Dutch appeal court overturns Bayer’s Xarelto dosing patent in Sandoz case

AI Market Summary
Dutch and French courts invalidated Bayer's Xarelto (rivaroxaban) dosage patent EP 1 845 961, undermining a key layer of European exclusivity ahead of its 2026 expiry. The rulings increase the probability of earlier generic entry by Sandoz and others, pressuring Xarelto-related cash flows and raising legal overhang despite potential further appeals. The decision also highlights disclosure risks from clinical-study materials in patent defensibility.
Impact level
● Medium
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Courts in the Netherlands and France have invalidated Bayer’s European patent EP 1 845 961 covering a specific dosing regimen for Xarelto (rivaroxaban). The Dutch Court of Appeal overturned a 2023 ruling by the District Court of The Hague and found the patent lacked an inventive step, while the Paris Judicial Court declared the French part invalid at Sandoz’s request. EP 1 845 961 had been due to expire in January 2026, and its loss would allow generics to enter earlier.