Supreme Court to weigh in on major second medical use patent case

Supreme Court to weigh in on major second medical use patent case

The Supreme Court has granted Warner-Lambert permission to appeal the order made by the Court of Appeal on 13 October 2016, in the case of Warner-Lambert Company LLC v Generics (UK) Ltd t/a Mylan and another. This is part of a long running dispute concerning a second medical use patent for the drug pregabalin, which is marketed by Warner-Lambert under the trade mark Lyrica.

The decision under appeal addressed two major issues, with the Court of Appeal agreeing with the judge at first instance that:

  • Key claims of the patent were invalid for sufficiency because the patent did not make it plausible that pregabalin would be effective for treating all types of pain encompassed by the claims.
  • Warner-Lambert’s attempt to limit the scope of its claims to address the sufficiency attack after the first instance trial had ended amounted to an abuse of process.

The Court of Appeal also provided some much needed guidance on direct and indirect infringement of Swiss-form second medical use claims and how generic drug manufacturers may exploit the market for unpatented indications lawfully (see here for our report on the Court of Appeal decision).

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