EUROPEAN PATENT SYSTEM UPDATES 6th Annual International Seminar on “Intellectual Property Rights: Advantage Business ” February 13-14, 2010 Patricia S

EUROPEAN PATENT SYSTEM UPDATES

6th Annual International Seminar on “Intellectual Property Rights: Advantage Business ”

February 13-14, 2010

Patricia S. Lecca

European & French patent

attorney

6th Annual International Seminar on “Accelerating Growth of IPR in Global Village”

INTRODUCTION and SCOPE OF PRESENTATION

EPC 2000 London Agreement Changes in Divisional filing practice Mandatory responses to ESR Insufficiency & priority issues EPO decisions


European Patent Convention 2000

“EPC 2000”

December 13, 2007

EPC 2000 – Deadlines

Many deadlines can be now saved if missed by further processing 31 month deadline for entering the EPO regional phase; deadlines for paying filing, search, designation, claims, examination fees;

... otherwise can be saved by restoration if unintentional 1 year convention year to claim priority date; 2 month delay for appeal; 2 month delay for request further processing; 6 month delay for paying annuity; 16 month for claiming priority ;

EPC 2000 – Medical treatment claims 1st medical use

“ Product X as a drug”

2nd and subsequent medical uses: Swiss claim format:

“ Product X for the preparation of a drug for treatment of disease Y”

New format claim: “ Product X for use as a medicament in treating disease Z”

EPC 2000 - Request of limitation of EP patent

filed by the patentee at any time no need to invoke any reasons or interests just file amended claims, description and figures of the granted patent BUT does NOT work if the patent is under opposition MAY work if filed before a national lawsuit the EPO will just check whether claims are indeed limited the EPO will not check patentability pay the granting fees + file translations Request of limitation may be withdrawn at any time the limitation of the patent will be effective ab initio

EUROPEAN PATENT SYSTEM UPDATES

EPC 2000 – Request of revocation

filed by the patentee at any time no need to invoke any reasons or interests just request revocation of the patent BUT does NOT work if the patent is under opposition MAY work if filed before a national lawsuit the European patent revocation will be effective ab initio the request of revocation may be withdrawn at any time


London Agreementfor translation requirement

May 1st 2008

London Agreement – post-grant Waiver of translation requirements post grant & of the registration of address of service

In case of an EP patent in English No translations required

France, UK, Germany, Switzerland, Liechtenstein, Luxembourg, Monaco

Translations of the claimsDenmark, Netherlands, Sweden, Croatia, Iceland, Latvia, Slovenia, Lithuania

Translations of the whole patent Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Estonia, Finland,

Greece, Hungary, Ireland, Italy, Malta, Norway, Poland, Portugal, Romania, San Marino, Slovak Rep, Spain, Turkey


Divisional filingsNew rules & strategies

-April 1st 2010


Restricting the opportunity & timing for filing a divisional Currently, divisional applications may be filed at any time up to the grant of the parent application

As of April 1st - divisionals may be filed at 2 occurrences:

a voluntary divisional application may be filed within 24 months from the first OA of the earliest application ;

and/or

a divisional may be filed further to an objection of non-unity within 24 months from said objection

Divisional applications – New rules


Divisional applications – New Strategies


6 month transition period: up to October 1, 2010 if the time limits have expired before April 1, 2010 or is still running on April 1, 2010, a divisional may still be filed within 6 months, i.e., up to October 1, 2010;

Recommendations: CHECK YOUR FILES !!

If 1st non-unity objection / 1st OA was received on or before October 1st, 2008 then consider filing a divisional NO LATER THAN October 1st, 2010

Divisional applications – Strategies

Pending decision from EPO Enlarged Board of Appeal

G 1/09

Concerns Rule 36(1) EPC: "pending" of parent application in case of divisional application "Is an application which has been refused by a decision of the Examining Division thereafter still pending within the meaning of Rule 25 EPC 1973 (Rule 36(1) EPC) until the expiry of the time limit for filing a notice of appeal, when no appeal has been filed?"


Mandatory responses to European Search Report

New rules-

April 1st 2010


Currently, there is no obligation to respond to European search reports, written opinions, etc...

