Mr Justice Birss in the English High Court issued a judgment on 9 July 2013 concerning an unusual “quia timet” injunction to prevent potential infringement by a generic company of a pharmaceutical patent and/or supplementary protection certificate (SPC). The case shows that UK courts may in future be stricter in requiring generic companies to be clearer about their plans concerning products covered by patents and/or SPCs.
The patent in question is EP(UK)0582455 owned by Merck Sharp Dohme Corp (“MSD”) and exclusively licensed to Bristol-Myers Squibb Pharmaceutical Ltd (“BMS”). The patent covers efavirenz, a non-nucleoside reverse transcriptase inhibitor that inhibits viral replication and is used in the control of HIV infections. Efavirenz is present in the branded medicines Sustiva and Atripla. The patent was in force until 3 August 2013, but an associated SPC extended protection for efavirenz until 19 November 2013.
The generic companies Teva Pharma B.V. and Teva UK Ltd (together, “Teva”) obtained a marketing authorisation (MA) in January 2012 for efavirenz from the European Medicines Agency, giving Teva the possibility to launch their own generic version of efavirenz.
In view of the MA granted to Teva, BMS considered there was a risk that Teva was intending to launch efavirenz in the UK prior to the expiry of the patent or its SPC. BMS requested from Teva an undertaking that they would not do so. Teva refused, saying that its plans were confidential and that it was not obliged to tell BMS (or the court) what its intentions were. BMS applied to the High Court in February 2012 for an interim injunction against Teva, and this was granted by the same judge in March 2012. The present case is the full trial proceedings relating to the interim injunction.
At issue in the case was whether Teva threatened and intended to infringe the patent and/or SPC, i.e. launch an efavirenz product before the SPC expiry date. Teva chose not to contest validity of the patent nor whether the patent covered Teva’s efavirenz product.
The judge concluded, following a review of relevant case law, that the question for the court was whether there was a “sufficiently strong probability” that an injunction against Teva would be required to prevent harm to MSD and BMS. The question of Teva’s intention was to be assessed on the basis of its subjective intention and also Teva’s acts (and hence the situation as perceived objectively by third parties).
The relevant date at which the threat had to be assessed was the date that the action was started by BMS, i.e. in February 2012. The judge held that from an external perspective, there was indeed a threat. Teva is a successful seller of generic pharmaceutical products and had a history of launching a generic product before patent or SPC expiry (a generic version of atrovastatin covered by a Warner-Lambert patent and SPC). With respect to Teva’s subjective intentions, the judge held based on documents before him that Teva had considered whether or not to launch an efavirenz product in the UK before the expiry of the SPC – and wanted to keep its options open to do so.
The judge accordingly upheld and maintained the injunction (now permanent until expiry of the SPC).
The decision is referenced as Merck Sharp Dohme Corp (MSD) and Bristol-Myers Squibb Pharmaceutical Ltd (BMS) v Teva Pharma B.V. and Teva UK Ltd,  EWHC 1958 (Pat) 09 July 2013 and can be read here.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.