Bayer Pharma AG is seeking an en banc review by the U.S. Court of Appeals for the Federal Circuit after a panel decision declined to revive claims in a patent covering its anticoagulant, Xarelto. The panel had concluded that the term “clinically proven effective” could not contribute to the claims’ patentability.
The patent in question, U.S. Patent No. 10,828,310, pertains to methods for reducing cardiovascular events by administering rivaroxaban (2.5 mg twice daily) and aspirin (75-100 mg daily) in amounts described as “clinically proven effective.” The Federal Circuit panel held that this phrase does not render an otherwise anticipated or obvious dosing regimen patentable, emphasizing that clinical validation does not transform an anticipated method into a patentable one when prior art already disclosed using the same drugs for the same purpose.
This decision underscores the challenges pharmaceutical companies face when attempting to secure patent protection based on clinical trial results. The court’s ruling suggests that relying on post hoc clinical success to establish patentability may not be sufficient if the claimed method is already known in the prior art.
Bayer’s request for an en banc review reflects the company’s ongoing efforts to defend its intellectual property rights amid increasing challenges from generic manufacturers. The outcome of this appeal could have significant implications for the pharmaceutical industry, particularly concerning the patentability of methods based on clinical efficacy.
In related developments, Bayer has faced similar challenges to its Xarelto patents in other jurisdictions. For instance, in April 2024, the UK’s High Court invalidated Bayer’s patent for Xarelto, ruling that the patent lacked an “inventive step.” This decision followed legal challenges from Sandoz and other competitors, potentially allowing for the release of generic versions of the drug.
These legal battles highlight the complex landscape of pharmaceutical patent law, where companies must navigate the fine line between protecting their innovations and the public interest in accessing affordable medications. The Federal Circuit’s forthcoming decision on Bayer’s en banc review request will be closely watched by industry stakeholders for its potential impact on patent strategies and the balance between innovation and competition in the pharmaceutical market.