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Patents in the pharmaceutical industry

Patents in the pharmaceutical industry. Lars Sparre Conrad Senior Patent Counsel Corporate Patents and Trademarks. The patent department. Chemical engineer, DTU (chemistry), 1990 PhD, DTU (bio-inorganic chemistry), 1992 European Patent Attorney, 2005

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Patents in the pharmaceutical industry

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  1. Patents in the pharmaceutical industry Lars Sparre Conrad Senior Patent Counsel Corporate Patents and Trademarks

  2. The patent department • Chemical engineer, DTU (chemistry), 1990 • PhD, DTU (bio-inorganic chemistry), 1992 • European Patent Attorney, 2005 • Research chemist, Novo Nordisk, enzyme business, 1992-2000 • Patent departments • 2000-2003 Leo Pharma • 2003-2005 Novo Nordisk • 2005- H Lundbeck

  3. The Patent DepartmentLundbeck • 11 patent counsels • 5 Chemical engineers • 2 Human biolog • 2 Cand Pharm • 1 Chemists • 1 Lawyer • 5 Counsels in the US

  4. Role of the Patent Department Target Assay Compound Indication Salts Polymorphs Formulation Process Device More indications Biomarkers Life Cycle Management Prosecution Drug Discovery Drug Development On the Market Freedom-To-Operate

  5. Examples from real life • Duloxetine (SNRI) from Lilly approved 2004 in the US and 2005 in EP • First compound application 1986 • In the period 1986-2003 (at least) • 2 compound applications • 11 indication applications • 13 combo application • 2 formulation applications • 1 process application • Janssen lists 16 patents for Risperidone in Orange Book

  6. Why Patents • Value of company not associated with tangible assets • Value associated with an “idea” and exclusive execution of the “idea” • IPR is they way to protect ideas • Protection of investments • The average cost of developing a prescription drug is about 800 mill $

  7. Patent Department involvement • Extreme cost and duration of pharmaceutical development => Focus on exclusivity • “The right to prevent others form doing something” => Focus on Freedom-to-Operate • “The right to do what you plan to do”

  8. Why

  9. Why The number of application is ever increasing

  10. Børsen, 30 Juli 2003

  11. What is a patent • A patent is an exclusive right which is granted in return for the technical contribution to the society

  12. Limitations of Rights Time – 20 years Geography – Country by country Scope – The claims

  13. What rights • Gives the right to stop others from • making • offering • putting on the market or • using the product or process • using/importing a product obtained by a process which is patented

  14. What rights A patent does not give you the right to: • Exercise your own invention • Somebody may have a dominating patent • Freedom-to-operate • Circumvent legislation in particular fields (pharmaceuticals, agrochemicals, chemicals in general, biotechnology, weapons, broadcasting etc.)

  15. What can not be patented • Discoveries, scientific theories and mathematical methods • Artistic creations • Plans, rules or methods for intellectual activity, for games or for business activity or computer programs (outside US) • Presentation of information

  16. What can not be patented • Methods for surgery / therapy / diagnosis (Patentable in the US!!!!!) • Cloning human beings • Germ line modification • Uses of human embryos • Modifying the genetic identity of humans

  17. Claims in the Pharma Industry • Compounds • Salts • Enantiomers • Polymorphs • Use of compound in therapy • Known compound; first use in therapy • Pharmaceutical composition comprising compound • E.g. in combination with specific excipients

  18. Claims in the Pharma Industry US Only • A method of treating X by the administration of compound • Compound for use in the treatment of X • Use of compound in the manufacture of a medicament for the treatment of X • Process of manufacture • Dosing regimes • Combination treatments

  19. Claims in the Pharma Industry • Biomarkers/patient selection/personalized medicine • Assays • Devices

  20. Claims in the Pharma Industry • Method of treatment claims • Allowed in the US • Not allowed in EP • Not considered industrially applicable – pre-2007 • Not considered patentable for moral reasons – post-2007 • Second medical use claims the equivalent outside US

  21. Requirements for patentability • Three separate criteria: • Novelty • Inventive step • Industrial applicability - seldom a problem • The criteria are examined individually and all must be fulfilled!

