NORWAY TRENDS AND DEVELOPMENTS Contributed by: Camilla Vislie, Magnus Hauge Greaker, Martin Guldbrandt Hansen and Nora Solberg Bjørnnes, Advokatfirmaet Thommessen AS
tical sector, including incentives for medicinal product development, supply chain security, and environmental considerations. While final adop - tion of these changes is not anticipated until 2026, stakeholders in Norway’s pharmaceutical industry and healthcare systems should proac - tively prepare for the forthcoming changes. Trends in pharmaceutical patent litigation In 2024, there have been notable developments in two cases within the Norwegian life science patent landscape, in particular in the field of anti- thrombotic agents: the Apixaban case concern - ing Bristol-Myers Squibb’s blockbuster drug Eliquis and the Rivaroxaban case concerning Bayer’s blockbuster drug Xarelto. These cases address important issues regarding inventive step, and they provide insights into how Norwe - gian courts interpret and apply patent law, par - ticularly in relation to an alleged technical effect substantiating inventive step. The Apixaban case, previously discussed in last year’s Chambers Trends and Developments arti - cle, was decided by the Court of Appeal in 2024. The case concerned the validity of Bristol-Myers Squibb’s (BMS) Norwegian patent NO 328 558 and supplementary protection certificate SPC/ NO 20110021, which protects apixaban, the active substance in BMS’s blockbuster throm - bosis drug Eliquis®. On 3 June 2024, the Borgarting Court of Appeal issued its ruling in the case (Case No LB-2023- 141798). Teva Pharmaceutical Industries Ltd. and Teva Norway AS had appealed Oslo Dis - trict Court’s ruling, arguing that the patent lacked inventive step because the technical effect of the invention was not sufficiently demonstrated in the patent application to support reliance on this technical effect in the assessment of inven - tive step.
The Court of Appeal addressed the requirements for demonstrating a technical effect in a patent application. It concluded that the standards for establishing a technical effect are not particularly stringent; it is sufficient that it appears credible to a skilled person that the claimed technical effect is achieved based on the application. The court assessed what a skilled person would derive from the application in light of common general knowledge. It found that a skilled per - son would consider it likely that apixaban is a potent and selective factor Xa inhibitor based on the application and the common general knowl - edge. The court determined that the application contained more than enough information to sup - port reliance on this technical effect in assessing inventive step. Ultimately, the Court of Appeal unanimously found both the patent and the SPC to be valid, dismissing Teva’s appeal. Following this deci - sion, Teva appealed to the Supreme Court; however, this appeal was not granted leave by the Supreme Court’s Appeals Selection Com - mittee. As a result, the Borgarting Court of Appeal’s judgment is now final and legally bind - ing, effectively concluding the legal proceedings and affirming the validity of BMS’s patent and SPC for apixaban in Norway. Thommessen rep - resented BMS before both the Court of Appeal and the Supreme Court. This decision provides further clarity on how Norwegian courts interpret and apply criteria for assessing technical effects in patent cases, par - ticularly following the European Patent Office’s Enlarged Board of Appeal decision in G 2/21. Also the Rivaroxaban case, previously reported on last year, has seen developments in 2024. Initially, the Oslo District Court upheld the valid -
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