Merck, Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd v Teva Pharma B.V. and Teva UK Ltd, England & Wales High Court, 9 July 2013,  EWHC 1958 (Pat), with thanks to Daniel Brook and Laura Whiting, Hogan Lovells, for providing the judgment and a summary in English
The English High Court today gave its judgment on what amounts to a threat to infringe a patent when a generic company has a marketing authorisation. The court held that Teva had threatened to infringe the patent and SPC and granted a final injunction preventing Teva from selling generic efavirenz in the UK until the expiry of the SPC on efavirenz (SPC/GB00/035 based on EP (UK) 0 582 455). In doing so, Mr Justice Birss continued the preliminary injunction he granted in March 2012, reported here.
In October 2011, Teva obtained a positive CHMP opinion for its generic efavirenz product. BMS wrote to Teva requesting an undertaking not to market any efavirenz product in any country in which the patent/SPC remained in force. Teva initially refused to give any undertaking on the basis that it was not obliged to inform competitors of its commercial intentions. On that basis BMS obtained a preliminary injunction.
The usual pleading in the UK in a quia timet (Latin: "because he fears") action for an injunction to restrain harm which has not yet occurred is that the defendant "threatens and intends" to infringe the patent. In this case neither validity nor infringement were in issue by the time of trial. The only issue to be decided was whether Teva did threaten and intend to infringe the patent/SPC.