Bristol-Myers Squibb Holdings Ireland Limited v Norton (Waterford) Limited trading as Teva Pharmaceuticals Ireland [2024] IECA 287
This was the appeal to the Irish Court of Appeal from the judgment of Barrett J given in the Dublin High Court last year in which he found that the patent for apixaban in Ireland was invalid as lacking plausibility. The Aplxaban patent has been attacked by generic producers across Europe and this case is the Irish arm of the dispute. The appeal was heard over four days in May 2024 and the Court of Appeal handed down its judgment on 25 November.
At the trial, Teva attacked the validity of the patent on the grounds of plausibility and lack of priority. The High Court rejected the priority attack and there was no appeal from that decision. BMS appealed the decision that the patent was invalid for implausibility.
After a detailed and careful review of the evidence, the Court of Appeal concluded that the trial judge had failed to make critical findings of fact and failed to explain the findings that he had made. The Court consequently overturned the first instance decision and remitted the case for rehearing before a different judge. The Court of Appeal noted particularly that the trial judge had leant heavily on findings in the parallel judgments in the English courts even though the evidence on the technical issues before the Irish courts was substantially different from that which was adduced in England. The retrial is expected to take place in about a year.
Michael Silverleaf appeared at the appeal for the successful appellant with Michael Howard SC, Yvonne McNamara SC and Paul Coughlan instructed by Wilmer Hale, London and McCann Fitzgerald, Dublin.