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German Federal Patent Court Revokes Key Xarelto Patent, Opening Door for Generic Competition

- The German Federal Patent Court revoked Bayer's crucial Xarelto patent EP 1 845 961 due to lack of inventive step, contradicting its earlier 2024 opinion that assumed the patent's validity. - The court's decision was influenced by Bayer's own clinical study conducted before the patent's priority date, which provided patients with dosage information that constituted prior art. - This ruling will likely lift preliminary injunctions against generic manufacturers like Stada and Aliud Pharma, allowing generic rivaroxaban products to enter the German market. - The patent, set to expire in January 2026, has faced challenges in 24 jurisdictions worldwide, with mixed results for Bayer's defense efforts across different countries.