COHAUZ & FLORACK successful in defending Bayer’s patent on the once-daily administration of rivaroxaban (Xarelto®)

Düsseldorf, November 4, 2021 – Following two-day oral proceedings in Munich, Board of Appeal 3.3.01 of the European Patent Office (EPO) on October 27, 2021 reversed the first instance decision and maintained Bayer’s patent EP 1 845 961 B1 on the once-daily administration of its best-selling anticoagulant and stroke prevention drug Xarelto^® (rivaroxaban).

Several generic drug manufacturers had initially successfully opposed the patent. With this final appeal decision of the European Patent Office, Bayer’s patent remains valid until mid-January 2026, almost two years longer than the extended compound patent protection. Until then and unless successfully challenged on country level, it will not be possible in EU countries (except Malta) and certain non-EU countries (e.g. UK, Switzerland) to launch generic rivaroxaban that is intended to be administered once a day without infringing the patent.

Involving a total of 15 opponents, the opposition proceedings were one of the largest in the history of the European Patent Office. For oral proceedings, the EPO’s main auditorium was repurposed as a courtroom in order to accommodate the large number of parties involved.

The case hinged on the question whether the once daily administration of Xarelto^® involved an inventive step. “The EPO Boards of Appeal apply very strict standards to find a dosage regimen patent valid which underscores the innovation underlying the present case.” says Dr. Natalie Kirchhofer, partner and patent attorney at COHAUSZ & FLORACK. “We are extremely pleased with the result that we could achieve for Bayer” adds Dr. Arwed Burrichter, partner and patent attorney at COHAUSZ & FLORACK.  

Xarelto^® made 4.515 billion euros ($5.26 billion) in worldwide revenues in 2020 and continued to grow in the first half of 2021.

The COHAUSZ & FLORACK team that represented Bayer in the EPO opposition and appeal proceedings was led by partners Dr. Arwed Burrichter and Dr. Natalie Kirchhofer. Hoffmann Eitle partner Dr. Joe Taormino and Dr. Claudia Unsin acted as co-counsel.