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Pharmaceutical Products and Trademarks
AIPPI ExCo 2013Workshop ‘Pharma 1’
Helsinki, September 6, 2013
Advantages of Trademarks
for pharmaceutical products
and goals for trademark development
Christian SchalkBayer Intellectual Property GmbH
Monheim am Rhein, Germany
Christian Schalk 3
• Instant quality recognitionExample: VOLTAREN®
• Establishment and maintenance of a good imageExample: SINUPRET®
• Easing customer decision makingExample: ASPIRIN®
• Trademarks can add to name safety more differentiated vs. INN Trademark clearance and continuous enforcement
ensure “space” around a name protected throughout lifetime
• Trademark life continues after Patents or Copyrights expireExample: 114 years of ASPIRIN®
Trademark development for pharmaceutical productsadvantages of trademarks
Christian Schalk 4
Photos: www.aspirin.de
Worldwide sales of ASPIRIN® in 2011: 844 Mio. € !
Case Study: 114 years of ASPIRIN® of Bayer
Christian Schalk 5
Development of trademarks which
are pronounceable and free from risks
of cultural- and linguistic problems in all major markets
are registrable worldwide
meet the regulatory requirements of
health authorities such as EMA and FDA
Trademark development processGoals
6
Regulatory Authorities:avoid drug safety issues !
No similarity with prior pharm. product names !!
Competitors:keep distance to my brand !!!!
Trademark Offices:be distinctive ! not confusingly
similar with existing trademark
covering similar goods and
services !
Trademark Dept.
Executive Board:global brand
Marketing:concise, short name
related to indication
Region:as soon as possible
The trademark dilemma
WHO:No similarity with INNs !!!
Trademark Development ProcessChallenges
Christian Schalk
Pharmaceutical Trademarks
a Latin American Perspective
Estela Mariel de Luca IP Consulting
Buenos Aires, Argentina
Latin America
General Aspects
Estela de Luca
Region Latin America
• Sub- regions:o North Americao Central Americao Caribbeano South America
Estela de Luca
Latin America
Trademark Issues
Estela de Luca
Particularities of Latin America TM law and procedures
One trademark application per jurisdiction(Exception: Madrid System: One application filing, through a local or regional
PTO. Members: Cuba, Colombia and Mexico).First –to – file – system
Attribute system vs. Prior use
Exceptions:
a) Well- know trademarksb) Trade agreements (Subregional Integration Agreement, Cartagena
Agreement: Decision 486)
c) Other international treaties (Pan American or Washington Convention: CO, CU, GT, HT, HN, NI, PA, PE, US. )
Principle of territoriality
Estela de Luca
Principle of territorialityException: Well-known TM
• Paris Convention Rights of priority (art. 4, six
months for trademarks).Exception: Puerto Rico.
Art. 6 bis, well-known trademarks.
• TRIPS Agreement Art.16: Application mutatis
mutandis to:
a) services,b) Connectionbetween
goods/services.
All the countries of the region aremembers of both agreements.
Estela de Luca
Principle of territoriality Exception: Andean Community (AC)
• Trade agreements: Decision 486• Bolivia, Colombia, Ecuador and Peru
• Andean Opposition (art. 147):owner of a TM in a singlecountry of the AC can oppose toa TM application in any othercountry of the AC.
• Andean Use (art. 165):It is possible to claim the use ofa TM in one country of the ACagainst a third party pursuing acancellation action in a differentcountry of the AC.
• Well-known trademarks:art. 224 and 134 h.
Estela de Luca
Trademark procedure
Filing anapplication with the
local PTOFormal examination
Publication foroppositionpurposes(except MX)
Administrative/ Judicial proceduresto adjudicateoppositions(ARG: mediationprocedure)
Substantive examination
Publication of theregistration
Estela de Luca
Use requirements
Extent of use :1) Effectivelocal use; 2) Manufacturingfor exportation; 3) Mere
transit
Use made byauthorized thirdparties benefit TM
owner
The main requirement for canceling a mark is the lapse of a particular period of time
Non‐use TMS are «in force» untildeclared invalid
Resumption of TM use before thefiling of a cancellation claim will
keep the TM in force
Estela de Luca
Publicdomain
• Signs that are ineligible for, or excluded from,trademark protection.
