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AIPPI Workshop Pharma I The European Perspective: First and Second Medical Uses Treatment Regimes

AIPPI Workshop Pharma I The European Perspective: First and Second Medical Uses Treatment Regimes. Dr. Jürgen Meier. Medical uses?. Claims?. Claims 1. Beer , comprising at least 20% EtOH. 2. Pharmaceutical composition comprising beer as characterized in claim 1.

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AIPPI Workshop Pharma I The European Perspective: First and Second Medical Uses Treatment Regimes

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  1. AIPPI Workshop Pharma IThe European Perspective:First and Second Medical Uses Treatment Regimes Dr. Jürgen Meier

  2. Medical uses?

  3. Claims? Claims 1. Beer, comprising at least 20% EtOH. 2. Pharmaceutical composition comprising beer as characterized in claim 1. 3. Use of beer as characterized in claim 1 for the preparation of a pharmaceutical composition for stress release, the treatment of nervous disorders and/or myogelosis. [1973] Beer as characterized in claim 1 [for use] in stress release, the treatment of nervous disorders and/or myogelosis. [2000] 4. The pharmaceutical composition of claim 2 or the use of claim 3, whereby the beer is to be administered after sunset.

  4. Claim categories of interest • 1st medical use: composition claims; • 2nd medical uses: use or “purpose-limited” composition claims; • specific treatment dosage regimen: claims as for new 2nd medical uses with specific details of how to administer.

  5. Legal Background A53 EPC - Exceptions to Patentability "European patents shall not be granted in respect of ... (a) ... (b) ... (c) methods for the treatment of the human or animal body by surgery or therapy and diagnostic methodspractised 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."  Claim format for medical use: Not patentable: "Method of medical treatment" Patentable: "Product for use in method of medical treatment"

  6. Legal Background A54(4) and A54(5) EPC - Novelty "§2 and 3 shall (also) not exclude the patentability of any substance or composition comprised in the state of the art, for(any specific) use in a method referred to in A53(c), provided that its use for any such method / such use is not comprised in the state of the art."  Purpose limitedproduct protection for 1st and 2nd medical use Product: "Substance X"novel over1st medical use: "Substance X for use inmedicine"novel over2nd medical use: "Substance X for use in treating disease Y"novel overFurther medical use: "Substance X for use in treating disease Z"

  7. First Medical Use: Then and Now The allowable claim format is the same under the old and the new EPC! Either: Compound X for use as an active pharmaceutical substance. (e.g. T 128/82, ”Pyrrolidine derivatives/HOFFMANN-LA ROCHE”) Or: Pharmaceutical composition comprising compound X and, optionally, a pharmaceutically acceptable carrier and/or diluent.

  8. First Medical Use: Then and Now When are such claims granted? - when compound claims are submitted and the pharmaceutical use is credible (T 604/04: grant of claims for using the protein but not the antibodies); • when specific applications are filed for a medical use: it must be credible and supported (T 1045/98). Note: There is no rejection of first medical use claims because only a limited number of possible uses is identified in the application.

  9. Claim Construction 2nd Medical Use under A54(5) EPC "Substance / Composition X for use in treating disease Y"  2nd medical use protection under to A54(5) EPC_2000;  novel over use of X in treating a different disease Z

  10. Second and Further Medical Uses – Dosage Regime (G 2/08) Same compound, same disease but - different dosage or different chronological order of administration; - extension/shortening/interruption of administration pattern Basic questions: Is a dosage regime a feature that is part of typical activities and duties of the doctor and therefore excluded from patentability? Can it be taken into account for the assessment of patentability?

  11. Claim Construction Swiss Type Claim Format (G5/83) "Use of compound X for the manufacture of a medicament for the treatment of disease Y"; • no provision for 2nd medical use under EPC1973; • adoption of practice applied by Swiss Federal IP Office for protecting further medical indications; • to be interpreted as encompassing the industrial packaging of the substance with the instructions for use ("augenfällige Herrichtung"); • applicable only up to an effective date of the application of 28 January 2011 (G2/08)

  12. Claim Construction Abolition of Swiss Type Claim Format (G2/08) NOW: "Compound X for use in the treatment of disease Y"; • with EPC2000 provision for 2nd medical use; • purpose-limited product protection under Art 54(5) EPC2000 for applications without decision of grant taken on 13 December 2007;  Swiss type claim format of G5/83 redundant;  Swiss type protection abolished within 3 months after publication of G2/08 in the Official Journal = 28 October 2010 for applications with effective date > 28 January 2011;  after this date Swiss type claim to be construed as mere process of manufacture without limitation by the therapeutic indication.

