US appeals court upholds validity of Amgen's Enbrel patents

Amgen said Wednesday that the US Court of Appeals for the Federal Circuit has decided in its favour regarding the validity of two Enbrel (etanercept) patents. In a 2-1 decision, the appellate tribunal affirmed a ruling by a US district court in New Jersey last August that upheld the validity of the two patents in a lawsuit Amgen had filed against Novartis' Sandoz unit over the latter's biosimilar Erelzi (etanercept-szzs).

US patents '182 and '522, which cover Enbrel's active ingredient and a process to make the drug, expire in November 2028 and April 2029, respectively. The medicine generated US sales of $5.1 billion last year, and accounted for roughly 22% of Amgen's total revenue. Meanwhile, Erelzi has been approved in the US since 2016, although Novartis has been unable to launch the product there due to the ongoing patent dispute with Amgen.

Amgen's lawsuit was filed in conjunction with Roche, which is the owner and licensor of the two patents. According to Amgen, Novartis had acknowledged before the trial that Erelzi infringes seven claims in patents '182 and '522, with the case only proceeding because the Swiss drugmaker argued that the patents should not have been issued. Amgen added that in October, "by stipulation of Amgen and Sandoz, the New Jersey District Court entered final judgment and a permanent injunction prohibiting Sandoz from making, using, importing, selling or offering for sale Sandoz's etanercept product."

Novartis weighing options

Commenting on the appellate court ruling, Novartis said it is "evaluating its options," including possibly filing an appeal with the US Supreme Court. Carol Lynch, president of Sandoz US, said the company "will continue its efforts to make Erelzi available to US patients with autoimmune and inflammatory diseases." She added that Sandoz still believes "the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug's exclusivity."

Regulators in Europe and Canada approved Erelzi in 2017 to treat multiple inflammatory diseases.

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