NORWAY TRENDS AND DEVELOPMENTS Contributed by: Camilla Vislie, Magnus Hauge Greaker, Martin Guldbrandt Hansen and Nora Solberg Bjørnnes, Advokatfirmaet Thommessen AS
ity of Bayer’s Norwegian patent NO 344 278 for rivaroxaban (the active substance in Bayer’s thrombosis drug Xarelto), despite Sandoz’s arguments. Notably, Sandoz had invoked the “several obvious steps” approach as part of the problem and solution method in assessing what was obvious to the skilled person. Following the District Court’s decision, generic manufacturers signalled their intention to enter the market, challenging the patent’s strength. In response to these threats, three ex parte prelimi - nary injunctions were issued to prevent generic market entry pending further legal proceedings. In the autumn of 2024, oral hearings were held in the PI cases, shedding more light on the com - plex issue at stake. The appeal case regarding the patent’s validity is scheduled for May 2025. In addition to the Apixaban and Rivaroxaban cases, a new case involving Merck Sharp & Dohme LLC (MSD) has brought attention to the intricacies of administrative patent limitations in Norway. The case concerned MSD’s request for adminis - trative limitation of patent NO 321 999, pertain - ing to the pharmaceutical substance sitagliptin. MSD, having obtained a Supplementary Protec - tion Certificate (SPC), sought to limit the patent claims to ensure SPC protection under Article 3(1) of the SPC Regulation. The Norwegian patent authorities had initially rejected MSD’s request for administrative patent limitation, arguing that the proposed limitation only affected dependent claims. This decision brought to the forefront a central issue: wheth - er a patent limitation requires amendments to an independent patent claim, rather than just dependent claims.
The Oslo District Court, in its judgment of 8 March 2024, interpreted Section 39a of the Nor - wegian Patent Act (which corresponds to Article 105a of the European Patent Convention) and concluded that a genuine limitation of patent scope requires changes to the independent pat - ent claim. The court determined that changes to dependent claims alone were insufficient, there - by upholding the patent authorities’ decision. MSD subsequently appealed to the Borgarting Court of Appeal. On 21 October 2024, the appel - late court reached the same conclusion as the district court, rejecting the appeal. As a result, the patent authorities’ decision to dismiss MSD’s request for patent limitation was upheld. This ruling provides important clarification regarding the requirements for patent limitations in Norway. It emphasises that to be considered a valid limitation, changes must be made to independent claims, not just dependent ones. This decision may significantly influence future strategies for pharmaceutical companies seek - ing to adjust their patent protection, particularly in cases involving SPCs. Decision on pharmaceutical advertising practices in Norway On 7 June 2024, the Norwegian Ministry of Health and Care Services (the HOD) issued a significant ruling in favour of Novo Nordisk, over - turning a previous decision by the NoMA dated 11 October 2023. The NoMA had imposed a fine of NOK1.5 million on Novo Nordisk for alleged illegal advertising related to its medicinal prod - ucts Ozempic, Wegovy and Saxenda. However, upon reviewing Novo Nordisk’s appeal, the HOD found substantial legal and procedural flaws in the NoMA’s decision.
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