Patentable Subject Matter and Medical Use Claims in the Pharmaceutical Sector

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1 Patentable Subject Matter and Medical Use Claims in the Pharmaceutical Sector 2012 LIDC Congress, Prague, 12 October 2012 Dr. Simon Holzer, Attorney-at-Law, Partner 3 October 2012

2 2 Introduction! Conflicting interests in the pharmaceutical sector:! Development of better and safer pharmaceutical products requires adequate protection of investments.! Reduction of healthcare costs.! Freedom of medical practitioners to prescribe or administer drugs.! Special patent solutions for the pharmaceutical sector:! Supplementary Protection Certificates.! Compulsory patent licenses for pharmaceuticals.! Exceptions to patentability.! Fiction of novelty with regard to first and second medical use.

3 3 Exceptions to Patentability! Physicians should be free to take all actions they considered suitable to prevent or to cure a disease, and in this exercise they should remain uninhibited by patents (Decision of the EPO s Enlarged Board of Appeal G 02/08, 5.3).! Article 53(c) EPC 2000 (see also Article 52(4) EPC 1973) European patents shall not be granted in respect of:! (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.! Conclusion: the use of substances or compositions in surgery, therapy and diagnostic methods is not excluded from patentability under Article 53(c) EPC.

4 4 Novelty Problem and Medical Use Claims under the EPC 1973! First Medical Use Claims:! Article 54(5) EPC 1973: The patentability of any substance or composition, comprised in the prior art, for use in a method referred to in Article 52, paragraph 4 (methods for treatment of the human or animal body by surgery or therapy and diagnostic methods) shall not be excluded, provided that its use for any method referred to in that paragraph is not comprised in the prior art.! First medical use claim under the EPC 1973:! Compound X for use as a medicament! Swiss-type Claims:! Strict interpretation of Article 54(5) EPC 1973 excludes patentability of additional medical uses if one single medical use of the concerned compound has been known in the prior art.! Solution: Swiss-type claim under the EPC 1973:! The use of compound X for the manufacture of a medicament for treating of disease Y! Swiss-type claims are not medical use claims in a narrow sense. "Swiss-type" claims were allowed for the first time by the Swiss Intellectual Property Office. The decision was adopted by a decision of the EPO s Enlarged Board (G 1/83).

5 5 Novelty Problem and Medical Use Claims under the EPC 2000! First Medical Use Claims:! Article 54(4) EPC 2000: The patentability of any substance or composition, comprised in the prior art, for use in a method referred to in Article 53(c) EPC (methods for treatment of the human or animal body by surgery or therapy and diagnostic methods) shall not be excluded, provided that its use for any such method is not comprised in the prior art.! First medical use claim under the EPC 2000: Compound X for use as a medicament! Second (and Further) Medical Use Claims:! Article 54(5) EPC 2000: 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) shall not be excluded, provided that such use is not comprised in the prior art.! Second medical use claim under the EPC 2000: Substance X for use in treating disease Y

6 6 Decision of EPO s Enlarged Board of Appeal (G 2/08): Swiss-type claims are no longer acceptable (I)! In its decision G 2/08 of 19 January 2010 the EPO s Enlarged Board of Appeal confirmed that it is possible to patent the compound X for use in the treatment of Y if the specific claimed treatment is novel and inventive.! The Enlarged Board of Appeal also confirmed that the new treatment could be a new and inventive dosage regime.

7 7 Decision of EPO s Enlarged Board of Appeal (G 2/08): Swiss-type claims are no longer acceptable (II)! The Enlarged Board of Appeal also decided that the Swiss-type claims were no longer allowable.! The Enlarged Board of Appeal reasoned that such claims were inappropriate because they had been allowed to close a legal loophole which was now closed by Article 54(5) EPC (second medical use) instead.! The Enlarged Board of Appeal noted that its decision had "no retroactive effect". Consequently, existing patents issued with Swiss-style claims are not affected.

8 8 Some Open Issues: Different Approaches! EPO: Art. 53(c) EPC 2000: second medical use claims! Second medical use claims are product claims: Compound Y for use in treating disease X! US: method-of-treatment claims! Method of treating disease X by administering compound Y! Japan: use-limited product claims! e.g. Pharmaceutical composition for treatment of disease X, comprising compound Y! Switzerland: Swiss-type claims are still required for national patents (see Article 7d of revised Swiss Patent Act (entered into force 1 July 2008))

9 9 Some Open Issues: Scope of Protection of Second Medical Use Claims (I)! Europe, Japan:! U.S.:! Infringement of second medical use claim = direct patent infringement.! Patentee must prove inducement to infringe. Not assumed if manufacturer knows that there is off-label use falling within the scope of the patent. Assumed if patented use is on drug s label.

10 10 Some Open Issues: Scope of Protection of Second Medical Use Claims (II)! Second medical use claims pursuant to Article 54(5) EPC can provide wider scope of protection compared to Swiss-type claims! Swiss-type claim: The use of compound X for the manufacture of a medicament for treating of disease Y! Art. 54(5) EPC claim: X for use in the treatment of Y! Possible Influence on doctors when they prescribe or administer drugs! See for example decision of the Swiss Federal Supreme Court dated 4 March 2011 (BGE 137 III 170):! The new second medical use format normally provides a broader scope of protection than the former Swiss-type claims since doctors treating their patients can fall within the scope of protection of second medical use claims.! National Lawmakers should provide for appropriate exemptions.

11 11 Q & A?