Generics (UK) Limited t/a Mylan v Warner-Lambert Company LLC [2015] EWHC 2548 (Pat)

Warner-Lambert’s patent was a second medical use patent, which covered the use of pregabalin for the treatment of pain. Pregabalin was known as a treatment for epilepsy and generalised anxiety disorder.

Mylan sought revocation of the patent for insufficiency and lack of inventive step. In the meantime, Actavis launched a generic version of pregabalin under a “skinny label” (i.e. one which gives only the non-patented indications), which triggered an infringement action by Warner-Lambert. Although Warner-Lambert’s application for an interim injunction against Actavis was dismissed, the Court did make an order that the NHS issue guidance to its Clinical Commissioning Groups, with the aim of ensuring that only Warner-Lambert’s pregabalin product would be prescribed for neuropathic pain ([2015] EWHC 485 (Pat)).

The validity and infringement trials were held back-to-back. The Secretary of State for Health intervened in the infringement trial.

Arnold J held that the patent was partially invalid for insufficiency. In particular the claims covering the use of pregabalin for the treatment for pain (claim 1) and the treatment of neuropathic pain (claim 3) were invalid. Some of the subsidiary claims were upheld. Arnold J went on to hold that even if claims 1 and 3 had been valid, he would nevertheless have found that Actavis had not infringed. 

Piers Acland QC and Kathryn Pickard appeared for Mylan on the validity issues. Michael Silverleaf QC appeared for the Secretary of State for Health on the infringement issues.

Generics (UK) Limited t/a Mylan v Warner-Lambert Company LLC [2015] EWHC 2548 (Pat) 

 

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