Appeals court upholds Amgen victory in Enbrel fight; Sandoz eyes Supreme Court
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A U.S. appeals court has ruled in favor of two patents for Amgen’s etanercept against the biosimilar etanercept-szzs from Novartis’ Sandoz, upholding a prior decision validating claims of patent infringement.
In a 2-1 decision, the ruling from the U.S. Court of Appeals for the Federal Circuit bolsters a previous ruling by a U.S. District Court judge in August 2019 that the Sandoz biosimilar Erelzi (etanercept-szzs) infringed on two Enbrel (etanercept) patents for active ingredient — U.S. Patent No. 8,063,182 — and manufacturing process — U.S. Patent No. 8,163,522. Owned by Hoffmann-La Roche and licensed to Amgen since 1999, these two patents for Enbrel are not expected to expire until 2029.
In a statement, Sandoz said the company will continue evaluating its options, “which may include an appeal to the U.S. Supreme Court.”
“Sandoz will continue its efforts to make Erelzi available to U.S. patients with autoimmune and inflammatory diseases,” Carol Lynch, president of Sandoz U.S. and head of Sandoz North America, said in the statement. “Our company respects valid intellectual property, however Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity.”
Sandoz became the first company to receive FDA approval for an etanercept biosimilar more than 3 years ago, in August 2016. However, the drug has yet to launch in the U.S. due to the ongoing patent litigation with Amgen.
Although Sandoz previously acknowledged that its biosimilar infringed on Amgen’s patents, the manufacturer countered that these two patents should not have been granted as the concepts were already contained in prior patents.
In the previous District Court ruling in 2019, Judge Claire C. Cecchi determined that Sandoz had “failed to show by clear and convincing evidence that the Patents-in-Suit are invalid” and ruled that the manufacturer had failed to meet the burden of proof to justify the patent infringements of its biosimilar.
In its appellate decision, the court’s majority affirmed Cecchi’s ruling, stating Roche still had substantial ownership rights in the patents, making the newer ones distinct.
According to a Bloomberg News report, Enbrel generated more than $5 billion in sales for Amgen in 2019, accounting for 22% of the company’s revenue. Following news of the ruling, Amgen’s stock value rose 7% Wednesday afternoon in New York trading, to $252.45.
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