Patent court rules in Pregabalin case and proposes system for NHS guidance

18 Sep 2015

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

Warner-Lambert has claimed a second medical use patent for the drug Pregabalin for treatment of neuropathic pain. Pregabalin was previously patented as a treatment for epilepsy and generalised anxiety disorder.

A competitor, Mylan, sought revocation of the second use patent for insufficiency and lack of inventive step against Warner-Lambert (“the validity proceedings”). Another competitor, Actavis, launched a generic version of the drug under a “skinny label” (being one with only non-patented indications) and Warner-Lambert brought an action against Actavis (“the infringement proceedings”). Although Warner-Lambert was earlier refused an interim injunction, a third party, NHS England, had been ordered to issue guidance with the aim of ensuring that only Warner-Lambert’s Pregabalin product would be prescribed for neuropathic pain pending trial. The Secretary of State for Health intervened in the infringement proceedings.

Following back-to-back hearings of the validity and infringement proceedings, Arnold J held that the principal second use patent claims (pain and neuropathic pain) were invalid for insufficiency. Some subsidiary use claims were upheld as protected by the patent. Arnold J held further that Actavis had not infringed, and would not have infringed even if those principal claims had been valid.

Arnold J concluded with observations on the need for a system, whereby patentees who wanted their second medical use patents enforced provided NHS England with all the information and assistance to enable it to issue appropriate guidance as and when required and generic companies who wanted their interests protected would also cooperate with NHS England.

Philip Moser QC was one of the counsel for the Secretary of State in the infringement proceedings.

To read the full judgment please click here: Generics (UK) Limited ta Mylan v Warner-Lambert Company LLC & ors