As of April 1st 2010

Euro-direct applications (Rule 70(1)a EPC)

- Applicant is invited to comment/correct within 6 months of the publication of the ESR - In absence of a response: Application is deemed withdrawn

Mandatory responses to WO, ESR, SESR


Euro-PCT applications EPO # ISA (Rule 70(2)a EPC) Applicant is invited to comment/correct within the period for indicating he wishes to proceed further with the application- In absence of a response: Application is deemed withdrawn EPO = ISA (Rule 161 EPC) - Applicant is invited to comment/correct within 1 month of the invitation - In absence of a response: Application is deemed withdrawn

Mandatory responses to WO, ESR, SESR


New rules will apply where the ESR or communications under Rule 161 have not been issued before April 1, 2010

Recommendations Prepare a response to objections raised during the international phase early because deadlines for answering are short Comply with the EPO requirements early : clarity, multiple independent claims, and conciseness

Consider that the European search report as the 1st official action

Mandatory responses to ESR – Strategies


Insufficiency issues&

Priority issues -

EPO trends

Insufficiency

T 409/91: Exxon v Fuel oils“The extent of the patent monopoly as defined by the claims should correspond to the technical contribution to the art.”

T 226/85 – T 1011/01 : Matsushita “Any embodiment of the invention as defined by the broadest claim must be capable of being realized on the basis of the disclosure. It is irrelevant whether or not the feature objected to was essential.”

T 609/02 : Salk Institute “if the description provides no more than a vague indication of a possible medical use claim for a chemical compound yet to be identified, more detailed evidence filed later cannot remedy to the insufficiency of the disclosure.”

T 1743/06 - experiments v. undue burden

Even though a reasonable amount of trial and error is permissible when it comes to assessing sufficiency of disclosure, there must still be adequate instructions in the specification, or on the basis of common general knowledge, leading the skilled person necessarily and directly towards success, through evaluation of initial failures. This is not the case here, since the preparation of the amorphous silicas claimed is made dependent on the adjustment of different process parameters for which no guidance is given in the patent in suit, so that the broad definition of an amorphous silica as presently claimed is no more than an invitation to perform a research program in order to find a suitable way of preparing the amorphous silicas over the whole area claimed.

Insufficiency

T 63/06 - Hitachi v. DaimlerChrysler

The burden of proof generally lies upon an opponent to establish insufficiency of disclosure. When the patent does not give any information of how a feature of the invention can be put into practice, only a weak presumption exists that the invention is sufficiently disclosed . In such case, the opponent can discharge his burden by plausibly arguing that common general knowledge would not enable the skilled person to put this feature into practice.

The patent proprietor then has the burden of proof for contrary assertion that common general knowledge would indeed enable the skilled person to carry out the invention.

Insufficiency

Priority issues

T 1212/05 – Breast and ovarian cancer

Priority claim for DNA sequences Priority document contained sequence errors G 2/98: same invention = same subject-matter

Priority of claim 1 of patent as granted : invalid Priority of limited auxiliary request: accepted

Priority issues

T 1178/04 – T 382/07 – T 62/05

Right of priority should be transferred before the date of filing the application which claims benefit of said priority rights

“The Appellant had tried to remedy the situation by transferring the patent to the legal person who had filed the application from which the priority had been claimed by an assignment executed nearly seven years after the filing date of the application for the opposed patent. »

“Such a retroactive transfer could not render the priority claim valid if the right to claim the priority did not lie, at the time of filing, with the applicant who actually filed the application for the opposed patent. »


EPO recent & pending decisionsEnlarged Board of Appeal

Patentability of dosage regimens

T1020/03 - pre EPC 2000

related to specific discontinuous administration regimen of IGF-1

But was claimed using the Swiss type format : “ ... For me manufacture of a medicament for the treatment of ...”

The board argue that there was no interference with the freedom of the physician because the patent proprietor would have a remedy only against the maker of, or dealer in the composition.


G2/08 Kos life sciences

The relevant part of claim 1 reads: “The use of nicotinic acid … for the manufacture of a sustained

release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia…”

As this application was pending when EPC 2000 entered into force, it is to be considered under the provisions of Articles 53(c) and 54(4) and (5) EPC 2000.

Article 54(5) EPC 2000 reads:

Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.



1. Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?

2. If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?

3. Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?"

Patentability of stem cells

G 2/06 "Use of embryos/WARF“

Rule 28(c) EPC forbids the patenting of claims directed to products which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims

It is NOT of relevance that AFTER the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos

Essential biological process for plant production

G 2/07 and G 1/08

Concern Article 53(b) EPC: exclusion of essentially biological processes for production of plantsReferral decisions: T 83/05 "Glucosinolates/PLANT BIOSCIENCE" (OJ 2007, 644) and T 1246/06 "Tomatoes/STATE OF ISRAEL" (OJ 2008, 517)

Patentability of surgical methods

G 1/07

Concerns Article 53(c) EPC: exclusion of surgical methods Referral decision T 992/03 "Treatment by surgery/

MEDI-PHYSICS" (OJ 2007, 557)

Thank you !

Feel free to contact me:[email protected]

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EUROPEAN PATENT SYSTEM UPDATES 6th Annual International Seminar on “Intellectual Property Rights: Advantage Business ” February 13-14, 2010 Patricia S