• Forms of using trademarked signs that remainunaffected by the exclusive rights of thetrademark owner
TrademarkLaw
• Signs excluded from registration and protection as trademarks,
• Signs which lack of distinctiveness,• Limits to the use of the protected sign.
Generic ordescriptive
terms
• Direct relationship with the goods or servicesto which the sign is or will be applied to
Estela de Luca
Latin America
Regulatory Issues
Estela de Luca
Latin America No Harmonization
Group 1
Brand drugs
Genericdrugs
Group 2
Innovativeor original
drugs
Similar drugs
Genericdrugs
Estela de Luca
Group 1
Branded drugs
• Identified by brand names
Generic drugs
• Using INN-DCI recommended byWHO or any other non-propietary names defined by thecountry or recognizedinternationally
Estela de Luca
Group 2
Innovative or original drugs
• Generally distinguished by brandnames.
Similar drugs/copies• Pharmaceutically equivalent to the
proprietary product.• Labelled by brand names or INN.
Generic drugs
• Products that have been provento be therapeutically equivalentand interchangeable with theproprietary drug.
Estela de Luca
Drug Prescribing
Use of INN is compulsory ?
Publicsector
Principle: YES
Privatesector
AR, BO, PA, PE, PY, UY
Estela de Luca
Substitution
Prescribe medicine
Generics/
similar drugs
1 ) BR: Not for similar drugs.
2 ) Not mandatoryAR, BO, CR, CO, EC, PE, UY; (CH: At the discretion of the patientand pharmacist) ,
3 ) Mandatory
4 ) MX, BR, PA.
Estela de Luca
Descriptive signs vs. evocative or suggestive signs
AR/BR/MX :
Evocative/suggestivesigns: Considered “weakTMs”, but registrable(contains elements thatgives them a fancifulnature, to some degree).
PY :It cannot be registered astrademarks for pharmaceuticalspecialties, generic names of activeprinciples.If a medicinal specialty isdistinguished by a TM or fancyname, same cannot be confusinglysimilar with a generic name orinduce to errors regarding thetherapeutic properties or the natureof the proprietary medicinalproduct. Law 1119, Paraguay
ARG: “Lab. Bagó SA c/ Sanofi Synthelabo Cease of TM Opposition” (File N°1817/2001). Federal Civil and Commercial Chamber, Tribunal II, August 23, 2005 -FENDIPRAZOL
“Lab. Northia SACIFIA vs Synthelabo ref. Cease of TM Opposition” (File N° 1589/2000).Federal Civil and Commercial Chamber, Tribunal II, April 28, 2005 – GASPRIDE
Estela de Luca
MERCOSUR
Full Member
Associate Member
Accessing Member (2012)
Estela de Luca
Mercosur
The proposed trademark is
evaluated by each Health Authority
Resolution GMC N° 23/95.Medicines must be distinguishedby the proposed commercialdesignation and the name of theactive substance according theInternational Common Designation–DCI-“.
Resolution GMC N° 55/96.Trademark is understood as aname that, in contraposition withcommon generic name,distinguishes one certainmedicine, under the property orexclusive use of laboratory and isby law for a specified period oftime”.
Estela de Luca
Mercosur
No general guideline / principles referring
to the connection between TM and INN.
Resolution GMC N° 54/96(Validity, modification, renewal and cancellationof the pharmaceutical products registry).Establishes different criteria for commercial designations:a) The name tend to be in accordance with the WHO recommendationsb) Use the name INN or the Portuguese version (DCB).c) The generic name must be added with the name of the laboratory.d) Commercial designation should not suggest therapeutic applicatione) If trademark issues arise, the marketing of a same product may be donewith a different commercial designation or trademark in each of thecountries.f) The commercial designation must not induce to mistakes. Particularly: a)The name must not be misleading, such as lead to assume the presence ofan active component not present in the formula, b) be similar to the nameof another product with different therapeutic indication, c) be similar toanother product with the same therapeutic indication, which has differentactive ingredients.
