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PATENT LIFE CYCLE MANAGEMENT

PATENT LIFE CYCLE MANAGEMENT. Strategies for originators and tactics for generics Dr Denis Schertenleib Avocat & Solicitor Partner Hirsch & Associés Paris France ds@hirschlex.com. 25 years is both too long and too short.

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PATENT LIFE CYCLE MANAGEMENT

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  1. PATENT LIFE CYCLE MANAGEMENT Strategies for originators and tactics for generics Dr Denis Schertenleib Avocat & Solicitor Partner Hirsch & Associés Paris France ds@hirschlex.com

  2. 25 years is both too long and too short • Originators are burdened with increasing costs for developing drugs • Originators have less and less blockbuster drugs in the pipeline • The costs of novel drugs are perceived as too high even for developed economies HIRSCH & PARTNERS

  3. There is a real pressure for • Originators to increase the duration of their monopoly beyond 25 years. • Generics to break that monopoly. HIRSCH & PARTNERS

  4. Second generation patents • These patents seek to protect a drug after the original patent on the drug has expired. • They protect some form of variation or improvement. HIRSCH & PARTNERS

  5. Second generation patents - examples • Second therapeutic use • Crystalline polymorphs • Single enantiomers HIRSCH & PARTNERS

  6. Second therapeutic use • Claims to a further medical use of a substance for which a therapeutic use was known. • E.g. a claim to the use of aspirin for fluidifying blood whereas aspirin was known as a pain killer for decades. HIRSCH & PARTNERS

  7. Second therapeutic use • Valid since EPO decision G5/83 if drafted in swiss type format: Use of product X for the manufacture of a medicament for treating illness Y • Until EPC 2000 validity was challenged at national level. HIRSCH & PARTNERS

  8. 2nd therapeutic use – EPC 2000 • EPC 2000 clearly removed any ambiguity as to validity of 2nd therapeutic use. • EPC 2000 allows straightforward drafting of 2nd therapeutic use claim: Product X for treating illness Y HIRSCH & PARTNERS

  9. 2nd therapeutic use – dosage regimen • Can dosage regimen be a patentable new use: • Eg: Fosamax • known to use Fosamax every day at 10mg • Patent on use of Fosamax once a week at 70 mg HIRSCH & PARTNERS

  10. 2nd therapeutic use – dosage regimen • Problem with EPC as methods of therapy are not patentable. • Is a dosage regimen a method of therapy in disguise? HIRSCH & PARTNERS

  11. 2nd therapeutic use – dosage regimen • Under EPC case law : unpatentable (T317/95)…. • Until T1020/03. • BUT referral to enlarged EPO Board pending G2/08 • In the UK: unpatentable under Bristol-Myer Squibbs (2001). • But now under Actavis UK Ltd v Merck & Co Inc CA 2008: potentially patentable to follow EPO HIRSCH & PARTNERS

  12. 2nd therapeutic use – valid new uses • T290/86, T486/01, T189/95, T254/93 and finally T1020/03: • New illnesses (sildenafil: viagra® and now for pulmonary hypertension) • New patient groups (Diovan® for adolescents) • Overall : need to open a new field of clinical application HIRSCH & PARTNERS

  13. 2nd therapeutic use – invalid new uses • T486/01 – a claimed use characterised by giving more information about a mode of action all ready practised was not novel. • T836/01 - a claimed use which specified a different mechanism of action could be novel over prior art disclosing the same use as it opened new therapeutic possibilities HIRSCH & PARTNERS

  14. 2nd therapeutic use - infringement • It is not the product that is protected but the use. • There is a need to show intended use not merely possibility of use. • Need to resort to evidence such as advertisement, marketing authorizations, user notices (Wyeth v Abbott Paris Court of Appeal 2004) • What if stated illness is different from patented use: • Allergic rhinitis v hayfever • Alzheimer v alzheimer caused by a specified trauma • Reducing mortality form illness v treating symptoms of illness • Always remember the validity /infringement squeeze HIRSCH & PARTNERS

  15. Cristalline polymorphs • Complex molecules can crystallize in may ways: • Diamond, coal and carbon nanotubes are different crystal structure of the same compounds HIRSCH & PARTNERS

  16. Cristalline polymorphs • Different crystal structure can result from: • Crystallization parameters (solvent, temperature ) • Hydration • Cristal partners (co-crystals) HIRSCH & PARTNERS

