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From blockbusters to biosimilars – the Patent Perspective . Dr. Thomas Friede Partner Patentanwalt & European Patent Attorney 2nd C5 Forum Biosimilars 2012. Important biologics patents expire. Biosimilars approved in Europe. Biosimilars under current review by EMA.

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From blockbusters to biosimilars – the Patent Perspective

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    1. From blockbusters to biosimilars – the Patent Perspective Dr. Thomas Friede Partner Patentanwalt & European Patent Attorney 2nd C5 Forum Biosimilars 2012

    2. Important biologics patents expire

    3. Biosimilars approved in Europe

    4. Biosimilars under current review by EMA

    5. Life cycle management - Evergreening • First generation: product patent • Second generation: processpatents, derivatives, formulations, different medicaluses • DecisionoftheEnlarged Board of Appeal G2/08 confirmsthepatentabilityofdosageregime • However: DE Federal Supreme Court „Carvedilol II“ December 19, 2006 dosageregimecannotbeconsideredfornoveltyinventivestep FRDecisionofthe Tribunal de Grande Instance Paris on September 28, 2010 „Actavis v. Merck“ dosageregimefeatureviolates Art. 53c) EPC

    6. Life cycle management – Evergreening (II) • Separate prosecution of different aspects of the same invention in parent and divisional is desirable (compounds, modes of administration, medical indications) • However: T 307/03: Prohibition of double patenting even if the compound claimed in the parent is only encompassed by the scope of the divisional application • Solution: Introduction of a Disclaimer • Decision G 2/10 of the EPO Enlarged Board of Appeal, Point 4 of the Reasons: A disclaimer is not only admissible based on prior art under Art. 54(2) and 54(3) EPC but also in other situations such as for non-patentability related reasons

    7. Industrial Applicability- The Principles • (i) The patent must disclose "a practical application" and "some profitable use" for the claimed substance, so that the ensuing monopoly "can be expected [to lead to] some … commercial benefit" (T 0870/04, para 4, T 0898/05, paras 2 and 4); • (ii) A "concrete benefit", namely the invention's "use … in industrial practice" must be "derivable directly from the description", coupled with common general knowledge (T 0898/05, para 6, T 0604/04, para 15); • (iii) A merely "speculative" use will not suffice, so "a vague and speculative indication of possible objectives that might or might not be achievable" will not do (T 0870/04, para 21 and T 0898/05, paras 6 and 21); • (iv) The patent and common general knowledge must enable the skilled person "to reproduce" or "exploit" the claimed invention without "undue burden", or having to carry out "a research programme" (T 0604/04, para 22, T 0898/05, para 6)

    8. Industrial Applicability (II) • (v) The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal (T 0898/05, paras 21 and 31, T 1452/06, para 5); • (vi) A "plausible" or "reasonably credible" claimed use, or an "educated guess", can suffice (T 1329/04, paras 6 and 11, T 0640/04, para 6, T 0898/05, paras 8, 21, 27 and 31, T 1452/06, para 6, T 1165/06 para 25); • (vii) Such plausibility can be assisted by being confirmed by "later evidence", although later evidence on its own will not do • (T 1329/04, para 12, T 0898/05, para 24, T 1452/06, para 6, T 1165/06, para 25)

    9. Broad claims • disclosureof a concept fit forgeneralisation required1 • Examinerhastosubstantiatereasonswhy he believestheeffectcannotbeachieved→ objectionsmaybebased on commongeneralknowledgeorpriorart • nogeneralruleseachcase must beassessed on ist own merits2 • 1 T 435/91, OJ EPO 1995, 188. • 2 See T 694/92, OJ EPO 1997, 408 concerning a plant patent.

    10. Harmonization of national Case law with EPO Case law • UK Supreme Court HGS v Eli Lilly of November 2, 2011: • “In a number of recent decisions of the House of Lords, attention has been drawn to "the importance of UK patent law aligning itself, so far as possible, with the jurisprudence of the EPO (and especially decisions of its Enlarged Boards of Appeal)", to quote Lord Walker in Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12; [2009] RPC 13, para 35.” • German Federal Supreme Court Xa ZB 10/09 of April 15, 2010: (“Walzenformgebungsmaschine”): • “German courts have to comply with decisions handed down by the courts of the European Patent Office or by courts in other EPC contracting states and which essentially concern the same issue, and if necessary they have to address the grounds which led to a divergent result in the prior decision.”