Estela de Luca
Trade Marks of Pharmaceutical Products
in the European Legal System
Joanna Sitko, PhDPatent Attorneys Office
Sitko, Czubkowska S&C PATENT, Warsaw, Poland and
Lublin University of Technology, Faculty of Management, Poland
Plan of presentation
1. Trade marks registration systems available in Europe,
2. Genuine use with respect to pharmaceutical trade marks
3. Assessment of the infringement of a right to a trade mark - issues determining the likelihood of confusiono relevant public/the average consumer of the products,o comparison of goods and services,o ccomparison of signs.
4. EMA (European Medicines Agency) – scope of assessment of a pharmaceutical trade mark
Joanna Sitko, PhD
TM registration systems available in Europe
National trade mark registration system performed by national authorities (e.g. Patent Office in Poland, INPI in France – Institut National de la Propriété Industrielle)
IR-Mark – the ‘Madrid system’for the international registration of marks established in 1891 andfunctioning under the Madrid Agreement (1891), and the Madrid Protocol (1989), administered by the International Bureau of WIPO located in Geneva, Switzerland.
CTM – Community Trade Mark, registered by OHIM (Office For Harmonization In The Internal Market, located in Alicante, Spain) on the basis of Council Regulation (EC) No 207/2009 on the CTM (hereafter: CTM Regulation).
Joanna Sitko, PhD
Premises of CTM registration
Absolute grounds for refusal are always assessed by OHIM (art. 7 of the CTM Regulation).o e.g. the word CTM Vektor-Lycopin was rejected because of lack of
distinctive character and its solely descriptive character for the German-and English-speaking public of the EC as for goods in class 5, 29, 30 in respect of which registration was sought - Art. 7.1.(b) and (c) of the CTM Regulation (case T-85/08, 9/07/2010, Exalation Ltd. v. OHIM)
o principle of uniform character of CTM protection (obstacle concerns only one country of EC = rejection of the whole CTM registration)
Relative grounds for refusal – a conflict with another earlier trade mark can be investigated by OHIM only as a result of opposition submitted by the owner of the earlier mark (art. 8 of the CTM Regulation)
Joanna Sitko, PhD
Consequences of the lack of a CTM ʻgenuine useʼ -crucial issue for pharma TM
Art. 15.1 CTM Regulation:
o ‘If, within a period of five years following registration, the proprietor has not put the Community trade mark to genuine use in the Community in connection with the goods or services in respect of which it is registered, or if such use has been suspended during an uninterrupted period of five years, the Community trade mark shall be subject to the sanctions provided for in this Regulation, unless there are proper reasons for nonuse.’
o The above mentioned sanction is the revocation of the right to a trade mark (art. 51.1.(a) CTM Regulaton).
Joanna Sitko, PhD
Genuine use of CTM – ways of using(OHIM, First Board of Appeal 16/09/2005, R-878/2004-1, DINAXIL),
In general, the intention of use and preparatory activities are notgenuine use of a trade mark. However, preparatory activities aretaken into consideration with regard to the evaluation of the genuineuse if they have external character.According to the OHIM decision, the examples of such activities are:
• the reference to the products in theIndice Nacional Terapêutico (it must be regardedas a form of advertising),
• the price authorization.
Doubt: Can we presume that according to this decision, clinical trials shall be
interpreted also as the activities that create a genuine use of a trade mark ?
Joanna Sitko, PhD
Genuine use of CTM – ways of using
To retain a CTM registration until gaining the authorizationof a medicine the owner can:o defer the date of filing the application for a CTM (it is good to wait
until the last stage of clinical trials),
o submit a re-application of the same CTM (repeated application) – riskof the bad faith allegation !
