Amgen nabs appeals win against Otezla generics, blocking Sandoz and Zydus copycats until 2028

Amgen has scored a win in its bid to defend its key immunology drug Otezla.

The U.S. Court of Appeals for the Federal Circuit backed a 2021 ruling against Novartis' Sandoz and Zydus. That prior ruling found the generics companies' products would infringe three Amgen patents.

With the win, the generics companies can't launch their versions until February 2028, according to an Amgen release.

Originally, Celgene filed the lawsuit against the generics makers. After Amgen bought Otezla from Celgene in 2019, the California-based drugmaker took over the lawsuit. Celgene claimed infringement of three patents, called the ‘638 patent, the ‘101 patent and the '541 patent.

A federal court in New Jersey previously ruled that Sandoz failed to show the obviousness of the ‘638 patent and the ‘101 patent but invalidated some claims on the ‘541 patent. On appeal, the Federal Circuit upheld all three rulings.

But it's not all bad news for Sandoz and Zydus. The ’541 patent would have expired in 2034, so their effort to invalidate certain claims on that patent should pay off after 2028.

Otezla, a PDE4 inhibitor, generated $1.88 billion in sales last year. It’s approved for plaque psoriasis, active psoriatic arthritis and Behçet's Disease-associated oral ulcers. It's the first oral treatment approved for all severities of psoriasis.