, shall not bebound to any business.

of the grant of the patent" (Art37.2).

• A Federal administrativeauthority can grant a non-exclusivelicense to anyone to serve the

public interest.

37.(1) If the person entitled to grant a license pursuant tosection 36 refuses to grant such a license, although thelicense applicant has taken efforts to obtain hisauthorization within a reasonable period of time andon reasonable commercial terms and conditions, the

Patent Office, on request of the license applicant, shalldecide in accordance to the procedural provisions

provided for the contestation of patents. In case alicense is granted, an adequate compensation shall bedetermined, wherein the economic value of the licenseis to be taken into consideration. The security, ifnecessary, as well as the other conditions of use shall bedetermined considering the nature of the invention and the circumstances of the respective case.The extent and the duration of the license according tosection 36 shall predominantly be granted for thesupply of the Austrian market and shall be limited tothe purpose requiring the license. In the case ofsemiconductor technology, the license shall only begranted for public noncommercial use or to remedy a

practice determined after judicial or administrative process to be anti-competitive.

(2) The grant of a license pursuant to section 36 (4)shall not be applied for until four years from the filingof the application or three years from the

announcement of the grant of the patent for whichthe license is sought, whichever period expires last.

(3) The requirement to obtain the authorization fromthe person entitled to grant a license may bedisregarded in the case of section 36 (5) in the case ofa national emergency or other circumstances ofextreme urgency. In this case, a preliminary

permission to use the invention shall be granted by wayof an interim decision.

(4) A license granted pursuant to subsection 1 shall beterminated upon request, subject to adequate protection

• There is a requirement for priorrequest to the patent holder forauthorization to use the patent.

• The Patent Office is the

administration in a position to grand compulsory licenses.

• In case of a license granted in the

public interest, this requirement iswaived in case of nationalemergency of other circumstancesof extreme urgency. This is morerestrictive than TRIPS.



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of the legitimate interests of the persons so authorized,if and when the circumstances which led to it cease toexist and are unlikely to recur. The Patent Office shalldecide on this request in accordance to the procedural

provisions provided for the contestation of patents.

(5) In proceedings concerning the grant or thetermination of licenses according to section 36 (2) and(3) a technically qualified member has to belong toevery Senate of the Nullity Department and atechnically qualified and a legally qualified member toevery Senate of the Supreme Patent and TrademarkChamber, who are nominated according to section 20(3) of the Law on the Protection of Plant Varieties 2001,Federal Law Gazette I No. 109, upon proposal of theFederal Minister for Agriculture, Forestry, Environment

and Water Management in agreement with the FederalMinister for Transport, Innovation and Technology.



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Belgium

Current law: Patents Act 1970 (as last amended by Federal Law Gazette (BGBl) I No.135/2009) See: http://www.patentamt.at/Media/PatG_englisch.pdf

Provisions CommentsArt. 31.§ 1er. Le Ministre peut octroyer, conformément auxarticles 32 à 34, une licence d'exploitation d'uneinvention couverte par un brevet :1° lorsqu'un délai de quatre années à compter de la

date de dépôt de la demande de brevet, ou de trois

années à compter de la délivrance du brevet, le délaiqui expire le plus tard devant être appliqué, s'est écoulésans que l'invention brevetée soit exploitée par

(importation ou) une fabrication sérieuse et continueen Belgique et sans que le titulaire du brevet justifie

son inaction par des excuses légitimes.Dans le cas d'un brevet ayant pour objet une machine, lafabrication sérieuse et continue en Belgique par letitulaire du brevet de produits obtenus à l'aide de cettemachine peut être considérée comme valant exploitationde l'invention brevetée en Belgique lorsque cette

fabrication apparait comme plus importante pourl'économie du pays que celle de la machine elle-même.Une licence obligatoire pour défaut ou insuffisance

d'exploitation ne sera accordée qu'à condition que lalicence soit octroyée principalement pourl'approvisionnement du marché national.

2° lorsqu'une invention, couverte par un brevetappartenant au demandeur de la licence, ne peut êtreexploitée sans porter atteinte aux droits attachés à un

brevet issu d'un dépôt antérieur et pour autant que le

brevet dépendant permette un progrès techniqueimportant, d'un intérêt économique considérable,

par rapport à l'invention revendiquée dans le brevetdominant et à condition que la licence soit octroyée

principalement pour l'approvisionnement dumarché national.Dans le cas de la technologie des semi-conducteurs telleque définie dans la directive 87/54 du Conseil du 16décembre 1986, les licences visées au 1° et au 2° du

présent paragraphe ne peuvent être accordées que sielles sont destinées à remédier à une pratique dont il aété déterminé, à l'issue d'une procédure judiciaire ouadministrative, qu'elle est anticoncurrentielle;

• Article 31 concerns licenses thatare granted by a Minister.



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3° lorsqu'un obtenteur ne peut obtenir ou exploiter undroit d'obtention végétale sans porter atteinte à un

brevet antérieur, dans la mesure où cette licence estnécessaire pour l'exploitation de la variété végétale à

protéger et pour autant que la variété représente un progrès technique important d'un intérêt économiqueconsidérable par rapport à l'invention revendiquée dansle brevet et a condition que cette licence soit octroyée

principale ment pour l'approvisionnement du marchénational;

4° au titulaire d'un droit d'obtention végétale, lorsque letitulaire d'un brevet concernant une invention

biotechnologique a, conformément aux dispositions dela loi sur la protection des obtentions végétales, obtenu

une licence obligatoire pour l'exploitation non-exclusivede la variété végétale protégée par ce droit d'obtentionvégétale parce qu'il ne peut exploiter l'invention

biotechnologique sans porter atteinte à ce droitd'obtention végétale antérieur et à condition que cettelicence soit octroyée principalement pourl'approvisionnement du marché national.

§ 2. Le demandeur de la licence doit établir :1) dans les cas visés au paragraphe précédent :a) que le titulaire du brevet tombe sous l'application del'une de ces dispositions;

b) qu'il s'est vainement adressé au titulaire du brevet

pour obtenir une licence à l'amiable;

2) en outre, si la licence est réclamée par application du1° du paragraphe précédent, qu'il disposerait, dansl'hypothèse où la licence lui serait octroyée, des moyens

nécessaires pour assurer une fabrication sérieuse etcontinue en Belgique d'après l'invention brevetée.

§ 3. Toute action en contrefaçon d'une inventioncouverte par un brevet dont une licence obligatoire estdemandée et intentée contre le demandeur d'une tellelicence suspend la procédure d'octroi de la licence

jusqu'au moment où le jugement ou l'arrêt acquiert forcede chose jugée. Si la contrefaçon est établie, la demandede licence obligatoire est rejetée.

§ 4. Est réservée l'application des lois prévoyantl'octroi de licences d'exploitation d'inventions brevetéesen des matières spéciales, notamment la défense

nationale et l'énergie nucléaire.

• To request a CL one first need totry to obtain a voluntary license

from the patent holder.

• The license seems to be only possibly granted to allow local production (and not importation).This is incredibly restrictive.



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Art. 31bis.§ 1er. Dans l'intérêt de la santé publique, le Roi peut,

par arrêté délibéré en Conseil des ministres, octroyerune licence d'exploitation et d'application d'uneinvention couverte par un brevet pour :

a) un médicament, un dispositif médical, un dispositifmédical ou un produit de diagnostic, un produitthérapeutique dérivé ou à combiner;

b) la méthode ou le produit nécessaire pour la production d'un ou plusieurs produits mentionnés sousa);c) une méthode de diagnostic appliquée en dehors ducorps humain ou animal.

§ 2. Le demandeur de la licence obligatoire doit établirqu'il dispose, dans le cas où la licence obligatoire lui

serait octroyée, des moyens ou de l'intention loyaled'obtenir les moyens qui sont nécessaires pour la

fabrication et/ou l'application sérieuse et continue enBelgique de l'invention brevetée.

§ 3. Toute procédure concernant une action encontrefaçon d'une invention couverte par un brevet pourlequel une licence obligatoire pour des raisons de santé

publique a été demandée et qui est intentée contre ledemandeur d'une telle licence, est suspendue en ce quiconcerne la question de la contrefaçon jusqu'au momentoù une décision concernant la licence obligatoire est

prise par le Roi conformément au § 1er.

§ 4. Les licences octroyées en application du présentarticle ne sont pas exclusives.

§ 5. La licence obligatoire peut être limitée dans letemps ou en ce qui concerne son champ d'application.

§ 6. Le demandeur d'une licence obligatoire soumet

sa demande au ministre et adresse une copie de celle-ci au Comite consultatif de Bioéthique. Le ministre transmet la demande dans un délai de dix

jours au Comité consultatif de Bioéthique. Durant lemême délai, le ministre informe le titulaire du brevet qui fait l'objet d'une demande de licence obligatoire, ducontenu de la demande et l'invite à faire connaître sonpoint de vue concernant l'octroi possible d'une licenceobligatoire ainsi que ses observations relatives à unerémunération raisonnable au cas où une licenceobligatoire serait accordée, dans un délai d'un mois au

Comité consultatif de Bioéthique avec une copie à lui-même.

• A special provision concerns public health, and mentionsmedicines. In such a case a licensecan be granted by the King with adecision of the council of the

Ministers.



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Le Comité consultatif de Bioéthique soumettra auministre un avis motivé et non contraignant sur le

bien-fondé de la demande.Dans un délai de trois mois après réception de l'avisdu Comité consultatif de Bioéthique, le ministre

soumettra, pour délibération au Conseil desministres, un projet d'arrêté royal motivé sur le bien-fondé de la demande. Le ministre soumettra égalementune proposition de rémunération pour le titulaire du

brevet.Si le Roi décide, conformément au § 1er, d'octroyer lalicence obligatoire, Il déterminera le cas échéant, par

arrêté délibéré en Conseil des ministres, la durée, lechamp d'application et les autres conditionsd'exploitation de cette licence. Les conditionsd'exploitation fixent également la rémunération

afférente à l'exploitation de l'invention brevetée durantla procédure d'octroi de la licence.En cas de crise de santé publique et sur propositiondu ministre ayant la santé publique dans sesattributions, le Roi peut, par arrêté délibéré enConseil des Ministres, prendre des mesures en vued'accélérer la procédure mentionnée dans le présent

paragraphe. Il peut, le cas échéant, prévoir que l'avis

du Comité consultatif de Bioéthique ne doit pas êtreobtenu, afin d'accélérer la procédure de prise d'octroide licence.Les décisions prises dans le cadre des procédures viséesaux alinéas précédents seront publiées au Moniteur

belge et mentionnées au Recueil.La licence obligatoire produit ses effets à compter du

jour de l'exploitation et au plus tôt à dater de lademande de la licence obligatoire.

§ 7. Une rémunération raisonnable doit être versée par le demandeur de la licence pour l'utilisation del'invention brevetée durant la période entre la demande

de licence obligatoire pour des raisons de santé publique et l'arrêté royal qui octroie lalicence obligatoire. Dans ce cas, le Roi fixe le montant

de la rémunération, par arrêté délibéré en Conseildes ministres.

§ 8. Dès l'octroi de la licence obligatoire, les rapportsentre le titulaire du brevet et le licencié sont assimilés,sauf dérogations décidées en vertu du § 6, à ceuxexistant entre un concédant et un licencié contractuels.

§ 9. L'octroi de la licence obligatoire, ainsi que lesdécisions s'y rapportant, sont inscrites au Registre.

• Art. 31bis. § 6. was addedrecently. It establishes that in thecase of a public health crisis, andon a proposal from the Minister of

public health, the King can,through a decision taken with theCouncil of Ministers, speed the

procedure. In particular, this cantake away the requirement for theopinion of the ConsultativeCommittee on Bioethics.

• The King, through a decisiontaken with the Council of Ministers,

set the remuneration.



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§ 10. Pour autant que des éléments nouveaux soientintervenus, le Roi peut, par arrêté délibéré en Conseildes Ministres, à la requête du titulaire du brevet ou dulicencié et conformément aux procédures prévues par le

§ 6, procéder à la révision de ce qui a été décidé en cequi concerne leurs obligations réciproques et, le caséchéant, les conditions d'exploitation.

§ 11. A la demande de tout intéressé et après avoir ànouveau pris connaissance de l'avis du Comitéconsultatif de Bioéthique, le Roi peut, par arrêtédélibéré en Conseil des Ministres, retirer la licenceobligatoire octroyée pour des raisons de santé publiquesi, après l'expiration du délai fixé pour l'exploitation, lelicencié n'a pas exploité en Belgique l'invention

brevetée par une fabrication sérieuse et continue.L'arrêté de retrait est publié par extrait au Moniteur

belge et mentionné au Recueil.

§ 12. Les articles 31, 32 à 38 ne s'appliquent pas à lalicence obligatoire visée au présent article. Lesdispositions du présent article ne s'appliquent pas

aux licences obligatoires visées par les articles 31, 32à 38.Art. 31ter.§ 1er Sans préjudice du § 2, le Roi est l'autoritécompétente au sens de l'article 2.4. duRèglement (CE) N° 816/2006 du Parlement européen etdu Conseil du 17 mai 2006 concernant l'octroi delicences obligatoires pour des brevets visant lafabrication de produits pharmaceutiques destinés àl'exportation vers des pays connaissant desproblèmes de sante publique.Les décisions relatives à l'octroi, à la révision, au rejetet au retrait d'une licence obligatoire sont prises pararrêté délibéré en Conseil des ministres.

§ 2. Le Roi peut désigner les autorités belgescompétentes pour mettre en œuvre les articles 6.1., 7,

14, 16.1., alinéa 2, 16.3. et 16.4. du Règlement (CE) N°816/2006.

§ 3. Le Roi est habilité à fixer des exigences purementformelles ou administratives nécessaires pour letraitement efficace des demandes de licence obligatoirevisées par le Règlement (CE) N° 816/2006.

• New article regarding the

exportation under CL.



18 / 141

§ 4. Les articles 31, 31bis et 32 à 38 ne s'appliquent pasà la licence obligatoire visée au présent article. Lesdispositions du présent article ne s'appliquent pas auxlicences obligatoires visées aux articles 31, 31bis et 32 à38.

Art. 32. § 1er. Les licences obligatoires octroyées parapplication de l'article 31 ne sont pas exclusives.

§ 2. Sans préjudice du deuxième alinéa du 1° du § 1erde l'article 31, la licence octroyée par application dudit1°, du § 1er, ne confère au licencié que le droitd'exploiter l'invention brevetée par fabricationsérieuse et continue en Belgique. Le Ministre fixe ledélai dans lequel une telle fabrication doit être réalisée,cette fabrication impliquant l'application intégrale du

procédé éventuellement revendiqué dans le brevet.

La licence obligatoire peut être limitée dans le temps ouà une partie seulement de l'invention lorsque celle-ci

permet la réalisation d'autres fabricants que ceux requis pour satisfaire les besoins dont question à l'article 31, §1er.Dès l'octroi de la licence obligatoire, les rapports entrele titulaire du brevet et le licencié sont assimilés, saufdérogations prévues par l'arrêté de l'octroi, à ceuxexistant entre un concédant et un licencié contractuels.

§ 3. La licence octroyée par application de l'article 31, §1er, 2°, est limitée à la partie de l'invention couverte parle brevet dominant dont l'utilisation est indispensable

pour l'exploitation de l'invention brevetée dépendante etne permet cette utilisation qu'en liaison avec laditeexploitation.Le troisième alinéa du § 2 du présent article estapplicable à la licence obligatoire.Le titulaire du brevet auquel la licence obligatoire estimposée peut, si les deux inventions se rapportent aumême genre d'industrie, se faire octroyer à son tour une

licence du brevet dont le demandeur de la licenceobligatoire s'est prévalue.

§ 4. La licence octroyée en application de l'article 31, §1er, 3° ou 4°, est limitée à la partie de l'inventioncouverte par le brevet dominant dont l'utilisation estindispensable pour l'exploitation de l'invention brevetéedépendante ou de la variété protégée par le droitd'obtention végétale dépendante et ne permet cette utilisation qu'en liaison avec ladite exploitation.Le troisième alinéa du § 2 du présent article est

applicable à la licence obligatoire octroyée enapplication de l'article 31, § 1er, 3° ou 4°.

• Compulsory licenses can only

allow production in Belgium. This

is a serious limitation, not required

by WTO.



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Art.33. § 1er. Dans les cas visés à l'article 31,§ 1er, le Ministre octroie les licences obligatoires surrequête.

§ 2. La requête est transmise par le Ministre à la

Commission des licences obligatoires afin que celle-cientende les intéresses, les concilie s'il se peut et, dans lecas contraire, lui donne un avis motivé sur le bien-fondéde la demande. La Commission joint à son avis ledossier de l'affaire.Le Ministre décide de la suite à réserver à la requête etnotifie sa décision aux intéressés par lettrerecommandée à la poste.

§ 3. (Dans les cas visés à l'article 31, § 1er, 2° et 3°, lademande de licence obligatoire est déclarée fondée si

le titulaire du brevet dominant ne conteste ni ladépendance du brevet ou du droit d'obtention végétaledu demandeur de la licence, ni sa validité, ni le fait quel'invention ou la variété permet un progrès techniqueimportant, d'un intérêt économique considérable, parrapport à l'invention revendiquée dans le brevet.) <L2005-04-28/33, art. 15, 006; En vigueur : 23-05-2005>

§ 4. Le fait pour le titulaire du brevet antérieur de nier ladépendance du brevet ou du droit d'obtention végétaledu demandeur de la licence emporte de plein droit pource dernier l'autorisation d'exploiterl'invention décrite dans son propre brevet ou dans sondroit d'obtention végétale ainsi que l'invention ditedominante sans pouvoir de ce chef être poursuivi encontrefaçon par le titulaire du brevet antérieur.La contestation de la validité du brevet ou du droitd'obtention végétale dépendant suspend la procédureadministrative relative à la reconnaissance du bien-fondé de la demande de licence, à condition, soit qu'une

action en nullité dudit brevet ou droit d'obtentionvégétale soit déjà introduite devant l'autoritécompétente par le titulaire du brevet dominant, soit quecelui-ci cite le demandeur de la licence devant letribunal dans les deux mois de la notification qui lui aété faite du dépôt de la demande de licence.La contestation du progrès technique important, d'unintérêt économique considérable du brevet ou du droitd'obtention végétale dépendant par rapport à l'inventiondécrite dans le brevet dominant suspend la procédureadministrative relative à la reconnaissance du bien-

fondé de la demande de licence, à condition que

• Article 33 concerns licenses

granted upon request by third

parties by a Minister.



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le titulaire du brevet dominant introduise, dans les deuxmois de la notification qui lui a été faite du dépôt de lademande de licence, une requête au tribunal siégeantcomme en référé. La décision judiciaire n'est passusceptible d'appel ou d'opposition.

L'inobservation du délai prévu aux deux alinéas précédents entraîne forclusion du droit du titulaire du brevet dominant de faire valoir sa contestation devant letribunal.Art.34. § 1er. Dans les quatre mois de la notification dela décision, le titulaire du brevet et le demandeur delicence concluent une convention écrite concernantleurs droits et leurs obligations réciproques. LeMinistre en est informé. À défaut d'une convention dansle délai susvisé, les droits et les obligations réciproquesseront fixés par le tribunal siégeant comme en référé,

sur citation de la partie la plus diligente.Une copie du jugement définitif est immédiatementtransmise au Ministre par le greffier.La fixation des obligations des parties comprendra entout cas une rémunération adéquate compte tenu de lavaleur économique de la licence.

§ 2. Le Ministre octroie la licence par un arrêté motivé.La licence obligatoire et les décisions s'y rapportantsont inscrites au Registre.L'arrêté est publié au Moniteur belge et mentionné auRecueil.

• In article 34 and the following,

the law goes in all the practical

details of the implementation of

compulsory licensing.

Art.35. § 1er. Il est institué au sein du Conseil central del'économie une Commission des licences obligatoires qui a pour mission d'accomplir les tâches qui lui sontdévolues par les articles 33, 36, 37 et 38.La Commission est composée outre le président, de huitmembres nommés par le Ministre.Six membres sont désignés en nombre égal sur

proposition :a) d'une part, des organisations représentatives de

l'industrie, de l'agriculture, du commerce et despetites et moyennes entreprises industrielles; b) d'autre part, des organisations représentatives destravailleurs et des coopératives de consommation.Deux des trois membres désignés par chacun desgroupes repris sous les litteras a) et b) ci-dessus doiventêtre membres du Conseil central de l'économie.Deux membres sont désignés, sur proposition conjointedes groupes repris sous les litteras a) et b) ci-dessus,

parmi les membres du Conseil supérieur de la propriétéindustrielle.

• A Committee for Compulsory

licenses has been established within

the Central Council of Economy

and is in charge of enacting articles

33, 36, 37 and 38. It seems that the

granting of CL under article 31 is

dealt with by the Committee.



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La Commission compte autant de membres suppléantsque de membres effectifs. Seul le membre suppléantremplaçant un membre effectif de son groupe a voixdélibérative.La Commission est présidée par le Président du Conseil

central de l'économie. En cas d'empêchement de cedernier, la présidence est assurée par le secrétaire duConseil, qui est également secrétaire de la Commission.Le président a voix délibérative.Le secrétariat de la Commission est assuré par lesecrétariat du Conseil central de l'économie.Le mandat de membre de la Commission est d'unedurée correspondante à celle du mandat des membresdu Conseil central de l'économie; il prend fin en mêmetemps que le mandat de ces derniers. Il est renouvelable.Lorsque le Conseil pourvoit au remplacement d'un

membre effectif ou suppléant, la personne nomméeachève le mandat de son prédécesseur.La Commission établit elle-même son règlement d'ordreintérieur qui est soumis à l'approbation du Conseilcentral de l'économie.La Commission ne peut délibérer valablement que si lamoitié au moins des membres sont présents. Toutefois,après une deuxième convocation, la Commissiondélibère valablement quel que soit le nombre desmembres présents. Les avis et décisions sont pris à lamajorité simple des voix. En cas de parité, la voix du

président est prépondérante.Les avis et décisions de la Commission sont motivés.

§ 2. Le Roi nomme auprès de la Commission deslicences obligatoires, parmi les membres des parquetsdes cours et tribunaux en fonction depuis au moins cinqans, un commissaire-rapporteur, ainsi que deuxcommissaires adjoints qui exercent la même missionsous la surveillance et la direction du commissaire-rapporteur.

Leur mandat est de cinq ans; il est renouvelable.Le Roi fixe le montant des jetons de présence et desindemnités de vacation alloués au commissaire-rapporteur et aux commissaires-rapporteurs adjoints,ainsi qu'éventuellement leurs indemnités pour frais devoyage et de séjour.Le commissaire-rapporteur recueille tousrenseignements, reçoit toutes dépositions ou toustémoignages écrits ou oraux, se fait communiquer, quelqu'en soit le détenteur, tous documents ou élémentsd'information qu'il estime nécessaires à

l'accomplissement de sa mission, procède sur place aux



22 / 141

constatations nécessaires, commet des experts dont ildétermine la mission.Il dispose dans les limites ci-après précisées du droit de

perquisition. Il a le libre accès aux locaux et lieux où ila des raisons de croire qu'il trouvera des documents

ou éléments d'information qu'il estime nécessaires àl'accomplissement de son instruction.Il ne peut saisir sauf sur place, ni apposer des scellés.Il ne peut procéder à des perquisitions dans lesappartements privés qu'au domicile des chefsd'entreprise, administrateurs, gérants, directeurs etcomptables et qu'entre le lever et le coucher du soleil. Ildoit être accompagné d'un des agents del'État désigné par le Roi.Dans l'accomplissement de sa mission, il peut requérirles agents de la force publique.

Sans préjudice des lois particulières qui garantissent lesecret des déclarations, les administrations publiquessont tenues de prêter leur concours au commissaire-rapporteur dans l'exercice de sa mission, notamment decommuniquer tous les documents et élémentsd'informations qui leur seraient demandés.Le commissaire-rapporteur se fait assister dans lestâches d'information par des agents de l'État désignés àcette fin par le Roi.Dans l'exercice de leur mission d'information les agentscités à l'alinéa précédent sont habilités a réunir toutedocumentation propre à les éclairer. Ils peuvent, de

plus, entendre toutes les personnes qui sont à même deleur procurer des renseignements utiles.Toutefois, les perquisitions ne peuvent être faites que

par deux agents conjointement au moins et avecl'autorisation préalable du commissaire-rapporteur.Dans l'exercice des missions qui leur sont confiées parle commissaire-rapporteur, ces agents sont soumis à sasurveillance.

§ 3. Le commissaire-rapporteur dépose son rapport au secrétariat de la Commission des licencesobligatoires et y joint son avis. La Commission n'émetson avis qu'après avoir entendu le titulaire du brevetet, le cas échéant, la personne qui requiert ou a obtenul'octroi d'une licence obligatoire. Ces personnes peuventse faire assister ou représenter, soit par un avocat, soit

par une personne que la Commission agréespécialement dans chaque affaire. La Commissionentend également les experts et les personnes qu'elle juge utile d'interroger. Elle peut charger le

commissaire-rapporteur de procéder à un complémentd'information.



23 / 141

Un mois au moins avant la date de la réunion de laCommission, le secrétaire avise par lettre recommandéeà la poste les personnes qui doivent être entendues aucours de cette réunion. En cas d'urgence, le délai estréduit de moitié.

§ 4. Tous empêchements ou entraves volontaires àl'exercice de la mission confiée par la présente loi aucommissaire-rapporteur et aux agents cités au § 2,dixième alinéa, du présent article sont punis d'unemprisonnement de huit jours à trois mois et d'uneamende de 26 F à 10 000 F ou d'une de ces peinesseulement.Toute fausse déclaration est punie des mêmes peines.Sont considérés notamment comme empêchant ouentravant volontairement l'exercice de la mission ceuxqui :

1) refusent de fournir les renseignements ou decommuniquer les documents demandés;2) fournissent sciemment des renseignements ou desdocuments inexacts.Les dispositions du livre premier du Code pénal, sansexception du chapitre VII et de l'article 85, sontapplicables aux infractions visées par le présent

paragraphe.

§ 5. Les frais de fonctionnement de la Commission deslicences obligatoires sont à charge du budget du Conseilcentral de l'économie.Art.36. Pour autant que des éléments nouveaux soientintervenus, il peut être procédé, à la requête du titulairedu brevet ou du licencié, à la révision des décisions

prises en ce qui concerne leurs obligations réciproqueset, le cas échéant, les conditions d'exploitation. Lacompétence de révision appartient à l'autorité de qui ladécision émane et la procédure à suivre est la même quecelle qui est prévue pour conduire à la décision soumiseà révision.

Art.37. § 1er. À la demande du titulaire du brevet, leMinistre retire la licence obligatoire s'il résulte d'un jugement coulé en force de chose jugée que lelicencie s'est rendu coupable à l'égard du titulaire du

brevet d'un acte illicite ou qu'il a manqué à sesobligations.

§ 2. À la demande de tout intéressé, le Ministre peutretirer la licence obligatoire concédée pour défautd'exploitation si, à l'expiration du délai fixé par leMinistre pour l'exploitation, le licencié n'a pas assuré en

Belgique une exploitation de l'invention brevetée parune fabrication sérieuse et continue.