  13. Case Law 2nd Medical Use - Delimitation by Patient Group T19/86(BoA 3.3.1) Facts & Decision "Use of... ...Aujeszky-virus for the manufacture of a vaccine for......protecting maternally immune pigs against Aujeszky's disease."  claimed group of sero-positive pigs does not overlap with the known group of sero-negative pigs;  treatment of Aujeszky's disease in sero-positive pigs novel over same treatment in sero-negative pigs (Art 54 EPC);  see also T893/90 (control bleeding in non-hemophilic vs. hemophilic mammals);

  14. Case Law 2nd Medical Use - Delimitation by Patient Group T233/96(BoA 3.3.2) Facts & Decision "Use of adenosine... ...in the preparation of a diagnostic agent for detecting... ...vascular disease of coronary arteries by... ...administration to a human who is unable to exercise adequately..."  not-adequately exercising patients at best a sub-group of the known group of coronary artery disease patients;  no functional relationship between selected sub-group and pharmacological effect of adenosine;  sub-group arbitrarily selected;  criteria for delimitation of selection inventions from prior art not fulfilled (Art 54 EPC);

  15. Case Law 2nd Medical Use - Delimitation by Patient Group Conclusion: Difference in patient group distinctive over prior art provided that • the claimed group does not overlap with the known group (T19/86),i.e. patient group represents an alternative vis-à-vis the prior art or • the claimed (sub-)group does not represent an arbitrary choice (T233/96),i.e. patient group represents a purposive and clearly distinguishable selection from the already known entirety of patients;

  16. Patentability of a specific treatment regimen

  17. Second and further medical uses Dosage regime Same compound, same disease but • different dosage or different chronological order of administration • extension/shortening/interruption of administration pattern Basic questions: Is dosage regime a feature that is part of typical activities and duties of doctor and therefore excluded from patentability? Can it be taken into account for assessment of novelty?

  18. T1319/04: „Nicotinic acid compositions for treating hyperlipidemia“ KOS LIFE SCIENCE Dosage regime ...for use in a treatment by oral administration once per day prior to sleep... Examining Division: ...feature reflected a medical activity excluded from patentability under Art. 52(4) EPC... But then !

  19. YES...he can! G2/08 !Dosage or Treatment Regimen Are Allowable!

  20. What Do We Learn From G2/08? Certain liberalization on second medical uses: - It is not per se necessary for the treatment to be directed to a different (novel) disease to confer novelty on a second medical use claim. - This applies also to second medical uses where the only novel feature is a "dosage regimen" - HOWEVER: There must be a clear technical effect of the dosage regime! (improvement, surprising effects or advantages) "Swiss-type language" is now obsolete and will from now on (3 months after publication of G 2/08; i.e. January 29, 2011) not be accepted by the EPO. Applications filed from now on are required to use the new EPC2000 format: "Substance X for use in a method of treating disease Y"

  21. But Was That Everything? • Scope of protection?: there is probably a difference for off-label use • "Double patenting" in divisional applications?: first med. use, sec. med. use old/new, regimen; T 307/03 … the "national DE view" …

  22. "Carvediol II" BGH X ZR 236/01

  23. Carvedilol II Main Request 1. Use of carvedilol for the manufacture of a medicament for decreasing mortality resulting from congestive heart failure in human patients in conjunction with an angio-tensin-converting enzyme inhibitor, a diuretic and a digi-talis glycoside, with said medicament being administeredat an initial dose containing either 3,125 mg or 6,25 mg carvedilol per day for a period of 7-28 days, followed by dose increases in bi-weekly intervals up to a maximum dose of 2 x 25 mg carvedilol per day.

  24. Carvedilol II Second Auxiliary Request: 1. Use of carvedilol for the manufacture of a medicament for decreasing mortality resulting from congestive heart failure in human patients in conjunction with an angiotensin-converting enzyme inhibitor, a diuretic and a digitalis glycoside, with said medicament being formulated for administration purposes at an initial dose containing either 3,125 mg or 6,25 mg carvedilol per day for a period of 7-28 days, followed by dose increases in bi-weekly intervals up to a maximum dose of 2 x 25 mg carvedilol per day.

  25. Carvedilol II Headnotes of the Decision: a) Administering a medication intended for the treatment of a particular condition amounts to a therapeutic procedure for the treatment of the human body.

  26. Carvedilol II 51.1 However, there are no reservations against the admissibility of the patent claims according to auxiliary request 2, which provides under both patent claims that the medication containing carvedilol is formulated in certain doses for administrationover certain periods.

  27. Carvedilol II 51.1 Accordingly, protection is to be accorded to the use of a chemical substance in the therapeutic treatment of the human body,such substance being formulated to suit such use– for instance by means of suitable packaging for the tablet sizes, an inscription on the package or package inserts.

  28. Carvedilol II YES, …he COULD… but: claim language requests a “formulation”; see reason 51.1 “…whereby said beer is formulated for administration after sunset…”

  29. The Future Carvedilol II comes from a time when EPC2000 did not exist. Question: How is Germany going to deal with second medical use claims granted under EPC2000? Answer: Limited accessibility because of Article 138 EPC1973/2000! and: The Patent Act has been adapted effective as of the same date! Olanzapine BGH X ZR 89/07 and Escalitopram BGH Xa ZR 130/07 demonstrate a tendency for "Europeanization" (Finasteride, UK).

  30. Thank you … … for your attention!!!!!!!!!! … and Dr. Dieter Tzschoppe (EPO Director Pure and Applied Organic Chemistry) for some slides Questions? meier@vossiusandpartner.com

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