The High Court refused Eli Lilly’s application to split its patent dispute with Novartis into two trial modules, finding that the proposed split might deprive Novartis of the opportunity to seek an injunction before the patent expired.
The ruling, delivered by Mr Justice Twomey on 21 December 2021, concerned the structure of the trial, not whether Eli Lilly infringed the patent or whether the patent was valid. Those substantive issues remained to be decided.
Novartis brought infringement proceedings concerning European patent (IE) 2 784 084 and Eli Lilly’s Taltz product. Eli Lilly separately sought revocation of the patent, arguing, among other things, that it lacked novelty. Eli Lilly also pleaded a competition-law defence and counterclaim, alleging that Novartis had abused a dominant position. Those were allegations, not findings in this application.
Both companies agreed that damages could be heard in a second module. Eli Lilly sought to put the competition defence and any injunction issues there too, after a first module addressing infringement, revocation and a supplementary protection certificate application. It argued that if it succeeded on infringement or revocation, the competition issues might not need to be heard, saving at least 10 days of court time. Novartis said the delay could cost it the chance to seek an injunction before the patent’s scheduled expiry on 2 June 2024.
The judge accepted that the competition issues were complex and that a split had the potential to save substantial court time. He also noted the public interest in conserving scarce hearing time. But the parties agreed that, under the proposed modular trial, the patent would have expired before judgment on the later issues. The judge could not determine whose estimates of the timing of a unitary trial were more likely. Because Eli Lilly had the burden of justifying departure from the usual unitary trial, that uncertainty mattered: the split would definitely remove the opportunity to seek an injunction, while a unitary trial would not necessarily do so.
The court held that this potential loss was sufficient prejudice to Novartis to refuse the application. It also concluded, on the balance of probabilities, that avoiding the injunction risk was a more important reason for Eli Lilly’s application than the proposed savings. The judge clarified that this conclusion did not mean Eli Lilly had acted wrongfully or with mala fides.
The court did not order a split, but said undertakings from Eli Lilly could facilitate one: either to consent to an interlocutory injunction if it lost the first module, or to proceed promptly with the second module despite an appeal. The judgment left those choices to Eli Lilly. The court asked the parties to seek agreement on outstanding matters and provisionally listed the case for mention on 13 January 2021, as stated in the judgment.