The Court of Appeal has dismissed Teva’s appeal against an injunction preventing it from launching generic apixaban while Bristol-Myers Squibb’s (BMS) challenge to the validity of the relevant patent and supplementary protection certificate (SPC) is heard.
The court affirmed the High Court order restraining Norton (Waterford) Limited, trading as Teva Pharmaceuticals Ireland, from infringing BMS’s SPC for Eliquis. The order applies pending determination of Teva’s revocation proceedings. The appeal concerned interim relief only: the court did not decide whether the patent or SPC is valid. The trial was listed to begin on 4 July 2023.
Teva accepts that its generic product falls within the patent claims and is covered by the SPC. Its defence in the infringement proceedings is that the patent and, consequently, the SPC are invalid. The appeal court said there was a fair question to be tried on validity.
BMS argued that damages would not adequately compensate it if Teva entered the market and BMS later succeeded in defending the SPC. The court upheld the High Court’s conclusion that lost monopoly rights could not adequately be remedied by damages, citing credible evidence about the lasting market effects of generic entry and price reductions. The judges did not overturn the High Court’s separate conclusion that some losses could be calculated.
Teva argued that delays in the revocation case had hindered its effort to clear the way for a launch, and that BMS’s discovery failures and its failure to disclose newly found documents before the injunction hearing showed it should not receive equitable relief. The appeal court acknowledged BMS’s missed deadlines and discovery failures but found they did not establish deliberate misconduct or “unclean hands”. It also said the contested injunction hearing did not carry the same disclosure duty as an application made without notice, and found no evidence that BMS had tried to mislead the High Court.
The court declined to assess Teva’s priority challenge as a strong invalidity case because Teva had provided no expert evidence on the relevant Delaware or US federal law. It also rejected Teva’s reliance on first-mover advantage as insufficient to outweigh the SPC’s presumptive validity. The SPC remains in force unless revoked; the court’s ruling does not resolve the validity dispute.
BMS was successful in the appeal. The court’s provisional view was that BMS should receive its appeal costs, subject to any request by Teva for a short hearing on costs within seven days.