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Patents & health: focus on access – WHO TBS June 2017 Dr Peter Beyer, Senior Advisor

Patents & health: focus on access – WHO TBS June 2017 Dr Peter Beyer, Senior Advisor. Patent. Gives the right to the inventor to exclude others from commercially using the invention against disclosure

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Patents & health: focus on access – WHO TBS June 2017 Dr Peter Beyer, Senior Advisor

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  1. Patents & health: focus on access – WHO TBS June 2017 Dr Peter Beyer, Senior Advisor

  2. Patent • Gives the right to the inventor to exclude others from commercially using the invention against disclosure • Claims define the scope and can differ from one country to the other depending on examination • Only what is claimed is protected: a patent on use of an antibiotic to treat ophthalmological infections does not prevent marketing a generic tablet; patent on polymorph B does not prevent a tablet using polymorph A

  3. Patents • There is nothing such as a worldwide patent! • WIPO Patent Cooperation Treaty allows for worldwide filing, but applicant receives individual national/regional patents

  4. One drug = one patent? "…a key element of life cycle management strategies is to extent patent protection for as long as possible by filing secondary patents to keep generics off the market" (Burdon and Sloper, The art of using secondary patents to improve protection, International Journal of Medical Marketing, Volume 3, Number 3, June 2003, pp. 226-238(13)

  5. Typical patent flow for pharmaceuticals (chemicals)

  6. Sofosbuvir: Expiry without patent term extension(s) Market Authorization US: 2013/14 www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/

  7. Patentability criteria: incremental innovation vs. "evergreening" India: patent applications rejected as known substances are not considered novel under Section 3d Patent Act (e.g. paediatric formulations, combination patents, polymorphs) unless patent applicant can prove enhanced efficacyExamples: patents refused on: polymorph of imatinib mesylate; suspension of nevirapine hemihydrate; tenofovir disoproxil

  8. What is a voluntary license? • The owner of a patent can allow others to use the invention, in particular to manufacture, sell, export or import the patented product • Such a mutual agreement is called voluntary license

  9. What is a voluntary license? • The owner of a patent can allow others to use the invention, in particular to manufacture, sell, export or import the patented product • Such a mutual agreement is called voluntary license • It lays down the conditions, namely • the territory (list of countries in which the licensee may sell the invention) • Royalties • Exclusive or non-exclusive

  10. What is a compulsory license? National patent laws mandate national authorities to allow third parties to use a patented invention without the authorization of the patent owner under certain conditions to address certain unwanted consequences • unfair competition, • not working the invention, • abusively high prices, • health emergencies and others • WTO TRIPS contains certain conditions, but does not limit the grounds

  11. Patent protection vs Data Exclusivity Patent Application Filed Patent Term Restoration Original Patent Term - 20 Years from filing Data Exclusivity, NCE (5 yrs) Patent Issued FDA Approved Data Exclusivity, Non-NCE (3 yrs) Orphan Drug Market Exclusivity (7 yrs) Biologicals (12 yrs)

  12. WHO Patent Landscapes www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/

  13. The of intellectual property in local production in developing countries http://www.who.int/phi/publications/int_prop_local_prod_opportunities_chanllenge s/en/ www.who.int/phi/publications/category/en/

  14. WHO Global Report on Access to Hepatitis C Treatment http://www.who.int/phi/publicat ions/category/en/

  15. Promoting Access to Medical Technologies and Innovation www.who.int/phi/promoting_access_medical_innovation/en/ www.who.int/phi/publications/category/en/ Dr Peter BeyerSenior AdvisorWorld Health Organizationbeyerp@who.intTel. +41-22-791 25 07

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