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Warner Lambert -and- Generics Ltd, Actavis, Caduceus (Pregabalin)

Case Summary  |  Judgment  |  13 October 2016


Richard Meade QC, Adrian Speck QC and Isabel Jamal appeared for the Respondents, Mylan and Actavis, in this appeal concerning validity and infringement of a Swiss form patent for the use of pregabalin for the treatment of pain.

At first instance the Judge had held the patent invalid for insufficiency, since it was not plausible that the drug would be effective for central neuropathic pain which was covered by the claims. He further found that, had the relevant claims been valid, the manufacture by Actavis of pregablin in the generic form for non-pain related indications would not have infringed the patent as it was not foreseeable that the generic drug would be intentionally administered for the treatment of pain.

Following judgment, Warner made an application to amend one of the claims to include only peripheral neuropathic pain. The Judge refused permission to amend on the basis that it would constitute an abuse of process.

Warner Lambert appealed the Judge’s findings on validity and infringement and appealed the decision on amendment and abuse of process. The Court of Appeal dismissed the appeal and upheld the Judge’s rulings on validity and abuse of process. The Court went on to consider the question of when a generic manufacturer might infringe a claim in the Swiss form for a new indication. Floyd LJ held that a manufacturer would have the necessary intention required for infringement of a Swiss Form claim where he knew, or could reasonably foresee, that a generic drug would intentionally be prescribed for an infringing use. However, if a manufacturer had taken all reasonable steps within his power to prevent those consequences occurring then this will negative the necessary intention and as such there will be no infringement.