Sigmapharm to appeal Pfizer and BMS’ Eliquis win

Generics maker  Sigmapharm Laboratories is appealing against a court win for  Pfizer and  Bristol Myers Squibb (BMS) over patents for blood-thinner  Eliquis (apixaban).

In that  decision, issued last month, the US District Court for the District of Delaware affirmed patents for the blockbuster drug, blocking Sigmapharm from manufacturing its own version.

Sigmapharm has now  informed the Delaware court that it is appealing to the US Court of Appeals for the Federal Circuit.

The dispute arose after Sigmapharm, as well as other generic manufacturers Sunshine Lake Pharma and Unichem Laboratories, planned to release a bioequivalent version of the blood-thinner.

Pfizer and BMS sued the companies, alleging infringement of two patents. The defendants, meanwhile, claimed the patents should be invalidated.

If upheld, Sigmapharm won’t be able to develop a generic version until the patents expire in 2031.

The US Food and Drug Administration has approved two Eliquis generics, developed by Micro Labs and Mylan Pharmaceuticals. But those companies reached a settlement with Pfizer and BMS under which their generics won’t be released until at least 2026.

If successful, Sigmapharm’s Federal Circuit appeal could clear the way for a generic to launch sooner than that.

Pfizer and BMS co-developed Eliquis and share the profits from the sale of the drug, which is among the most commonly prescribed in the US.

The drug is used to lower the risk of blood clots and stroke among patients with irregular heart rhythm.

At the time of the Delaware court’s decision, Pfizer and BMS said the ruling “indicates the innovative science behind Eliquis and the strength of our IP”.

BMS last week announced a deal to buy Forbius, a protein engineering company active in the field of oncology.

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