References/30 May 2024
Borenius secures win for Teva in a patent dispute over blockbuster anticoagulant drug
We successfully advised Teva Pharmaceuticals on a patent dispute before the Finnish Market Court concerning Bristol-Myers Squibb Holdings Ireland Unlimited Company’s (“BMS”) patent and supplementary protection certificate (“SPC”) for the blockbuster drug apixaban, marketed under the brand name Eliquis. The Market Court handed down a ruling in the joined invalidity and infringement cases on 22 May 2024 (MAO:290/2024 and MAO:291/2024) declaring BMS’ patent and related SPC invalid and dismissing BMS’ infringement action against Teva. Consequently, the preliminary injunction imposed against Teva was cancelled.
The Market Court declared BMS’ patent invalid on the lack of novelty after finding that the priority from an earlier application claimed by the patent was not valid. First, the Market court concluded that third parties have the right to challenge the validity of the priority claimed by the patent as determining the right to priority is a prerequisite for the assessment of novelty. Second, the Market Court concluded that the recent decision of the Enlarged Board of Appeal of the European Patent Office (“EBA”) in cases G 1/22 and G 2/22 discussing the right to priority does not impose a binding legal rule on national courts, and that the Finnish legislation does not provide for any presumption of the validity of the patent’s right to claim priority. The Market Court held that neither party bears a burden of proof of the contents of foreign law, but it is for the Market Court to conduct its own legal assessment of the applicable foreign law. Finally, the Market Court concluded that the priority claimed by the patent was not valid in light of the extensive evidence presented in the case. The decision is not final.
Eliquis is one of the world’s top-selling medicine. In 2023, the reimbursement costs for Eliquis in Finland exceeded 68 million euros. The introduction of fair generic competition for a drug in such widespread use is likely to lead to substantial savings in the Finnish drug reimbursement system. This underscores the critical role of generic drugs in fostering a more cost-effective and accessible medicines framework in Finland.