BMS, Pfizer win patent dispute over blockbuster drug, Eliquis

In a victory for Bristol-Myers Squibb and Pfizer, the US Court of Appeals for the Federal Circuit has affirmed the validity of a pair of patents covering blood clot treatment, Eliquis (apixaban).

The Federal Circuit handed down its brief opinion on Friday, September 3, blocking any generic version of the blood-thinning treatment for another seven years.

BMS and Pfizer complained that the bioequivalent versions of Eliquis that generic makers Sigmapharm Laboratories, Sunshine Lake Pharma and Unichem Laboratories were planning to bring to market would infringe two patents.

In August 2020, the US District Court for the District of Delaware affirmed the patents and Sigmapharm appealed to the Federal Circuit a month later, contending that the patents were invalid.

The patents, US numbers 6,967,208 and 9,326,945, claim apixaban and certain compositions containing apixaban, respectively.

BMS and Pfizer co-developed Eliquis, an anticoagulant used to prevent serious blood clots, and share profits and losses.

In its conclusion, the Federal Circuit praised the lower court’s “thorough and thoughtful” ruling, noting that it could “find no error, and certainly no clear error, in the district court’s findings of fact, including its expert witness credibility determinations”.

In 2019, the US Food and Drug Administration approved Micro Labs and Mylan Pharmaceuticals’ applications for the first generics of Eliquis. However, the two companies reached a settlement with BMS and Pfizer, preventing the launch of the generic until at least 2026.

According to a report by FiercePharma, Eliquis earned more than $9 billion for BMS and Pfizer last year, enough to rank it in the top five of the world’s bestselling medicines.

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