Setterwalls Represents Sandoz in Successful Patent Challenge to Xarelto (rivaroxaban) in Sweden

Setterwalls represented Sandoz in a dispute against Bayer concerning the patent that protected once‑daily dosing of rivaroxaban, the active ingredient in Bayer’s anticoagulant Xarelto. The proceedings concerned European patent 1 845 961. Sandoz initiated proceedings in the Swedish Patent and Market Court (PMC) in 2022, seeking a declaration that the patent was invalid in Sweden for lack of inventive step. On 1 February 2024 the PMC dismissed Sandoz’s action. Sandoz appealed and the Patent and Market Court of Appeal (CoA) granted leave to appeal. The main hearing took place over 11 days in October and November 2025. On 18 December 2025 the CoA issued its judgment in case PMT 2840-24, overturning the PMC, declaring Bayer’s patent invalid and awarding Sandoz compensation for its litigation costs in both instances. The CoA’s judgment is final and cannot be appealed. The ruling brings to a close the patent disputes in Sweden over this patent that have been ongoing in recent years, while parallel disputes continue in other jurisdictions. The judgment also addressed key legal issues, including the circumstances in which information published in connection with clinical studies constitutes prior art and guidance on when phase I and phase II studies may render a patent lacking inventive step. The decision is among a series of recent rulings favourable to generic manufacturers. Setterwalls represented Sandoz with a team composed by: Martin Levinsohn, Elin Sjörén and Adeline Fredriksson. Practice areas: Intellectual property, marketing and media law.

Setterwalls Represents Sandoz in Successful Patent Challenge to Xarelto (rivaroxaban) in Sweden

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