24 / 141

§ 3. Les décisions de retrait sont soumises par leMinistre, pour avis, à la Commission des licencesobligatoires.Le retrait fait l'objet d'une décision motivée. Celle-ci

mentionne le cas échéant la raison pour laquelle l'avisde la Commission n'a pas été suivi.L'arrête de retrait est publié par extrait au Moniteur

belge et mentionné au Recueil.Art.38. Le titulaire d'une licence obligatoire ne peuttransférer par cession ou sous-licence à des tiers lesdroits attachés à la licence qu'avec la partiede l'entreprise ou du fonds de commerce affectée àl'exploitation de la licence (et sous réserve queles licences octroyées par application de l'article 31, §1er, 2°, ne sont cessibles qu'avec le brevet dépendant).

L'article 45 est applicable par analogie.



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Bulgaria

Current law: Law on Patents and Utility Model Registration (as last amended 2012), inBulgarian only.See: http://www.wipo.int/wipolex/en/details.jsp?id=14120

Text available in English: Patent Law No. 27/2 of 1993 as last amended by Law No. 59/20of July 2007http://www.wipo.int/edocs/lexdocs/laws/en/bg/bg044en.pdf

Provisions CommentsArticle 32(1) Any person concerned, who has unsuccessfullytried to get a contractual license from the holder

under fair conditions, may request the Patent Office togrant him a compulsory license to use theinvention, provided that at least one of the followingconditions is met:1. failure to use the invention for a period of fouryears from filing of the patent application orthree years from the grant of a patent, the time limitwhich expires later being applicable;2. insufficient working of the invention to satisfy theneeds of the national market, within the time limitsset out in item 1 above, unless the patent owner gives

valid reasons therefor.

(2) The person requesting a license under the preceding paragraph shall be required to prove that he is in aposition to work the invention within the limits of thecompulsory license requested.

(3) Beyond the cases referred to in paragraph (1), acompulsory license may be granted, where demandedby the public interest, without negotiating with theholder of the right in the invention enjoying

patent protection.

(4) A compulsory license may be granted to a holder,whose invention is the subject matter of a later patentand is included in the scope of another, earlier patent, ifthe owner of the earlier patent refuses to grant a licenseunder fair conditions, where the subject matter of thelater patent represents significant technical progress ofgreat economic importance compared to the subjectmatter of the earlier patent.The owner of the earlier patent shall be entitled to across license under reasonable conditions for

• Requirement for prior request to

the patent holder for a voluntarylicense.• The Patent Office is the

administration in a position to grand compulsory licenses.• There is no government use typeof CL in the law.

• In case of a license granted in the public interest, the requirement for prior request to the patent holder

for authorization is waived.



26 / 141

working the invention claimed in the later patent.

(5) A compulsory license may only be non-exclusive. Itmay only be assigned together with the enterprise inwhich the licensed invention is being worked.

(6) A compulsory license may be terminated if withinone year of its grant the licensee has made no

preparation for working the invention. A compulsorylicense shall be terminated in all cases ifthe licensee fails to start working the invention withintwo years of grant.

(7) The scope of a compulsory license shall be determined by the purpose it was granted for.

(8) A compulsory license shall not be granted to aninfringer of the patent.

(9) Bilateral and multilateral treaties to which theRepublic of Bulgaria is a party may lay down furtherconditions for the grant of a compulsory license to

patent owners from States party to such treaties.

(10) The compulsory licensee shall owe thepatent owner remuneration.

(11) A compulsory license shall be terminated as soonas the ground therefore no longer exists.

(12) The procedure of granting and terminatingcompulsory licenses shall be specified in the Regulationreferred to in Article 55(3).Compulsory Cross-LicenseArticle 32a(1) Where a breeder cannot obtain or use the right in a

plant variety without infringing an earlier patent, he

may apply for a compulsory license for non-exclusiveuse of the invention enjoying patent protection, in so faras the license is required for using the plant variety forthe purposes of its legal protection, subject to the

payment of a respective remuneration. Where such alicense is granted, the patent owner shall be entitled to across-license for using the protected plant varietyunder fair conditions.

(2) Where the owner of a patent for a biotechnologicalinvention cannot use it without infringing an earlier

plant variety right, he may apply for a compulsorylicense for non-exclusive use of the protected



27 / 141

plant variety, subject to the payment of a respectiveremuneration. Where such a license is granted, the

protected variety owner shall be entitled to get a cross-license for using the invention under fair conditions.

(3) The person applying for the grant of a compulsorylicense according to paragraphs (1) and (2) shall provethat:

1. he has tried unsuccessfully to get a contractuallicense from the patent or plant variety owner;2. the plant variety or the invention representssignificant technical progress of great economicimportance compared to the patented invention orthe protected plant variety.

Compulsory LicenseArticle 74c

(1) A compulsory license shall be granted to a utilitymodel owner, where the utility model cannot be usedwithout infringing the right in another utility model theowner of which refuses to grant a license under fairconditions.

(2) A compulsory license shall be granted to a patentowner, where the invention according to the patentcannot be used without infringing the right in a utilitymodel the owner of which refuses to grant a licenseunder fair conditions.

(3) The compulsory license treatment under Article 32shall equally apply to registered utility models.



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Croatia

Current law: Patent Act and Acts on amending and supplementing the Patent Act (OGNos. 173/2003, 87/2005, 76/2007, 30/2009, 128/2010, 49/2011 & 76/2013) (2013) See: http://www.wipo.int/edocs/lexdocs/laws/en/hr/hr093en.pdf

Provisions Comments1. Common ProvisionsCOMPETENCE AND PROCEDURE FOR THEGRANT OF A COMPULSORY LICENCE

Article 67a(1) The Commercial Court in Zagreb shall becompetent to grant compulsory licences.

(2) The procedure for the grant of a compulsory licenceshall be instituted by a legal action against the ownerof a patent or a holder of a SupplementaryProtection Certificate, containing an application forthe grant of a compulsory licence. In the notice of legalaction, the plaintiff shall indicate all the facts and

present all the evidence, on which the application is based. The court shall decide on the grant of acompulsory licence by a judgment.

(3) The decisions of the court issued in the procedures

for the grant of a compulsory licence may be appealedin accordance with the rules laid down in the Act onCivil Proceedings.

(4) In the absence of proof to the contrary, it shall beconsidered that, in the procedure for the grant of acompulsory licence, the owner of a patent or the holderof a Supplementary Protection Certificate is the personwho is entered as such in the Register of Patents.

(5) The Act on Civil Proceedings shall apply to

particular matters relating to the procedure for the grantof a compulsory licence, not regulated by this Act.

2. Compulsory licences in the cases of insufficientexploitation of a patent, national emergencies, the needfor protection from unfair market competition,exploitation of another patent or protected plant variety,and cross-licensing.”

• The Commercial Court in Zagrebis competent to grant compulsorylicenses. The procedure is"instituted by a legal action against

the owner of a patent or a holder ofa Supplementary ProtectionCertificate".• There seems to be no possibility

for CL granted by administrativedecision or government use type ofCL in Croatia.

Article 68 - Grant of a compulsory licence(1) The competent court in the Republic of Croatia

may grant a compulsory license for lack orinsufficiency of exploitation of a patent to any person

• Compulsory licenses are granted

by an ad hoc court

http://www.wipo.int/wipolex/en/details.jsp?id=13252







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filing a request for the grant of a compulsory license, orto the Government of the Republic of Croatia, if the

patent owner has not exploited the invention protected by a patent in the territory of the Republic of Croatia onreasonable terms or has not made effective and

serious preparations for its exploitation.

(2) A request for the grant of a compulsory license based on paragraph (1) of this Article can be filed afterthe expiration of a period of four years from the filingdate of a patent application, or after the expirationof three years from the date the patent was granted.

(3) A compulsory license cannot be granted if the patentowner provides legitimate reasons to justify non-exploitation or insufficiency of exploitation of the

protected invention.

(4) Upon a reasoned request, the court may grant acompulsory license in respect of a first patent to theowner of a patent or to the owner of a plant variety rightwho cannot use his patent (second patent) or his plantvariety right without infringing the first patent, providedthat the invention claimed in the second patent or a

protected plant variety involves an important technicaladvance of considerable economic significance inrelation to the invention claimed in the first patent. Thecompetent court may take any measure it regards asuseful to verify the existence of such a situation.

(5) In the case of a compulsory license as provided in paragraph (4) of this Article, the owner of the first patent shall be entitled to a cross license on reasonableterms to use the invention protected by the second

patent or protected plant variety.

(6) The court may grant a compulsory license if the

exploitation of the patented invention is necessary insituations of extreme urgency (national security, public interest protection in the field of health, foodsupply, environmental protection and improvement,specific commercial interest) or when it is necessary toremedy a practice determined by a judicial oradministrative process to be anti-competitive.

(7) In the case of semi-conductor technology, acompulsory license may be granted only in the cases setout in paragraph 6 of this Article.

• Compulsory license granted bythe ad hoc court can apply to situation of extreme urgencyrelated to the field of health.



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(8) A compulsory license may be granted only if the person filing the request has made efforts to obtainauthorization from the patent owner on reasonablecommercial terms and conditions and if such effortshave not been successful within a reasonable period of

time. The court may derogate from these conditions in the situations set out in paragraph (6) of this Article.The right holder shall be informed of the granting of acompulsory license as soon as is reasonably possible.

• Requirement for prior request tothe patent holder for authorization.

• Requirement waived in the situation set out in §6, including

situation of extreme urgencyrelated to the field of health.

Article 69 - Conditions applicable to the grant ofa compulsory license

(1) A compulsory license shall be non-exclusive, andits scope and duration shall be exclusively limited to the

purpose for which it was authorized.

(2) A compulsory license shall be transferred only withthe production plant or the part thereof respectively, inwhich the invention it is granted for has been exploited.

(3) A compulsory license shall be grantedpredominantly for the purposes of supplying thedomestic market unless it is necessary to correct apractice determined by judicial or administrativeprocess to be anti-competitive.

(4) The competent authority shall, upon reasonedrequest by an interested person, cancel a compulsorylicense, subject to adequate protection of the legitimateinterests of the persons so authorized, if and when thecircumstances which led to its authorization cease toexist and are unlikely to recur.

(5) The patent owner has the right to remuneration,taking into account the economic value of theauthorization and need to correct anti-competitivepractice.

(6) A compulsory license according to Article 68 paragraph (4) of this Act shall be non-transferableexcept with a transfer of the second patent or the

protected plant variety.

• Waiver on the requirement that

the CL serves to supply predominantly the domestic market.

Compulsory licences for patents relating to themanufacture of pharmaceutical products intended forexport to countries having public health problemsGRANTING OF A COMPULSORY LICENCE Article 69a(1) The court may grant to any person filing an

application pursuant to the provisions of this Act, acompulsory licence for a patent and/or issue a

• Article 69a to 69e concerns theamendments introduced about theexportation of medicines undercompulsory licenses.



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Supplementary Protection Certificate required for themanufacture and sale of pharmaceutical products, whensuch products are intended for export to importingcountries having public health problems. Whendeciding on the grant of a compulsory licence the court

shall take into consideration in particular, the need toimplement the Decision adopted by the WTO GeneralCouncil on 30 August 2003 on the implementation of

paragraph 6 of the Doha Declaration on the TRIPSAgreement and Public Health (hereinafter: theDecision) of 14 November 2001.

(2) The pharmaceutical product referred to in paragraph(1) of this Article shall be any product of the

pharmaceutical industry, including medicinal productsfor human use, comprising any substance or

combination of substances intended for treating or preventing disease in human beings, and any substanceor combination of substances, which may beadministered to human beings with a view to restoring,correcting or modifying physiological functions inhumans, by exerting a pharmacological, immunologicalor metabolic action, or to making a medicinal diagnosis,including active ingredients and diagnostic kits ex vivo.

(3) The importing country referred to in paragraph (1)of this Article shall be any country to which the

pharmaceutical product is to be exported. The importingcountry may be:

(a) any least-developed country appearing as such inthe United Nations list;(b) any member of the WTO, other than the least-developed country members referred to in item (a) ofthis paragraph that has made a notification to theCouncil for TRIPS of its intention to use the system asan importer, including whether it will use the systemin whole or in a limited way;

(c) any country that is not a member of the WTO, butis listed in the OECD Development AssistanceCommittee's list of low-income countries with a grossnational product per capita of less than USD 745, andhas made a notification to the Office of its intention touse the system as an importer, including whether itwill use the system in whole or in a limited way.

(4) Any WTO member that has made a declaration thatit will not use the system as an importing WTO memberis not an eligible importing country.



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(5) Importing countries, which are not WTO members,and are least developed or developing countries, eligibleunder paragraph (3) of this Article shall comply withadditional requirements:

(a) the importing country shall make the notification

pursuant to the Decision directly to the Office;(b) the importing country shall state in thenotification that it will use the system to address

public health problems, and not as an instrument to pursue industrial or commercial policy objectives,and that it will adopt the measures referred to in

paragraph 4 of the Decision;(c) the court may, upon a legal action instituted by aright holder or by the Office, terminate a compulsorylicense, if the importing country has failed to complywith its obligations referred to in item (b).

(6) A legal action containing an application for the grantof a compulsory license shall be instituted before thecourt pursuant to the provisions of Article 67a of thisAct, if in the territory of the Republic of Croatia there isa patent or a Supplementary Protection Certificate theeffects of which cover the intended manufacturing andsale activity for export purposes.

(7) A legal action shall contain:(a) information concerning the applications forcompulsory licences filed in other countries for thesame product with details of the quantities andimporting countries concerned;(b) information concerning the applicant for acompulsory licence and of her/his representative, ifany;(c) the non-proprietary name of the pharmaceutical

product, which the applicant intends to manufactureunder the compulsory licence;(d) the quantity of the pharmaceutical product, which

the applicant intends to manufacture under thecompulsory licence;(e) the importing country;(f) evidence of prior negotiations with the rightholder pursuant to the provisions of paragraph (10)of this Article;(g) evidence of a specific request from an authorizedrepresentative of the importing country, or a non-governmental organization acting with the formalauthorization of one or more importing countries, orUN bodies or other international health organization

acting with the formal authorization of one or more



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importing countries, indicating the quantity of the product required.

(8) When deciding on an application for the grant of acompulsory license, the court shall verify in particular

the following:(a) whether each importing country cited in theapplication, which is a WTO member, has made anotification to the WTO pursuant to the Decision, orwhether each importing country cited in theapplication, which is not a WTO member, has madea notification to the Office pursuant to the provisionsof this Article in respect of each of the productscovered by the application. This shall be without

prejudice to the possibility, which the least-developed countries have pursuant to the Decision of

the TRIPS Council of 27 July 2002;(b) that the quantity of the product cited in theapplication does not exceed that notified to the WTOand the Office, respectively, by an importingcountry, which is a WTO member;(c) that, taking into account other compulsorylicenses granted elsewhere, the total amount of the

product authorized to be produced for any importingcountry does not significantly exceed the amountnotified by that country to the WTO, and the Office,respectively.

(9) The information referred to in paragraph (8) of thisArticle shall be provided and presented in a legal action

by the applicant for the grant of a compulsory licence.

(10) A compulsory license may be granted only if theapplicant has made efforts to obtain authorization fromthe patent owner for the exploitation of the protectedinvention on reasonable commercial terms andconditions, and if such efforts have not been successful

within thirty days prior to a legal action. This provisionshall not apply in situations of national emergency orother circumstances of extreme urgency, or in cases of

public non-commercial use, pursuant to Article 31, item(b) of the TRIPS Agreement.

COMPULSORY LICENSE CONDITIONSArticle 69b(1) A compulsory license shall be granted as a non-exclusive license, and its scope and duration, whichshall be cited in a decision on its grant, shall be

exclusively limited to the purpose for which it has beengranted. The quantity of products to be manufactured



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under such licence shall not exceed the quantitynecessary to satisfy the needs of the importing country,or importing countries cited in a legal action, taking intoaccount the quantity of the products manufacturedunder compulsory licenses granted elsewhere.

(2) A compulsory license shall be transferred only withthe production plant in which the invention, it is grantedfor, has been exploited.

(3) In its decision the court shall specify the acts, whichthe applicant is entitled to perform, and which arenecessary for the purpose of manufacturing the productsintended for export and distribution in the country orcountries cited in the application. No product made orimported under a compulsory license shall be offered

for sale or put on the market in any country other thanthat cited in the application, except where an importingcountry avails itself of the possibilities undersubparagraph 6(i) of the Decision to export to fellowmembers of a regional trade agreement that share thehealth problem in question.

(4) In its decision the court shall order that the productsmade under such license shall be clearly identified,through specific labeling or marking, as being producedunder a compulsory licence. The products shall bedistinguished from those made by the right holderthrough special packaging and/or special coloring orshaping, provided that such distinction is feasible, anddoes not have a significant impact on price. The

packaging and any associated literature shall bear anindication that the product is subject to a compulsorylicense, giving the name of the competent court whichgranted it, the file number and specifying clearly thatthe product is intended exclusively for export to anddistribution in the importing country or countries.

Details of the product characteristics shall be madeavailable to the customs authorities in the Republic ofCroatia and the Member States of the European Union.

(5) In its decision the court shall order that beforeshipment to the importing country the licensee shall

post on a web site, the address of which shall becommunicated to the Office, the following information:(a) the quantities of products being supplied under thelicence to the importing countries;(b) the distinguishing features of the product concerned.



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(6) If a product covered by a compulsory licencegranted in the Republic of Croatia, is patented in theimporting country cited in the application, the productshall only be exported if those countries have issued acompulsory licence for the import, sale and/or

distribution of the product concerned.

(7) In its decision the court shall order the applicant to pay remuneration to the right holder, as determined bythe court as follows:(a) in the cases of national emergency or othercircumstances of extreme urgency or in cases of publicnon-commercial use under Article 31 item (b) of theTRIPS Agreement, the remuneration shall be amaximum of 4% of the total price to be paid by theimporting country or on its behalf;

(b) in all other cases, the remuneration shall bedetermined taking into account the economic value ofthe use authorized under the license to the importingcountry or countries concerned, as well as humanitarianor non-commercial circumstances relating to the issueof the license.

(8) When the court decision on the grant of acompulsory license has become final, the court may,upon a claim for the preservation of evidence filed bythe right holder, inspect books and other records kept bythe licensee, for the sole purpose of checking whetherall the obligations contained in the court decision on thegrant of a compulsory license, and in particular thoserelating to the final destination of the products, have

been complied with. The books and records shallcontain a proof of exportation of the product, in theform of a declaration of exportation certified by thecustoms authority, and a proof of importation.

(9) The license conditions shall be without prejudice to

the method of distribution in the importing country.REFUSAL OF AN APPLICATION FOR THE GRANTOF A COMPULSORY LICENCEArticle 69cThe court shall refuse by a decision an application forthe grant of a compulsory license if it does not containelements necessary for taking a decision, or if any of theconditions for the grant of a compulsory licence laiddown in this Act have not been met.

TERMINATION OR MODIFICATION OF ACOMPULSORY LICENCE



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Article 69d(1) The right holder or the licensee may institute a legalaction claiming from the court to terminate acompulsory licence, if it has established that the counter

party has failed to respect a decision on the grant of a

compulsory license. In its decision to terminate thecompulsory license, the court shall specify the time period within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected at his expense to the countries in needreferred to in Article 69a of this Act, or otherwisedisposed of, in consultation with the right holder.

(2) When notified by the importing country that theamount of pharmaceutical product has becomeinsufficient to meet its needs, the licensee may institute

a legal action, claiming the modification of the licenceconditions, for the purpose of permitting themanufacture and export of additional quantities of the

product to the extent necessary to meet the needs of theimporting country concerned. In such cases the courtshall apply expeditious proceedings. If the additionalquantity of the product requested does not exceed 25%,the provisions of Article 69a paragraph (8) of this Actshall not apply.

NOTIFICATIONSArticle 69e(1) The court shall notify the Council for TRIPSthrough the intermediary of the Office of its finaldecisions on the grant of compulsory licenses, and ofthe license conditions, as well as of its termination ormodification.(2) The information provided shall include in particular:(a) the name and address of the licensee;(b) the product concerned;(c) the quantity to be supplied;

(d) the importing country;(e) the duration of the licence;(f) the website address referred to in Article 69b,

paragraph (5) of this Act.

PROHIBITION OF IMPORTATIONArticle 69f(1) The import into the Republic of Croatia and themember countries of the European Union of productsmanufactured under a compulsory license granted

pursuant to the provisions of this Act for the purposes

of release for free circulation, re-import, placing under



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suspensive procedures or placing in a free zone or freewarehouse shall be prohibited.

(2) Paragraph (1) of this Article shall not apply in thecase of re-export to the importing country cited in the

application and identified in the packaging anddocumentation associated with the product, or placingunder a transit or customs warehouse procedure or in afree zone or free warehouse for the purpose of re-exportto that importing country.



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Cyprus

Current law: Patents (Amendment) Act 2006 (2006) (only in Greek)

See: http://www.wipo.int/wipolex/en/details.jsp?id=9475

Text available in English: Patent Law of 1998.See: http://www.wipo.int/wipolex/en/text.jsp?file_id=126098

Provisions CommentsPART IX

NON-VOLUNTARY LICENCES ANDGOVERNMENT USE

49.-( 1) At any time after the expiration of four years,or of such other period licences as may be prescribed,from the date of the granting of a patent, any person may apply to the Registrar on one or more of thegrounds specified in subsection (2) below:(a) for a non-voluntary licence under the patent,(b) where the applicant is a government department,for the grant to any person specified in the applicationof a licence under the patent.

(2) The grounds for the submission of an application fornon-voluntary licence are

(a) where the patented invention is capable of beingcommercially worked in Cyprus but it is not being soworked or is not being so worked to the fullest extentthat is reasonably practicable;(b) where the patented invention is a product, that ademand for the product in Cyprus

(i) is not being met, or(ii) is not being met on reasonable terms, or(c) that by reason of the refusal of the owner of the

patent to grant a licence or licences on reasonableterms

(i) a market for the export of any patented productmade in Cyprus is not being supplied, or(ii) the use or efficient use in Cyprus of any other

patented invention which makes a substantialcontribution to the art is prevented or hindered, or(iii) the establishment or development ofcommercial or industrial activities in Cyprus isunfairly prejudiced;

(d) that by reason of conditions imposed by the ownerof the patent on the grant of licences under the patent,or on the disposal or use of the patented product or on

the use of the patented process, the manufacture, use ordisposal of materials not protected by the patent, or the

• Non-voluntary licences are granted by the Registrar.

• A ground to request non-voluntary license is the fact that the

"demand for the product is not (...)met on reasonable terms". Thiscould apply to excessive price.






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establishment or development of commercial orindustrial activities in Cyprus is unfairly prejudiced.

(3) Subject to the provisions of subsections (4) to (6) below, if the Registrar is satisfied that any grounds are

established, he may(a) where the application is made under subsection(1 )(a) above, order the grant of a licence to theapplicant on such terms as the Registrar thinks fit;(b) where the application is made under subsection (1 )(b) above, order the grant of a licence to the personspecified in the application on such terms as theRegistrar thinks fit.

(4) Where the application is made on the ground thatthe patented invention is not being commercially

worked in Cyprus or is not being so worked to thefullest extent that is reasonably practicable, and itappears to the Registrar that the time which has elapsedsince the publication in the Official Gazette of a noticeof the grant of the patent has for any reason beeninsufficient to enable the invention to be so worked,the Registrar may by order suspend the application forsuch period as will in his opinion give sufficient timefor the invention to be so worked.

(5) No entry shall be made in the register under thissection on the ground mentioned in subsection (2) (c)(i)above, and any licence granted under this section onthat ground shall contain such provisions as appear tothe Registrar to be expedient for restricting thecountries in which any product concerned may bedisposed of or used by the licensee.

(6) No order or entry shall be made under this section inrespect of a patent (the patent concerned) on thegrounds mentioned in subsection (2) (c) (ii) above

unless the Registrar is satisfied that the owner of the patent for the other invention is able and willing togrant to the owner of the patent concerned and hislicensees, a licence under the patent for the otherinvention on reasonable terms.

(7) An application may be made under this section inrespect of a patent notwithstanding that the applicant isalready the holder of a licence under the patent; and no

person shall be prevented or excluded from alleging anyof the matters specified in subsection (2) above by

reason of any admission made by him, whether in such

• Here is a possibility for the right

holder to extend the period to have

the patent worked from the date ofthe granting of this patent.



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a licence or otherwise, or by reason of his havingaccepted such a licence.50.-(1) Where the Registrar is satisfied, on anapplication made under section 49 above in respect of a

patent, that the manufacture, use or disposal of

materials not protected by the patent is unfairly prejudiced by reason of conditions imposed by theowner of the patent on granting of licences under the

patent, or on the disposal or use of the patented productor the use of the patented process, he may (subject tothe provisions of that section) order the granting oflicences under the patent to such customers of theapplicant as he thinks fit as well as to the applicant.

(2) Where an application under section 49 above ismade in respect of a patent by a person who holds a

licence under the patent, the Registrar(a) may, if he orders the granting of a licence to theapplicant, order the existing licence to be cancelled, or(b) may, instead of ordering the granting of a licence tothe applicant, order the existing licence to be amended.

(3) Where, on an application under section 49 above inrespect of a patent, the Registrar orders the granting of alicence, he may direct that the licence shall operate(a) to deprive the owner of the patent of any right he hasto work the invention concerned or grant licences underthe patent;(b) to revoke all existing licences granted under the

patent.51.-(1) The powers of the Registrar in relation to anapplication under section 49 above in respect of a patentshall be exercised with a view to securing the followinggeneral purposes:(a) that inventions which can be worked on acommercial scale in Cyprus which should in the publicinterest be so worked shall be worked there without

undue delay and to the fullest extent that isreasonably practicable;(b) that the inventor or other person beneficially entitledto a patent shall receive reasonable remunerationhaving regard to the nature of the' invention;(c) that the interests of any person for the time beingworking or developing an invention in Cyprus under the

protection of a patent shall not be unfairly prejudiced.

(2) Subject to subsection (I) above, the Registrar shall,in determining whether to make an order or entry in

pursuance of such an application, take account of thefollowing matters, that is to say:

• This article makes it possible for

the registrar to limit the period given to the patent holder to start to

work the patent when it is in the public interest that it is worked.



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(a) the nature of the invention, the time which haselapsed since the publication in the Official Gazette ofthe Republic of a notice of the granting of the patentand the measures already taken by the owner of the

patent or any licensee to make full use of the invention;

(b) the ability of any person to whom a licence would be granted under the order concerned to work theinvention to the public advantage: and(c) the risks to be undertaken by that person infinancing capital and working the invention if theapplication for an order is granted, but shall not berequired to take account of matters subsequent to themaking of the application.52.-(1) The owner of the patent concerned or any other

person wishing to oppose an application under sections49 to 51 above may, in accordance with rules, give to

the Registrar notice of opposition; and the Registrarshall consider the opposition in deciding whether togrant the application.

(2) Where an application under sections 49 to 51 aboveis opposed under subsection (1) above, and either(a) the parties consent, or(b) the proceedings require a competent examination ofdocuments or any scientific or local investigation whichcannot in the opinion of the Registrar conveniently bemade before him, the Registrar may at any time orderthe whole proceedings, or any question or issue of factarising in them, to be referred to an arbitrator orspecialist agreed upon by the parties, or in default ofagreement, appointed by the Registrar.

