The German Federal Patent Court has revoked Bayer's key patent protecting Xarelto (rivaroxaban), dealing a significant blow to the pharmaceutical giant's efforts to maintain market exclusivity for its blockbuster anticoagulant. The court ruled that patent EP 1 845 961 lacks inventive step, opening the door for generic competition in Germany's lucrative pharmaceutical market.
Court Reverses Earlier Position
The Federal Patent Court's decision marks a dramatic reversal from its qualified opinion issued in 2024, where judges had assumed the patent's validity. The revoked patent EP 961 contains "Swiss-form" claims covering the use of rivaroxaban to manufacture medication for treating thromboembolic disorders, specifically covering a rapid-release tablet for once-daily administration over at least five days.
Set to expire on January 19, 2026, this patent has been crucial for securing Xarelto's market exclusivity, particularly after the basic patent EP 1 261 606 expired in December 2020 and its subsequent supplementary protection certificate ended on April 1, 2024.
Clinical Study Proves Decisive
According to court information, Bayer's own clinical research became the foundation for the patent's downfall. The so-called "Einstein DVT study," conducted by Bayer prior to the patent's priority date, played a crucial role in the court's decision. As part of this study, Bayer had provided patients with information letters containing details about drug dosage, which the court determined constitutes prior art that undermines the patent's inventive step.
Notably, this clinical study had not been considered in the court's preliminary opinion issued in January 2024, highlighting the evolving nature of the legal proceedings.
Immediate Market Impact Expected
The ruling will very likely result in the lifting of preliminary injunctions against generic drug manufacturers, allowing companies like Stada and Aliud Pharma to launch their rivaroxaban products in the German market. In February, the Higher Regional Court Munich had upheld preliminary injunctions that continued to bar these generic manufacturers from market entry.
Recognizing the high stakes involved, the patent court raised the value in dispute from €10 million to €30 million, the maximum amount permitted under German law, reflecting Xarelto's status as a blockbuster drug.
Global Patent Battle Continues
Bayer faces patent challenges across 24 jurisdictions worldwide, with mixed results in its defense efforts. The company has successfully defended Xarelto in many European countries, including the Netherlands, Austria, Sweden, Lithuania, Belgium, Croatia, Czechia, Portugal, and Slovakia.
However, significant setbacks have occurred in multiple markets. The patent was revoked in Norway yesterday due to lack of inventive step, while the Paris Court of Appeal declared it invalid in early July. Ireland's High Court in Dublin also found the patent invalid in June, and Switzerland's Federal Patent Court revoked the Swiss portion of the patent in January.
The UK Court of Appeal upheld a High Court decision declaring the patent invalid, with the Supreme Court refusing leave to appeal. Outside Europe, the patent has been held invalid in Australia and South Africa, with the Australian decision now final.
Legal Teams and Ongoing Proceedings
Ten claimants initially filed nullity suits at the Federal Patent Court, though Accord has since withdrawn its action after reaching an agreement with Bayer. The remaining generic manufacturers are represented by various legal teams, with Bayer relying on experienced counsel from Cohausz & Florack and A&O Shearman.
Further proceedings remain pending in Turkey, Greece, Estonia, Hungary, Poland, Bulgaria, Latvia, Spain, Romania, Finland, Italy, Denmark, and Austria, indicating that the global battle over Xarelto's patent protection is far from over.
While Bayer is likely to appeal the German decision to the Federal Court of Justice, the ruling represents a significant development in the ongoing effort by generic manufacturers to challenge patent protection for one of the world's most valuable anticoagulant medications.
