BMS, Pfizer secure victory over generic makers
In a victory for Bristol-Myers Squibb (BMS) and Pfizer, a US federal judge has affirmed patents covering blood-thinner Eliquis (apixaban).
The decision, handed down by Judge Leonard Stark of the US District Court for the District of Delaware on Wednesday, August 5, will stave off generic versions of the blockbuster drug.
BMS and Pfizer had claimed 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.
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 response to the suit, the defendants alleged that the asserted claims of both patents were invalid.
Following a nine-day bench trial in October and November last year, the court has now concluded that the patents are valid, Sigmapharm has infringed the ‘208 patent and all three defendants have infringed the ‘945 patent.
Pending the outcome of any potential appeal, the defendants won’t be able to launch generic versions until 2031.
In a statement, BMS and Pfizer said: “We believe this decision indicates the innovative science behind Eliquis and the strength of our IP. While subject to appeal, at present the generic manufacturers currently involved in the case cannot launch their apixaban products until 2031.”
It added that, based on settlement agreements reached with other generic makers, BMS expects generic entry could occur after 2026 but before 2031, subject to appeals and future challenges.
Late last year, 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.
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