(3) Where a question or issue of fact is so referred, thearbitrator or specialist shall report his findings to theRegistrar and the Registrar shall proceed to issue adecision.Art 53 In any proceedings on an application made in

relation to a patent under sections 49 to 51 above, anystatement With respect to any activity in relation to the patented invention, or with respect to the granting orrefusal of licences under the patent, contained in a reportof the Commission for protection against UnfairCompetition' shall be prima facie evidence of the mattersstated.54 The import into Cyprus of any product protected by

patent granted by any member country of the WorldTrade Organisation shall be considered as use inCyprus.

• Importation is considered as use

of a patent.

55 Where the national security or public safety sorequires, the Council of Ministers may authorize, even

• National security or public safetyare grounds for non-authorized



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without the agreement of the owner of the patent or the patent application, by notice published in the OfficialGazette, a government agency or a person designated inthe said notice to make, use or sell an invention towhich a patent or an application for a patent relates,

subject to payment of equitable remuneration to theowner of the patent or the application for the patent. Thedecision of the Council of Ministers with regard toremuneration may be the subject of a recourse to theCourt.

used of patented invention upondecisions of the Council of

Ministers.

56 Where according to sections 50, 51 and 55 of the present Law a licence is given for use of the subjectmatter of a patent without the authorization of the owner,including use by the government or third partiesauthorized by the government, the following provisionsshall be respected:

(a) authorization of such use shall be considered on itsindividual merits;(b) such use may only be permitted if, prior to such use,the interested user has made efforts to obtainauthorization from the owner on reasonablecommercial terms and conditions and that such effortshave not been successful within unreasonable periodof time. This requirement is waived in the case of anational emergency or other circumstances ofextreme urgency or in cases of public non-commercial use. In a situation of national emergencyor other circumstances of extreme urgency, the ownershall, nevertheless, be notified as soon as reasonably

practicable. In the case of public non-commercial use,where the government or contractor, without making a

patent search, knows or has demonstrable grounds toknow that a valid patent is being or will be used by orfor the government, the right holder shall be informedpromptly;(c) the scope and duration of such use shall be limited tothe purpose for which it was authorized, and in the case

of semiconductor technology shall only be for publicnoncommercial use or to remedy a practice determinedafter judicial or administrative process to beanticompetitive;(d) such use shall be non-exclusive;(e) such use be non-assignable to a third party, exceptwith that part of the enterprise or goodwill which enjoyssuch use;(f) any such use shall be authorized predominantly forthe supply of the domestic market;(g) authorization for such use shall be liable, subject to

adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the

• Prior efforts to obtain

authorization from the owner should take place.

• This requirement is waived incases of a national emergency orother circumstances of extremeurgency or in cases of public non-commercial use.



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circumstances which led to it cease to exist and areunlikely to recur. The Registrar shall have the authorityto review, upon motivated request, the continuedexistence of these circumstances;(h) the right holder shall be paid adequate

remuneration in the circumstances of each case, takinginto account the economic value of such use;(i) the legal validity of any decision relating to theauthorization of such use shall be subject to review bythe appropriate Court;(j) any decision relating to the remuneration providedin respect of such use shall be subject to review by theCourt; (k) it is not necessary to apply the conditions set forth insubparagraphs (b) and (f) where such use is permitted toremedy a practice determined after judicial or

administrative process to be anti-competitive. The needto stop anti-competitive practices may be taken intoaccount in determining the amount of remuneration insuch cases. The Registrar shall have the authority torefuse termination of authorization if and when theconditions which led to such authorization are likely torecur;(I) where such use is authorized to permit theexploitation of a patent ("the second patent") whichcannot be exploited without infringing another patent("the first patent"), the following additional conditionsshall apply:

(i) the invention claimed in the second patent shallinvolve an important technical advance ofconsiderable economic significance in relation to theinvention claimed in the first patent;(ii) the owner of the first patent shall be entitled to across-licence or reasonable terms to use theinvention claimed in the second patent; and(iii) the use authorized in respect of the first patentshall be non-assignable except with the assignment

of the second patent.

• A court reviews decisions about

the authorization of CL and theremuneration of the patent holder.



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Czech Republic

Current law: Law No. 527/1990 of November 27, 1990 on Inventions and RationalizationProposals (as last amended by No. Act No. 378/2007 Coll.) (only in Czech)See: http://www.wipo.int/wipolex/en/details.jsp?id=942

English text available: Law on Inventions, Industrial Designs and RationalizationProposals No. 527 of 27/11/1990 as last amended by Act No. 207/2000 Coll. and Act No.378/2007 http://www.wipo.int/edocs/lexdocs/laws/en/cz/cz032en.pdf

Provisions CommentsCompulsory License20.-

(1) If no agreement is reached on the conclusion of alicense contract, the Office may grant a compulsorylicense:

(a) if the owner of the patent does not work his patent at all or works it insufficiently and cannot givelegitimate reasons for his failure to act; a compulsorylicense may not be granted prior to the expiration offour years as from the filing date of the patentapplication or three years as from the date of grant of the patent, whichever period expires last;

(b) If an important public interest is

endangered.

(2) The grant of a compulsory license shall not affectthe right of the owner to obtain compensation inrespect of the value of the license.

• The patent office is the entity thatcan grant a CL.

• An "important public interest" is a ground for a compulsory licence.



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Denmark

Current law: The Consolidate Patents Act (Consolidate Act No. 108 of January 24, 2012)(2012)See: http://www.wipo.int/wipolex/en/text.jsp?file_id=267151

Provisions Comments45.(1) If a patented invention is not worked to a reasonableextent in this country when 3 years have elapsed fromthe grant of the patent and 4 years have elapsed fromthe filing of the patent application, any person wishingto work the invention in this country may obtain acompulsory licence to do so, unless there are legitimate

reasons for the failure to work the invention.

(2) The Minister of Business and Growth may provide that for the purposes of the provision ofsubsection 1 working of the invention in anothercountry shall be equivalent to working in thiscountry. Such a provision may be made subject toreciprocity.

• The authority that can grant a

compulsory licence is the Ministerof Business and Growth.

46.(1) The proprietor of a patent for an invention theexploitation of which is dependent on a patent or a

registered utility model which belongs to another personmay obtain a compulsory licence to exploit theinvention protected by the latter patent or the creation

protected by the utility model registration, provided thatthe former invention constitutes significant technical

progress of considerable economic importance.

(2) The proprietor of the patent for the invention or ofthe registered utility model for the exploitation of whicha compulsory licence has been granted pursuant to the

provision of subsection 1 shall on reasonable terms beable to obtain a compulsory licence for the exploitationof the other invention.

46a.(1) A breeder who cannot acquire or exploit a plantvariety right without infringing a prior patent may applyfor a compulsory licence for the exploitation of theinvention, provided that the compulsory licence isnecessary for the exploitation of the plant variety to be

protected, subject to the payment of an appropriate

royalty. The compulsory licence shall only be granted ifthe breeder demonstrates that the variety constitutes






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significant technical progress of considerable economicimportance compared with the invention.

(2) If under the Plant Variety Protection Act a proprietor of a patent has obtained a compulsory licence

to exploit a protected plant variety, the breeder shall beentitled on reasonable terms to obtain a cross-licencefor the exploitation of the invention.47.When required by important public interests, anyperson who wishes to exploit an inventioncommercially for which another person holds a patentmay obtain a compulsory licence to do so.

• "Important public interests" ar e grounds for any person to obtain acompulsory licence.

48.(1) Any person who, at the time when a patentapplication was made available to the public, was

exploiting the invention for which the patent is appliedfor commercially in this country may, if the applicationresults in a patent, obtain a compulsory licence for theexploitation, provided that exceptional circumstancesmake it desirable, and he had no knowledge of theapplication and could not reasonably have obtainedsuch knowledge.Such a right shall also, under similar conditions, beenjoyed by any person who had made substantialpreparations for a commercial exploitation of theinvention in this country.

(2) Such a compulsory licence may include the time preceding the grant of the patent.

(3) The Minister of Business and Growth may providethat, for the purposes of the provision of subsection 1,exploitation of the invention in another country shallbe equivalent to exploitation in this country. Such a

provision may be made subject to reciprocity.49.

(1) A compulsory licence shall only be granted topersons who have not been able by agreement toobtain a licence on reasonable terms and who maybe considered capable of exploiting the invention in areasonable and proper manner and in compliance withthe licence.

(2) A compulsory licence shall not prevent the proprietor of the patent from exploiting the inventionhimself or from granting licences to others.

(3) A compulsory licence may only be transferred toothers together with the business in which it is exploited

• Prior attempt to obtainauthorization from the patentholder to use the patent is required.



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or in which the exploitation was intended. With respectto compulsory licences granted pursuant to section46(1) it shall moreover apply that any transfer of thecompulsory licence shall be effected together with the

patent the exploitation of which is dependent on a

patent or a registered utility model which belongs toanother person.

(4) Compulsory licences concerning semiconductortechnology may only be granted for public non-commercial exploitation or for terminating an anti-competitive practice which has been established by acourt decision or an administrative decision.50. The Maritime and Commercial Court shall decide asthe court of first instance whether a compulsory licenceshall be granted and shall also determine the extent to

which the invention may be exploited, fix thecompensation and lay down the other terms of thecompulsory licence. If circumstances should changeconsiderably, the Court may, at the request of either

party, cancel the licence or lay down new terms of thelicence.



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Estonia

Current law: Patent Act (Act No. RT I 1994, 25, 406, as last amended by Act No. RT I,28.12.2011,1) (2012)See: http://www.wipo.int/wipolex/en/details.jsp?id=11584

Provisions Comments§ 47. Compulsory licence(1) A person who is interested in using a patentedinvention and is capable of doing so in the Republic ofEstonia, may, upon refusal of the proprietor of thepatent to grant a licence, file an action with a court foracquiring a compulsory licence if:1) the proprietor of the patent has not used the invention

in the Republic of Estonia within three years from thepublication of the notice concerning the grant of thepatent or within four years from the filing of thepatent application, and in such case the term whichwill expire later shall apply;2) the proprietor of the patent does not use the inventionto an extent corresponding to the needs of thedomestic market of the Republic of Estonia;3) the patent hinders the use of another, technicallyadvanced invention significant for the economy of theRepublic of Estonia;

4) national defence, environmental protection, publichealth and other significant national interests of theRepublic of Estonia require the use of the invention,including the need to use the invention in connectionwith a natural disaster or other emergency.5) the patent hinders the grant of plant variety rights

pursuant to the Plant Propagation and Plant VarietyRights Act or the use of the protected variety.

[RT I 2005, 70, 540 – entry into force 01.01.2006]

(11) A compulsory licence shall not be granted if the proprietor of a patent imports the product protectedby the patent from any member state of the WorldTrade Organisation to an extent corresponding to theneeds of the domestic market of the Republic ofEstonia.

(2) In the case provided for in clause (1) 3) of thissection, the proprietor of a patent has the right toacquire a compulsory licence for another invention,unless the exchange of licences is agreed on (cross-licence).

• Anyone can request a compulsorylicence provided that a priorattempt was made to obtainauthorization from the patentholder.

• The patent not being used "to anextent corresponding to the needsof the domestic market" is a ground

for compulsory licence.

• Public health is a reason torequire the use of an inventionthrough compulsory licence.

• Import from a WTO Member isconsidered as working the patent in

Estonia.









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(3) Upon the grant of a compulsory licence, a courtshall determine the terms and conditions of thecompulsory licence, including the extent and durationof the use of the invention and the amount and

procedure for payment of the licence fee. The extent

and duration of the use of the invention shall bedetermined on the basis of the needs of the domesticmarket of the Republic of Estonia.

(4) The right to use an invention on the basis of acompulsory licence may transfer to another person onlytogether with the enterprise in which the compulsorylicence is used or was intended to be used pursuant tothe terms of the compulsory licence.

(5) The grant of a compulsory licence does not hinder

the proprietor of a patent from using the invention orgranting licences to other persons.

(6) A compulsory licence is valid as of the date ofmaking an entry in the register. A request for themaking of a register entry together with a copy of thecourt judgment and information on payment of the statefee shall be filed with the Patent Office within onemonth after entry into force of the court judgment.

(7) If circumstances change, both the licensor and thelicensee may file an action with a court for amendmentof the terms of the compulsory licence.

(8) Regulation (EC) No 816/2006 of the EuropeanParliament and of the Council on compulsory licensingof patents relating to the manufacture of pharmaceutical

products for export to countries with public health problems (OJ L 157, 09.06.2006, pp. 1-7) applies tofiling an action for acquiring a compulsory licence forthe manufacture of pharmaceutical products protected

by a patent for import or export.[RT I 2009, 4, 24 – entry into force 01.03.2009]

• Condition of the granting of a

compulsory licence is set by acourt.

§ 471. National non-commercial use(1) A patented invention may be used by theGovernment of the Republic or a third personauthorised by the Government of the Republic withoutthe permission of the proprietor of the patent in theevent of an epidemic within the meaning of theCommunicable Diseases Prevention and Control Act

and in an emergency situation within the meaning of the

• Non-commercial use is limited tothe event of an "epidemic within themeaning of the Communicable

Diseases Prevention and Control Act and in an emergency situationwithin the meaning of the

Emergency Situation Act".



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Emergency Situation Act (hereinafter national non-commercial use).

(2) National non-commercial use may include theactivities specified in § 15 of this Act.

(3) The conditions for making decisions concerningnational non-commercial use and for grant ofcompensation to the proprietor of a patent are provided

by law.

[RT I 2009, 4, 24 – entry into force 01.03.2009]



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Finland

Current law: Patents Act (Act No. 1967/550 of December 15, 1967, as amended up to ActNo. 2013/101 of January 31, 2013)See: http://www.wipo.int/edocs/lexdocs/laws/en/fi/fi114en.pdf

Provisions CommentsSection 45Where three years have elapsed since the grant of thepatent and four years have elapsed from the filing ofthe application, and if the invention is not worked orbrought into use to a reasonable extent in Finland,any person who wishes to work the invention in Finlandmay obtain a compulsory licence to do so unless

legitimate grounds for failing to work the invention may be shown. (22.12.1995/1695)Subject to reciprocity, the Government may decree that,for the purposes of subsection (1) of this section, theworking of an invention in a foreign State shall bedeemed equivalent to working in this country.

• The two conditions arecumulative.

Section 46The proprietor of a patent for an invention whoseexploitation is dependent on a patent held by another

person may obtain a compulsory licence to exploit theinvention protected by such patent if deemed reasonable

in view of the importance of the first-mentionedinvention or for other special reasons.The proprietor of a patent in respect of which acompulsory licence is granted under subsection (1) ofthis section may obtain a compulsory licence to exploitthe other invention unless there are special reasons tothe contrary.

Section 46a (30.6.2000/650) Where a breeder cannotacquire or exploit a plant variety right withoutinfringing a prior patent, he may apply for a compulsorylicence for non-exclusive use of the invention protected

by the patent inasmuch as the licence is necessary forthe exploitation of the plant variety to be protected,subject to payment of an appropriate royalty. Wheresuch a licence is granted, the holder of the patent will beentitled to a cross-licence on reasonable terms to use the

protected variety.Applicants for the licence referred to in subsection 1above must demonstrate that they have appliedunsuccessfully to the holder of the patent to obtain a

contractual licence and that the plant variety constitutessignificant technical progress of considerable economic



52 / 141

interest compared with the invention claimed in the patent.Provisions concerning the right of a patent holder toobtain a compulsory licence for the exploitation of a

plant variety protected by plant breeder's right are laid

down by the Act on Plant Breeders' Rights (No.789/1992).Section 47In the event of considerable public interest, a personwho wishes to exploit commercially an invention forwhich another person holds a patent may obtain acompulsory licence to do so.

• Does "considerable public

interest" waive the conditions inSection 45 ?

Section 48Any person who was commercially exploiting in thiscountry an invention which is the subject of a patentapplication, at the time the application documents were

made available under section 22, shall, if the applicationresults in a patent, be entitled to a compulsory licencefor such exploitation, provided there are special reasonsfor this and also provided that he had no knowledge ofthe application and could not reasonably have obtainedsuch knowledge. Such a right shall also be enjoyed,under corresponding conditions, by any person who hasmade substantial preparations for commercialexploitation of the invention in this country.Compulsory licences may also relate to the period oftime preceding the grant ofthe patent.Section 49 (22.12.1995/1695) A compulsory licencemay only be granted to a person deemed to be in aposition to exploit the invention in an acceptablemanner and in accordance with the terms of the licencewho, before filing a claim for a compulsory licence, hasmade a verifiable effort to obtain, on reasonablecommercial terms, a licence to the patented invention.A compulsory licence shall not prevent the proprietor ofthe patent from exploiting the invention himself or from

granting licences under the patent. A compulsorylicence may only be transferred to a third party togetherwith the business in which it is exploited or wasintended to be exploited.

• Prior negotiation with patent

holder his required. No options towaive this requirement.

Section 50 (31.1.2013/101) Compulsory licences aregranted by a court of law, which also decides the extentto which the invention may be exploited and determinesthe remuneration to be paid and any other conditionsunder the licence. In the event of a substantial change inthe circumstances, the court may, at the request of the

party concerned, revoke the compulsory licence or lay

down new conditions.

• A CL is granted by a court (no

option of administrative decision).



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The Market Court is the competent authority referred toin article 3(1) of the Regulation (EC) No 816/2006 ofthe European Parliament and of the Council oncompulsory licensing of patents relating to themanufacture of pharmaceutical products for export to

countries with public health problems.



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France

Current law: Intellectual Property Code, Law No.92-597 of 01/07/1992 (consolidatedversion 2015) Code de la propriété intellectuelle (version consolidée au 23 février 2015)See: http://codes.droit.org/cod/propriete_intellectuelle.pdf(English version from 2004 available here)

Provisions CommentsArticle L613-11Toute personne de droit public ou privé peut, àl’expiration d’un délai de trois ans après la délivrance

d’un brevet, ou de quatre ans à compter de la datedu dépôt de la demande, obtenir une licenceobligatoire de ce brevet, dans les conditions prévues aux

articles suivants, si au moment de la requête, et saufexcuses légitimes le propriétaire du brevet ou son ayantcause :a) N’a pas commencé à exploiter ou fait des

préparatifs effectifs et sérieux pour exploiter l’invention

objet du brevet sur le territoire d’un État membre de laCommunauté économique européenne ou d’un autre

État partie à l’accord sur l’Espace économique

européen. b) N’a pas commercialisé le produit objet du breveten quantité suffisante pour satisfaire aux besoins du

marché français.

Il en est de même lorsque l’exploitation prévue au a) ci-dessus ou la commercialisation prévue au b) ci-dessus aété abandonnée depuis plus de trois ans.

Pour l’application du présent article, l’importation de produits objets de brevets fabriqués dans un Etat partieà l’accord instituant l’Organisation mondiale du

commerce est considérée comme une exploitation de ce brevet.

• One of the conditions to obtain aCL is the fact that the product innot commercialized in sufficientquantity to satisfy the needs in thecountry.• Cessation of exploitation or

commercialization for more than 3 years is also a ground for CL.• The law explicitly mentions that

importation of patented objectswithin a member of the WTO isconsidered as exploitation of the

patent.

Article L613-12La demande de licence obligatoire est formée auprès dutribunal de grande instance : elle doit être accompagnéede la justification que le demandeur n’a pu obtenir du

propriétaire du brevet une licence d’exploitation etqu’il est en état d’exploiter l’invention de manière

sérieuse et effective. La licence obligatoire est accordéeà des conditions déterminées, notamment quant à sa

durée, son champ d’application et le montant desredevances auxquelles elle donne lieu. Ces conditions

peuvent être modifiées par décision du tribunal, à larequête du propriétaire ou du licencié.

• Requirement for prior request ofauthorization to the patent holder.• C L are granted by a court.

https://www.google.fr/url?sa=t&rct=j&q=&esrc=s&source=web&cd=6&ved=0ahUKEwjpp6aBsIHMAhUFKw8KHU-SC7oQFghGMAU&url=https%3A%2F%2Fwww.legifrance.gouv.fr%2Fcontent%2Fdownload%2F1959%2F13723%2Fversion%2F3%2Ffile%2FCode_35.pdf&usg=AFQjCNFhhZEkgic0eLUERKkt5gfPgo7aXA






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Article L613-13Les licences obligatoires et les licences d’office sont

non exclusives. Les droits attachés à ces licences ne peuvent être transmis qu’avec le fonds de commerce,

l’entreprise ou la partie de l’entreprise auquel ils sont

attachés [*cession indissociable*].Article L613-14Si le titulaire d’une licence obligatoire ne satisfait pas

aux conditions auxquelles cette licence a été accordée,le propriétaire du brevet et, le cas échéant, les autreslicenciés peuvent obtenir du tribunal le retrait de cettelicence.Article L613-15Le titulaire d’un brevet portant atteinte à un brevet

antérieur ne peut exploiter son brevet sans l’autorisation

du titulaire du brevet antérieur ; ledit titulaire ne peut

exploiter le brevet postérieur sans l’autorisation dutitulaire du brevet postérieur. Lorsque le titulaire d’un

brevet ne peut l’exploiter sans porter atteinte à un brevet

antérieur dont un tiers est titulaire, le tribunal de grandeinstance peut lui accorder une licence d’ex ploitation du

brevet antérieur dans la mesure nécessaire àl’exploitation du brevet dont il est titulaire et pour

autant que cette invention constitue à l’égard du brevet

antérieur un progrès technique important et présente unintérêt économique considérable. La licence accordéeau titulaire du brevet postérieur ne peut être transmisequ’avec ledit brevet. Le titulaire du brevet antérieurobtient, sur demande présentée au tribunal, laconcession d’une licence réciproque sur le brevet

postérieur. Les dispositions des articles L. 613-12 à L.613-14 sont applicables.Article L613-15-1Lorsqu’un obtenteur ne peut obtenir ou exploiter un

droit d’obtention végétale sans porter atteinte à un

brevet antérieur, il peut demander la concession d’une

licence de ce brevet dans la mesure où cette licence est

nécessaire pour l’exploitation de la variété végétale à protéger et pour autant que la variété constitue à l’égard

de l’invention revendiquée dans ce brevet un progrès

technique important et présente un intérêt économiqueconsidérable. Lorsqu’une telle licence est accordée, letitulaire du brevet obtient à des conditions équitables,sur demande présentée au tribunal, la concession d’une

licence réciproque pour utiliser la variété protégée. Lesdispositions des articles L. 613-12 à L. 613-14 sontapplicables.

• This article was modified by the

law n°2004-1338 of December 8,

2004.

Article L613-16

Si l’intérêt de la santé publique l’exige et à défautd’accord amiable avec le titulaire du brevet, le


law n°2004-1338 of December 8,2004.



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ministre chargé de la propriété industrielle peut, surla demande du ministre chargé de la santé publique,soumettre par arrêté au régime de la licence d’office,

dans les conditions prévues à l’article L. 613-17, tout brevet délivré pour :

a) Un médicament, un dispositif médical, un dispositifmédical de diagnostic in vitro, un produit thérapeutiqueannexe ;

b) Leur procédé d’obtention, un produit nécessaire à

leur obtention ou un procédé de fabrication d’un tel

produit ;c) Une méthode de diagnostic ex vivo.

Les brevets de ces produits, procédés ou méthodes dediagnostic ne peuvent être soumis au régime de lalicence d’office dans l’intérêt de la santé publique que

lorsque ces produits, ou des produits issus de ces procédés, ou ces méthodes sont mis à la disposition du

public en quantité ou qualité insuffisantes ou à desprix anormalement élevés, ou lorsque le brevet est

exploité dans des conditions contraires à l’intérêt dela santé publique ou constitutives de pratiquesdéclarées anticoncurrentielles à la suite d’une

décision administrative ou juridictionnelle devenuedéfinitive. Lorsque la licence a pour but de remédier àune pratique déclarée anticoncurrentielle ou en cas

d’urgence, le ministre chargé de la propriétéindustrielle n’est pas tenu de rechercher un accord

amiable.

• The Minister in charge of

industrial property can, upon the

request of the Minister of Health, if

it is required by public health

interest, and in the absence of an

agreement with the patent holder, a"licence d'office" (a special sort of

CL).

• This provision can be used for

medicines, a medical device, amedical device for in vitrodiagnosis, an additionaltherapeutic product, their process

for the breeding, a productnecessary for their breeding or a

process for manufacturing such

product, an ex vivo diagnosticmethod.• This provision can be triggeredonly when these products "aremade available to the public ininsufficient quantity or quality or atabnormally high prices" or "wherethe patent is exploited underconditions contrary to the interestof the public health".• The prior requirement to try to

obtain an agreement from the patent holder only when the licenseis " to remedy an anti-competitive

practice or in urgent cases". Article L613-17-1La demande d’une licence obligatoire, présentée en

application du règlement (CE) n° 816/2006 duParlement européen et du Conseil, du 17 mai 2006,concernant l’octroi de licences obligatoires pour des

brevets visant la fabrication de produits

pharmaceutiques destinés à l’exportation vers despays connaissant des problèmes de santé publique,est adressée à l’autorité administrative. La licence est

délivrée conformément aux conditions déterminées parl’article 10 de ce règlement. L’arrêté d’octroi de la

licence fixe le montant des redevances dues. La licence prend effet à la date la plus tardive à laquelle l’arrêté est

notifié au demandeur et au titulaire du droit.


law n°2007-1544 of October 2007.

• This article concerns theexportation under CL to countries

facing public health problems.

Article L613-18Le ministre chargé de la propriété industrielle peutmettre en demeure les propriétaires de brevets

d’invention autres que ceux visés à l’article L. 613-16d’en entreprendre l’exploitation de manière à satisfaire



57 / 141

aux besoins de l’économie nationale. Si la mise endemeure n’a pas été suivie d’effet dans le délai d’un an et si l’absence d’exploitation ou l’insuffisance en

qualité ou en quantité de l’exploitation entreprise

porte gravement préjudice au développement

économique et à l’intérêt public, les brevets, objets dela mise en demeure, peuvent être soumis au régime delicence d’office par décret en Conseil d’État. Leministre chargé de la propriété industrielle peut

prolonger le délai d’un an prévu ci-dessus lorsque letitulaire du brevet justifie d’excuses légitimes etcompatibles avec les exigences de l’économie nationale. Du jour de la publication du décret qui soumet le brevetau régime de la licence d’office, toute personne

qualifiée peut demander au ministre chargé de la propriété industrielle l’octroi d’une licence

d’exploitation. Cette licence est accordée par arrêtédudit ministre à des conditions déterminées quant à sadurée et son champ d’application, mais à l’exclusion

des redevances auxquelles elle donne lieu. Elle prendeffet à la date de notification de l’arrêté aux parties. Àdéfaut d’accord amiable, le montant des redevances est

fixé par le tribunal de grande instance.Article L613-19L’État peut obtenir d’office, à tout moment, pour les

besoins de la défense nationale, une licence pourl’exploitation d’une invention, objet d’une demande de

brevet ou d’un brevet, que cette exploitation soit faite

par lui-même ou pour son compte. La licence d’office

est accordée à la demande du ministre chargé de ladéfense par arrêté du ministre chargé de la propriétéindustrielle. Cet arrêté fixe les conditions de la licence àl’exclusion de celles relatives aux redevances

auxquelles elle donne lieu. La licence prend effet à ladate de la demande de licence d’office. A défautd’accord amiable, le montant des redevances est fixé

par le tribunal de grande instance. A tous les degrés de

juridiction, les débats ont lieu en chambre du conseil.Article L613-19-1Si le brevet a pour objet une invention dans le domainede la technologie des semi-conducteurs, une licenceobligatoire ou d’office ne peut être accordée que pour

une utilisation à des fins publiques non commercialesou pour remédier à une pratique déclaréeanticoncurrentielle à la suite d’une procédure

juridictionnelle ou administrative.



