In Long-Awaited Decision in Etanercept Litigation, Court Sides With Amgen Over Sandoz

A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi. Sandoz’s biosimilar etanercept, referencing the brand-name Enbrel, was approved by the FDA in 2016, but has not launched in the US market due to the patent suit brought by Amgen, Immunex, and Roche.

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 the method of manufacturing Enbrel. The 2 patents expire in 2028 and 2029, respectively. Roche was the first to file applications for these patents, and Amgen (which sells Enbrel) 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. United States District Judge Claire C. Cecchi, JD, found that Sandoz failed to show by clear and convincing evidence that the patents are invalid.

Robert Bradway, chairman and chief executive officer of Amgen, said in a statement that the company was pleased with the outcome of the trial, and that “Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients.”

Carol Lynch, president of Sandoz US and head of North America, said in a statement that “Sandoz respectfully disagrees with the Court’s ruling…valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid. Amgen asserted [2] patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029.”

In an email to The Center for Biosimilars^®, a Sandoz representative indicated that the company will appeal the ruling in the US Court of Appeals for the Federal Circuit, and also said that both parties have agreed to an expedited appeal.