Setterwalls has successfully represented Sandoz in a patent dispute regarding Xarelto® (rivaroxaban) in Sweden

Setterwalls has successfully represented Sandoz in a dispute concerning Bayer’s patent that protected once-daily dosing of rivaroxaban—the active ingredient in Bayer’s blockbuster anticoagulant Xarelto®. The Patent and Market Court of Appeal (CoA) has now issued its judgment invalidating the patent. The judgment is final and cannot be appealed.

The ruling marks the end of the patent disputes that have been ongoing between Bayer and various generic companies in Sweden concerning the patent in recent years. Parallel patent disputes have also been underway, and remain ongoing, in a number of other jurisdictions. The judgment is one of a series of recent decisions handed down in favor of the generics side.

As early as 2022, Sandoz brought an action against Bayer before the Patent and Market Court (PMC), seeking a declaration that European patent 1 845 961 was invalid in Sweden for lack of inventive step. On 1 February 2024, the PMC rendered its judgment in the case and dismissed Sandoz’s action.

Sandoz appealed the judgment and the CoA granted leave to appeal. The main hearing spanned 11 days in October and November 2025. The CoA has now issued its judgment in the case (see the CoA’s judgment of 18 December 2025 in case number PMT 2840‑24). The CoA overturned the PMC’s judgment, declared Bayer’s patent invalid, and awarded Sandoz compensation for its litigation costs in both the first and second instances.

The judgment addresses several interesting issues. Among other things, the CoA clarifies the conditions under which information published in connection with clinical studies is to be considered prior art. The judgment also provides guidance on when phase I and phase II studies render a patent lacking in inventive step.