The Federal Circuit has dealt a significant blow to Bayer AG's efforts to protect its blockbuster blood-thinning drug Xarelto from generic competition, rejecting the company's appeal to dismiss patent validity challenges and remanding the case to continue proceedings that could potentially clear the path for generic versions.
In a precedential opinion issued Tuesday, the appellate panel upheld key aspects of a 2023 Patent Trial and Appeal Board ruling that favored three generic drug makers challenging the validity of Bayer's patent protection for Xarelto. The Federal Circuit's decision ensures that the generic companies' challenge will proceed, maintaining pressure on one of Bayer's most important revenue sources.
Court Rejects Bayer's Patentability Arguments
The central issue in the case revolves around patent language describing a combination of Xarelto with aspirin as "clinically proven effective." Bayer argued that this phrase should render otherwise obvious aspects of the patent patentable, but the Federal Circuit firmly rejected this position.
The court determined that the phrase "clinically proven effective," even if considered limiting, "cannot breathe patentability" into patent elements that would otherwise be deemed obvious. This ruling represents a significant setback for Bayer's strategy to maintain patent protection through clinical efficacy claims.
Patent Board Proceedings Continue
While the Federal Circuit vacated part of the Patent Trial and Appeal Board's original ruling, the core finding that favored the generic drug makers remains intact. The case now returns to the administrative tribunal, which had previously sided with the generic companies in their challenge to the patent's validity.
The three generic drug makers involved in the challenge are continuing their efforts to invalidate Bayer's patent protection, which could potentially open the market to generic competition for the blood-thinning medication. The Patent Trial and Appeal Board will now proceed with further proceedings based on the Federal Circuit's guidance.
Implications for Xarelto Market Protection
This legal development poses a significant threat to Bayer's ability to maintain exclusive market protection for Xarelto, a blockbuster drug that represents a crucial revenue stream for the pharmaceutical giant. The ongoing patent challenge creates uncertainty around the timeline for potential generic entry into the anticoagulant market.
The Federal Circuit's precedential opinion also establishes important legal precedent regarding the limits of using clinical efficacy language to support patent validity, potentially affecting how pharmaceutical companies structure their patent claims in future filings.
