Merck Sharp Dohme Corp & Anor v Teva Pharma BV & Anor

Quia timet relief depends on whether, viewed in all the relevant circumstances, there was a sufficiently strong probability that an injunction would be required to prevent the threatened harm. Mere possibilities are insufficient. The defendant’s subjective intention is ordinarily important, and a genuine absence of intention will usually be decisive, but the inquiry is not confined to intention. Overt acts, commercial circumstances and the defendant’s conduct may also establish a concrete, strong and tangible risk. The court must distinguish the position at the commencement of proceedings from the position at trial and assess whether bringing proceedings was justified when they began.

The claimants, proprietors and exclusive licensee of a patent and supplementary protection certificate relating to efavirenz, sought a permanent quia timet injunction restraining the defendants’ proposed generic launch before expiry of the relevant rights. The defendants accepted that the rights covered their product but denied having any intention to launch before expiry.

An interim injunction had previously been granted and the defendants’ application to strike out the claim had been dismissed. At trial, the central issue was whether, on 9 February 2012, there was a sufficiently strong probability that an injunction would be required to prevent infringement.

1. Applicable test. The court asked whether, viewed in all the relevant circumstances at the date proceedings were issued, there was a sufficiently strong probability that an injunction would be required to prevent infringement. Mere possibility was insufficient. The assessment was directed to justice between the parties and depended on the circumstances of the case.
2. Relevant factors. The defendant’s actual intention was important but was not the only consideration. The court could also examine overt acts, commercial incentives, regulatory preparations, the feasibility of infringement, and conduct indicating what the defendant was threatening to do. Corporate intention had to be inferred from the evidence.
3. Application. Teva’s marketing authorisation made an at-risk launch feasible. Its commercial incentives, established willingness to launch products at risk and without notice, active consideration of an early launch, and refusal to provide advance notice showed that the option of infringement was being consciously kept open. The unchanged preliminary limiting marketing date did not disprove that inference.
4. Although Teva had no concrete launch plan at the issue date, the court held that this materially understated its position. A later decision to launch would have been the crystallisation of an option already under active consideration. Teva’s subsequent statement that it had no plans to launch before expiry carried less weight because it was made after proceedings and the interim injunction.
5. The probability that an injunction would be required was therefore sufficiently strong to justify the proceedings. Judgment was given for the claimants and a permanent injunction was granted restraining infringement of the patent and supplementary protection certificate until their expiry.

The judgment describes earlier interlocutory proceedings. The application to strike out the claim was dismissed and an interim injunction was granted on 15 March 2012. The present decision was the first-instance trial judgment.