Bird & Bird Advises Ratiopharm in Landmark Xarelto Patent Revocation Case

The team played a critical role in challenging the patent's validity, contributing to the decision that found the claimed once-daily rivaroxaban dosage lacked inventive step. The court's reasoning hinged in part on Bayer’s own Einstein DVT study, which had not been fully considered for the preliminary opinion.

Although the patent had survived challenges in several European jurisdictions, the tide has turned. This decision by Germany's patent court has already led to a stay of enforcement of PIs that had been issued e.g. against Ratiopharm last year and which had blocked them from entering the market. Proceedings to lift the PIs are pending before the Regional Court in Munich. Bayer is likely to appeal the Federal Patent Court’s revocation decision to the Federal Court of Justice. 

Lessons Learned
This case highlights the evolving dynamics at the German Federal Patent Court. Since legislative changes, preliminary opinions now arrive much earlier in proceedings—typically six months after the action is filed—but hearings can still take more than a year to be scheduled. This delay creates an opportunity to introduce new arguments and evidence.

Here, new documents fundamentally changed the outcome. The presiding judge acknowledged that, based on the original opinion, the court would have likely upheld the patent—until the updated evidence tipped the scales. In any case though, the Federal Patent Court would not have upheld the patent as granted, since Bayer only defended the patent based on the auxiliary request and had dropped the main request after the Court’s introductory remarks.

Key takeaway: Even after a negative preliminary opinion, it’s worth staying engaged. In long-running proceedings, persistence and proactive strategy can decisively shift the result.