Federal Panel Upholds Decision Against Sandoz 2-1 in Enbrel Battle With Amgen

The next stop in a long-running court battle between Sandoz and Amgen over a biosimilar etanercept could be the Supreme Court of the United States, after a federal court upheld 2 patents held by Amgen for its originator drug Enbrel. In a 2-1 decision Wednesday, the US Court of Appeals for the Federal Circuit ruled against Sandoz, which won FDA approval for Erelzi in August 2016.

In a statement, Sandoz said it was reviewing all options, including a possible appeal to the high court, and said it “cannot speculate on next steps or timing."

“Sandoz will continue its efforts to make Erelzi available to US patients with autoimmune and inflammatory diseases,” said Carol Lynch, president of Sandoz US and head of North America, 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."

The win solidifies Amgen’s biggest moneymaker and best seller; Enbrel generated $1.15 billion in first-quarter sales for this year and is the biotech company’s best-selling drug.

The case relates to claims of US Patent 8,063,182, which covers the fusion protein etanercept, and US Patent 8,163,522, which covers a method of manufacturing. The 2 patents expire in 2028 and 2029, respectively. Roche was the first to file applications for these patents, and Amgen and its subsidiary Immunex obtained rights to the patents from Roche.

Prior to a 2-week bench trial in September 2018, Sandoz did not contest infringement of the patents, but asked the court to find the patents invalid because of a lack of written description and enablement, obviousness, and obviousness-type double patenting.

US District Judge Claire C. Cecchi, JD, found that Sandoz failed to show by clear and convincing evidence that the patents are invalid. Two judges Wednesday affirmed her decision, saying it founded the biosimilar manufacturer’s arguments unpersuasive.

Elrezi, like another eteanercept biosimilar, Eticovo from Samsung Bioepis, is sold in the European Union. Eticovo is also FDA-approved but has yet to launch.

A 2018 report found that 72% of Enbrel's total patent applications were filed after it had already received FDA approval.