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Germany

Current law: Act on Amendments of Patent Law and Other Industrial Property Laws(2013) (only in German)See: http://www.wipo.int/wipolex/en/details.jsp?id=14067

Version accessible in English: Patent Law (as amended by the Law of July 31, 2009)See: http://www.wipo.int/edocs/lexdocs/laws/en/de/de116en.pdf

Provisions CommentsSection 13(1) A patent shall have no effect should the FederalGovernment order that the invention is to be used in theinterest of public welfare. Nor shall the effect of a patentextend to any use of the invention ordered in the interests ofthe security of the Federal Republic by the competent highestfederal authority or, on the latter’s instructions, by asubordinate agency.(2) Should an order under subsection (1) be challenged, theFederal Administrative Court [Bundesverwaltungsgericht]shall have jurisdiction if said order was issued by the FederalGovernment or the competent highest federal authority.(3) In those cases referred to in subsection (1), the patenteeshall have a claim against the Federal Republic for reasonable compensation. In the event of dispute as to theamount, legal action may be brought before the ordinary civil

courts. Any order by the Federal Government under the firstsentence of subsection (1) shall be communicated to theperson recorded as patentee in the Register (Section 30(1))before the invention is used. If the highest federal authoritythat has issued an order or an instruction under the secondsentence of subsection (1) becomes aware that a claim forcompensation has arisen under the first sentence, said highestfederal authority shall communicate this to the personrecorded in the Register as patentee.

• Section13 describe s anadministrative order, equivalent toa governmental use, to serve publicinterest.

Section 24(1) A non-exclusive authorization to commercially use aninvention shall be granted by the Patent Court in

individual cases in accordance with the following provisions(compulsory license) if1. the person seeking a license has unsuccessfullyendeavored during a reasonable period of time to obtainfrom the patentee consent to use the invention underreasonable conditions usual in trade; and2. public interest commands the grant of a compulsorylicense.

(2) When the person seeking a license is unable to exploitan invention for which he holds protection under a patentof later date without infringing the patent of earlier date,

said person shall been titled to the grant of a compulsorylicense from the owner of the patent of earlier date if

• Section 14 concerns regular CL

that are granted by the PatentCourt.• Prior attempt to obtain avoluntary license from the patentholder is required.



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1. the condition stipulated in subsection (1), no. 1, is fulfilledand2. the invention of said person includes, in comparison withthe invention under the patent of earlier date, an importanttechnical progress of considerable commercialsignificance.The patentee may request the grant of a counter-licenseunder reasonable conditions by the person seeking a licensefor the use of the patented invention of later date.

(3) Subsection (2) shall apply mutatis mutandis if a plant breeder cannot obtain or exploit a plant variety patent without infringing an earlier patent.

(4) A compulsory license under the provisions of subsection(1) may only be granted for a patented invention in the fieldof semiconductor technology if said grant is necessary to

remove an anti-competitive practice on the part of the patentee that has been established in judicial oradministrative proceedings.

(5) When a patentee does not work the patented invention or does not work it predominantly in Germany,compulsory licenses under the provisions of subsection (1)may be granted to ensure an adequate supply of the patented product to the domestic market. Importing shallinsofar be deemed to constitute working of the patent inGermany.

(6) The grant of a compulsory license to a patent shall become permissible only after the patent has beengranted. The license may be granted subject to restrictionsand made dependent upon conditions. The scope andduration of use shall be restricted to the purpose for whichsaid license has been granted. The patentee shall be entitledto remuneration from the holder of a compulsory licensecommensurate with the circumstances and taking intoconsideration the commercial value of the compulsorylicense. With regard to the recurring remuneration due in thefuture, should there be a significant change in thecircumstances decisive for the determination of the amount

of this remuneration, each party shall be entitled to demand acorresponding adjustment. If the circumstances on whichthe grant of a compulsory license was based no longer applyand if it is unlikely that they will reoccur, the patentee maydemand that the compulsory license be revoked.

(7) A compulsory license to a patent may only betransferred together with the business concerned with theexploitation of the invention. A compulsory license to aninvention that is the subject matter of a patent of earlier datemay only be transferred together with the patent of later date.

• The law states explicitly that

importation is a form of working ofthe patent (exploitation).

• No CL can be granted while a

patent application is pending.



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Greece

Current law: Law No. 1733/1987 on Technology Transfer, Inventions and TechnologicalInnovation (2011) (Greek only)See: http://www.wipo.int/wipolex/en/text.jsp?file_id=228973

English version: Law on Technology Transfer, Inventions and Technical Innovation asamended by Law No. 2516/1997 See: https://www.jpo.go.jp/shiryou_e/s_sonota_e/fips_e/pdf/greece/patent_law.pdf

Provisions CommentsArticle 13 - Non-contractual licence1. The competent court mentioned in paragraph 10 ofthe present article may grant to a third party, without

prior consent of the patentee, a licence for exploitationof the patent in case that the following prerequisitesconcur accumulatively:a. A period of three years has elapsed since the grantof the patent or a period of four years has elapsedsince the filing date of the patent application;

b. The relevant invention has not been exploited inGreece or, in case it has, the production of the productsthereof is insufficient to cover local demand;c. The third party is in a position to exploitproductively the invention covered by the patent;

d. The third party notified the patentee, one month prior to the initiation of the judicial proceedings,regarding his intention to request a non-contractuallicence.

2. The non-contractual licence shall not be granted incase the patentee justifies lack of exploitation orinsufficient exploitation in the country. Theimportation of the product does not constitute anexcuse for the invocation and application of this

paragraph.

The regulation of item 1 above shall not apply to products imported from Member States of the EuropeanUnion and the Member States of the World TradeOrganization(1).

3. The grant of a non-contractual licence may notexclude other contractual or non-contractual licences.The non-contractual licence may be assigned only alongwith the part of the enterprise which exploits theinvention.

4. The owner of the patent may request from thecompetent court mentioned in paragraph 10 the grant of

• A CL is granted by a court.

• The "accumulative" aspect is notrequired by TRIPS.

• Article 13.1.b refers to"productive exploitation" whichimplies that exploitation cannot be

fulfilled by importation.• Article 13.1.c requires the third

party that will benefit from the

license to be able to produce the product covered by the patentwhich is a severe limitation forthird parties, because it means theycannot rely on importation.• In accordance with the Parisconvention (Art 5. 1.4), article 13.2

provides the possibility for the patent holder to justify the lack ofexploitation or insufficientexploitation and block the non-

contractual license. According tothe second sentence of the

paragraph, importation cannot beused as an excuse by the patentowner to justify lack of orinsufficient local exploitation,which implies that importation isnot considered to be exploitation.The first two sentences of article13.2 were added to the patent lawof 1987 in 1992. Later on, in 1995,a third sentence was added to

specify that the second sentence



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a non-contractual licence on an earlier patent, providedthat his invention relates to the invention of the earlier

patent, the productive exploitation of said invention isnot possible without offending the rights of the ownersof the earlier patent and his invention constitutes a

significant progress in comparison with the invention ofthe prior patent. When the aforementioned non-contractual licence has been granted, the owner of theearlier patent may request the granting of a non-contractual licence for the subsequent invention.

5. The non-contractual licence shall be grantedfollowing petition of the interested party before thecompetent court mentioned in paragraph 10.The petition is accompanied by the opinion of theIndustrial Property Organisation regarding the existence

of the prerequisites for granting the non-contractuallicence in accordance with the preceding paragraphs,the amount, the terms of the compensation to be givento the owner of the patent, and the exclusive or non-exclusive character of the exploitation of the invention.The Industrial Property Organisation states its opinionfollowing petition of the party interested in exploitingthe patent. The opinion of O.B.I. is granted within onemonth form the date the relevant petition is filed and isnot binding for the competent court. Copy of theapplication for granting a non-contractual licence alongwith the relevant opinion of O.B.I. and the note fixingthe day of the trial shall be notified to the owner of the

patent and to the beneficiaries of other contractual ornon-contractual licences.

6. In case the petition is approved, the competent courtgrants a non-contractual licence. The licence pertains tothe extent of the exploitation rights of the invention, theduration of its validity, the date of commencement ofthe productive exploitation of the invention in Greece

and the amount and terms of compensation to be paid tothe patentee by the beneficiary of the licence. Theamount and the terms of the compensation aredetermined in accordance with the extent of theindustrial exploitation of the protected invention.

7. The decision of the court in accordance with paragraph 6 shall be recorded to the Patents Register ofO.B.I., published in the Industrial Property Bulletin andnotified to the persons mentioned in paragraph 5.

8. Following petition of the owner of the patent or the beneficiary of the non-contractual licence, the

does not apply to productsimported from EU Members andmore generally WTO Members.This means that for these countries(161 members of the WTO, which

include all EU members)importation can be considered asexploitation – however this remainsnot true for the rest of the countriesin the world. The addition from1995 is improving the text a little,but it does not totally mitigate thelimitation introduced in 1992.

Article 13.6 sets that the license shall be used for "productiveexploitation" which excludes the

possibility of importation. It alsomentions that the terms of thecompensation depend on the

"extent of the industrialexploitation" which can beunderstood as meaning that the

percentage of royalty can bereduced if the exploitation isimportant (see insert below aboutremuneration).



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competent court mentioned in paragraph 10 may amendthe terms of granting of the licence if new data justifythe amendment or revoke the non-contractual licence ifits beneficiary does not respect the terms of the licenceor if the prerequisites for its granting have ceased

existing. If the immediate revocation brings about asignificant damage to the beneficiary of the non-contractual licence, the court may allow thecontinuation of the exploitation for a reasonable periodof time.

9. The non-contractual licence does not grant the rightfor importation of the products covered by theinvention.

10. The competent court for the grant, assignment,

amendment or revocation of a non-contractual licence isthe three member court of first instance at the place ofresidence of the petitioner, which judges in accordancewith the proceeding of article 741 to 781 of the Code ofCivil Procedure Law.

• Article 13.9 clearly sets that thenon-contractual license cannot beused to import products which is amajor limitation, when patentowners with headquarters in the

EU or any country member of theWTO do have the possibility toexploit their invention(s) throughimportation (article 13.2).

Article 14 Licence to the Public Sector1. For imperative reason of serving public health andnational defense after justified decision of the Ministerof Industry, Energy, and Technology and, accordingto the case, any competent Ministers, a licence forexploitation of an invention can be granted to bodies ofthe public sector which may exploit the invention inGreece, provided that the relevant invention has not

been productively exploited in Greece or the productionof the products thereof is insufficient to cover localneeds.

2. Prior to the issue of the relevant decision, the patentee and anyone who is in position to give usefuladvice, are called upon to express their views.

3. By the same decision, following the opinion ofO.B.I., the amount and the terms of the compensation tothe owner or the patent are determined. The amount ofthe compensation is determined in accordance with theextent of the industrial exploitation of the invention. Incase of disagreement of the patentee as regards theamount of the compensation, the compensation isdetermined by the relevant one-member court of firstinstance of the jurisdiction, in the injunction

proceedings.

• The patent license to the PublicSector is an administrative decisiondedicated to serve public health ornational defense.• Article 14.1 establishes that the

compulsory patent license shall be granted by the Minister of Industry, Energy, and Technology, which should be the ministerial authorityin charge of Industry, as patentsare industrial property titles.• The Minister of Health can either

take part to the decision or advisethe competent authority making thedecision in place of the Minister of

Industry, Energy, and Technology.

The license is granted to a body oran institution belonging to the public sector to exploit the patent, for instance order the supply of generic medicines to the public system.• As in article 13, the condition to

grant the license is that the patenthas not been productively exploitedin Greece or that ongoing

production is insufficient to cover

local demand.



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• As explained in article 14.2 and

14.3 before the relevantadministrative decision is issued,the patentee is asked to express itsviews, while the Patent Office is

asked to provide an opinion aboutthe non-contractual license. Article14.3 also establishes that the

Minister of Industry, Energy, andTechnology is to set the amount andterms of the compensation by the

same decision. As in article 13 thecompensation needs to take intoaccount the "extent of the industrialexploitation of the invention".



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Hungary

Current law: Act No. XXXIII of 1995 on the Protection of Inventions by Patents(consolidated text as of March 15, 2014) See: http://www.wipo.int/edocs/lexdocs/laws/en/hu/hu098en.pdf

Provisions CommentsChapter IVCOMPULSORY LICENSESCompulsory licenses for lack of exploitationArticle 31If within four years from the date of filing of thepatent application or within three years from thegrant of the patent, whichever period expires last, the

patentee has not exploited the invention in theterritory of the country to satisfy the domestic demandor if he has not undertaken serious preparations or hasnot granted a license for such purpose, a compulsorylicense shall be granted to the applicant for the license,unless the patentee justifies the lack of exploitation.

• There is no ground for CL besidethe lack of exploitation. No

government use, nothing specific tohealth (expect the CL forexportation).

Compulsory licenses in respect of dependent patentsArticle 32(1) If the patented invention cannot be exploitedwithout infringing another patent (hereinafterreferred to as “the dominant patent”), a compulsory

license shall be granted, on request and to the extentnecessary for the exploitation of the dominant patent, tothe holder of the dependent patent, provided that theinvention claimed in the dependent patent involves animportant technical advance of considerable economicsignificance in relation to the invention claimed in thedominant patent.

(2) Where a compulsory license has been granted under paragraph (1) with respect to a dominant patent, theholder of such a patent shall be entitled on reasonableterms to a license to exploit the invention claimed in thedependent patent according to the common provisionson compulsory licenses.

(3) The provisions of Article 33(1) and (2) shall alsoapply mutatis mutandis if the subject matter of a plantvariety protection provided for in Chapter XIII cannot

be exploited without infringing a patent.Common provisions governing compulsory licensesgranted for lack of exploitation and in respect of

dependent patentsArticle 33



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(1) An applicant for a compulsory license shall berequired to prove that the requirements for acompulsory license have been complied with, andfurther that(a) the patentee was unwilling to grant a voluntary

license to exploit the patent under appropriateconditions and within a reasonable period of time;(b) he is able to exploit the invention to the requiredextent.

(2) A compulsory license may only be granted forexploitation necessary to satisfy predominantly thedomestic demand; the compulsory license shall notafford an exclusive right of exploitation. The scope andduration of a compulsory license shall be established bythe court, taking into account the purpose of the

exploitation authorised by the compulsory license; acompulsory license may be granted with or withoutlimitation. Unless relinquished or cancelled, acompulsory license shall have effect until expiration ofthe term of validity fixed by the court or until the lapseof patent protection. Compulsory licenses shall berecorded in the Patent Register.

(3) The patentee shall receive adequate compensationfor the compulsory license, which shall be fixed, failingagreement between the parties, by the court. Thecompensation shall take into adequate account theeconomic value of the compulsory license. In particular,it shall be commensurate with the royalty the holder ofthe compulsory license would have paid on the basis ofan exploitation contract concluded with the patentee,taking into account the licensing conditions in thetechnical field of the invention.

(4) The holder of a compulsory license shall have thesame rights as the patentee in regard to the maintenance

of the patent and the exercise of the rights deriving from protection.

(5) If the holder of a compulsory license ceases to existor if any of its organizational units are separated, thecompulsory license shall be transferred to the successorin title. A compulsory license granted with respect to adominant patent may only be assigned together with thedependent patent. However, a compulsory license maynot be assigned or transferred to any other person. Theholder of a compulsory license may not grant a license

of exploitation.



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(6) The holder of a compulsory license may relinquishhis compulsory license at any time. If the holder doesnot begin exploitation within one year from thedefinitive grant of the compulsory license, the patenteemay claim modification or cancellation of the

compulsory license.

(7) The patentee may request modification orcancellation of a compulsory license if thecircumstances on which it was based cease to exist andare unlikely to occur again. Modification or cancellationshall take a form that does not prejudice the legitimateinterests of the holder of the compulsory license.Compulsory licenses to address public health problemsArticle 33/A(1) The Hungarian Intellectual Property Office shall

grant a compulsory license for the exploitation of aninvention in the cases and on the terms laid down inRegulation (EC) No 816/2006 of the EuropeanParliament and of the Council of 17 May 2007 oncompulsory licensing of patents relating to themanufacture of pharmaceutical products for export tocountries with public health problems (hereinafterreferred to as “Regulation816/2006/EC”). (2) The licensee may not grant a license of exploitationon the basis of the compulsory license under paragraph(1).(3) The licensee may relinquish his compulsory licenseunder paragraph (1) at any time. Unless relinquished orcancelled, a compulsory license under paragraph (1)shall have effect until expiration of the term of validityfixed by the Hungarian Intellectual Property Office oruntil the lapse of patent protection.

• This provision concerns the newoption for production and export ofmedicines under CL.



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Ireland

Current law: Patents (Amendment) Act, 2006 (S.I. No. 31 of 2006)See: http://www.wipo.int/edocs/lexdocs/laws/en/hu/hu098en.pdf

Provisions Comments70. — (1) At any time after the expiration of the periodof three years, or such other period as may be

prescribed, beginning on the date of the publication ofnotice of grant of a patent any person may apply to theController for a licence under the patent, or for anentry in the register to the effect that licences under the

patent are to be available as of right, on any or all of thefollowing grounds:

(a) that — (i) a demand in the State for the subject matter ofthe patent is not being met or is not being met onreasonable terms, or

(ii) a demand in the State for a product which is protected by the patent is being met by importationother than from a member of the World TradeOrganisation;

(b) that the establishment or development ofcommercial or industrial activities in the State isunfairly prejudiced.

(2) If an invention protected by a patent (in this sectionreferred to as ‘the second patent’) cannot be exploited in

the State without infringing rights deriving from another patent (in this section referred to as ‘the first patent’)

the proprietor of the second patent may apply to theController for a licence under the first patent to theextent necessary for the exploitation of the inventionconcerned, provided that such invention involves animportant technical advance of considerable economicsignificance in relation to the invention claimed in the

first patent.

(3) Where an application is made under this section, ifthe Controller is satisfied:

(a) that any of the grounds specified in subsection(1) are established, or

(b) that an invention protected by a patent cannot be exploited without infringing rights deriving from thefirst patent as referred to in subsection (2),the Controller may make an order in accordance withthe application and, where the order is for the grant of alicence, the order may require the licence to be granted

• The patent Controller is the entity

that can grant compulsory licenses.• The fact that "a demand in the

State for the subject matter of the patent is not being met or is notbeing met on reasonable terms" is a

ground for CL.• The fact that a product is

imported from a country that is nota member of the WTO (and not produced in Ireland or imported from a WTO member) is a ground for CL.



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upon such terms as the Controller thinks fit, providedthat:

(i) any licence granted shall be non-exclusive;(ii) any licence granted shall be predominantly forthe supply of the market in the State;

(iii) any licence granted may only be assigned withthe prior authorization of the Controller and with that part of the enterprise or goodwill which uses the patented invention and, in the case of a licencegranted on an application under subsection (2) inrespect of the first patent, the licence may only beassigned by the proprietor of the second patent inconjunction with the assignment of the second

patent;(iv) a licence shall only be granted subject to the

payment to the proprietor of the patent of adequate

remuneration in the circumstances of the case,taking into account the economic value of thelicence;(v) the scope and duration of the licence shall belimited to the purpose for which it is granted;(vi) any licence granted on an application undersubsection (1) in respect of a patent which relates tosemi-conductor technology shall only be for publicnon-commercial use;(vii) no order shall be made on an application undersubsection (2) unless the proprietor of the second

patent is able and willing to grant the proprietor ofthe first patent and the licensee of that proprietor across-licence, on reasonable terms, to use theinvention claimed in the second patent.

(4) The Controller shall, in determining whether tomake an order pursuant to an application under thissection, take account of the following matters,namely —

(a) the nature of the relevant invention, the time

which has elapsed since the grant of the patent and themeasures already taken by the proprietor or any licenseeto make full use of the invention,

(b) the ability of any person to whom a licencewould be granted under the order to exploit the patent tothe public advantage, and

(c) the risks to be undertaken by that person in providing capital and exploiting the patent if theapplication is granted.

(5) Section 68(3) shall apply to a licence granted

pursuant to an order under this section as it applies to alicence granted by virtue of section 68.”.



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71. — (1) Where an order for the grant of a licence or foran entry in the register has been made pursuant to anapplication under section 70, any person may apply tothe Controller to amend or cancel the order on thegrounds that the circumstances which led to the order

have changed or have ceased to exist and are unlikely torecur.

(2) Where the Controller is satisfied that thecircumstances referred to in subsection (1) havechanged or have ceased to exist and are unlikely torecur, the Controller may order the amendment orcancellation of the existing order upon such terms as theController thinks fit, including, in particular, termswhich provide for the protection of the interests of thelicensee concerned.

(3) Section 73 shall, in so far as it is applicable, apply inrelation to an application under subsection (1).

(4) Where, following an application under subsection(1), an order is amended, subsections (1), (2) and (3)shall, in so far as they are applicable, apply in relationto the order so amended.72.- (1) At any time after the expiration of the period ofthree years beginning on the date of the publication of

notice of grant of a patent, or such other period as may be prescribed under section 70(1), any Minister of theGovernment may apply to the Controller upon anyone or more of the grounds specified in section 70 foran entry in the register to the effect that licences underthe patent are to be available as of right, or for the grantto any person specified in the application of a licenceunder the patent, and the Controller may, if satisfiedthat any of those grounds are established, make an orderin accordance with the application.

(2) Sections 70(3) and 71 shall, so far as applicable,apply in relation to an application and an order madeunder this section as they apply in relation to anapplication and an order under section 70.



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73.- (1) Every application under section 70 or 72 shallspecify the nature of the order sought by the applicantand shall contain a statement (to be verified in suchmanner as may be prescribed) setting out the nature ofthe applicant’s interest (if any) and the facts upon which

the application is based and shall be accompanied byevidence indicating that the applicant sought to obtain alicence from the proprietor of the patent but has beenunable to obtain such a licence on reasonable termsand within a reasonable time.

(1A) The Controller may, when so requested by theapplicant, dispense with the evidence referred to insubsection (1) —

(a) where there exists a national emergency or

other circumstances of extreme urgency, or

(b) in the case of an application for a licence forpublic non-commercial use:

Provided that the proprietor of the relevant patent hasbeen informed as soon as reasonably practicable ofthe intention of the applicant to apply to theController for a licence under the patent.

(2) Where the Controller is satisfied, upon considerationof any application referred to in subsection (1), that a

prima facie case has been made out for the making of anorder, he shall direct the applicant to serve copies ofthe application upon the proprietor of the relevantpatent and any other persons appearing from theregister to be interested in the patent in respect of whichthe application is made, and shall advertise theapplication in the Journal.

(3) The proprietor of the relevant patent or any other

person desiring to oppose an application referred to insubsection (1) may, within such time as may be prescribed, give to the Controller notice of opposition.

(4) A notice of opposition given under this section shallcontain a statement (to be verified in such manner asmay be prescribed) setting out the grounds on which therelevant application is opposed.

(5) Where a notice of opposition is duly given underthis section, the Controller shall notify the applicant and

shall, subject to the provisions of section 74 withrespect to arbitration, determine the question.

• Prior request for authorization to

use the patent is requested.

• The requirement that

authorization should be asked tothe patent holder can be dispensedin case of "national emergency andother circumstances of extreme

urgency" or in case of public non-commercial use.

• The patent holder must be

informed of the applicant'sintention to apply for a CL. This isnot required by TRIPS.

• The patent holder gets copies ofthe application before the CL is

granted. This is not required byTRIPS.

• The patent holder can oppose the

request for CL before it is granted.This is not required by TRIPS.



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74.- (1) On any appeal from any order made by theController in pursuance of an application under section70, 71 or 72 the Attorney General shall be entitled toappear and be represented.

(2) Where an application is opposed and either:(a) the parties consent; or(b) the proceedings require a prolonged examination

of documents or any scientific or local investigationwhich cannot, in the opinion of the Controller,conveniently be made before him,

The Controller may at any time order the wholeproceedings, or any question or issue of fact arisingtherein, to be referred to an arbitrator agreed on bythe parties, or, in default of agreement, appointed by

the Controller.

(3) Where the whole proceedings are referred under thissection, section 35 of the Arbitration Act, 1954 (whichrelates to the statement of cases by arbitrators for thedecision of the Court), shall not apply to the arbitration;

but unless the parties otherwise agree before the awardof the arbitrator is made, an appeal to the Court shalllie from the award.

(4) Where a question or issue of fact is referred underthis section, the arbitrator shall report his findings to theController.75.- (1) Any order under this Act for the grant of alicence shall, without prejudice to any other method ofenforcement, have effect as if it were a deed, executed

by the proprietor of the patent and all other necessary parties, granting a licence in accordance with the order.

(2) An order may be made on an application undersection 70 or 72 for an entry in the register to the effect

that licences under the relevant patent are to beavailable as of right notwithstanding any contract whichwould have precluded the making of such an entry inrespect of the patent on the application of the proprietorof the patent under section 68, and any such order shallfor all purposes have the same effect as an entry madein pursuance of an application under section 68.

(3) No order shall be made in pursuance of anyapplication under section 70, 71 or 72 which would beat variance with the Treaty establishing the European

Economic Community or with the TRIPs Agreement.PART V



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Use of Inventions for the Service of the State76.- (1) Any inventor, or any applicant for or proprietorof a patent, may (either for or without valuableconsideration) make to a Minister of the Government,and such Minister may take on behalf of the State, an

assignment of the whole of or any share or interestin the benefit of an invention, of a patent applicationtherefor, or of any patent obtained or to be obtainedtherefor, and where a Minister of the Government takesany such assignment, such Minister may do, or, as may

be appropriate, join in doing, on behalf of the State, allor any of the following things, that is to say-

(a) develop and perfect such invention,(b) form or promote an incorporated company or

an unincorporated association of persons to develop and perfect such invention,

(c) sell or lease any such patent application or patent or grant licences under any such application or patent on such terms as he shall, with the agreement ofthe Minister for Finance, think proper,

(d) form or promote an incorporated company oran unincorporated association of persons to workcommercially any such invention,

(e) do all such things as may be necessary for themaintenance or preservation of any such application or

patent or be otherwise incidental to the ownershipthereof.

(2) Every Minister of the Government shall, beforethe 1st day of April in every year, lay before eachHouse of the Oireachtas a report of every (if any)exercise by him during the year ending on the previous31st day of December of the several powers conferredon him by paragraph (c) or (d) of subsection (1) andalso, if and so far as he considers it to be in the publicinterest, of any or all of the powers conferred by

paragraph (a), (b) or (e) of subsection (1).

(3) All expenses incurred by a Minister of theGovernment under this section shall, to such extent asmay be sanctioned by the Minister for Finance, be paidout of moneys provided by the Oireachtas.

• This article describes licences for

government use.