  17. Cristalline polymorphs – relevance? • New polymorphs can have enhanced: • Stability and Shelf life • Improved production process and handling • Biovailability • Examples include: Ranitidine (Zantac®), Paroxetine (Deroxat®), Cefnidir (Omnicef ®) HIRSCH & PARTNERS

  18. Cristalline polymorphs – commercial relevance • Useful to extend patent monopoly if the market switches. • Generic that uses the “old” crystalline form can be seen as “outdated” even if no actual benefit result. HIRSCH & PARTNERS

  19. Cristalline polymorphs – patent definition? • At present cannot be defined directly by structure • Need to show X-ray or Infrared absorption data. • These are akin to identification by fingerprinting HIRSCH & PARTNERS

  20. Cristalline polymorphs – Xray data • Atorvastatin: form V form VI HIRSCH & PARTNERS

  21. Cristalline polymorphs – Xray data • The products claimed are defined by selecting characteristic peak • Claim 1 : Crystalline atorvastatin hemi-calcium characterized by a PXRD pattern having peaks at 3.8, 8.0, 8.9, and 10.4±0.2 degrees 2 theta. HIRSCH & PARTNERS

  22. Cristalline polymorphs – Issue with validity - Novelty • How different should X ray spectra be? • Should peaks be of different heights, different positions? • Lord Justice Jacob in Laboratoire Servier v Apotex 2008 CA: • “The individual peaks of the table should not have too much significance attached to them –it is the overall set that matters” HIRSCH & PARTNERS

  23. Cristalline polymorphs – Issue with validity - Novelty • Was the “new” polymorph already manufactured in the past? • Polymorphs are know to interconvert or revert spontaneously to other forms. • Servier v Apotex • Patented form a was the inevitable product of the prior art protocols. HIRSCH & PARTNERS

  24. Cristalline polymorphs – Issue with validity – Inventive step • Often polymorph patents claim several new forms at once but do not state what the new polymorph is for? • Often polymorph patent make vague claims about improved stability with no data • Problems with inventive step under the EPO problem/solution approach. • Is there an invention or a crystalline oddity? HIRSCH & PARTNERS

  25. Cristalline polymorphs – Infringement • What if some peaks are different? • What if the X ray spectra of the alleged infringement is more similar to the prior art X ray spectra? • The novelty/infringement squeeze • Evidential problems arise easily as excipient peaks (such as lactose) easily mask the relevant peaks. • The Lord Chief Justice in Servier v Apotex: “The evidence gave the case the spurious veneer of technical complexity” HIRSCH & PARTNERS

  26. Enantiomers • Molecules can have asymmetric shapes so that a mirror image of them is different form the original • They are called chiral HIRSCH & PARTNERS

  27. Chiral molecules • Chiral molecules can exist in the two mirror image form. They are called enantiomers. • A mixture of both enantiomers is called racemic • The two enantiomers are called the L and the D form (or + and – or S and R ). HIRSCH & PARTNERS

  28. Enantiomers – medical relevance? • Often drugs can exist in the L and the D form. • One form can be therapeutic and the other toxic. • Thalidomide: one enantiomer was therapeutic and the other was teratogenic. HIRSCH & PARTNERS

  29. Enantiomers – commercial relevance: “patent and switch” • Useful to extend patent monopoly if the market switches. • Generic that uses the “old” racemic form form can be seen as “outdated” even if no actual benefit result. • Eg: Zyrtec® : racemic form of cetirizine outdone by the “new” L-cetirizine : Xyzall®. • Actual clinical benefit still controversial. HIRSCH & PARTNERS

  30. Enantiomers – patentability • Novelty : T1046/97: enantiomers can be novel of the racemic mixture. • But are they inventive over growing literature in the last 20 years prompting the skilled worker to investigate individual enantiomers? • See T944/04 obvious to try out individual enantiomers • See Ranbaxy attack on Lipitor®; English Court of Appeal : skilled worked would investigate the properties of the enantiomers. HIRSCH & PARTNERS

  31. Enantiomers – defending infringement claims • Extrinsic evidence of speculative results. • Some patentee file on the same day pairs application each directed to one of the two enantiomers. • But is this an invention or a wild guess? • Patent require some credible evidence of claimed effect: see T1329/04, T609/02 and T715/03. HIRSCH & PARTNERS

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