  22. Novelty • Absolute novelty approach • Everything which is made public available prior to the filing date belongs to prior art • Photographic identity • Written, orally or in any other way • Not a question of whether somebody has actually read the document but whether it was available to anyone who wanted to see it

  23. Novelty

  24. Novelty

  25. Inventive step • The invention must not be obvious to the skilled person in view of the state of art • A leap in cognition • Known to use alkali metal salts  Probably obvious to use the sodium salt • Allowed to combine documents or information when evaluating inventive step

  26. Inventive step • Insulin solution characterised in that it comprises Zn2+ ions in an amount of above4 Zn2+ per hexamer insulin but below the limit for precipitation of zinc-insulin complexes • Prior art disclosed insulin solutions with4 Zn2+ per hexamer insulin

  27. Inventive step Inventive step Stability factor Zn++ / insulin hexamer

  28. NoveltyInventive step Not novel Invention Invention Prior art Prior art Inventive?

  29. PAUSE!!!!

  30. From cradle to grave 30 months 18 months 2-7 years 7-10 years 20 years 12 months Year 0 Grant PCT filing Publication Priority filing Opposition Enforcement National/regional filings

  31. How to obtain a patent • File application, pay fees and prosecute • Priority application (T=0) • One application in one country • Filing date determines what is prior art • Provides 12 months period to evaluate the invention • PCT – Patent Corporation Treaty (T=12 months) • One application for “the whole world” • Does not issue patents • Issues a preliminary opinion on patentability • Delays need for expensive translations

  32. How to obtain a patent • National/regional filings (T=30 months) • EPO – European Patent Office • One application for ~35 European countries • Issues patents – bundle of national patents

  33. Stakeholders Innovative Pharma Long exclusivity for ensure revenue on investments Generic Industry Short exclusivity for early Market entry Society/Payers Stimulate innovation - Make innovation worthwhile - No resting on the laurels Affordable medicine

  34. Patent peculiarities in Pharma • 1st medical use claim • Patent term extension • Limitation of exclusivity • Rewards for challenging pharma patents in courts (Hatch-Waxman act)

  35. Supplementary Protection Certificate Counsel regulation 1768/92 • Pharmaceutical research plays a decisive role in public health • Pharmaceutical research long and costly • Effective exclusivity period ineffective to cover investment • Extension of the patent term

  36. SPC – conditions for grant • Product must be protected by the patent in force • MA has been issued • An SPC has not already been issued for the active compound • The MA is the first MA in EU

  37. SPC - Term • (Market authorisation – Patent Filing)-5 years • Max 5 years extension • Max 15 years market exclusivity Market entry +5 20 0 • A balance of interests

  38. SPC – Scope of protection • Only the product covered by the patent within the limits of the patent • The patent as such is not extended • Esters and salts covered – ECJ392/97

  39. Patent Term Extension IND NDA MA • Investigational New Drug • New Drug Application • Marketing Authorisation • PTE= • Maximum 5 years extension • Maximum 14 years market exclusivity

  40. Limitation of scopeBolar Provision • 2004/27/EC Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products • 35 U.S.C §271(e)(1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (..)solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

  41. Generic Avenue Tech. Difficulties Reg. Environ ment Data Exclusivity Patents

  42. Data Exclusivity EU • Counsel regulation 2001/83 and 2004/27 • A generic may refer to the originators registration data 8 years after originators MA • A generic drug cannot be marketed before 10 years after originators MA • Global Marketing Authorisation

  43. Data Exclusivity EU • Data exclusivity extended to 11 years if originator obtains MA for new indication • Within 8 years • Requiring clinical trials • Superior to existing treatment

  44. Data Exclusivity EU • Generic drug • Same active substance • Salt, ester, ether, derivative etc unless they differ significantly • Same pharmaceutical form • All oral IR formulation are ”same” • Bio-equivalence

  45. Orphan drug EU • EU regulation 141/2000 • Life-threatening or debilitating disease affecting less than 5 out of 10000, or • Where the development of drug is unlikely to generate sufficient return, and • With no existing treatment • 10 years exclusivity for similar drug and same indication

  46. Orphan drug EU • Exclusivity period reduced or annuled if • There is a profitable return • A superior product is brought to the market

  47. Paediatric exclisivity EU1901/2006 • Paediatric Investigation Plan (PIP) after Phase I • Deferral • Waiver • Data must be included in MA application and leaflet • Incentives • 6 months extension of SPC • Paediatric Use Marketing Authorisation (PUMA) • 10 years data exclusivity • Orphan drug period extended to 12 years

  48. Questions

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