The Court of Appeal has restrained Norton (Waterford) Ltd, trading as Teva Pharmaceuticals Ireland, from launching a generic version of Eliquis while Bristol-Myers Squibb’s appeal over the validity of the medicine’s patent is determined.
In a judgment delivered on 13 June 2024, Ms Justice Costello, with whom Justices Noonan and Allen agreed, allowed BMS’s appeal against a High Court refusal to continue an injunction. The order prevents Teva from launching its generic apixaban product pending the determination of the substantive appeal. The Court of Appeal did not decide that appeal or determine whether the patent is valid.
The High Court had ruled in December 2023 that Irish Patent No. EP (IE) 1 427 415 was invalid. Because the patent underpins BMS’s Supplementary Protection Certificate, the High Court also treated the certificate as invalid. BMS appealed that decision. The patent’s revocation had been stayed pending appeal, and the parties had agreed to continue that stay.
The Court of Appeal found that the High Court had given too much weight to its own invalidity ruling when considering an injunction pending appeal. BMS had arguable grounds of appeal, a threshold accepted by Teva and the High Court. Given the complexity of the substantive appeal, the Court of Appeal said it was not appropriate at this stage to weigh the parties’ prospects of winning it.
The court considered the competing risks. It accepted that restraining Teva could cause it losses that damages might not adequately compensate, including the loss of an early market advantage. But it found that BMS faced a greater risk of harm if generic products entered the market and BMS later succeeded on appeal. The court pointed to the risk of multiple generic launches, falling prices and lasting changes to market expectations that could make BMS’s exclusivity difficult to restore or compensate.
The judgment also noted that the substantive appeal had been scheduled for a four-day hearing beginning on 13 May 2024, limiting the period of uncertainty for both sides. The court concluded that the balance of justice clearly favoured an injunction and said that, even if the balance were close, the prudent course would be to preserve the position before generic entry.
BMS was wholly successful in the injunction appeal. The court’s provisional view was that BMS should receive its appeal costs, while allowing Teva 10 days to request a short hearing to contest costs. The judgment does not state the eventual outcome of the substantive patent appeal.