77.- (1) A patent and a patent application shall haveto all intents the like effect as against the State as ithas against an individual; provided that any Ministerof the Government may, by himself or by such of hisofficers, servants or agents as may be authorized inwriting by him or by any other person acting on his

behalf at any time after the making of an application fora patent, do for the service of the State any of the



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following acts in the State in relation to an inventionwhich is the subject of the application or patent, withoutthe consent of the applicant for or the proprietor of the

patent, that is to say-(a) where the invention is a product, make, use,

import or stock the product or dispose of or sell or offerto dispose of or sell it to any person;(b) where the invention is a process, use it or do in

relation to any product obtained directly by means ofthe process anything mentioned in paragraph (a);

(c) supply or offer to supply to any person any ofthe means, relating to an essential element of thatinvention, for putting the invention into effect.

(2) Anything done by virtue of subsection (1) in relationto an invention which is the subject of an application or

a patent, is subsequently in this section and in section78 referred to as “use of the invention” and the doing of

any such thing shall not amount to an infringement ofthe application or patent concerned.

(3) Use of an invention under this section shall besubject to such terms as may, either before or after theuse thereof, be agreed on, with the approval of theMinister for Finance, by any Minister of theGovernment and the applicant for or the proprietor ofthe patent relating to the invention, or, in default ofagreement, as may be settled in the manner hereinafter

provided, and the terms of any agreement or licenceconcluded between such applicant or proprietor and any

person other than a Minister of the Government shallnot operate to prevent or regulate the use of theinvention for the service of the State.

(4) Where an invention which is the subject of any patent or application for a patent has, before the date offiling, or, where priority is claimed, the priority date of

the application, been duly recorded in a document by, or been tried by or on behalf of any Minister of theGovernment (such invention not having beencommunicated directly or indirectly by the applicant foror the proprietor of the relevant patent), any Ministerof the Government or such of his officers, servantsor agents as may be authorized in writing by him,may use the invention so recorded or tried for theservice of the State free of any royalty or other paymentto the applicant for or the proprietor of the patent,notwithstanding the existence of the application or

patent, and, if in the opinion of such Minister thedisclosure to the applicant or the proprietor, as the case



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may be, of the document recording the invention or theevidence of the trial thereof would be detrimental to the

public interest, such disclosure may be madeconfidentially to counsel on behalf of such applicant or

proprietor or to any independent expert mutually agreed

upon.

(5) Where any use of an invention is made by or withthe authority of a Minister of the Government under thissection, then, unless it appears to such Minister that itwould be contrary to the public interest so to do, theMinister shall notify the applicant for or the proprietorof a patent (if any) relating to the invention as soon as

practicable after the use is begun and furnish him withsuch information as to the extent of the use as he mayfrom time to time reasonably require.

(6) In the case of any dispute as to or in connection withthe use of an invention under this section or the termstherefor, or as to the existence or scope of any record ortrial referred to in subsection (4), the matter shall bereferred to the Court for decision, and the Court shallhave the power to refer the whole matter or anyquestion or issue of fact arising thereon to be heard byan arbitrator upon such conditions as it may direct; theCourt or arbitrator in settling the dispute shall beentitled to take into consideration any benefit orcompensation which the applicant for or proprietor of a

patent (if any) relating to the invention or any other person interested in such application or in such patentmay have received directly or indirectly from the Statein respect of such application or patent.

(7) In any proceedings under this section the Minister ofthe Government who is a party to the proceedings may-

(a) put in issue the validity of the relevant patentwithout applying for its revocation;

(b) if the proprietor of a patent is a party to the proceedings, apply for revocation of the patent uponany ground upon which a patent may be revoked undersection 58.

(8) The right to use an invention for the service of theState under the provisions of this section shall include a

power to dispose of or sell, or offer to dispose of or sell,any products made in pursuance of such right which areno longer required for the service of the State.

(9) Any person who acquires products disposed of orsold in the exercise of powers conferred by this section



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and any person claiming through him shall have powerto deal with the products in the same manner as if theyhad been made pursuant to a patent held on behalf ofthe State.

(10) In this section “service of the State” means aservice financed out of moneys charged on or advancedout of the Central Fund or moneys provided by theOireachtas or by a local authority for the purposes ofthe Local Government Act, 1941.78.- (1) During any period when an order undersubsection (2)(a) is in force the power exercisable inrelation to an invention by a Minister of theGovernment, or a person authorized by a Minister of theGovernment under section 77, shall include power touse the invention for any purpose which appears to such

Minister to be necessary or expedient-(a) for the maintenance of supplies and services

essential to the life of the community;(b) for securing a sufficiency of supplies and

services essential to the well-being of the community;(c) for promoting the productivity of commerce

and industry, including agriculture;(d) generally for ensuring that the whole resources

of the community are available for use and are used, ina manner best calculated to serve the interests of thecommunity;

(e) for assisting the relief of suffering and therestoration and distribution of essential supplies andservices in any country or territory other than the Statethat is in grave distress; or

(f) for ensuring the public safety and the preservation of the State.

(2)(a) Where the Government are of opinion that,

owing to the existence of exceptional circumstances, it

is desirable in the interests of the community that a power conferred by subsection (1) shall be available,they may by order declare that the power shall beavailable.(b) Where an order under paragraph (a) of thissubsection is for the time being in force and theGovernment are of the opinion that the exceptionalcircumstances referred to in that paragraph no longerexist, they shall by order revoke the first-mentionedorder.

• T his articles poses grounds for government use.



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Italia

Current law: Industrial Property Code (Legislative Decree No. 30 of February 10, 2005,as amended up to Decree-Law No. 1 of January 24, 2012, converted into law withchanges by Law No. 27 of March 24, 2012) (only in Italian)See: http://www.wipo.int/wipolex/en/details.jsp?id=13123

Text available in English: Industrial Property Code (Legislative Decree No. 30 ofFebruary 10, 2005, as amended up to Legislative Decree No. 131 of August 13, 2010)See: http://www.wipo.int/edocs/lexdocs/laws/en/it/it204en.pdf

Provisions Comments70.Compulsory license due to lack of implementation.

1. Once three years have passed from the date ofissue of a patent or four years from the date of filingof an application, whichever comes last, if the owner ofthe patent or his successor in title has not implementedthe patented invention, directly or through one ormore licensees, producing in the territory of theCountry or importing objects produced in a MemberState of the European Union or the EuropeanEconomic Area or a Member State of the WorldTrade Organization, or has implemented it to anextent that is gravely disproportionate to the

Country's needs, a mandatory license may be grantedfor the non-exclusive use of the invention, to anyinterested party who so requests.

2. The compulsory license pursuant to paragraph 1 mayalso be granted if the implementation of the inventionhas been suspended or reduced in such a manner as to

be gravely disproportionate to the Country’s needs, formore than three years.

3. The compulsory license is not granted if the lack of

or insufficient implementation is due to causes outsidethe control of the owner of the patent or his successorin title. Such causes shall not include the lack offinancial means, and if the same product is circulatedabroad, the lack of demand in the internal market forthe product patented or obtained with a patented

procedure.

4. The granting of the compulsory license does notrelease the owner of the patent or his successor in titlefrom the obligation to implement the invention. The

patent shall be forfeited if the invention has not beenimplemented within two years of the date of

• Implementation of a patent covers

importation from a Member Stateof the European Union or the European Economic Area or a Member State of the World TradeOrganization.• Implementation of a patented

invention to an extent that is gravely disproportionateconstitutes a ground forcompulsory license.

• The Italian law does not include provisions concerning publicinterest, public health, nor does itinclude licenses for governmentuse.



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granting of the first compulsory license or if it hasbeen implemented to an extent that is gravelydisproportionate to the Country's needs.71.Dependent patent.

1. A compulsory license may be granted if the invention protected by the patent cannot be used without harm tothe rights relating to a patent granted based on a

previous application. In that case, the license may begranted to the owner of the later patent to the extentnecessary to exploit the invention, provided that withrespect to the object of the earlier patent, it representsimportant technical progress of considerable economicimportance.

2. A license thus obtained may not be transferred unless

accompanied by the patent on the dependent invention.The owner of the patent on the principal invention, inturn, shall have the right to be granted a compulsorylicense at reasonable conditions on the patent of thedependent invention.72.Common provisions.1. Whoever requests the granting of a compulsorylicense pursuant to Articles 70 and 71 must prove thathe has contacted the owner of the patent first and has

been unable to obtain a contractual license from him atfair conditions.

2. A compulsory license may be granted only against payment of fair compensation by the licensee to theowner of the patent or his successors in title, and

provided that the party requesting the license gives thenecessary guarantees in relation to a satisfactoryimplementation of the invention in accordance with theconditions set in the license.

3. A compulsory license shall not be granted if it isfound that the requesting party has infringed the patent,unless the party can demonstrate its good faith.

4. A compulsory license may be granted for anexploitation of the invention aimed principally atsupplying the internal market.

5. A compulsory license is granted for a duration notgreater than the remaining duration of the patent, and

provided the consent exists of the owner of the patent or

his successor in title, it may only be transferred with the



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business activity of the licensee or the particular branchof the same in which the license is used.

6. The granting of a compulsory license does not harmthe possibility, including for the licensee, to take legal

action concerning the validity of the patent or theextension of the rights that derive from the same.

7. In the order granting the license the following shall be determined: the scope and duration, the methods ofimplementation, the terms and other conditions onwhich the granting of the license is conditioned upon inrelation to its purpose, the amount and method of

payment of the compensation. In the event ofopposition, the amount and method of payment of theconsideration are determined in accordance with Article

80.

8. The conditions of the license may be modified by adecree of the Ministry of Productive Activities onrequest from each of the interested parties, if validreasons exist in that regard.

9. For the modification of the compensation, Article80 shall apply.

10. In the event that the owner of the patent for which acompulsory license is granted or his successor in titleallows third parties to use the patent at conditions thatare more advantageous than those established for thecompulsory license, those same conditions are extendedto the compulsory license, on request from the licensee.

• Conditions of the CL can be

modified by a decree of the Ministry of Productive Activities.

73.Revocation of compulsory license.1. A compulsory license shall be revoked by a decreeof the Ministry of Productive Activities if it is foundthat the conditions established for implementation of the

invention have not been fulfilled, or if the owner of thelicense has not made payment of the compensation inthe amount or by the methods set.

2. A compulsory license shall also be revoked by adecree of the Ministry of Productive Activities if andwhen the circumstances that led to it being grantedcease to exist and it is unlikely that they will recur, or

by a mutual request from the parties.

3. The revocation may be requested by the owner of the

patent with a request filed with the Italian Patent andTrademark Office, which shall promptly notify the



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owner of the compulsory license by registered mailletter, return receipt requested. Within sixty days ofreceipt of the registered mail letter, the owner may file agrounded opposition to the revocation, by a petitionfiled with the Italian Patent and Trademark Office. The

provisions of Article 199, paragraphs 3, 4, 5, 6 and 7shall apply.

4. In the event of revocation, the party who obtained thelicense may implement the invention at the sameconditions, within the limits of previous use or thelimits that are determined by serious and actual

preparations.



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Latvia

Current law: Patent Law (as amended up to January 1, 2016) See: http://www.wipo.int/wipolex/en/details.jsp?id=15899

Text available in English: Patent Law (as amended up to January 1, 2012)See: http://www.wipo.int/wipolex/en/text.jsp?file_id=352738

Provisions CommentsSection 54.Compulsory Licence(1) If within four years following the filing date orwithin three years following the day when thenotification regarding the grant of a patent was

published the patented invention has not been utilisedor has been utilised to an insufficient extent in theRepublic of Latvia, any person may file an applicationto the administrative court requesting to provide a

permit (compulsory licence) to him or her to utilise the patented invention in conformity with this Law andcourt adjudication. This provision shall not be applied ifthe owner of the patent proves to the court that therehave been justified reasons for the failure to utilise orinsufficient utilisation of the invention.

(2) If the owner of the patent of a biotechnologicalinvention is not able to utilise it without violating the

prior right to a plant variety, he or she may apply for acompulsory licence for the utilisation of such a plantvariety which is protected by the referred to right, and

pay a compensation determined by the court to theowner. In the case of a grant of such a licence, theowner of the plant variety is entitled to qualify for across-licence with justified conditions for the utilizationof the protected invention.

(3) The compulsory licence of the patented inventionmay be obtained in conformity with Paragraphs one andtwo of this Section if:

1) the patented subject or the product acquired with a patented method is of vital importance for ensuringthe welfare, defence or economic interests of Latvianinhabitants; or2) an invention of a particular economic significancemay not be utilised without the utilisation of another

previously patented invention.(4) The compulsory licence shall be granted by thecourt if the claimant within a reasonable time period hasmade an effort to acquire but has not acquired the

• CLs can be granted by an

administrative court.



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licence from the owner of the patent on commerciallyacceptable conditions.

(5) If an emergency situation has been declared in theState, a compulsory licence may be granted by the

Cabinet.

(6) In the case provided for in Paragraph three, Clause 1of this Section the court, when reviewing the facts ofthe case regarding the grant of a compulsory licence,shall observe additionally the following requirements:

1) the scopeof and the time limit for utilisation of the patent may

be limited, depending on the purpose for which thecompulsory licence has been granted;2) the compulsory licence shall be regarded as equal to

a non-exclusive licence;3) a compulsory licence may not be transferred toanother person, except for the case when it istransferred together with an undertaking directlyrelated to the utilisation of the relevant patent or a partof such an undertaking; and4) the compulsory licence shall be granted forutilisation in the internal market of Latvia.

(7) In the case provided for in Paragraph three, Clause 2of this Section, the court, when reviewing the facts ofthe case regarding the grant of a compulsory licenceshall observe additionally the following requirements:

1) the owner of a patent granted earlier (the first ) mayrequest a cross-licence on reasonable provisions forthe utilisation of an invention of a subsequent ownerof the patent;and2) the licence to the first patent shall not be transferredfurther unless it is transferred together with the right tothe subsequent patent.

(8) The court may decide regarding the termination ofthe time limit for a compulsory licence if the factsreferred to in Paragraph one or Paragraph three, Clause1 of this Section no longer exist and the repeatedcommencement thereof is hardly credible.

(9) The holder of a compulsory licence shall pay to theowner of the patent a compensation, the amount ofwhich shall be determined by the court, observing theeconomic value of the licence, the scope of utilisation

of an invention and other circumstances.

• In case of an emergency situationdeclared in the State, a compulsory

licence can be granted by theCabinet.



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Lithuania

Current law: Law on Patents of 18 January 1994, No. I-372 (As last amended on 10 May2007 – by Law No. X-1119) See: http://www.wipo.int/wipolex/en/details.jsp?id=7173

Provisions CommentsArticle 38. Compulsory Cross-licensing when anInvention is Related to the Protected Plant Variety

Where a breeder cannot acquire or exploit a plantvariety right without infringing the exclusive rights

protected by a prior patent, he may apply for acompulsory licence for non-exclusive use of the

invention protected by the patent inasmuch as thelicence is necessary for the exploitation of the plantvariety to be protected, subject to payment of anappropriate royalty. Where such a licence is granted, the

patent owner will be entitled to a cross-licence onreasonable terms to use the protected variety.

Where the owner of a patent concerning a biotechnological invention cannot exploit it withoutinfringing a prior plant variety right, he may apply for acompulsory licence for non-exclusive use of the plant

variety protected by that right, subject to payment of anappropriate royalty. Where such a licence is granted, theholder of the variety right will be entitled to a cross-licence on reasonable terms to use the protectedinvention.Applicants for the licences referred to in paragraphs 1and 2 of this Article must demonstrate that:

1) they have applied unsuccessfully to the owner of the patent of a biological invention or the holder of the plant variety right to obtain a contractual licence;

2) the plant variety or the biological inventionconstitutes significant technical progress ofconsiderable economic interest compared with theinvention claimed in the patent or the protected plantvariety.

The court shall make a decision regarding the grantingof licences referred to in paragraphs 1 and 2 of thisArticle, the amount of royalty and other conditions andextent of a compulsory licence. If the conditions ofgrating of a compulsory licence change or disappear, atthe request of the owner of the patent of a biological



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invention or the holder of the plant variety right, thecourt may revoke a compulsory licence or change itsconditions.Offices keeping a list of protectable plant varieties andthe Patent Register of the Republic of Lithuania shall be

responsible for the registration, in the manner prescribed by legal acts, of the licences referred to paragraphs 1 and 2 of this Article.Where a licence for a plant variety can be granted only

by the Community Plant Variety Office, Article 29 ofCouncil Regulation (EC) No 2100/94 of 27 July 1994on Community plant variety rights shall apply.

Article 38.1. Compulsory Licence for Pharmaceutical ProductsA competent institution authorized by the Government

shall grant mandatory licences in compliance withRegulation (EC) No 816/2006 of the EuropeanParliament and of the Council of 17 May 2006 oncompulsory licensing of patents relating to themanufacture of pharmaceutical products for export to countries with public health problems.

• Recent addition to the law

concerning exportation under CL.

Article 39. Exploitation of an Invention with theAuthorisation of the Government of the Republic ofLithuaniaThe Government of the Republic of Lithuania mayadopt a resolution to permit a State or municipalinstitution, natural or legal persons to market, withoutthe consent of the owner of a patent, a patentedinvention within the territory of the Republic ofLithuania, if:1) an invention protected by a patent is related to publicneeds, national security and public healthprotection, development of economically importantsectors;2) the court determines that a method of theexploitation of an invention employed by the owner of a

patent or licensee is anti-competitive.An invention may be exploited only for the purpose inrespect of which the resolution has been adopted. Theowner of a patent must, for the exploitation of theinvention, be remunerated fairly, taking intoconsideration economic value of the invention.If the owner of a patent or a person who hasauthorization to use an invention, requests, theGovernment of the Republic of Lithuania may, takinginto consideration their reasons, change the conditions

of the use of a patented invention, and time limits of thevalidity of permission.

• CL is granted through aresolution by the Government of the

Republic of Lithuania.

• Public needs, national security

and public health protection are grounds for CL.

• The anti-competitiveness of theexploitation of a patent is

established by court (not just anadministrative decision).



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When authorization to use a patented invention is issuedto the owner of a patent which improves a previously

patented invention (second invention) and that mayinfringe the exclusive rights of the owner of the first

patent, the Government of the Republic of Lithuania

shall, before the adoption of this resolution, take intoconsideration the following additional conditions:1) the claimed in the second patent shall involve animportant technical advance of considerableeconomic significance in relation to the inventionclaimed in the first patent;2) the use authorized in respect of the first patentshall be non-assignable except with the assignmentof the second patent.3) the use authorized in respect of the first patentshall be non-assignable except with the assignment

of the second patent.

The Government of the Republic of Lithuania maydeclare the resolution null and void, if thecircumstances which led to the authorization to use a

patented invention cease to exist, or if a State ormunicipal institution, natural or legal persons use a

patented invention for the purpose other than that inrespect of which the resolution has been adopted.Authorization to exploit an invention must be non-exclusive, i.e. the owner of a patent shall not lose theright to use a patented invention himself, and it shall not

prohibit the owner of a patent to conclude licenseagreements related to the use of a patented invention aswell as to further exploit a patented invention or toimplement his rights in other ways.Authorization to use a patented invention may not betransferred, except when the enterprise (or a partthereof) in which a patented invention is used, istransferred in a manner prescribed by law.Attached to a request to permit the exploitation of a

patented invention must be evidences confirming thatthe person seeking authorization has requested, buthas not received authorization of the owner of a

patent to use the patented invention. This provisionshall not apply in the case of a national emergency orother circumstances of extreme urgency or in casesof public non-commercial use of a patentedinvention. The owner of a patent must be informed inwriting about a resolution, which is being drawn up,concerning the authorization to use a patentedinvention, and about an intention to use a patented

invention for the purposes provided for in subparagraph1 of paragraph 1 of this Article.

• Requesting an authorization from

the patent holder prior torequesting a CL is required.• National emergency or othercircumstances of extreme urgencyor in cases of public non-commercial use of a patentedinvention are reasons to waive therequirement to first try to obtainauthorization from the patent

holder.



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Resolutions of the Government of the Republic ofLithuania concerning the authorization to use a patentedinvention without the consent of the owner of a patentmay be appealed against in court in a manner

prescribed by law.

Upon the receipt of the resolution of the Government ofthe Republic of Lithuania concerning the authorizationto exploit an invention, the State Patent Bureau shall

publish information on the authorization in the nextissue of its Official Bulletin.



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Luxembourg

Current law: Loi du 20 juillet 1992 portant modification du régime des brevetsd'invention, telle que modifiée par la loi du 24 mai 1998See: http://www.wipo.int/edocs/lexdocs/laws/fr/lu/lu040fr.pdf

Provisions CommentsArt. 59. Licence obligatoire 1. Toute personne de droit public ou privé peut, àl'expiration d'un délai de trois ans après ladélivrance d'un brevet, ou de quatre ans à compterde la date de dépôt de la demande de brevet, le délai quiexpire le plus tard devant être pris en considération,obtenir une licence obligatoire de ce brevet, dans les

conditions prévues aux articles suivants, si, au momentde la requête, et sauf excuses légitimes, le propriétairedu brevet ou son ayant cause;a) n'a pas commencé à exploiter ou fait despréparatifs effectifs et sérieux pour exploiter l'invention objet du brevet sur le territoire du Grand-Duché ou d'un autre État partie à l'Accord instituantl'OMC;

b) n'a pas exploité l'invention objet du brevet demanière suffisante pour approvisionner le marchéluxembourgeois.

2. Il en est de même lorsque l'exploitation au Grand-Duché ou dans un autre État partie à l'Accord instituantl'OMC a été abandonnée depuis plus de trois ans.Art. 60. Procédure d’octroi et conditions d’une licence

obligatoire1. La demande de licence obligatoire est formée auprèsdu tribunal ; elle doit être accompagnée de la

justification que le demandeur n’a pas pu obtenir du

propriétaire du brevet une licence d’exploitation et qu’il

est en état d’exploiter l’invention de manière effective

et sérieuse.2. La licence ne peut être que non exclusive ; elle estaccordée à des conditions déterminées, notammentquant à sa durée, son champ d’application et le

montant des redevances auxquelles elle donne lieu.Ces conditions peuvent être modifiées par décision dutribunal, à la requête du propriétaire du brevet ou dulicencié.3. La licence est accordée principalement pourl’approvisionnement du marché luxembourgeois. Dansla fixation du montant des redevances, le tribunal tient

compte de la valeur économique de la licence.

• CL are granted by a court.



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4. Les jugements rendus conformément aux dispositionsqui précèdent sont sujets à appel, quelle que soit lavaleur du litige.Art. 61. Retrait de la licence obligatoire1. Si le titulaire d'une licence obligatoire ne satisfait pas

aux conditions auxquelles cette licence a été accordée,le propriétaire du brevet et, le cas échéant, les autreslicenciés peuvent obtenir du tribunal le retrait de cettelicence.2. Le retrait d'une licence obligatoire peut égalementêtre obtenu lorsque les circonstances ayant conduit àson octroi cessent d'exister et ne se reproduirontvraisemblablement pas.Art. 62. Brevets interdépendants1. Le propriétaire d’un brevet portant sur un

perfectionnement à une invention déjà brevetée au profit d’un tiers ne peut exploiter son invention sansl’autorisation du titulaire du brevet antérieur ; ledittitulaire ne peut exploiter le perfectionnement brevetésans l’autorisation du titulaire du brevet de

perfectionnement.2. Le tribunal peut, le ministère public entendu, dansl’intérêt public, accorder sur sa demande, qui ne peut

être antérieure à l’expiration du délai prévu à l’article

59, une licence non exclusive au titulaire du brevet de perfectionnement dans la mesure nécessaire àl’exploitation de l’invention qui fait l’objet de ce brevet

et pour autant que l’invention, objet du brevet de perfectionnement, présente à l’égard du brevet antérieur

un progrès technique important et un intérêtéconomique considérable. Le propriétaire du premier

brevet obtient, sur requête présentée au tribunal, laconcession d’une licence sur le br evet de

perfectionnement.3. Les dispositions des articles 59, 60, 61 et 65 sontapplicables.Art. 63. Licence d’office

1. Le brevet est soumis à un régime de licence d’office pour autant qu’un arrêté grand-ducal, sur avisobligatoire du Conseil d’État, a déclaré d’intérêt

public la mise en œuvre de l’invention. Sauf en cas

d’urgence, cet arrêté ne peut être pris que s’il est établi

que le titulaire du brevet n’est pas disposé à accorderde licence volontairement et à des conditions etmodalités commerciales raisonnables.2. Du jour de la publication de l’arrêté soumettant le

brevet au régime de la licence d’office toute personne qualifiée peut demander au ministre l’octroi d’une

licence d’exploitation. Cette licence, qui ne peut êtreque non exclusive, est accordée par arrêté du ministre

• A license can be granted by theGrand Duchy upon advice of theCouncil of State if the invention isdeclared of public interest.• Prior request to t he patent holderto obtain authorization to use the

patent is required.• This requirement is waived incase of urgency.



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à des conditions déterminées, en particulier quant à sadurée et son champ d’application, mais non quant auxredevances auxquelles elle donne lieu. La licence estaccordée principalement pour l’approvisionnement dumarché luxembourgeois. Elle prend effet à la date de

la notification de l’arrêté aux parties.3. A défaut d’accord amiable entre les parties

intéressées, le montant des redevances est fixé judiciairement. Dans la fixation du montant desredevances, le tribunal tient compte de la valeuréconomique de la licence.4. La licence d’office peut être retirée par arrêté motivé

du ministre à l’expiration d’un délai fixé dans l’arrêté

d’octroi de la licence, si l’invention brevetée n’est pas

exploitée d’une manière sérieuse ou si l’exploitation ne

se fait pas aux conditions imposées ou convenues. Elle

peut également être retirée lorsque les circonstancesayant conduit à son octroi cessent d’exister et ne se

reproduiront vraisemblablement pas.

Art. 63bis. Licences obligatoires ou d’office dans le

domaine des semi-conducteursSi le brevet a pour objet une invention dans le domainede la technologie des semi-conducteurs, une licenceobligatoire ou d’office ne peut être accordée que pour

une utilisation destinée à remédier à une pratiquedéclarée anticoncurrentielle à la suite d’une procédure

judiciaire ou administrative.

• The license is granted by aministerial decision.

• Royalties are set by a court.

Art. 64. Obligations du titulaire du brevet faisant l'objetd'une licence obligatoire ou d'une licence d'officeLe titulaire d'un brevet faisant l'objet d'une licenceobligatoire ou d'office est tenu de fournir au licencié,au moment de l'octroi de la licence, les précisionstechniques qui, à ce moment, sont à sa connaissance

et indispensables pour la mise en œuvre de

l'invention brevetée.

• The patent holder has to transfer

to the licensee the technicalitiesthat are necessary to implement theinvention.

Art. 65. Transmission d'une licence obligatoire ou d'une

licence d'office1. Les droits attachés à une licence obligatoire ou à unelicence d'office ne peuvent être cédés qu'avec le fondsde commerce, l'entreprise ou la partie de l'entrepriseauquel ils sont attachés.2. Une licence telle que visée à l'article 62, paragraphe2, première phrase ne peut en outre être cédée qu'avecle brevet de perfectionnement.Art. 66. Inscription des décisions rendues en matière delicence obligatoire ou de licence d'office1. Les licences obligatoires et les licences d'office ainsi

que les décisions s'y rapportant sont inscrites auregistre à la requête du bénéficiaire sur remise d'une

http://www.wipo.int/wipolex/fr/text.jsp?file_id=128632#JD_LU035_62_2






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copie certifiée conforme de l'expédition de la décision juridictionnelle ou administrative qui les a accordées,ou, le cas échéant, modifiées et de la preuve du

paiement de la taxe d'inscription.2. L'exercice des droits résultant d'une licence

obligatoire ou d'une licence d'office par le licencié estsubordonné à l'accomplissement des formalitésd'inscription.



