EPO upholds Bayer's Xarelto dosage patents
Following two-day oral proceedings at the Munich Board of Appeal of the European Patent Office (EPO), the court has upheld the validity of a Bayer Pharmaceuticals’ dosing patent for Xarelto (rivaroxaban).
Xarelto is Bayer’s flagship anticoagulant and stroke prevention drug.
The decision, handed down on October 27, reversed a first instance decision and maintained Bayer's European patent EP 1,845,961B1.
The patent was opposed by 15 generic drug manufacturers, who managed to convince the EPO to invalidate the patent.
But the successful appeal will keep the ‘961 patent valid until mid-January 2026—almost two years longer than the protection for the treatments extended compound patent.
This could block generics manufacturers from launching their version of rivaroxaban in Europe until 2026, maintaining Bayer’s market exclusivity for the highly-profitable drug until then.
Xarelto sales equated to 4.515 billion euros ($5.26 billion) in revenue for Bayer in 2020.
German law firm Cohausz & Florack represented Bayer in the EPO opposition and appeal proceedings, led by partners Arwed Burrichter and Natalie Kirchhofer.
Inventive steps
The appeal proceedings centred around whether the once-per-day administration of Xarelto counted as an inventive step.
Natalie Kirchhofer, partner and patent attorney at Cohausz & Florack said: “The EPO Boards of Appeal apply very strict standards to find a dosage regimen patent valid which underscores the innovation underlying the present case."
“We are extremely pleased with the result that we could achieve for Bayer” added Arwed Burrichter, partner and patent attorney at Cohausz & Florack.
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