Nick Reeve Reddie & Grose LLP Japan Patent Law Nick Reeve Reddie & Grose LLP

Contents Exams Practical Considerations Novelty Inventive Step Disclosure Requirement Excluded Subject Matter Grace Periods Patent Term Extensions Opposition and Appeal

Statistics (Japanese Applications) Courtesy of the JPO: http://www.jpo.go.jp/shiryou_e/toushin_e/kenkyukai_e/pdf/annual_report2014/part1.pdf

Statistics (Japanese Applicants at EPO) Courtesy of the EPO: http://www.epo.org/about-us/annual-reports-statistics/statistics/filings.html

Procedure Filing Examination Appeal Opposition Notice of Reasons for Rejection (1) Notice of Reasons for Rejection (2) Possible Notice of Reasons for Rejection Filing Examination Appeal Opposition Exam Request (by three years) Decision Decision of Rejection Opposition (6 month term) 1 April 2015 1st medical use: broad claims where compound is known but not for medical use 2nd medical use: purpose limited claims. Novelty lies in new medical use. Prior to EPC 2000 no provision for second medical use claims. Case law established the “swiss” style claim. Under EPC 2000 new provision added (Art 54(5)) which specifically provides for the patentability of a known substance for a second or further medical use, provided that use is novel.

Novelty: Art 29(1) Art 29(1): not novel if publically known, publically worked, described in a printed publication, or publically available through an electronic telecommunication line (e.g. the Internet!) in Japan or a foreign country, prior to the filing of the patent application. Two topics which are both generating a lot of interest at the moment, not least because they are both the subject of a pending Enlarged Board of Appeal decision at the EPO. The first topic was also the subject of a Court of Appeal decision in May 2008. Each case relates to the patentability of particular types of medical inventions and the referrals seek clarification of certain definitions of excluded subject matter under the EPC.

Inventive Step: Art 29(2) Where, prior to the filing of the patent application, a person ordinarily skilled in the art of the invention would have been able to easily make the invention based on an invention prescribed in any of the items of the preceding paragraph (e.g. Article 29(1)), a patent shall not be granted for such an invention. Two topics which are both generating a lot of interest at the moment, not least because they are both the subject of a pending Enlarged Board of Appeal decision at the EPO. The first topic was also the subject of a Court of Appeal decision in May 2008. Each case relates to the patentability of particular types of medical inventions and the referrals seek clarification of certain definitions of excluded subject matter under the EPC.

Novelty & The Grace Period: Art 30 See Article 30 for details. Must file application for disclosed subject matter within 6 months Disclosing act must be carried out by person entitled to file the application A written submission must be filed with the application Evidence must be filed within 30 days Rationale: On the one hand: for public policy reasons its important not to restrict freedom of medical practitioners to treat their patients On the other hand: important to encourage research in the pharmaceutical and diagnostics industries Inevitably debate about the definitions of unpatentable subject matter

Claims Multiple Dependencies Claims fees (examination) for EACH claim – but not high Consideration of Special Technical Features (STF) and Shift Amendments – now historic

Examination Reports Usually two then refusal/allowance Limitation on amendments after the first O.A Many objections are based on: Inventive step or description requirements.

Limitation on Amendments After responding to the first office action, amendments are limited to: a) the deletion of a claim or claims; b) the restriction of the scope of claims providing the industrial applicability and the problem to be solved of the invention stated in the said claim or claims prior to the amendment are identical with those after the amendment. c) the correction of errors; and d) the clarification of an ambiguous statement limited to the matters stated in the reasons for refusal in the notice of reasons for refusal.

Appeals 64% of Japanese applications are refused 17% of refused applications are appealed 74% of appealed cases are successful. Pre-Appeal stage amendments are important. 61% of successful appeals involve amendment. Source SHIGA Newsletter 2010 “88.2% of all statistics are made up on the SPOT”: VIC REEVES (Guiness Advert)

Opposition For the past 10 years, there has been no opposition procedure. A new procedure came into force in 2015 Merck already had patent app for use of finasteride as a drug for prostate enlargement (5mg) and treating a type of MPB (5mg) First instance: Taxol case followed, with result that claims to novel dosage regime were found to constitute an unpatentable method of treatment Court of Appeal: decision reversed. Dosage regimes held to be allowable in certain cases. Hailed as “landmark case” for pharmaceutical industry. Recognises that research into new and better dosage regimes is desirable. Important since established new exception to the rule that Court of Appeal is bound by earlier decision when there is established EPO BoA case law. Recognition for the need to harmonise interpretation of EPC will be welcomed. Does this give the green light to the patenting of all new dosage regimes? No. New dosage regimes will nearly always be obvious since it is standard practice to investigate appropriate dosage regimes.

Opposition A written Procedure like re-examination. An Opposition request causes the Examiner to issue a further Office Action, to which the parties can respond. No Oral Proceedings. Appeal to IP High Court for Patentee. No Appeal for Opponent, who may instead file a request for an Invalidity Trial. JPO Appeal Board not involved. Merck already had patent app for use of finasteride as a drug for prostate enlargement (5mg) and treating a type of MPB (5mg) First instance: Taxol case followed, with result that claims to novel dosage regime were found to constitute an unpatentable method of treatment Court of Appeal: decision reversed. Dosage regimes held to be allowable in certain cases. Hailed as “landmark case” for pharmaceutical industry. Recognises that research into new and better dosage regimes is desirable. Important since established new exception to the rule that Court of Appeal is bound by earlier decision when there is established EPO BoA case law. Recognition for the need to harmonise interpretation of EPC will be welcomed. Does this give the green light to the patenting of all new dosage regimes? No. New dosage regimes will nearly always be obvious since it is standard practice to investigate appropriate dosage regimes.

Patent Term Extension Article 67: (Not surprisingly) the term of a patent is 20 years from filing. But, Art 67(2) SPC like Extensions available on request (PTE patent term extensions). http://thespcblog.blogspot.com/2011/05/japanese-patent-term-extensions-ii.html General question as to whether diagnostic methods including a step which involves a physical interaction with the body should be excluded from patentability.

Courts In the case in question, the method was found not to fall within the method of diagnosis exclusion, which following earlier case G1/04 has been established as a very narrow exclusion. Conflicting case law: Some case law emphasises that the nature of the intervention is key. Any method including a step requiring the use of a surgical instrument would be excluded. This is the view set out in the Guidelines for examination. Other case law emphasises that the purpose of the intervention is key. Only interventions aimed at maintaining or restoring health were objectionable. If this narrower interpretation is followed, diagnostic methods involving a surgical step would be potentially allowable. Amicus briefs file by various interested parties, including CIPA, who agree with second approach where purpose is key.

Other Matters Patent Numbers: S and H Searching

Some words Good luck : Gambare / Gambatte Kudasai Patent Attorney: Ben-ri-shi Patent: Tok-kyo Exam: Shi-ken Everyone: Mina-san Benrishi-no-mina-san, tok-kyo no shiken gambatte kudasai. Two topics which are both generating a lot of interest at the moment, not least because they are both the subject of a pending Enlarged Board of Appeal decision at the EPO. The first topic was also the subject of a Court of Appeal decision in May 2008. Each case relates to the patentability of particular types of medical inventions and the referrals seek clarification of certain definitions of excluded subject matter under the EPC. 18

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