The Court of Appeal has allowed Bristol-Myers Squibb Holdings Ireland Unlimited Company’s appeal over an Irish patent covering apixaban, and sent the dispute back to the High Court for a rehearing before a different judge.
The appeal concerned a High Court judgment that found the patent invalid for failing to make its claimed technical effect plausible. The High Court had also ordered the revocation of the patent and a related supplementary protection certificate. In its 28 November 2024 judgment, the Court of Appeal held that the High Court had not made or explained essential findings on the expert evidence and Bristol-Myers Squibb’s central arguments. It said the trial judgment could not stand because the company could not know why it had lost and the appeal court could not properly assess the decision.
The patent relates to factor Xa inhibitors, a class of anticoagulants, and includes apixaban, marketed as ELIQUIS. Teva challenged the patent on priority and plausibility grounds. The High Court rejected the priority challenge but found against the patent on plausibility. No appeal was brought against the priority ruling.
The appeal court did not decide that the patent is valid. It found that the High Court’s treatment of the evidence and arguments about the drug-development process, potency and selectivity was not adequately reasoned. It also identified errors in the High Court’s consideration of foreign decisions, including its use of the English judgment as a “reality check” despite differences in the evidence and arguments.
The rehearing is limited to the challenge to the patent’s validity on plausibility grounds. The High Court must apply the standard set out by the Enlarged Board of Appeal of the European Patent Office in G 2/21, known as Sumitomo. The appeal court said Bristol-Myers Squibb may present its case under that standard at the rehearing. The judge hearing the case must also consider later decisions from other European Patent Convention states.