    11. Scope of Biotech Patents • Scopeof EP patentsgovernedby Art. 69 EPC andprotocol on theinterpretationof Art. 69 EPC • However: Interpretation by national Case Law • Germany: - knownforbroadclaiminterpretation (function-orientedapproach) - applyingthedoctrineofequivalents

    12. Scope of Biotech Patents • The German Federal Supreme Court hasdevelopedthreequestionsforthedeterminationofequivalency: • 1. Does the modified embodiment solve the problem underlying the invention with means that have objectively the same technical effect? • 2. Was the person skilled in the art, using his specialist knowledge, able to find the modified means at the priority date as having the same effect? • 3. Are the considerations that the person skilled in the art had to apply oriented to the technical teaching of the patent claim in such a way that the person skilled in the art took the modified embodiment into account as being an equivalent solution?

    13. Scope of Biotech Patents • Federal Supreme Court X ZB 12/00 of March 12, 2002 („Custodiol I“) The indicationofnumericallydefinedrangesisgenerallybinding.Figures outside theclaimedrangeare not consideredtobeequivalent. Exceptionfromtherule: tolerances due tolimits in workingprecision

    14. Scope of Biotech Patents Federal Supreme Court X ZR 16/09 of May 10, 2011 („Okklusionsvorrichtung“): Where the description discloses several ways of achieving a specific technical effect, as a rule, patent infringement by equivalent means is to be denied if only one of these ways is incorporated in the claim. Federal Supreme Court X ZR 69/10 of September 13, 2011 („Diglycidverbindung“): at least two requirements would have to be met for infringement under the doctrine of equivalence: (1) the specific effects of the variant are in accord with the claimed solution, and (2) the variant differs from the alternative merely outlined in the description but not in the claims in a similar fashion as the claimed solution differs from it.

    15. Recent Biotech Patent Decisions of German Courts – thermostable DNA polymerase • OLG Düsseldorf of January 14, 2010 • I-2 U 69/08 • Claim 1 of the Patent relates to a thermostable DNA polymerase having a molecular weight of 86.000 to 90.000 Da as determined by SDS page. • The attacked embodiment: • DNA polymerase having a molecular weight of 85.000 Da • The attacked DNA polymerase was found not to infringe the patent. • Court ruling: • No equivalent infringement having regard to the Federal Supreme Court Schneidmesser and Custodiol decisions which rule that numerical ranges in claims are binding.

    16. Recent Biotech Patent Decisions of German Courts – Ranibizumab • LG Düsseldorf of November 18, 2011 • 4a O 143/10: MedImmune vs. Novartis (Ranibizumab) • RepresentativesMedImmune: Johannes Heselberger, Thomas Friede • Litigation also in UK, FR, CH and NL • Claim 1 ofthe Patent relatesto a methodcomprising Phage Display Technology • Ranibizumabis a Fabfragmentspecificfor VEGF usedforthetreatmentof AMD (age-relatedmaculadegeneration) • Annual Ranibizumabsales (Europe): US-$ 1.3 billion • Patent foundtobeinfringedbyimportandsaleof immediate productoftheprocess

    17. Recent Biotech Patent Decisions of German Courts - Ranibizumab • Ranibizumab differs from the binding molecule actually obtained by the process by several substitutions introduced after the phage display step. • However: • Claim covers binding molecule, fragment or derivative with binding specificity for the target • => Claim encompasses Ranibizumab.

    18. Recent Biotech Patent Decisions of German Courts - Ranibizumab • Narrowing claim construction by the Defendants: • The Defendants argued that the core of the invention resides in a screening method which does not generate a product. • Court reasoning: • The claimed method is a manufacturing method since it comprises manufacturing steps.

    19. Thank you for your attention ! • Questions? • Dr. Thomas Friede • BARDEHLE PAGENBERG • Prinzregentenplatz 7 • 81675 München • •