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Pfizer statement on the Court of Appeal decision regarding the Lyrica® (pregabalin) pain patent

London, 13th October 2016: Pfizer is disappointed with the decision issued by the Court of Appeal in London on 13th October 2016 and will seek to appeal the decision.  The Court of Appeal affirmed the High Court’s decision finding that the patent covering Lyrica® (pregabalin) for pain is not infringed by Actavis and also finding patent claims directed generally to pain and neuropathic pain invalid. However, the Court of Appeal affirmed the High Court’s decision in upholding as valid Pfizer’s patent claims directed to certain types of pain, including acute herpetic pain, postherpetic pain and causalgia pain.

While Generics (UK) Limited (trading as Mylan) and Actavis Group PTC ehf had challenged the validity of the pain patent, Pfizer maintains its strong belief in the validity and importance of the second medical use patent for the use of Lyrica® in pain and intends to seek permission to appeal the decision to the Supreme Court.

The UK patent at issue, EP (UK) 0934061,1 covers the use of pregabalin, the active ingredient of Lyrica®, for the treatment of pain and expires in July 2017.2 Pfizer has always made clear that it has not sought to prevent the use of generic pregabalin to treat generalised anxiety disorder or epilepsy. Following the Court of Appeal’s judgment, and pending the outcome of its appeal to the Supreme Court, Pfizer will now seek to have the NHS England Pregabalin Guidance on prescribing and dispensing by brand name, Lyrica®, limited to prescribing and dispensing for the types of pain in those patent claims upheld as valid by the Court of Appeal.

References:

  1. EP patent EP0934061 B3
  2. Mylan and Actavis v Warner-Lambert [2015]. EWHC 2548 (Pat)