The Guidelines relating to proceedings before OHIM (Part D,Section 2, paragraph 4.3.3) contains the following assumption:‘Where the proprietor of a CTM makes repeated applications for thesame mark with the effect of avoiding the consequences of revocationfor non-use of earlier CTMs, whether in whole or in part, the proprietoris acting in bad faith.’
Joanna Sitko, PhD
Genuine use of CTM – ways of using
In order to determine whether the applicant is acting in bad faith for the purposes of Article 52.1(b) of Regulation No 207/2009, account must be taken of all the relevant factors (Court of Justice of EU, case C-529/07 Chocoladefabriken Lindt & Sprüngli):
o the fact that the applicant knows or should know that a third party is using, in at least one Member State, an identical or similar sign for an identical or similar product liable to be confused with the sign for which registration is sought;
o the applicant’s intention of preventing that third party from continuing to use such a sign;
o the degree of legal protection enjoyed by the third party’s sign and by the sign for which registration is sought.
Joanna Sitko, PhD
Genuine use of CTM - territorial scope of use(C-149/11, 19-12-2012, Leno Marken BV v. Hagelkruis Beheer BV, TM: ONEL)
‘Article 15(1) must be interpreted as meaning that the territorial borders of the Member States should be disregarded in the assessment of whether a trade mark has been put to ‘genuine use in the Community’ within the meaning of that provision’.
‘A Community trade mark is put to ‘genuine use’ within the meaning of Article 15(1) when it is used:
o in accordance with its essential function ando for maintaining or creating market share within the EU for the goods or services
covered by it.’
The member state court needs to decide whether the conditions of CTM use were met on a case-by-case basis
Conclusion: what was predictable - simple test of territorial use -has now become confusing and unpredictable.
Joanna Sitko, PhD
Genuine use of CTM – form of use(case C-252/12 of 18/12/2013, Specsavers and
parallel judgment C-12/12, Colloseum Holding v. Levi Strauss & Co.)
Genuine use within the meaning of Article 15.1 ‘may be fulfilled where aCommunity figurative mark is used only in conjunction with a Community wordmark which is superimposed over it, and the combination of those two marksis, furthermore, itself registered as a Community trade mark, to the extent thatthe differences between the form in which that trade mark is used and that inwhich it was registered do not change the distinctive character of that trademark as registered.’
registered trade marks Used trade mark
Specsavers (word trade mark)
Joanna Sitko, PhD
Genuine use of CTM – form of use(case C-252/12 of 18/12/2013, Specsavers)
‘Article 9(1)(b) and (c) of CTM Regulation must be interpreted as meaning,that where a Community trade mark is not registered in color, but the proprietor hasused it extensively in a particular color or combination of colors with the result thatit has become associated in the mind of a significant portion of the public withthat color or combination of colors, the color or colors which a third party usesin order to represent a sign alleged to infringe that trade mark are relevant inthe global assessment of the likelihood of confusion or unfair advantage underthat provision.’
Joanna Sitko, PhD
Assessment of the infringement of a right to a trade mark(on the basis of the judgments of European courts and OHIM decisions)
Issues determining the likelihood of confusion(art. 9.1(b) CTM Regulation):
1. relevant public/the average consumer of theproducts,
2. similarity of goods and services,
3. similarity of trade marks.
Joanna Sitko, PhD
General definition of the customer
The average consumer is deemed to be ‘a reasonablywell informed, reasonably observant and circumspectperson.’
The average consumer’s level of attention is likely tovary according to the category of goods or services inquestion.
