Under English law, a patentee can ask the court for an injunction to be granted before an infringing act has taken place (known as quia timet injunctions). The Patents Court recently handed down its decision in Merck Sharp Dohme Corp and Bristol-Myers Squibb Pharmaceuticals Limited v Teva Pharma BV and another where the requirements for obtaining quia timet injunctions were considered.
By way of background, Bristol-Myers Squibb (BMS - a long standing client of Dehns) held an EP(UK) patent and supplementary protection certificate (SPC) relating to efavirenz. The generics company Teva obtained marketing approval for efavirenz while the patent and SPC were still in force. BMS contacted Teva to determine if it intended to launch efavirenz before the patent rights expired, but Teva stated its intentions were confidential.
Dissatisfied with the uncertainty, BMS applied for a quia timet injunction to prevent Teva from launching efavirenz. When considering whether BMS had a right to bring the action against Teva, the Judge proposed that the question to be asked was whether, viewed in all the relevant circumstances at the date BMS initiated proceedings, there was a sufficiently strong probability that an injunction would be required to prevent Teva from infringing.
On the facts of the case, the Judge awarded the injunction and prevented Teva from launching efivirenz until the patent and SPC had expired. Notably, the Judge held that Teva would not have suffered any harm if it had told BMS that it would delay launch until the patent and SPC had expired, particularly if that information was imparted under terms of confidentiality to prevent competitors of Teva who may also be planning to launch efavirenz from finding out.
The judgement provides useful guidance for pre-action correspondence to ascertain when a company plans to launch its generic pharmaceutical. Generics companies withholding this information from patent proprietors may face actions for quia timet injunctions, and should therefore consider providing confidential assurances that generic drugs will not be launched while patent rights remain in force.