The Norwegian Court of Appeal has revoked the Norwegian validation of Bayer Intellectual Property GmbH’s European patent EP 1 845 961 following invalidity proceedings initiated by Sandoz A/S, clearing the way for generic competition for rivaroxaban in Norway.
Bayer’s patent and supplementary protection certificate (SPC) for the active ingredient rivaroxaban (EP 1 261 606) expired 2 April 2024. Bayer argued that generic rivaroxaban products would still infringe EP 1 845 961, which covers the use of rivaroxaban for treating thromboembolic disorders, specifically a rapid-release tablet administered once-daily for at least five days.
Bayer initially obtained preliminary injunctions against several generic manufacturers, blocking the launch of generic rivaroxaban products in Norway based on alleged infringement of EP 1 845 961.
Before these preliminary injunctions were issued, Sandoz had already initiated invalidity proceedings against EP 1 845 961. In June 2023, the Oslo District Court (Oslo tingrett) upheld the patent and dismissed Sandoz’s invalidity claims.
On appeal, Sandoz succeeded in overturning the first instance decision before the Court of Appeal (Borgarting lagmannsrett). As is normal procedure for appeals on the merits in Norway, the Court of Appeal conducted a full re-hearing of the case, including testimonies and cross-examination of witnesses. In the appeal proceedings, Glenmark Pharmaceuticals also intervened to support of Sandoz A/S. The Court of Appeal concluded that the once-daily dosage regime was obvious to the skilled person and invalidated the patent for lack of inventive step. The Court of Appeal therefore declared the patent as invalid.
Bayer sought leave to appeal to the Norwegian Supreme Court, which was refused. The Court of Appeal’s decision is now final, and the Norwegian validation of EP 1 845 961 stands revoked, opening the Norwegian market for generic competition.
The Court of Appeal’s decision is available (in Norwegian) here.
Sandoz was represented by the authors of this contribution