Case C-342/97 Lloyd Schuhfabrik Meyer, 22/06/1999
Joanna Sitko, PhD
The average consumer with regard to the OTC-medicines(over-the-counter-medicines)
healthcare professionals (doctors, nurses, pharmacists) and
average end-consumers (without any medical or pharmaceutical knowledge)
o decision of the Bord of Appeal of OHIM (hereafter: BoA) of 04/02/2004, R 987/2002-1
o case T-256/04, RESPICUR v. RESPICORT, 13/02/2007
Joanna Sitko, PhD
The average consumer in the case of prescription-only-medicines (two approaches)
only highly qualified, specialised professionals according to the former case-law
o BoA Case R 304/2003-1, RIBOMUNYL v. RIBOMUSTIN
o BoA Case R 1154/2000-4, QUARTAMIN v. TAMIN
o BoA Case R366/2001-4, MEDREL v. MEDROL
both healthcare professionals and end-users (patients) according to the latest case-law
o case T-222/09, ALPHAREN v. ALPHA D3, 9/2/2011
o case C-412/05 TRAVATAN v. TRIVASTAN, 26/4/2007
Joanna Sitko, PhD
I. The average consumer in the case of prescription-only medicines: only highly qualified, specialised professionals
OHIM BoA Case R 304/2003-1, RIBOMUNYL v. RIBOMUSTIN
o not everyday goods but used for the treatment of very specific and serious diseases, sold on prescription (i.e. pharmaceutical preparations for immunotherapy),
o The relevant public is composed of highly qualified, specialisedprofessionals (doctors, nurses, pharmacists)
o Likelihood of confusion is reduced and even small differences, as e.g. differences in one letter may be enough to excludeconfusion.
Joanna Sitko, PhD
II. The average consumer in the case of prescription-only-medicines: both healthcare professionals and end-users
Judgment of General Court, 9 February 2011, Ineos Healthcare Ltd v. OHIM & Teva Pharmaceutical Industries Ltd, T-222/09
o Later word CTM ALPHAREN v. earlier national word mark ALPHA D3”
o ‘Even though the choice of those products is influenced or determined by intermediaries, a likelihood of confusion can also exist for consumers since they are likely to be faced with those products, even if that takes place during separate purchasing transactions for each of those individual products, at various times.’
Joanna Sitko, PhD
The threshold of attention of an average consumer in relation to pharma products when assessing the likelihood of confusion
if only healthcare professionals:o higher threshold of attention
if both healthcare professionals and end-users (patients):o normal threshold of attention C-412/05 TRAVATAN v. TRIVASTAN, 26/04/2007
(case related to prescription-only medicines: ophthalmic pharmaceutical products)
o higher threshold of attenton because of serious diseases and side effects) T-256/04, RESPICORT v. RESPICUR, 13/02/2007 (case related to prescription-onlymedicines and OVC-medicines) (‘Since many respiratory illnesses are serious conditions, patients suffering from those illnesses (…) generally showing a higher than average level of attention’) and BoA of 25/11/2003, R-151/2002-2, RESPIR v. RESPERO
o ‘Degree of consumer attention might be very low in the case of certain types of OVC-medicines for mild disorders and minor afflictions such as painkillers, sleeping pills, healing ointments’ (BoA of 25/04/2001, R- 816/1999-3, A-MULSIN v. AlMOXIN)
Joanna Sitko, PhD
Similarity of signs – general rules
The global assessment of the likelihood of confusion, as far as it concerns the visual, phonetic or conceptual similarity of the opposing signs, must be based on the overall impression given by the signs, bearing in mind, inter alia, their distinctive and dominant elements
o Case T-292/01 Phillips-Van Heusen v OHIM [2003] ECR II-4335, o Case C-334/05 P OHIM v Shaker [2007] ECR I-4529).
The consumer generally pays greater attention to the beginning of a mark than to the end
o Case T-109/07 L’Oréal v OHIM – Spa Monopole (SPA ,THERAPY) [2009] ECR II-675, decision of Opposition Division of OHIM on opposition No 137193, RACEVAL v Race Cat).