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Malte

Current law: Patents and Designs Act (Chapter 417) (2007) See: http://www.wipo.int/wipolex/en/profile.jsp?code=MT

Provisions CommentsPART XI

NON-VOLUNTARY LICENCES ANDGOVERNMENT EXPLOITATION39.(1) The Civil Court, First Hall, may, on a swornapplication filed by any person who proves his ability towork the patented invention in Malta, made after the

expiration of a period of four years from the date of

filing the application for the patent or three yearsfrom the grant of the patent, whichever is later, directthe Comptroller to grant a non-exclusive, non-voluntary licence if the patented invention is not

worked or is insufficiently worked in Malta.

(2) The grant of the non-voluntary licence shall besubject to the payment of such equitable remuneration to the proprietor of the patent as may be determined by

the Civil Court, First Hall, and may be permitted if, prior to the institution of such proceedings, the

proposed user has made efforts to obtainauthorization from the right holder on reasonablecommercial terms and conditions and if such effortshave not been successful within a reasonable period oftime.

(3) Notwithstanding sub article (1), a non-voluntarylicence shall not be granted if the Court is convincedthat circumstances exist which justify the non-workingor insufficient working of the patented invention inMalta.

(4) In deciding whether to grant a non-voluntarylicence, the Court shall give both the proprietor of the

patent and the person requesting the non-voluntarylicence an adequate opportunity to present arguments according to the provisions of the Code of Organizationand Civil Procedure.

(5) Any non-voluntary licence shall be revoked whenthe circumstances which led to its granting cease toexist, taking into account the legitimate interests of the

proprietor of the patent and of the licensee. Thecontinued existence of these circumstances shall be

• A CL is granted by the Controller

under the direction of a civil court.

• Pr ior to the request for CL anattempt to obtain authorization

from the patent holder to use the

patent is required .






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reviewed upon the request of the proprietor of the patent by sworn application before the Civil Court, First Hall.

(6) Article 27(3)(a) of this Act shall be interpreted inthe sense that if the patented product is put on the

market by a licensee pursuant to a non-voluntarylicence, it will not be deemed to have been put on themarket with the express consent of the proprietor of the

patent.

(7) The scope and duration of a non-voluntary licenceshall be limited to the purpose for which it wasauthorized and shall be:

(a) non-exclusive,(b) non-assignable, except with that part of theenterprise or goodwill which enjoys such

authorization,(c) terminated if and when the circumstances whichled to it cease to exist, and(d) predominantly for the supply of the domestic market.

(8) The Civil Court, First Hall, may on a swornapplication filed by the owner of a patent (the second

patent) which cannot be exploited without infringing anearlier patent (the first patent), direct the Comptroller togrant a non-exclusive, non-voluntary licence providedthat:

(i) the invention claimed in the second patent shallinvolve an important technical advance ofconsiderable economic significance in relation to theinvention claimed in the first patent;(ii) the owner of the first patent shall be entitled to across-licence on reasonable terms to sue theinvention claimed in the second patent; and(iii) the use authorized in respect of the first patentshall be non-assignable except with the assignment

of the second patent.(9) Where a breeder cannot acquire plant variety

protection or exploit a plant variety without infringing a prior patent, he may apply to the Civil Court, First Hall,for a compulsory licence for non-exclusive use of theinvention protected by the patent in so far as the licenceis necessary for the exploitation of the plant variety to

be protected, subject to payment of an appropriateroyalty.Where such a licence is granted, the holder of the patent

will be entitled to a cross-licence on reasonable terms touse the protected variety:



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Provided that an applicant for a licence referred to inabove shall demonstrate that:

(a) he had applied unsuccessfully to the holder of the prior patent to obtain a contractual licence;(b) the plant variety constitutes significant technical

progress of considerable economic interest comparedwith the invention claimed in the prior patent.

(10) Where the holder of a patent concerning a biotechnological invention cannot exploit it withoutinfringing a prior plant variety right, he may apply for acompulsory licence for non-exclusive use of the plantvariety protected by that right, subject to payment of anappropriate royalty. Where such a licence is granted, theholder of the variety right will be entitled to a cross-licence on reasonable terms to use the protected

invention:Provided that an applicant for a licence referred to inabove shall demonstrate that:

(a) he had applied unsuccessfully to the holder of the prior plant variety right to obtain a contractuallicence;(b) the invention constitutes significant technical

progress of considerable economic interest comparedwith the plant variety protected by the prior plantvariety right.

(11) With regard to plant variety protection sub articles(9) and (10) shall only come into force when therelevant form of plant variety protection comes intoforce as provided in article 4(5)(e).40.(1) Where the national security or public safety sorequires, the Minister may authorize, even without theagreement of the proprietor of the patent or the patentapplication, by notice published in the prescribed form,a Government agency or a person designated in the

said notice to make, use or sell an invention to which a patent or an application for a patent relates, subject to payment of equitable remuneration to the proprietorof the patent or the application for the patent.(2) The conditions set out in article 39(7) and (8) shallalso apply in respect of an authorization issued by theMinister under this article.(3) Any decision taken by the Minister under this articlemay be the subject of an appeal in an action by swornapplication before the Civil Court, First Hall.

• A CL can be granted by an

administrative order in cases ofnational security or public safety.• In such case , there seem to be norequirement for prior attempt to

obtain authorization from the patent holder to use the patent .



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Netherlands

Current law: Patent Act 1995 (Act of December 15, 1994 Containing Rules Relating toPatents) (2008)See:http://www.wipo.int/wipolex/en/details.jsp?id=3226Non-voluntary

Provisions Comments Article 571. If Our Minister considers it in the public interest hemay grant a licence under a patent to a party that hedesignates, provided that he precisely indicates therelevant content. Before rendering his decision, unless itis incompatible with the urgency of the matter OurMinister shall ascertain whether the patent holder is

willing to grant the licence voluntarily and onreasonable terms. To this end, he shall give the patentholder an opportunity to express his opinions on thematter in writing and, at his request, also orally. The

patent holder and the licensee shall be notified of thedecision. In his decision Our Minister may impose uponthe licensee the obligation to provide security within acertain term. The lodging of an objection and anappeal shall have a suspensive effect, unless thedecision of Our Minister provides otherwise in view ofthe urgency of the matter.

2. If, after three years have elapsed since the grant ofthe patent, neither the patent holder nor any other partywho has been granted a licence operates an industrialestablishment in the Kingdom or in another State to bedesignated by general order in council for the Kingdomin which the product concerned is being made orwhere the process concerned is being applied in goodfaith and on a sufficient scale, the patent holder shallbe obliged to grant the licence needed for operatingsuch an establishment unless valid reasons are shown to

exist for the absence of such an establishment. Thisobligation shall apply in respect of the holder of aEuropean patent if, after three years have elapsed sincethe date on which the notification of the grant of theEuropean patent was published in accordance withArticle 97(4) of the European Patent Convention, anindustrial establishment as referred to above is not inoperation in the Netherlands or in the NetherlandsAntilles or in another State to be designated by generalorder in council for the Kingdom.

3. Paragraph (2) shall not apply if the patent holder orany other party who has been granted a licence has an

• The Minister of Economic Affairsis the authority that can grant CLsto serve public interest.

• It is the Minister who shallestablish if the patent holder is

ready to grant a voluntary licence, before granting a CL, except whenthis is "incompatible with theurgency of the matter".



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industrial establishment in operation in that part of thecontinental shelf contiguous to the Netherlands or

Netherlands Antilles in which the Kingdom hassovereign rights, in which those acts referred to in that

paragraph are performed in good faith and on a

sufficient scale, provided that such acts are associatedwith and performed during the exploration for orrecovery of natural resources.

4. The patent holder is obliged at all times to grant alicence required for the use of a patent granted inrespect of an application that has the same or a laterdate of filing or, if a right of priority exists in respect ofthe application, the same or later date of priority, insofaras the patent for which the licence is requestedrepresents a considerable technical advance involving a

considerable economic value; however the patent holderwill be obliged to grant a licence required for the use ofa European patent only after the term for filing anopposition to the European patent has expired or afteropposition proceedings thus instituted have ended.The scope of such a licence shall not extend further thanis necessary for the use of the licensee’s patent. The

latter will be obliged to grant a reciprocal licence underhis patent to the holder of the other patent.

5. The patent holder shall grant a plant breeder a licencein exchange for a reasonable fee if the plant breedercannot obtain or exploit a plant breeder’s right in

respect of the plant variety without infringing the patentthat was granted earlier and the licence is necessary forthe exploitation of the plant variety to be protected,which represents a significant technical advanceinvolving a considerable economic value in respect ofthe invention protected by the patent.

6. If a patent holder is granted a licence on the ground

of Article 42(2) of the Dutch Seeds and PlantingMaterials Act (Zaaizaad- en Plantgoedwet), the patentholder shall grant the holder of the plant breeder’s right

a reciprocal licence, at the latter’s request, to use the

protected invention subject to reasonable conditions.



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Article 57a Notwithstanding the provisions contained in Article 57,a compulsory patent licence in the field ofsemiconductor technology may be granted only for non-commercial use by the government or in order to

combat an act that has been determined to be restrictiveof competition after judicial or administrative proceedings. Article 581. If the licence referred to in Article 57(2), (4), (5) or(6) is unjustifiably withheld, the licence shall be grantedby the court on the basis of a claim brought by theinterested party. At the claimant’s request the Office

shall enter the writ of summons in the patent register.

2. If a patent is granted on the basis of this KingdomAct, the claimant’s claim shall be inadmissible if hedoes not attach to his writ of summons the results of areport by the Office or the European Patent Office asreferred to in the European Patent Conventionconcerning the state of the art with regard to the subjectmatter of the patent for which the licence is beingclaimed.

3. The grant of a licence claimed pursuant to the firstsentence of Article 57(4) may be suspended, subject toa term or subject to no term, if a claim to have the

patent for which the licence is being claimedinvalidated has been submitted within two months afterservice of the writ of summons in which the licence isclaimed.

4. In the description of the licence granted the courtmay derogate from the licensee’s claims and may also

require that the licensee furnish security within a certainterm. A licence granted pursuant to the first sentence ofArticle 57(4) may be transferred only together with the

licence holder’s patent. A licence granted pursuant tothe first or third sentence of Article 57(4) shall notexpire because the patent on which the licence isgranted has lapsed upon the expiry of the periodreferred to in Article 36(6) or has been successfullyclaimed, but such a licence shall expire insofar as the

patent is invalidated in whole or in part as a result of theclaim referred to in paragraph (3).

5. A decision within the meaning of Article 57(1) or acourt decision that has become final and has acquired

the force of res judicata shall be entered in the patentregister by the Office.

• CL granted under conditions

described in Article 57(2), (4), (5)or (6) are granted by a court.



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If an obligation to furnish security has been imposed,the entry shall not be made before that obligation has

been met. A fee, the amount of which shall be fixed bygeneral order in council for the Kingdom, shall be duefor the entry. The licence shall enter into effect only

after the entry, but shall subsequently also have effectwith regard to parties who became entitled to the patentafter the entry in the register of the writ of summonsreferred to in paragraph (1).However, a registered licence granted on the ground ofArticle 57(4) shall have retroactive effect to the date onwhich the writ of summons was entered.

6. On the ground of a claim brought by the initiating party, in the absence of agreement the court shall fix thefee that the licensee must pay to the patent holder. In

that context the court may also require that the licenseefurnish security within a certain term or confirm orchange the security stipulated by virtue of Article 57(1)or paragraph (5) of this Article.

Article 58a1. A licence granted on the ground of Article 57 is notexclusive.

2. A licence granted on the ground of Article 57 may betransferred only together with the part of the business orthe goodwill of the part of the business in which thelicence is exercised.3. A licence granted on the ground of Article 57 may berevoked if, taking into consideration a reasonable

protection of the licensee’s justified interests, the

circumstances that led to the licence being granted haveceased to exist and it is unlikely that they will berevived. On the ground of a substantiated request theauthority that granted the licence shall investigatewhether the aforementioned circumstances continue toapply.

Article 591. In the interest of the defense of the Kingdom, and ona joint recommendation by Our Minister and OurMinister who is directly concerned, it may be

provided by Royal Decree that the State shall beauthorized to perform or cause others to perform acts, to

be described precisely in that Decree, that the patentholder to be specified in that Decree has the exclusiveright to perform pursuant to Articles 53 and 53a. Theauthorization shall apply as long as the patent is ineffect, unless a shorter term has been specified in the

Decree.

• Article 59 states a form of government use that can be grantedby Royal decree following therecommendation of the Minister of

Economic Affairs and the Ministerconcerned in the interest of thedefense of the Kingdom.• The law does not allow

government use for other reasonsthan defense.



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2. Upon the entry into force of a Decree as referred to in paragraph (1), Our Minister who is directly concernedshall determine, by agreement with the patent holder,the fee to be paid to the patent holder by the State. IfOur Minister who is directly concerned has not reached

an agreement with the patent holder within six monthsfrom the date of the entry into force of that Decree,Article 58(6) shall apply mutatis mutandis, with theexception of the provisions concerning the furnishing ofsecurity.

Article 2 of the Policy Rules on issuing compulsorylicenses pursuant to WTO decision WT/L/5401. In the interests of solving public health problems inan importing state or group of states, the Minister shall,upon receiving an application that satisfies the

requirements of articles 3 and 4 of these policy rules,issue a compulsory licence as referred to in section 57,subsection 1 of the Patents Act 1995 for the

pharmaceutical product that is needed to address the public health problems in question.

2. The compulsory licence shall at a minimum state thetype and amount of the pharmaceutical product towhich the compulsory licence issued for the purposes ofthe order applies.

3. The compulsory licence shall relate only to pharmaceutical products intended for the nationalmarket or markets of the importing state or group ofstates.

• Article 2 concerns the exportation

of medicines under CL following onthe WTO decision.



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Poland

Current law: Act of July 24, 2015, amending the Act on Industrial Property and someother Acts (in Polish only)See: http://www.wipo.int/wipolex/en/details.jsp?id=15803

Law available in English: Act of June 30, 2000, on Industrial Property (as amended byAct of January 23, 2004, and Act of June 29, 2007)See: http://www.wipo.int/edocs/lexdocs/laws/en/pl/pl028en.pdf

Provisions CommentsArticle 681. The patent holder or the licensee may not abuse hisrights, in particular by preventing the invention from

being exploited by a third party, if such exploitation isnecessary for the purpose of meeting home marketdemands and is particularly dictated by public interest

considerations, and consumers are supplied with theproduct in insufficient quantity or of inadequate

quality, or at excessively high prices. 2. Preventing third parties from exploiting the inventionwithin a period of three years from the date of the

grant of the patent shall not be considered the abuse ofrights, referred to in paragraph (1).3. The Patent Office shall have the right to request a

patent holder or a licensee to submit any explanations asto the scope of the exploitation of the invention for the

purpose of establishing whether or not the patent is

abused.4. The provisions of paragraphs (1) and (2) shall not

prejudice the provisions on counteracting

monopolistic practices.

• Thi s article stresses cases wherethe patent holder should let a third

party exploit a patent when it isnecessary, according to public

interest considerations, because

consumers are supplied with the

product in insufficient quantity or

of inadequate quality, or at

excessively high prices.

Article 821. The Patent Office may grant authorization toexploit a patented invention of another person (acompulsory license), where:

(i) it is necessary to prevent or eliminate a state ofnational emergency, in particular in the field ofdefense, public order, the protection of humanlife and health, as well as the protection ofnatural environment, or

(ii) it has been established that the patent has beenabused within the meaning of Article 68, or

(iii) it has been established that the patent holderenjoying the right of priority of an earlierapplication (the earlier patent) prevents, by

refusing to conclude a license contract, themeeting of home market demands through the

• CL are granted by the Patent

Office.

• The protection of human life andhealth is one of the grounds to

grant CLs.



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exploitation of the patented invention (thedependent patent), whose exploitation wouldencroach upon the earlier patent; in such case, theholder of the earlier patent may demand that anauthorization be given to him for the exploitation

of the invention that is the subject matter of thedependent patent (cross-license).

2. The grant of a compulsory license for the exploitationof an invention in the case referred to in paragraph(1)(iii) shall be conditional upon ascertainment that theexploitation of the invention that is the subject matter ofthe dependent patent, where the both inventions concernthe same subject matter, involves an important technicaladvance of considerable economic significance. In caseof an invention concerning semi-conductor technology,

a compulsory license may only be granted to counteractunreasonable anti-competitive practices.

3. Where the Patent Office finds that the patent isabused within the meaning of Article 68, it may decidethat a compulsory license may be applied for and shallannounce this in “Wiadomości Urzędu Patentowego”.

4. A compulsory license may be granted, if the applying party is able to prove that it has earlier made, in goodfaith, efforts to obtain a license. This requirement may

be waived in the case of a compulsory license to begranted for the purpose of preventing or eliminating astate of national emergency or where it is announcedthat a compulsory license may be applied for.

5. Where it is announced that a compulsory license may be applied for, waiver of the requirement referred to in paragraph (4) shall not be applicable in respect ofapplications for the grant of a license submitted after theexpiration of a period of one year counted from the

date of that announcement. 6. The provision of paragraph (1) (iii) shall applyaccordingly, where a plant breeder is not able toexercise his right to the protected plant variety ordemands a cross-license to be granted to him by the

patent holder.

• An attempt to obtain a license

from the patent holder is requiredto apply for a CL.• This requirement can only be

waived when a CL is granted forthe purpose of preventing oreliminating a state of nationalemergency or where it isannounced that a compulsorylicense may be applied for(following the condition describedin (5)).

Article 83The compulsory license shall be non-exclusive.

Article 88The provisions on the grant of a compulsory license in

the case referred to in Article 82(1) (iii) shall apply



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accordingly to a utility model, whose exploitationwould encroach upon the earlier patent.



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Portugal

Current text: Industrial Property Code (consolidated as of 2008) See: http://www.wipo.int/edocs/lexdocs/laws/en/pt/pt071en.pdf

Provisions CommentsArticle 106OBLIGATION TO EXPLOIT1. The patentee is obliged to exploit a patentedinvention directly or through a person authorized byhim and to market the results obtained in order to fulfilthe needs of the national market.

2. Exploitation shall begin within four years of the

date of the patent application or three years of thegrant date, whichever is greater.

3. It is possible to enjoy patent rights with nodiscrimination as to place of invention, thetechnological field or the fact that the products areimported from any country belonging to theEuropean Union or WTO or produced locally.

• The working of patent covers

importation from an EU or WTOmembers – but not from othercountries.

Article 107COMPULSORY LICENCES1. Compulsory licences may be granted for a certain

patent, in any of the following cases:a) Lack or insufficient exploitation of a patentedinvention;

b) Dependency between patents;c) Reasons of public interest.

2. Compulsory licences shall be non-exclusive and mayonly be transferred with the part of the company orestablishment that exploits them.

3. Compulsory licences may only be granted if the potential licensee has made efforts to obtain acontractual licence from the patentee on acceptablecommercial conditions and said efforts have not beensuccessful within a reasonable period of time.

4. A compulsory licence may be revoked withoutlegitimate prejudice to the appropriate protection of thelicensees' interests if and when the circumstances thatgave rise to it cease to exist or are not likely to occuragain. The competent authority may re-examine the

continuation of said circumstances on duly justifiedrequest.

• Reasons of public interest is a

ground to grand CLs.

• Prior attempt to obtain a

voluntary license is required to geta CL.



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5. If a patent concerns semiconductor technology,compulsory licences may only granted for a non-commercial, public purpose.

6. The patentee shall receive appropriate payment ineach concrete case on the basis of the economic value of the licence.

7. A decision granting or denying payment is subjectto judicial or arbitral appeal under Articles 48 to 50.

• A court is setting royalties.

Article 108LICENCE DUE TO FAILURE TO EXPLOITINVENTION1. After the time limits referred to in Article 106(2) have expired, a patentee who, without a good reason or

legal basis, does not exploit an invention, directly orunder licence, or does not do so in such a way as tomeet national needs, may be obliged to grant a licencefor its exploitation.

2. A patentee may also be obliged to grant anexploitation licence for an invention if he ceases toexploit it for three consecutive years without a goodreason or legal basis.

3. Objective technical or legal reasons beyond the patentee's control and irrespective of his situationmaking the exploitation of the invention impossible orinsufficient are considered good reason, but noteconomic or financial difficulties.

4. For as long as a compulsory licence remains in force,the patentee may not be obliged to grant another beforethe previous one is cancelled.

5. A compulsory licence may be cancelled if the

licensee does not exploit the invention in such a way asto meet national needs.

• Not exploiting the invention in a

way as to meet national needs is a ground for CL.

• Economic or financial difficultiescannot be considered as acceptablereason to justify lack or insufficientexploitation of a patent.

Article 109DEPENDENT LICENCES1. If it is not possible to exploit a patented invention,without prejudice to the rights conferred by a previous

patent, and the two inventions are used for differentindustrial purposes, a licence may only be granted if thefirst invention is essential to the exploitation of thesecond, and only in the part necessary for saidexploitation, and the holder of the first patent is entitled

to fair compensation.



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2. If inventions protected by dependent patents serve thesame industrial purpose and a compulsory licence is to

be granted, the previous patentee may also demand acompulsory licence for the previous patent.

3. If an invention concerns a process for preparing achemical, pharmaceutical or food product protected bya current patent, and whenever this process patentrepresents notable technical progress in relation to the

previous patent, both the holder of the process patentand the holder of the product patent are entitled todemand a compulsory licence for the other holder's

patent.

4 If the obtainer of a plant variety cannot obtain orexploit a plant securing right without infringing a prior

patent, he may request a compulsory licence for non-exclusive exploitation of the invention protected by the

patent, provided that this licence is necessary for theexploitation of the same plant variety, on payment ofappropriate remuneration.

5. Whenever a licence of the type provided for in the previous paragraph is granted, the patentee is entitled toa reciprocal licence on reasonable terms to use the

protected variety.

6. If the holder of a patent for a biotechnologicalinvention is unable to exploit it without infringing a

previous plant variety securing right, he may request acompulsory licence for non-exclusive exploitation ofthe variety protected by the securing right on paymentof an appropriate sum.

7. Whenever a licence of the type provided for in the previous paragraph is granted, the holder of the securingright is entitled to a reciprocal licence on reasonable

terms to use the protected invention.8. Applicants for the licences referred to in paragraphs 4and 6 must prove that:a) They approached the patentee or plant securing rightholder in vain to obtain a contractual licence;

b) The plant variety or invention represents importanttechnical progress of considerable economic interest inrelation to the invention claimed in the patent or to the

plant variety being protected.

9. This article also applies whenever one of theinventions is protected by a patent and the other by a



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utility model.Article 110PUBLIC INTEREST1. A patentee may, in the public interest, be obliged togrant a licence for the exploitation of his invention.

2. There are considered to be reasons of public interestif the start, increase or generalization of the exploitationof the invention, or an improvement in the conditions ofits exploitation, is of vital importance to public health or national defense.

3. There are also considered to be reasons of publicinterest if failure to exploit or insufficient quality orquantity of exploitation is highly detrimental to thecountry's economic or technological development.

4. The government shall be responsible for granting alicence in the public interest.

• Response to a matter of vital

importance to public health can justify the ground of public interestto grant a CL.

Article 111REQUESTS FOR COMPULSORY LICENCES1. Compulsory licences shall be requested from theNational Industrial Property Institute. Applicantsshall submit proof to justify their request.

2 Requests for compulsory licences shall be examinedin the order in which they are submitted to the NationalIndustrial Property Institute.

3 On receiving a request for a compulsory licence, the National Industrial Property Institute shall give the patentee two months in which to say anything he seesfit and to submit proof .

4 The National Industrial Property Institute shallconsider the parties' arguments and the guarantees ofexploitation of the invention offered by the applicant for

the compulsory licence and decide, within twomonths, whether or not it should be granted.

5. If it decides in favor, it shall give both parties onemonth to appoint an expert who, together with theexpert appointed by the National Industrial PropertyInstitute, shall agree, within two months, on theconditions of the compulsory licence and thecompensation to be paid to the patentee.

• The National Industrial Property

Institute is the entity authorized to grant CLs.• There is no government use type

of CL in the law.

Article 112 NOTIFICATION OF AND APPEAL AGAINST

GRANT OR REFUSAL OF LICENCE



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1. The National Industrial Property Institute shallinform both parties of the grant or refusal of a licenceand its exploitation conditions.

2. Appeals may be lodged against the decision of the

National Industrial Property Institute to grant or refusethe licence, or only the conditions in which it has beengranted, to the competent court under the terms ofarticles 39 et seq., within three months of the date of thenotification referred to in the previous paragraph.

3. A decision to grant shall only be effective after itsconfirmation and annotation at the National IndustrialProperty Institute, where the appropriate fees shall be

paid as for an ordinary licence.

4. An extract of the registration referred to in the previous paragraph shall be published in the IndustrialProperty Bulletin.



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Romania

Current law: Law No. 64/1991 on Patents (as amended up to Law No. 83/2014) See: http://www.wipo.int/edocs/lexdocs/laws/en/ro/ro081en.pdf

Provisions CommentsCHAPTER V - TRANSFER OF RIGHTSArt. 42- (1) The right to the patent, the right to the grant of a

patent and the rights deriving from a patent shall betransferable, either wholly or in part.(2) Transfers may be effected by assignment, by thegrant of exclusive or non-exclusive licenses or by legalor testamentary succession.

(3) Transfers shall produce effects in respect of third parties only as from the date of publication in theOfficial Industrial Property Bulletin of the mention ofthe transfer registered with OSIM.Art. 43- (1) Upon request by any interested person, theCourt of Bucharest may grant a compulsory licenseafter 4 years have elapsed from the patentapplication filing date or after 3 years have elapsedfrom the grant of the patent, whichever period expireslater.

(2) The provisions of paragraph (1) shall only applywhere the invention has not been exploited or hasbeen insufficiently exploited on the territory ofRomania, and the patent owner cannot justify hisinaction, and where no agreement has been reachedwith him regarding the conditions and commercialmethods for applying the invention.

(3) The Court of Bucharest shall authorize thecompulsory license, if it considers, based on givencircumstances, that, in spite of all efforts made by theinterested person, no agreement could be reachedwithin a reasonable time period.

(4) Besides the cases referred to in paragraph (2), acompulsory license may be authorized by the Court ofBucharest:a) in national emergency cases;

b) in other cases of extreme emergency;c) in cases of public use for non-commercial

purposes.

• A CL is granted by the Court of

Bucharest.

• All type of CL have to fulfill Art.

43 (1).

• A CL can only be granted after anattempt to reach an agreement withthe patent holder is made.

• Exception to this requirementconcerns national emergency

cases, other cases of extremeemergency, public use for non-



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(5) The grant of the compulsory license, for one of thereasons provided under paragraph (4), shall not requirethe fulfillment of the conditions mentioned underparagraph (2). Nevertheless, the licensee shall informthe applicant or patent owner about the authorization

given by the Court, within the shortest delay.

