Amgen wins lawsuit against Sandoz and Zydus for Otezla patent

Otezla is approved to treat adults with plaque psoriasis, active psoriatic arthritis and oral ulcers linked with Behçet’s disease.

The US District Court for the District of New Jersey has upheld patents that protect the Amgen psoriasis treatment, Otezla (apremilast), in a patent infringement case against Sandoz and Zydus Pharmaceuticals (US).

Otezla is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP).

The drug is indicated in the US to treat adult patients with moderate to severe plaque psoriasis, candidates for phototherapy or systemic therapy.

Otezla is also approved in the region for treating active psoriatic arthritis and oral ulcers linked with Behçet’s disease.

The asserted patents claimed apremilast as a composition of matter (COM), methods of treating psoriasis with the drug and its crystalline forms.

The court found that Sandoz and Zydus infringed Amgen’s patents and upheld the validity of four patents, three against each defendant.

Meanwhile, the court ruled against Amgen on claims in US patent covering methods of psoriasis treatment with apremilast as per a peculiar dosing regimen.

The ruling will prevent Sandoz and Zydus from making, using, marketing, offering to sell, or importing any of the generic versions of Otezla until patent expiration in February 2028.

21 Sep 2021

https://www.pharmaceutical-technology.com/