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The Medicines Patent Cliff

The Medicines Patent Cliff. Ian Allen Lead Category Manager Commercial Medicines Unit. BASICS. Invention – inventive step 20 Year Period Obviousness Prior Art Publication: Protection allows others to learn from the invention. Pharmaceuticals – a strategy problem.

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The Medicines Patent Cliff

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  1. The Medicines Patent Cliff Ian Allen Lead Category Manager Commercial Medicines Unit

  2. BASICS • Invention – inventive step • 20 Year Period • Obviousness • Prior Art • Publication: • Protection allows others to learn from the invention

  3. Pharmaceuticals – a strategy problem • Patent period can be eaten up by R&D, trials etc. • Others may patent in the same area • The wait may reveal more data, e.g. activity or acceptability to better define the patent • Secondary patents may arise, e.g. further indications or for manufacturing processes • Thickets* or clusters of patents *See: Intellectual Property Office “Patent Thickets – An Overview” November 2011

  4. Pharma strategy – some regulatory help • Patent period can be eaten up by R&D, trials etc.: Supplementary Protection Certificates • 5 years • Paediatric Investigation Plans • 6 months

  5. Expiring patents • PMSG Transition sub-group • Assessment of optimum time to tender • Patent loss dates as a driver • Remember: Secondary patents (or other IP protection!) may arise, e.g. further indications or for manufacturing processes • Biological, complex and/or nano-size molecules(liposomal, pegylated etc.) require further investigation • Typically involving clinical trials – area of evolving regulation

  6. Sources • Commercial sources of patent analysis • Product licensing is public domain information • Only suppliers really know when they will bring a product to market • http://nww.cmu.nhs.uk/Medicines/Documents/patent%20review%20May%202012.pdf

  7. Research resources • Commercial research agents • UK: http://www.ipo.gov.uk/ • European: http://www.epo.org/searching/free/register.html?hp=stages • Companies own publications, e.g. Annual Reports, Investor Relations materials etc. (esp. useful for complex/combination products):

  8. US SEC Form 10-K 2011 Gilead Sciences, Inc. N.B. LITIGATION

  9. http://nww.cmu.nhs.uk/Medicines/Documents/patent%20review%20May%202012.pdfhttp://nww.cmu.nhs.uk/Medicines/Documents/patent%20review%20May%202012.pdf PMSG Transition product sub-Group Patent expiry review

  10. Patent reviewto 2020 and >£20millions

  11. A Changing paradigm? • Chemical entities – patent expiry date = key milestone in terms of competition • Biological, complex and nanopharmaceuticals – patent expiry date = not the critical RLS

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