(6) In cases of public use for non-commercialpurposes, the Government or third parties authorized

by the Government, if they know or have demonstrablereasons to know that a valid patent is or will be used bythe Government or the third parties, shall inform thepatent owner accordingly, within a reasonable time.

(7) In cases where a patent cannot be exploited withoutinfringing the rights conferred by other patent granted

for an application having a prior regular national filingdate, a compulsory license for exploiting the subsequent

patent may only be authorized if the followingadditional conditions are cumulatively fulfilled:

a) the invention claimed in the subsequent patentinvolves an important technical advance ofconsiderable economic significance as comparedwith the invention in the earlier patent;

b) the owner of the earlier patent is entitled to across-license on reasonable terms for using theinvention claimed in the subsequent patent;c) the use authorized in respect of the earlier patentshall be non-transferable, except for the transfer withthe subsequent patent.

commercial purposes (asallowed by TRIPS).

Art. 44- (1) Compulsory licenses shall be non-exclusive andshall be granted by the Court of Bucharest, underspecific conditions regarding their extent andduration, as well as the amount of royalties to whichthe right holder is entitled, established in accordancewith the commercial value of the licenses granted.

(2) Beneficiaries of the compulsory license can also bethe Government or third parties authorized by theGovernment.

(3) Compulsory licenses shall be authorized mainly forsupplying the market.

(4) The extent and duration of compulsory licenses shall be limited to the purposes for which they have beenauthorized. In case of the inventions in the

semiconductor technology field, the license shall begranted only for public non-commercial purposes or



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to remedy a practice declared as anti-competitive, asa result of a judiciary or administrative procedure.

(5) When the owner of a plant variety patent cannotexploit the patent without infringing a prior patent, he

may request a compulsory license for the invention protected by said patent.

(6) When the owner of a patent relating to a biotechnological invention cannot exploit the patentwithout infringing a prior plant variety patent, he mayrequest a compulsory license for the exploitation of the

plant variety protected by said patent.

(7) Where a compulsory license is authorized forremedying an anti-competitive practice, the provisions

of Art. 43, paragraphs (3) and (4) and Art. 44, paragraph (3) shall not be applicable.Art. 45- The compulsory license shall not be transferredotherwise than with the part of the enterprise or thestock of goods benefitting by said use.Art. 46- (1) Upon the justified request presented by theinterested person, the Court of Bucharest may withdrawthe compulsory license, when the circumstances leadingto the grant of the license ceased to exist, provided thatthe legitimate interests of the licensee should be

protected adequately. The license shall not bewithdrawn if the circumstances which determined thegrant of the license are likely to occur again.

(2) The decisions of the Court of Bucharest concerningthe authorization for using a compulsory license, as wellas those concerning the remuneration prescribed asagainst the use of the license, may be appealed againstonly with the Court of Appeal of Bucharest.

Art. 47- The final and irrevocable Court decisions concerningthe grant or the withdrawal of the compulsory license,as the case may be, shall be communicated by theinterested person to OSIM, which shall enter saiddecisions in the National Register of PatentApplications or in the National Register of Patents, asthe case may be, and shall publish the mention of suchdecisions in the Official Industrial Property Bulletinwithin one month from communication.



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Slovak Republic

Current law: Act No. 435/2001 Coll. on Patents, Supplementary Protection Certificatesand Amendment of Some Acts (The Patent Act, consolidated version 2009) See: http://www.wipo.int/edocs/lexdocs/laws/en/sk/sk041en.pdf

Provisions CommentsCompulsory licenceArticle 27(1) On request the court shall be entitled to grant acompulsory licence to any person who can prove thecapability to exploit an invention, which is a subject-matter of a granted patent, within the territory of theSlovak Republic, provided that

a) 4 years have expired since filing of anapplication or 3 years have expired from granting apatent, where the time limit, which expires later, shallapply,

b) person requesting granting of a compulsorylicence has offered before filing a request to a patentowner a proper conclusion of a licence agreement,whilst this offer was not accepted by a patent ownerwithin three months from its filing, and

c) invention has not been exploited within theterritory of the Slovak Republic without an appropriate

reason by a patent owner, or it has been exploitedinsufficiently, while a subject-matter of a patentedinvention as a product has not been supplied to themarket of the Slovak Republic in a sufficient quantity.

Non-existence of an appropriate reason shall be presupposed, unless proved otherwise.

(2) Compulsory licence may be granted only as a non-exclusive licence, whilst its duration and scope shall belimited to purpose for which it has been granted

provided that domestic market needs shall be satisfied

preferentially.

(3) If a subject-matter of a patent is a technology ofsemiconductor products, compulsory licence may begranted only for public non-commercial exploitation orto prevent a patent owner from further action, which

pursuant to a decision of a competent body can beconsidered as an action abusing or restricting economiccompetition 13) or in case of serious public interestmenace.

• CLs are granted by a court.

• The person petitioning for the

grant of the CL must try to first geta voluntary license from the patentholder.

• The patent has not been exploited

or it has not been exploited sufficiently, which can translate ininsufficient supply to the market.



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(4) Notwithstanding paragraph 1(a) and (b) compulsorylicence may be granted in case of serious publicinterest menace.

(5) Notwithstanding presuppositions pursuant to

paragraph 1 and conditions pursuant to paragraph 2, acourt shall be entitled to grant a compulsory non-exclusive licence for utilization of a biotechnologicalinvention on request, if a cultivator shall not be able toexploit or acquire right to a plant variety withoutinfringing earlier right to a patent, if the plaintiff provesthat

a) before filing a request he has offered to a patentowner a proper conclusion of a licence agreement,whilst this offer was not been accepted by a patentowner within three months from its filing, and 13) Act

No 136/2001 Coll. on Protection of EconomyCompetition and on Amendment of the Act of the

National Council of the Slovak Republic No 347/1990Coll. on Organisation of Ministries and Other CentralState Administration Authorities of the Slovak Republicas amended.

b) plant variety represents an important technical progress of a considerable economic importancecomparable with an invention which is a subject-matterof a request for granting a compulsory licence.

(6) In case of granting a compulsory licence pursuant to paragraph 5, a patent owner shall have right for grantinga cross compulsory licence for utilization of a plantvariety pursuant to a special regulation 2).

(7) If a patent owner has granted a compulsory licencefor utilization of a plant variety pursuant to a specialregulation 13b), an owner of a cultivator certificate shallhave right for granting a cross compulsory licence forutilization of a biotechnological invention.

(8) Assignment or transfer of right of a compulsorylicence holder shall be possible exclusively as a part ofan assignment or transfer of a company or of its part,within which an invention is being used on a basis of acompulsory licence.

(9) A holder of a compulsory licence shall be entitled towaive rights from a compulsory licence by a writtennotice delivered to the Office. Waiver of right shallcome into effect from the day of delivery of a notice to

the Office or on a later day which is stated in a notice as

• CL can be granted in case of

serious public interest menace. But1(c) still applies.



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a day from which a compulsory licence rights holderwaives his rights.Article 28(1) By granting a compulsory licence, right of a patentowner to adequate compensation shall remain

unaffected; Article 26(3) shall apply mutatis mutandisto purposes of determining compensation forexploitation of an invention, which is a subject-matterof a compulsory licence.

(2) In case of substantial change of circumstances,which led to granting a compulsory licence, the courtshall be entitled on a request of one of parties to licencerelation to cancel a decision on granting a compulsorylicence, provided that re-occurrence of reasons forgranting a compulsory licence is improbable or

compulsory licence rights have not been used duringone year.

(3) The Office shall enter valid decision on granting andcancelling compulsory licence into the Register.



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Slovenia

Current law: Industrial Property Act (ZIL-1-UPB3) of May 23, 2001 as last amended on6 February 2006 (as in force from 11 March 2006)See: http://www.wipo.int/edocs/lexdocs/laws/en/si/si028en.pdf

Provisions CommentsChapter XCOMPULSORY LICENCESArticle 125Compulsory licences(1) The court may decide that a third party or theGovernment of the Republic of Slovenia exploit theinvention without the authorization of the owner of the

patent:

(a) where the public interest concerning, in particular, national security, nutrition, health or thedevelopment of other vital sectors of the nationaleconomy so requires,

or(b) where the court has determined that the owner

of the patent or his licensee abuses the patent rights, in particular where the manner of exploitation, contrary tothe adopted regulations, restrains competition.

(2) The court shall grant compulsory licences under

paragraph (1) with regard to given circumstances andafter hearing the owner of the patent.

(3) Compulsory licences under paragraph (1) shall begranted provided that the person filing the request

proves that he has made efforts to conclude a licencecontract with the owner of the patent on reasonablecommercial terms and that such efforts failed tosucceed within a reasonable period of time.

(4) Paragraph (3) shall not apply if a state of war or

similar state of emergency has been declared. Nevertheless, the owner of the patent shall be notifiedof the decision of the court as soon as reasonably

practicable.

• CLs are granted by a court. The isno government use type of CL(through administrative order).

• Health is among the publicinterests stated by the law as

grounds for the granting of a CL.

• The other possible ground is anabuse of patent rights establishedby a court.

• Efforts must be made to obtain alicense from the patent holderbefore requesting a CL.

Article 126Conditions for granting compulsory licences(1) Compulsory licences under Article 125 shall begranted under the following conditions:

(a) scope and duration shall be limited with regardto their purpose;

(b) they shall be non-exclusive;(c) they shall be non-transferable, with the



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exception of the part of the enterprise or business of thelicence owner to which the licence refers;

(d) they shall be granted primarily for the supplyof the market of the Republic of Slovenia.

(2) Where a patent, hereinafter referred to as "thesecond patent", cannot be exploited without infringinganother patent, hereinafter referred to as "the first

patent", the following conditions, in addition to those ofArticle 125 and paragraph (1) above, for the grant ofcompulsory licence in respect of the first patent shall bemet:

(a) the invention claimed in the second patent shallinvolve a technical advance of considerable economicsignificance compared to the invention claimed in thefirst patent;

(b) the owner of the first patent shall underreasonable conditions be entitled to a cross-licence touse the invention claimed in the second patent;

(c) the use authorized in respect of the first patentshall not be transferable except with the simultaneoustransfer of the second patent.

(3) The court shall decide that a compulsory licenceexpire if the circumstances which led to it being grantedhave ceased to exist and are unlikely to recur. Article 127Remuneration for compulsory licences(1) Owners of patents under a compulsory licence shall

be entitled to remuneration.

(2) The amount of the remuneration shall be determinedwith regard to the circumstances of each case and takinginto account the economic value of the compulsorylicence.



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Spain

Current text: Law No. 24/2015 of July 24, 2015 on Patents (en espagnol seulement) See: http://www.wipo.int/wipolex/en/details.jsp?id=15768

Text available in English: Law No. 11/1986 of March 20, 1986 on Patents (as last amendedby Law 50/1998 on Tax, Administrative and Social Policy Measures) See: http://www.wipo.int/edocs/lexdocs/laws/en/es/es069en.pdf

Provisions CommentsChapter I Obligation to Work83.The owner of a patent shall be obliged to work the

patented invention either himself or through a person

authorized by him, by implementing it in Spain or onthe territory of a Member of the World TradeOrganization in such a manner that the working issufficient to satisfy demand on the national market.Working must take place within a period of four yearsfrom the date of filing the patent application or threeyears from the date on which grant of the patent waspublished in the Official Bulletin of IndustrialProperty, the period which expires latest beingautomatically applied.84.

(1) The owner of the patent shall prove its working before the Registry of Industrial Property by means ofan official certificate issued by the relevant body andcorresponding to the prescribed criteria and generalregulations.

(2) The certificate of working shall be based oninspection of the manufacturing process in the industrialestablishment where the invention is being worked andon proof that the object of the invention is effectively

being marketed.

(3) The said certificate shall be issued within threemonths following the date on which it was requestedand shall state specifically that the patented invention is

being worked, setting out the information substantiatingthat statement.

(4) The certificate of working shall be recorded at theRegistry of Industrial Property.85.

When working has been proved before the Registry ofIndustrial Property by means of the relevant certificate,



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unless there is proof to the contrary, it shall be presumed that the patented invention is being worked inthe form required by Article 84 of the present Law.Chapter II Requirements for the Granting ofCompulsory Licenses

86.Where a particular patent is not the subject of the offerof ex-officio licenses and where one of the following situations exists, a compulsory license may be granted:

(a) failure or insufficiency of working of the patented invention;

(b) export necessities;(c) dependency of patents;(d) existence of reasons of public interest.

• Conditions are note cumulative in

article 86.

87.(1) Following expiration of the period laid down in

Article 83 for working the invention protected by the patent, any person may request the granting of acompulsory license for the patent provided that, at thetime of the request, unless there are legitimateexcuses, working of the patent has not commenced oreffective and concrete preparations have not been madeto work the invention that is the subject matter of the

patent, or working has been suspended for more thanthree years.

(2) Legitimate excuses shall be deemed to be objectivedifficulties of a legal technical nature, independent ofthe will and circumstances of the owner of the patent,which make working of the patent impossible or

prevent its working from being more extensive that it is.

• But article 87 states that request

for CL necessarily concerns cases

where the patent is not worked.

88.Where the export market cannot be satisfactorilysupplied due to insufficient production of the subjectmatter of the patent, thus creating serious prejudice forSpain's economic and technological progress, theGovernment may, by Royal Decree, make the said

patent subject to a regime of compulsory licenses theobjective of which shall cover exclusively theunsatisfied needs of the export market.

• In case local production is

insufficient to supply the exportmarket, a Royal decree can grant aCL to cover the export market.

89.(1) Where it is not possible to work the invention

protected by a patent without harming the rightsconferred by an earlier patent, the owner of thesubsequent patent may at any time require the grantingof a compulsory license for the earlier patent providedthat his invention has distinctive industrial objectives orrepresents considerable technical progress in

comparison with the earlier patent.



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(2) Where inventions used for the same industrial purpose are protected by patents that are dependent oneupon another and a compulsory license has beengranted to the owner of the dependent patent, the ownerof the earlier patent may also apply for the grant of a

license for the later patent.

(3) Where the subject matter of a patent is a process toobtain a chemical or pharmaceutical substance

protected by a patent in force and provided that the patent for the process represents considerable technical progress in comparison with the earlier patent, both theowner of the patent for the process and the owner ofthe patent for the product shall have the right toobtain a compulsory license for the patent of the other

party.

(4) The content of a compulsory license granted forreasons of dependency of patents shall only besufficient to allow working of the invention protected

by the patent concerned and it shall no longer haveeffect after invalidation or forfeiture of any of the

patents on which it is dependent.

• In case of patent on process to

obtain a chemical or pharmaceutical substance that is patented, owners of the patent forthe process and of the patent for the

product shave the right to obtain acompulsory license for the patent ofthe other party.

90.(1) For reasons of public interest, the Governmentmay at any time make a patent application or a patentalready granted subject to the grant of compulsorylicenses, acting in that respect by Royal Decree.

(2) Reasons of public interest shall be deemed to existwhen the initiation, increase or generalization ofworking of the invention, or improvement of theconditions in which it is being worked, are ofparamount importance for public health or nationaldefense.Reasons of public interest shall also be deemed to existwhen failure to work or the insufficient quality or

quantity of working leads to serious prejudice forSpain's economic or technological development.

(3) A Royal Decree on the granting of compulsorylicenses shall be drawn up at the proposal of theMinistry of Industry and Energy. In cases where theimportance of working the invention concerns publichealth or national defense, the proposal shall beformulated jointly with the competent Minister forhealth or defense, respectively.

(4) A Royal Decree making a patent subject to thegranting of compulsory licenses because of its

• CLs for public interest are

granted by the government through Royal Decree (administrativedecision).

• Public health is one case of public

interest that justifies the use of CLs.

• In case of public health issues, a proposal for CL must be preparedby the Ministry of Industry and

Energy together with the ministerin charge of health.



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importance for national defense may reserve the possibility of soliciting one or several specificenterprises for such licenses.

(5) Where public interest can be met without the need to

generalize working of the invention or entrusting itsworking to a person other than the owner of the patent,the Royal Decree may conditionally make the patentsubject to the granting of compulsory licenses,authorizing the Minister of Industry and Energy toallow the owner a period not exceeding one year toinitiate, increase or improve working of theinvention to the extent necessary to meet the publicinterest. In such cases, the Minister of Industry andEnergy, having heard the owner of the patent, mayallow the period he deems appropriate or may

immediately make the patent subject to the granting oflicenses. Following expiration of the period which has

been fixed, where appropriate, the Minister of Industryand Energy shall decide whether the public interest has

been met and, if such is not the case, shall make the patent subject to the granting of compulsory licenses.Chapter III Procedure for Granting CompulsoryLicenses91.(1) Before applying for a compulsory license, theinterested party may r equest the mediation of theRegistry of Industrial Property in order to obtain acontractual license for the same patent.

(2) The request for mediation shall be subject topayment of a fee and shall contain the following:

(a) full indications concerning the applicant;(b) the patent to which the request refers, together

with an indication of its owner,(c) the relevant circumstances that may justify the

granting of compulsory licenses;

(d) the scope of the license sought and the reasonssubstantiating that claim;(e) information permitting a decision on whether or

not the applicant can effect real and effective workingof the patented invention and can offer the securitiesreasonably required by the owner of the patent forgranting a license.

(3) The request for mediation shall be accompanied by:(a) documents supporting the claims made therein;(b) a document attesting to constitution of a security,

the amount of which shall be prescribed in the

• Before requesting a CL, the

interested party must request the Registry of Industrial Property toorganize a mediation with the

patent holder in order to obtain avoluntary license.



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Regulations, to be used to meet the costs of the procedure to be paid by the applicant;

(c) a complete copy of the application and theaccompanying documents.92.

(1) Following submission of the request for mediation,within the non-extendable period of one month, theRegistry of Industrial Property shall decide whetherto agree to mediate.

(2) The Registry shall agree to mediate when theinterested party's request and the accompanyingdocuments, as well as the investigations carried out bythe Registry itself, reasonably show that there arecircumstances that could lead to the granting ofcompulsory licenses for the patent, that the applicant is

solvent and that he has at his disposal the necessarymeans to achieve serious working of the patentedinvention.

(3) The Registry shall notify its decision to theinterested party and to the owner of the patent, and atthe same time shall transmit a copy of the request formediation to the latter.

(4) No appeal may be made against the Registry'sdecision.93.(1) Where the Registry of Industrial Property agreesto mediate, it shall immediately notify the interested

parties accordingly and shall invite them to commencenegotiations on the granting of a contractual license,with the Registry participating as mediator. Thenegotiations shall last a maximum of two months.

(2) In its role as mediator, the Registry shall take anactive part in bringing together the positions of the

interested parties and facilitating the granting of acontractual license.

(3) When it has agreed to mediate and during the period provided for negotiations, the Registry shall carry outthe necessary inquiries to acquaint itself with thespecificities of the case and evaluate satisfactorily the

positions of the interested parties, in particular, byascertaining whether circumstances justify the grantingof a compulsory license. This investigative work shall

be carried out whatever the progress of the negotiations

and whether or not they have broken down or not yet begun.



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(4) At the expiration of a period of two months afternotification to the interested parties of its agreement tomediate, if no agreement has been reached on thegranting of a contractual license, the Registry shall

declare its mediation and investigation terminated andshall inform the interested parties accordingly.This period of two months may be extended for aspecified period at the joint request of the two parties,

provided that the Registry deems that such an extensionwill effectively serve to achieve the granting of thelicense. Where the Registry considers that no possibilityof reaching agreement exists, it may terminate itsmediation even though the specified period of extensionhas not expired.

(5) Both before and after the final decision, thedocumentation on mediation may only be consulted bythe parties, who may have copies made of all thedocuments at their own expense. The parties and theRegistry staff who have access to the documentationshall respect the secrecy of the contents.94.(1) Where, as a result of the negotiations carried outwith the mediation of the Registry of IndustrialProperty, the parties agree to a license for the patent,they may request that no applications for compulsorylicenses for the patent be permitted during the periodnecessary for the licensee to start working the invention.This period may under no circumstances exceed oneyear.

(2) For the Registry of Industrial Property to respondfavorably to the request, the following conditions shall

be met:(a) the license agreed upon is exclusive and its

exclusivity is not contrary to the objective that could be

pursued by making the patent subject to the granting ofcompulsory licenses;(b) the interested parties provide documentary proof

that the licensee has at his disposal the meansnecessary to work the invention and the periodrequested is indispensable for commencement ofworking;

(c) the interested parties provide what the Registry ofIndustrial Property considers to be a sufficient securityto meet any liabilities incurred if working of theinvention does not commence within the prescribed

period;(d) the legally prescribed fee has been paid.



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(3) Having examined the documentation submitted bythe interested parties and having carried out theinvestigations and consultations it deems necessary, theRegistry of Industrial Property may suspend the

submission of applications for compulsory licenses forthe patent in question for a specified period, providedthat the conditions laid down in the preceding paragraphhave been met and that, under the circumstances, it isconsidered that the parties seriously wish to commenceworking the patented invention without delay. Thissuspension shall be entered in the Patent Register.

(4) The interested parties shall each month provide proof of the efforts being made to commence workingand the Registry of Industrial Property shall order the

inspections that it deems necessary.

(5) The Registry of Industrial Property may annul thesuspension of submission of applications forcompulsory licenses if it is proved that a serious errorwas committed when evaluating the circumstances

justifying its decision or that the interested parties arenot undertaking serious and continuous activity tocommence working within the prescribed period.

(6) Where the licensee does not commence workingwithin the prescribed period, the Registry of IndustrialProperty shall impose a fine on the interested parties theamount of which shall be calculated on the basis of theaverage sum to be paid by the licensee to the owner ofthe patent as royalties during the period of the contract'svalidity equivalent to the period of suspension.95.(1) Following a period of three months from theexpiration of the period referred to in Article 83, orfrom the refusal of the Registry to accept the

proposed mediation, or from the expiration of the period established by mediation, without anyagreement being reached between the parties, theinterested party may apply to the Registry for thegranting of a compulsory license for the patent.

(2) In the application for a compulsory license, whichshall be subject to payment of the legally prescribedfee, the interested party shall, on the basis of thecontents of the mediation documentation, whereappropriate, and the documents he provides, explain his

application and set out the circumstances justifyingit, the interest on which it is based, the means by

• At the end of the mediation

process and in case of failure toreach an agreement, the interested

party can apply for a CL to the Registry of Industrial Property.



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which he intends to achieve real and effectiveworking of the patented invention and the securitieshe can offer if the license is granted.

(3) The application shall be accompanied by the

following:(a) documents proving the claims made therein andwhich do not appear in the mediation documentation,where appropriate;

(b) a document attesting to the constitution of asecurity, the amount of which shall be fixed in generalin the Regulations, to be used to meet the proceduralcosts payable by the applicant;

(c) a complete copy of the application and thedocuments submitted.96.

(1) Following application for a compulsory license and provided that the conditions mentioned in the precedingArticle have been met, the Registry shall commence therelevant procedure, including therein the mediationdocumentation, where appropriate, and shall transmit acopy of the application and the accompanyingdocuments to the owner of the patent so that he maycontest it within a period not exceeding one month.

(2) Where an application for a compulsory license isaccompanied by proof that the Registry refused tomediate, the period during which the owner of thepatent may contest it shall be two months.

(3) Contestation shall take into account the contents ofthe mediation documentation, where appropriate, andshall be accompanied by evidence substantiating theclaims made therein and which do not appear in the saiddocumentation. It shall be accompanied by a completecopy for transmission to the applicant.

(4) Where satisfactory working of the patentedinvention is invoked, the owner of the patent shallinclude in his contestation information concerning thesaid working, together with evidence proving itsexactitude.97.(1) Following receipt of the patent owner's contestation,the Registry shall transmit it to the other party and,within a non-extendable period of one month, shalltake a decision to grant or refuse a compulsory license.



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(2) Where the owner of the patent does not contest theapplication within this period, the Registry shallimmediately grant the license.

(3) The decision granting the license shall specify its

contents. In particular, it shall determine the scope ofthe license, the royalties, the term, the securities tobe provided by the licensee, the time at whichworking shall commence and any other clauses toensure serious and effective working of the patentedinvention.

(4) The decision shall specify the costs to be paid byeach party, which shall be those occasioned by therequest. Common costs shall be divided in half.Payment of all the costs may be imposed on one of the

parties where he is declared to have acted imprudentlyor in bad faith.

(5) Contentious administrative appeals may be lodgedagainst the Registry's decision. Lodging of an appealshall not suspend execution of the act imposed;however, the Registry may authorize the licensee,following a substantiated request by him, to postponecommencement of working until the decision on thelicense becomes final.98.(1) Following the filing of an application for acompulsory license, the Registry may automaticallytake the necessary steps in order to reach a decision ongranting the license.

(2) At the duly substantiated joint request of theapplicant for a license and the owner of the patent, theRegistry may, at any time, on one occasion only,suspend the procedure at the stage reached for aspecified period not exceeding three months. Following

expiration of the period of suspension, the Registryshall notify the parties and the procedure shall beresumed.99.(1) License contracts agreed with the mediation of theRegistry that directly or indirectly involve payment inforeign currency shall be subject to the authorization

provided for in the regulations governing transfer offoreign technology.

(2) Any decision by the Registry of Industrial Property

on granting a compulsory license that directly orindirectly involves payment in foreign currency shall



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require the issuance of a prior favorable report by the body competent to authorize contractual licensesinvolving such forms of payment.

(3) The necessary coordination between the Registry of

Industrial Property and the body authorizing licensesinvolving payment in foreign currency shall beestablished so as to harmonize criteria and simplify

procedure for the purposes laid down in the presentArticle.100.Where the owner of a patent does not have his legaldomicile or usual residence in Spain, thecommunications provided for under the present Titleshall be sent to the representative, an industrial propertyattorney, who has previously been designated for this

purpose.Chapter IV Compulsory License System101.(1) Compulsory licenses shall not be exclusive.

(2) The license shall provide for adequateremuneration according to the particular circumstancesof each case, due regard being had to the economicimportance of the invention.102.(1) Relations between the owner of the patent and thelicensee who has been granted a compulsory licenseshall be governed by the principle of good faith.

(2) Where a legal decision declares that the owner ofthe patent has violated that principle, the licensee mayrequest the Registry to reduce the royalties fixed for thelicense in proportion to the importance of the unfulfilledobligation for working the invention.103.(1) Compulsory licenses shall include additions to the

relevant patent at the time of granting the license.

(2) Following the grant of a compulsory license, wherenew additions are made to the patent and their subjectmatter has the same industrial application as the

patented invention that is the subject of the license, thelicensee may request the Registry to include the newadditions in the license. Where the interested parties donot reach agreement with the mediation of the Registry,the latter shall fix the royalties and the other conditionsunder which the scope of the license may be extended.

104.



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(1) The transfer of a compulsory license shall only bevalid where the license is transferred together with theenterprise or the part of the enterprise that works the

patented invention and the transfer shall be notedspecifically by the Registry of Industrial Property. In

the case of licenses for dependent patents, the licenseshall be transferred with the dependent patent.

