Life Sciences and Pharma IP Litigation 2025

NORWAY TRENDS AND DEVELOPMENTS Contributed by: Camilla Vislie, Magnus Hauge Greaker, Martin Guldbrandt Hansen and Nora Solberg Bjørnnes, Advokatfirmaet Thommessen AS

The Latest Trends and Developments Within Norwegian Life Sciences and Pharmaceutical

behind Norway’s neighbouring countries, Den - mark and Sweden. In their “Life Science Trend Analysis” for 2024, BiotechGate, Nordic Life Sciences Database and Venture Valuation (in collaboration with The Life Science Cluster and Oslo Cancer Cluster) reported that in 2023, biotechnology companies comprised 48% of companies in the life science sector, and that nearly half of these companies fall under the category “Biotech – Other”. This category describes companies in areas such as AgBio, environmental, veterinary, and industrial biotechnology. In the field of therapeutics and diagnostics, oncology remains the frontrunner in terms of therapeutic development in Norway. Biotech companies in the therapeutics and diag - nostics field appear to be mainly focusing on developing small molecules (16%), immunother - apies (15%), and anti-infectives (10%). A notable point from the above-mentioned anal - ysis is that in 2023, digital health had emerged as a key sector, now representing a fourth of all life science companies in Norway. Another nota - ble point from the analysis is that fully integrated pharma companies only constitute 3% of the life science companies in Norway. The emerging focus on the life science industry in Norway has also been cemented by The Asso - ciation of the Pharmaceutical Industry in Norway, a sector organisation for the pharmaceutical industry, and Norway Bio forming a new group for CEOs of biotech companies – the Norwegian Biotech CEO Group. The purpose of the group is to address the common challenges these com - panies face, enhance the political influence, and bolster sustainable development in the sector. A spokesperson for Norway Bio has pointed to a number of challenges facing the life science

IP Litigation Introduction

In 2024, the Norwegian pharmaceutical patent landscape continued to evolve, marked by legal developments that addressed issues of patent validity and inventive step. Notable cases, such as those involving Bristol-Myers Squibb’s patent covering apixaban and Bayer’s patent covering rivaroxaban, have provided insights into how Norwegian courts interpret patent law, particu - larly in relation to an alleged technical effect substantiating inventive step. Additionally, a ruling concerning Merck Sharp & Dohme LLC provides clarification regarding the requirements for administrative patent limitations. As for public administrative matters, the Norwe - gian Ministry of Health and Care Services (the HOD) upheld Novo Nordisk’s appeal against a decision by the Norwegian Medical Products Agency (the NoMA) regarding alleged illegal advertising of its medicinal products Wegovy, Saxenda and Ozempic. This decision under - scores the importance of procedural fairness in administrative regulatory actions and highlights ongoing discussions regarding medicinal prod - uct advertising standards in Norway. Ongoing discussions regarding the EU’s phar - maceutical reform may also have implications for Norway’s regulatory framework and the pharmaceutical industry. This article will explore these developments and their potential impact on stakeholders within the sector. Market development – increased focus on developing the life science industry in Norway The Norwegian life sciences industry continues to show development and innovation, but is still

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