On July 29, 2025, the Third Senate of the Federal Patent Court declared the European patent EP 1 845 961, which concerns a specific oral dosage of the anticoagulant Rivaroxaban (trade name Xarelto®), invalid for Germany (Ref. 3 Ni 11/22 (EP)). Nine generic drug manufacturers had filed an action for annulment, arguing that the claimed once-daily application was not based on an inventive step, but had already been anticipated by preliminary clinical work such as the "Einstein DVT" study. The court agreed with this argumentation. Bayer had recently defended the protective right granted in 2015 only in a limited form, but failed. An appeal against the ruling can be lodged with the Federal Court.

At the same time, disputes are ongoing about the role of the Information Center for Pharmaceutical Products (IFA), whose "Lauer-Taxe" database is a prerequisite for the distribution of generic drugs. Although the Munich Regional Court issued a preliminary injunction in favor of Bayer in the first instance, the Higher Regional Court denied that the IFA had violated its duty to review, so that Bayer withdrew its claim. This leaves unclear the extent to which the IFA must conduct patent law assessments prior to listings – an area of dispute that also affects other drugs.

The BPatG ruling now paves the way for generic drug manufacturers to introduce Rivaroxaban products on the German market. In view of the billions in sales generated by Xarelto, Bayer is likely to go through all legal remedies.