(2) Any sublicenses granted by the owner of acompulsory license shall be null and void.105.(1) Both the licensee and the owner of the patent mayrequest the Registry to modify the royalties or otherconditions of the compulsory license when new factsoccur that justify such changes, in particular, where,after granting of the compulsory license, the owner of

the patent grants contractual licenses under conditionsthat are unjustifiably more favorable.

(2) Where the licensee fails seriously or repeatedly tofulfill any of his obligations under the compulsorylicense, the Registry of Industrial Property mayautomatically or at the request of the interested partyannul the license.106.To the extent that they are not specifically contrary tothe provisions of the present Title, the provisionsgoverning contractual licenses in Chapter II of TitleVIII of the present Law shall apply to compulsorylicenses.Chapter V Promotion of Applications for CompulsoryLicenses107.(1) The Registry of Industrial Property shall makesystematic efforts to promote effectively licenseapplications for patents subject to the granting ofcompulsory licenses. The Registry of Industrial

Property shall also publish periodically details of such patents.

(2) Where the importance of working patentedinventions in Spain so warrants, the Government mayinstitute financial and other incentives to encourageenterprises to apply for licenses for specific patentssubject to the granting of compulsory licenses forreasons of public interest.



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Sweden

Current law: The Patents Act (1967:837) (version in force from July 1, 2014)See: http://www.wipo.int/edocs/lexdocs/laws/en/se/se125en.pdf

Provisions CommentsArticle 44.If a patent has been transferred to another party or alicense has been granted, this fact shall, upon request,

be recorded in the Register of Patents.If it has been proved that a license recorded in theRegister has ceased to be valid, the recording of thelicense shall be cancelled.The provisions of the first and second Paragraphs shall

apply, mutatis mutandis, to compulsory licenses andrights referred to in Article 53, second Paragraph.In lawsuits and other legal cases concerning a patent,the party shall be deemed to be the patent holder whohas last been recorded in the Register of Patents in suchcapacity.Article 45.A compulsory license for the use of an invention inSweden may be granted if1. three years have passed from the granting of thepatent and four years from the filing of the patent

application, 2. the invention is not used to a reasonable extent inSweden, and3. there is no acceptable reason for the non-use of theinvention.For the purposes of the application of the firstParagraph, item 2, importation of the invention toSweden from a State within the European EconomicArea or a State or a territory that is party to theAgreement Establishing the World TradeOrganization (WTO) is equal to the use of theinvention. (Act 2004:159).

• The invention not being used to a

reasonable extent is a ground forCL.

Article 46.A holder of a patent for an invention the exploitationof which is depending on a patent that belongs tosomeone else may be granted a compulsory license toexploit the invention protected by the other patent. Sucha license may be granted only if the applicant provesthat the first-mentioned invention constitutes animportant technical progress of considerable economicinterest compared with the other invention.

If a compulsory license is granted pursuant to the firstParagraph, the holder of the patent for which a



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compulsory license has been granted is entitled toobtain, on reasonable conditions, a compulsory license(cross-license) to exploit the other invention.(Act 2004:159).Article 46 a.

A plant breeder who cannot obtain or exploit a plantvariety right or a Community plant variety right withoutinfringing a patent granted earlier, may obtain acompulsory license to exploit the invention that is

protected by the patent where such a license isnecessary for the plant variety to be exploited. Such alicense may be granted only if the applicant proves thatthe plant variety constitutes an important technical

progress of considerable economic interest comparedwith the invention.Of a patent holder obtains a compulsory license in

respect of a plant variety right or a Community plantvariety right, the holder of the plant variety right isentitled to obtain, on reasonable conditions, acompulsory license (cross-license) to exploit theinvention of the patent holder.Provisions on the possibility for the holder of a patenton a biotechnical invention to obtain, under certainconditions, a compulsory license to exploit a protected

plant variety are contained in Chapter 7, Article 3a, ofthe Act on the Protection of Plant Variety Rights(1997:306) and, in so far as concerns the Community

plant variety rights, in Article 29 of the CouncilRegulation (EEC) No 2100/94 of 27 July 1994 on theCommunity Plant Variety Rights.(Act 2007:516).Article 47.If a public interest of exceptional importance sorequires, anyone who desires to make commercial useof an invention for which another party holds a patentmay obtain a compulsory license to that effect.Article 48.

Any person who in this country was commerciallyexploiting an invention that is the subject of a patentapplication at the time when the application documentswere made available pursuant to Article 22, may, if theapplication results in a patent, obtain a compulsorylicense for the exploitation if particularly strong reasonsexist and he had no knowledge of the application andhad not reasonably been able to obtain such knowledge.Under corresponding conditions such a right shall also

be granted to anyone who had made substantial preparations for commercial exploitation of the

invention in this country. Such a compulsory license



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may also apply for a period of time before the patentwas granted.Article 49.A compulsory license may only be granted to a partythat can be assumed to exploit the invention in an

acceptable manner and in accordance with the license.The applicant must also prove that he or she hasunsuccessfully turned to the patent holder in order toobtain a contractual license on reasonable conditions.A compulsory license does not prevent the patent holderfrom exploiting the invention himself or to grantlicenses. A compulsory license may be assigned tosomeone else only together with a business where it isexploited or was intended to be exploited. In respect ofcompulsory licenses referred to in Article 46, firstParagraph, and Article 46 a, first Paragraph, also applies

that the license may be assigned only together with the patent or the plant variety right to which the licenseapplies.(Act 2004:159).Article 50.A compulsory license is granted by a Court, whichalso decides to what extent the invention may beexploited and determines the remuneration and otherterms for the license. When substantially changedcircumstances call for it, the Court may, upon demand,revoke the license or establish new conditions for it.

• A CL is grant by a court. There is

no government use type of CL inthe Swedish law.



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United Kingdom

Current law: The Patents Act 1977 (Chapter 37, as amended by the Tribunals, Courtsand Enforcement Act 2007)See: http://www.wipo.int/edocs/lexdocs/laws/en/gb/gb324en.pdf

Provisions CommentsCompulsory licences: general48.-(1) At any time after the expiration of three years,or of such other period as may be prescribed, fromthe date of the grant of a patent, any person mayapply to the comptroller on one or more of therelevant grounds –

a) for a licence under the patent;

(b) for an entry to be made in the register to theeffect that licences under the patent are to be availableas of right; or

(c) where the applicant is a governmentdepartment, for the grant to any person specified in theapplication of a licence under the patent.

(2) Subject to sections 48A and 48B below, if he issatisfied that any of the relevant grounds areestablished, the comptroller may -

(a) where the application is under subsection

(1)(a) above, order the grant of a licence to the applicanton such terms as the comptroller thinks fit;

(b) where the application is under subsection(1)(b) above, make such an entry as is there mentioned;

(c) where the application is under subsection (1)(c) above, order the grant of a licence to the personspecified in the application on such terms as thecomptroller thinks fit.

(3) An application may be made under this section inrespect of a patent even though the applicant is already

the holder of a licence under the patent; and no personshall be estopped or barred from alleging any of thematters specified in the relevant grounds by reason ofany admission made by him, whether in such a licenceor otherwise, or by reason of his having accepted alicence.

(4) In this section “the relevant grounds” means -(a) in the case of an application made in respect of

a patent whose proprietor is a WTO proprietor, thegrounds set out in section 48A(1) below;

(b) in any other case, the grounds set out insection 48B (1) below.

• The comptroller is the entity thatcan grant the CL.



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(5) A proprietor is a WTO proprietor for the purposes ofthis section and sections 48A, 48B, 50 and 52 below if -

(a) he is a national of, or is domiciled in, acountry which is a member of the World Trade

Organisation; or(b) he has a real and effective industrial orcommercial establishment in such a country.

(6) A rule prescribing any such other period undersubsection (1) above shall not be made unless a draft ofthe rule has been laid before, and approved byresolution of, each House of Parliament.Compulsory licences: WTO proprietors48A.-(1) In the case of an application made undersection 48 above in respect of a patent whose proprietor

is a WTO proprietor, the relevant grounds are -(a) where the patented invention is a product, that

a demand in the United Kingdom for that product isnot being met on reasonable terms;

(b) that by reason of the refusal of the proprietorof the patent concerned to grant a licence or licenceson reasonable terms -

(i) the exploitation in the United Kingdom ofany other patented invention which involvesan important technical advance ofconsiderable economic significance inrelation to the invention for which the patentconcerned was granted is prevented orhindered, or(ii) the establishment or development ofcommercial or industrial activities in theUnited Kingdom is unfairly prejudiced;

(c) that by reason of conditions imposed by theproprietor of the patent concerned on the grant oflicences under the patent, or on the disposal or use ofthe patented product or on the use of the patented

process, the manufacture, use or disposal ofmaterials not protected by the patent, or theestablishment or development of commercial orindustrial activities in the United Kingdom, is unfairlyprejudiced.

(2) No order or entry shall be made under section 48above in respect of a patent whose proprietor is a WTO

proprietor unless -(a) the applicant has made efforts to obtain a

licence from the proprietor on reasonable commercial

terms and conditions; and

• CL can be granted when a

demand for a product is not met onreasonable terms (which could bethe price in the case of a medicine)and when because of the refusal

from the patent holder to grant alicense the exploitation is preventedof hindered, or the establishment – or development of commercial orindustrial activities in the countryis unfairly prejudiced (that will not

play in the case of medicines). Thismeans that there is no exploitationon reasonable terms. In additionthe conditions imposed by the

patent holder have to "unfairly prejudice" the establishment ordevelopment of commercial orindustrial activities.



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(b) his efforts have not been successful within areasonable period.

(3) No order or entry shall be so made if the patentedinvention is in the field of semi-conductor technology.

(4) No order or entry shall be made under section 48above in respect of a patent on the ground mentioned insubsection (1) (b)(i) above unless the comptroller issatisfied that the proprietor of the patent for the otherinvention is able and willing to grant the proprietor ofthe patent concerned and his licensees a licence underthe patent for the other invention on reasonable terms.

(5) A licence granted in pursuance of an order or entryso made shall not be assigned except to a person to

whom the patent for the other invention is alsoassigned.

(6) A licence granted in pursuance of an order or entrymade under section 48 above in respect of a patentwhose proprietor is a WTO proprietor -

(a) shall not be exclusive;(b) shall not be assigned except to a person to

whom there is also assigned the part of the enterprisethat enjoys the use of the patented invention, or the partof the goodwill that belongs to that part;

(c) shall be predominantly for the supply of themarket in the United Kingdom;

(d) shall include conditions entitling the proprietorof the patent concerned to remuneration adequate inthe circumstances of the case, taking into account theeconomic value of the licence; and

(e) shall be limited in scope and in duration tothe purpose for which the licence was granted.Compulsory licences: other cases48B.-(1) In the case of an application made under

section 48 above in respect of a patent whoseproprietor is not a WTO proprietor, the relevantgrounds are -

(a) where the patented invention is capable of being commercially worked in the United Kingdom,that it is not being so worked or is not being so workedto the fullest extent that is reasonably practicable;

(b) where the patented invention is a product, thata demand for the product in the United Kingdom -

(i) is not being met on reasonable terms, or(ii) is being met to a substantial extent by

importation from a country which is nota member State;



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(c) where the patented invention is capable of being commercially worked in the United Kingdom,that it is being prevented or hindered from being soworked -

(i) where the invention is a product, by the

importation of the product from a countrywhich is not a member State,(ii) where the invention is a process, by theimportation from such a country of a productobtained directly by means of the process or towhich the process has been applied;

(d) that by reason of the refusal of the proprietorof the patent to grant a licence or licences on reasonableterms -

(i) a market for the export of any patented product made in the United Kingdom is not

being supplied, or(ii) the working or efficient working in theUnited Kingdom of any other patentedinvention which makes a substantialcontribution to the art is prevented or hindered,or(iii) the establishment or development ofcommercial or industrial activities in theUnited Kingdom is unfairly prejudiced;

(e) that by reason of conditions imposed by the proprietor of the patent on the grant of licences underthe patent, or on the disposal or use of the patented

product or on the use of the patented process, themanufacture, use or disposal of materials not protected

by the patent, or the establishment or development ofcommercial or industrial activities in the UnitedKingdom, is unfairly prejudiced.

(2) Where -(a) an application is made on the ground that the

patented invention is not being commercially worked in

the United Kingdom or is not being so worked to thefullest extent that is reasonably practicable; and(b) it appears to the comptroller that the time which

has elapsed since the publication in the journal of anotice of the grant of the patent has for any reason beeninsufficient to enable the invention to be so worked, hemay by order adjourn the application for such period aswill in his opinion give sufficient time for the inventionto be so worked.

(3) No order or entry shall be made under section 48

above in respect of a patent on the ground mentioned insubsection (1)(a) above if -



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(a) the patented invention is being commerciallyworked in a country which is a member State; and

(b) demand in the United Kingdom is being met by importation from that country.

(4) No entry shall be made in the register under section48 above on the ground mentioned in subsection (1) (d)(i) above, and any licence granted under section 48above on that ground shall contain such provisions asappear to the comptroller to be expedient for restrictingthe countries in which any product concerned may bedisposed of or used by the licensee.

(5) No order or entry shall be made under section 48above in respect of a patent on the ground mentioned insubsection (1)(d)(ii) above unless the comptroller is

satisfied that the proprietor of the patent for the otherinvention is able and willing to grant to the proprietor ofthe patent concerned and his licensees a licence underthe patent for the other invention on reasonable terms.

Powers exercisable following merger and marketinvestigations50A.-(1) Subsection (2) below applies where –

a) section 41(2), 55(2), 66(6), 75(2), 83(2),138(2), 147(2) or 160(2) of, or paragraph 5(2) or 10(2)of Schedule 7 to, the Enterprise Act 2002 (powers totake remedial action following merger or marketinvestigations) applies;

(b) the Competition Commission or (as the casemay be) the Secretary of State considers that it would

be appropriate to make an application under this sectionfor the purpose of remedying, mitigating or preventing amatter which cannot be dealt with under the enactmentconcerned; and

(c) the matter concerned involves -(i) conditions in licences granted under a

patent by its proprietor restricting the use of

the invention by the licensee or the right ofthe proprietor to grant other licences; or(ii) a refusal by the proprietor of a patent togrant licences on reasonable terms.

(2) The Competition Commission or (as the case may be) the Secretary of State may apply to the comptrollerto take action under this section.

(3) Before making an application the CompetitionCommission or (as the case may be) the Secretary of

State shall publish, in such manner as it or he thinksappropriate, a notice describing the nature of the



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proposed application and shall consider anyrepresentations which may be made within 30 days ofsuch publication by persons whose interests appear to itor him to be affected.

(4) The comptroller may, if it appears to him on anapplication under this section that the application ismade in accordance with this section, by order cancel ormodify any condition concerned of the kind mentionedin subsection (1)(c)(i) above or may, instead or inaddition, make an entry in the register to the effect thatlicences under the patent are to be available as of right.

(5) References in this section to the CompetitionCommission shall, in cases where section 75(2) of theEnterprise Act 2002 applies, be read as references to the

Office of Fair Trading.

(6) References in section 35, 36, 47, 63, 134 or 141 ofthe Enterprise Act 2002 (questions to be decided by theCompetition Commission in its reports) to taking actionunder section 41(2), 55, 66, 138 or 147 shall includereferences to taking action under subsection (2) above.

(7) Action taken by virtue of subsection (4) above inconsequence of an application under subsection (2)above where an enactment mentioned in subsection(1)(a) above applies shall be treated, for the purposes ofsections 91(3), 92(1)(a), 162(1) and 166(3) of theEnterprise Act 2002 (duties to register and keep underreview enforcement orders etc.), as if it were themaking of an enforcement order (within the meaning ofthe Part concerned) under the relevant power in Part 3or (as the case may be) 4 of that Act.

Powers exercisable in consequence of report ofCompetition Commission51.-( 1) Where a report of the Competition

Commission has been laid before Parliamentcontaining conclusions to the effect -(a) [repealed](b) [repealed](c) on a competition reference, that a person was

engaged in an anti-competitive practice which operatedor may be expected to operate against the publicinterest, or

(d) on a reference under section 11 of theCompetition Act 1980 (reference of public bodies andcertain other persons), that a person is pursuing a course

of conduct which operates against the public interest,



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the appropriate Minister or Ministers may apply to thecomptroller to take action under this section.

(2) Before making an application the appropriateMinister or Ministers shall publish, in such manner as

he or they think appropriate, a notice describing thenature of the proposed application and shall considerany representations which may be made within 30 daysof such publication by persons whose interests appear tohim or them to be affected.

(3) If on an application under this section it appears tothe comptroller that the matters specified in theCommission’s report as being those which in the

Commission’s opinion operate, or operated or may be

expected to operate, against the public interest include -

(a) conditions in licences granted under a patent by its proprietor restricting the use of the invention bythe licensee or the right of the proprietor to grant otherlicences, or

(b) a refusal by the proprietor of a patent to grantlicences on reasonable terms he may by order cancel ormodify any such condition or may, instead or inaddition, make an entry in the register to the effect thatlicences under the patent are to be available as of right.

(4) In this section “the appropriate Minister or

Ministers” means the Minister or Ministers to whom the

report of the Commission was made.Use of patented inventions for services of the Crown55.-(1) Notwithstanding anything in this Act, anygovernment department and any person authorizedin writing by a government department may, for theservices of the Crown and in accordance with thissection, do any of the following acts in the UnitedKingdom in relation to a patented invention without theconsent of the proprietor of the patent, that is to say -

(a) where the invention is a product, may -(i) make, use, import or keep the product, orsell or offer to sell it where to do so would beincidental or ancillary to making, using,importing or keeping it; or(ii) in any event, sell or offer to sell it forforeign defense purposes or for the

production or supply of specified drugs andmedicines, or dispose or offer to dispose of it(otherwise than by selling it) for any purposewhatever;

(b) where the invention is a process, may use it ordo in relation to any product obtained directly by means

• This is a form of non-governmentuse.



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of the process anything mentioned in paragraph (a)above;

(c) without prejudice to the foregoing, where theinvention or any product obtained directly by means ofthe invention is a specified drug or medicine, may sell

or offer to sell the drug or medicine;(d) may supply or offer to supply to any personany of the means, relating to an essential element of theinvention, for putting the invention into effect;

(e) may dispose or offer to dispose of anythingwhich was made, used, imported or kept in the exerciseof the powers conferred by this section and which is nolonger required for the purpose for which it was made,used, imported or kept (as the case may be), andanything done by virtue of this subsection shall notamount to an infringement of the patent concerned.

(2) Any act done in relation to an invention by virtue ofthis section is in the following provisions of this sectionreferred to as use of the invention; and “use”, in relation

to an invention, in sections 56 to 58 below shall beconstrued accordingly.

(3) So far as the invention has before its priority date been duly recorded by or tried by or on behalf of agovernment department or the United Kingdom AtomicEnergy Authority otherwise than in consequence of arelevant communication made in confidence, any use ofthe invention by virtue of this section may be made freeof any royalty or other payment to the proprietor.

(4) So far as the invention has not been so recordedor tried, any use of it made by virtue of this section atany time either –

(a) after the publication of the application for the patent for the invention; or

(b) without prejudice to paragraph (a) above, in

consequence of a relevant communication made afterthe priority date of the invention otherwise than inconfidence;

shall be made on such terms as may be agreedeither before or after the use by the governmentdepartment and the proprietor of the patent with theapproval of the Treasury or as may in default ofagreement be determined by the court on a referenceunder section 58 below.

(5) Where an invention is used by virtue of this section

at any time after publication of an application for a patent for the invention but before such a patent is

• Terms of the use of the patent

have to either be approved by theTreasury or by the court.



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granted, and the terms for its use agreed or determinedas mentioned in subsection (4) above include terms asto payment for the use, then (notwithstanding anythingin those terms) any such payment shall be recoverableonly -

(a) after such a patent is granted; and(b) if (apart from this section) the use would, ifthe patent had been granted on the date of the

publication of the application, have infringed not onlythe patent but also the claims (as interpreted by thedescription and any drawings referred to in thedescription or claims) in the form in which they werecontained in the application immediately before the

preparations for its publication were completed by thePatent Office.

(6) The authority of a government department in respectof an invention may be given under this section eitherbefore or after the patent is granted and either beforeor after the use in respect of which the authority is givenis made, and may be given to any person whether or nothe is authorized directly or indirectly by the proprietorof the patent to do anything in relation to the invention.

(7) Where any use of an invention is made by or withthe authority of a government department under thissection, then, unless it appears to the department that itwould be contrary to the public interest to do so, thedepartment shall notify the proprietor of the patent assoon as practicable after the second of the followingevents, that is to say, the use is begun and the patent isgranted, and furnish him with such information as to theextent of the use as he may from time to time require.

(8) A person acquiring anything disposed of in theexercise of powers conferred by this section, and any

person claiming through him, may deal with it in the

same manner as if the patent were held on behalf of theCrown.

(9) In this section “relevant communication”, in relation

to an invention, means a communication of theinvention directly or indirectly by the proprietor of the

patent or any person from whom he derives title.

(10) Subsection (4) above is without prejudice to anyrule of law relating to the confidentiality of information.

(11) In the application of this section to NorthernIreland, the reference in subsection (4) above to the

• This sort of CL can be used even

before the patent is granted duringthe examination.



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Treasury shall, where the government departmentreferred to in that subsection is a department of theGovernment of Northern Ireland, be construed as areference to the Department of Finance for NorthernIreland.

Rights of third parties in respect of Crown use57 .-(1) In relation to -(a) any use made for the services of the Crown of

an invention by a government department, or a personauthorized by a government department, by virtue ofsection 55 above, or

(b) anything done for the services of the Crown tothe order of a government department by the proprietorof a patent in respect of a patented invention or by the

proprietor of an application in respect of an inventionfor which an application for a patent has been filed and

is still pending, the provisions of any licence,assignment, assignation or agreement to which thissubsection applies shall be of no effect so far as those

provisions restrict or regulate the working of theinvention, or the use of any model, document orinformation relating to it, or provide for the making of

payments in respect of, or calculated by reference to,such working or use; and the reproduction or

publication of any model or document in connectionwith the said working or use shall not be deemed to bean infringement of any copyright or design rightsubsisting in the model or document.

(2) Subsection (1) above applies to a licence,assignment, assignation or agreement which is made,whether before or after the appointed day, between (onthe one hand) any person who is a proprietor of or anapplicant for the patent, or anyone who derives titlefrom any such person or from whom such personderives title, and (on the other hand) any personwhatever other than a government department.

(3) Where an exclusive licence granted otherwise thanfor royalties or other benefits determined by referenceto the working of the invention is in force under the

patent or application concerned, then -(a) in relation to anything done in respect of the

invention which, but for the provisions of this sectionand section 55 above, would constitute an infringementof the rights of the licensee, subsection (4) of thatsection shall have effect as if for the reference to the

proprietor of the patent there were substituted a

reference to the licensee; and

• This article sets the conditions ofthe use of a patent for the service ofthe Crown allowed by art. 55.



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(b) in relation to anything done in respect of theinvention by virtue of an authority given under thatsection, that section shall have effect as if the saidsubsection (4) were omitted.

(4) Subject to the provisions of subsection (3) above,where the patent, or the right to the grant of the patent,has been assigned to the proprietor of the patent orapplication in consideration of royalties or otherbenefits determined by reference to the working of theinvention, then -

(a) in relation to any use of the invention by virtueof section 55 above, subsection (4) of that section shallhave effect as if the reference to the proprietor of the

patent included a reference to the assignor, and any sum payable by virtue of that subsection shall be divided

between the proprietor of the patent or application andthe assignor in such proportion as may be agreed on bythem or as may in default of agreement be determined

by the court on a reference under section 58 below; and(b) in relation to any act done in respect of the

invention for the services of the Crown by the proprietor of the patent or application to the order of agovernment department, section 55(4) above shall haveeffect as if that act were use made by virtue of anauthority given under that section.

(5) Where section 55(4) above applies to any use of aninvention and a person holds an exclusive licence underthe patent or application concerned (other than such alicence as is mentioned in subsection (3) above)authorising him to work the invention, then subsections(7) and (8) below shall apply.

(6) In those subsections “the section 55(4)” payment means such payment (if any) as the proprietor of the

patent or application and the department agree under

section 55 above, or the court determines under section58 below, should be made by the department to the proprietor in respect of the use of the invention.

(7) The licensee shall be entitled to recover from the proprietor of the patent or application such part (if any)of the section 55(4) payment as may be agreed on bythem or as may in default of agreement be determined

by the court under section 58 below to be just havingregard to any expenditure incurred by the licensee -

(a) in developing the invention, or

(b) in making payments to the proprietor inconsideration of the licence, other than royalties or



140 / 141

other payments determined by reference to the use ofthe invention.

(8) Any agreement by the proprietor of the patent orapplication and the department under section 55(4)

above as to the amount of the section 55(4) paymentshall be of no effect unless the licensee consents to theagreement; and any determination by the court undersection 55(4) above as to the amount of that paymentshall be of no effect unless the licensee has beeninformed of the reference to the court and is given anopportunity to be heard.

(9) Where any models, documents or informationrelating to an invention are used in connection with anyuse of the invention which falls within subsection (1)(a)

above, or with anything done in respect of the inventionwhich falls within subsection (1)(b) above, subsection(4) of section 55 above shall (whether or not it appliesto any such use of the invention) apply to the use of themodels, documents or information as if for the referencein it to the proprietor of the patent there weresubstituted a reference to the person entitled to the

benefit of any provision of an agreement which isrendered inoperative by this section in relation to thatuse; and in section 58 below the references to terms forthe use of an invention shall be construed accordingly.

(10) Nothing in this section shall be construed asauthorising the disclosure to a government departmentor any other person of any model, document orinformation to the use of which this section applies incontravention of any such licence, assignment,assignation or agreement as is mentioned in this section.Special provisions as to Crown use during emergency59.-(1) During any period of emergency within themeaning of this section the powers exercisable in

relation to an invention by a government department ora person authorized by a government department undersection 55 above shall include power to use theinvention for any purpose which appears to thedepartment necessary or expedient -

(a) for the efficient prosecution of any war inwhich Her Majesty may be engaged;

(b) for the maintenance of supplies and servicesessential to the life of the community;

(c) for securing a sufficiency of supplies andservices essential to the well-being of the community;

(d) for promoting the productivity of industry,commerce and agriculture;



(e) for fostering and directing exports andreducing imports, or imports of any classes, from all orany countries and for redressing the balance of trade;

(f) generally for ensuring that the whole resourcesof the community are available for use, and are used, in

a manner best calculated to serve the interests of thecommunity; or(g) for assisting the relief of suffering and the

restoration and distribution of essential supplies andservices in any country or territory outside the UnitedKingdom which is in grave distress as the result of war;and any reference in this Act to the services of theCrown shall, as respects any period of emergency,include a reference to those purposes.

(2) In this section the use of an invention includes, in

addition to any act constituting such use by virtue ofsection 55 above, any act which would, apart from thatsection and this section, amount to an infringement ofthe patent concerned or, as the case may be, give rise toa right under section 69 below to bring proceedings inrespect of the application concerned, and any referencein this Act to “use for the services of the Crown” shall,

as respects any period of emergency, be construedaccordingly.

(3) In this section “period of emergency” means any

period beginning with such date as may be declared byOrder in Council to be the commencement, and ending

i h h d b d l d b h

Documents

The Use of Compulsory Licenses in EU Countries to Facilitate Access to Medicines