Joanna Sitko, PhD
Similarity of signs in relation to pharma TM
‘Visual similarity of marks is of lesser importance than thephonetic one’, having in mind that pharmaceuticals are in general (except for very harmless medicines as painkillers or dietary supplements) not bought in self-service-stores but in pharmacies where the consumer has to actively demand a certain medicine from the pharmacist
o BoA decision, case R- 304/2003-1 RIBOMUNYL/RIBOMUSTIN
Comment:This thesis can be questionable as far as the on-line pharmacy is concerned !
Joanna Sitko, PhD
Similarity of goods as for the pharma products
According to the OHIM (the Manual concerning opposition, Chapter 2: ‘Comparison of goods and services’),
products similar to pharmaceuticals are:
o cosmetics,
o dietetic foodstuff and substances,
o food for babies,
o sanitary preparations,
o disinfectants.
Joanna Sitko, PhD
Assessment of Pharma trade marks by Authorities
Trade Mark Offices o OHIM (Office For Harmonization In The Internal Market)o National Trad Mark Offices
Health Authoritieso EMA (European Medicines Agency)o National Health Authorities
(e.g. FDA (U.S. Food and Drug Administration)
Joanna Sitko, PhD
Legal basis for a trade mark assessment by EMA (European Medicines Agency)
The 5 th update of EMA guideline of December 11, 2007 on the acceptability of names for human medicinal products processed through the centralised procedure.
The 6th update currently under review
Joanna Sitko, PhD
Principles of a trade mark assessment by EMA according to the 5th uptade of EMA guideline
EMA is obliged to ‘consider whether the invented name proposed for a medical product could create a public health concern or potential safety risk’.
The ‘invented name’ (a trade mark) of a medical product shouldnot:o be liable to cause confusion in print, handwriting or speech with the
invented name of another medical product,
o convey misleading therapeutic or pharmaceutical connotations,
o be misleading with respect to the composition of the product,
o be liable to confusion with INN.
Joanna Sitko, PhD
Scope of a pharma trade mark assessment as for the likelihood of confusion
Evaluation of likelihood of confusion between trade marks in respect of origin of goods or services
Assessment of another entityIP rights infringement
Trade Mark Offices (OHIM and national offices)
Health Authorities(EMA)
Evaluation of likelihood of confusion between invented names in respect of safety issues as to the use of pharmaceutical products
No assessment of anotherentity IP rights infringement
Joanna Sitko, PhD
Exaples of rejected trade marks
OHIM
o SANTARIS PHARMA A/S was rejected because of SANTIS PHARMA AG - likelihood of confusion (Opposition 12114, October 30, 2012). The differences were unlikely to exclude the likelihood of confusion even though the products with a trade mark were purchased with a higher degree of attention
o CLOPIN vs. CLOPACIN no likelihood of confusion (Opposition 12284, November 6, 2012). The board found that the phonetic differences between the marks were sufficient to exclude the likelihood of confusion because consumers usually purchase pharmaceuticals with a higher degree of attention.
EMAo CAMPATH was rejected because of CAMPTO
(CAMPATH turned into MABCAMPATH)Joanna Sitko, PhD
Trademarks and Drug Safety
Christian SchalkBayer Intellectual Property GmbH
Monheim am Rhein, Germany
56Christian Schalk
57
Antimycotic prep.
Treatment againstepileptic symptoms
Photo: Financial Times Deutschland, January 16, 2004
Christian Schalk
Trademarks and drug safety
58
Source: EMA
Christian Schalk
Trademarks and drug safety
59
Aloxi 13, Aloxi B, Aloxil 3 ?
Source: EMA
Christian Schalk
Trademarks and drug safetyhere: look or sound alike
60
• Salagen (pilocarpine) - to treat dry mouth symptoms• (Selegiline) - to treat Parkinson’s disease
• Mixup between brandname and generic name• Telephone order misunderstood as (selegiline)• Both products available in 5 mg tablets• Ref: http://www.ismp.org/Newsletters/acutecare/articles/20050922_1.asp
Source: EMA
Christian Schalk
Trademarks and drug safetyhere: look or sound alike
Questions to the speakers ?
