Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Co LLC [2016] EWCA Civ 1006
This was the hearing of three appeals arising from the “pregabalin” litigation, which concerned validity and infringement of a second medical use patent. The three questions for the CA were: (i) had the Judge correctly applied the law of insufficiency in finding some, but not all, of the claims invalid; (ii) was the Judge right to hold that the patentee’s post-trial amendment application constituted an abuse of process; and (iii) if there were any valid claims, was the Judge right to find that they were not infringed?
The Court of Appeal upheld the Judge’s findings on validity: the insufficiency attack was one of plausibility and the test of plausibility imposed a very low threshold. The Judge had not erred in finding that the teaching was plausible for peripheral neuropathic pain but not for central neuropathic pain. The Court of Appeal also upheld the Judge’s conclusion on abuse of process. In the premises, it was not necessary to determine the infringement appeal. Nevertheless the Court of Appeal reaffirmed that the test of direct infringement of a second-medical use patent was one of objective intention; such intention could be negatived where the manufacturer had taken all steps in its power to prevent the medication being used for the patented indication.
Michael Silverleaf QC appeared for the Secretary of State for Health, intervener on the infringement appeal. Kathryn Pickard appeared for Mylan on the validity and abuse appeals.