Immunex Corporation and Amgen Manufacturing, affiliates of Amgen, and the owner and licensor of the two patents, Hoffmann-La Roche brought the patent infringement action to the federal court. The action is against Sandoz’ Enbrel biosimilar Erelzi (etanercept-szzs).
According to Amgen, Sandoz acknowledged, before the trial, that Erelzi infringes seven patent claims. The trial proceeded only on Sandoz’s challenges to the validity of the seven patent claims. The court ruled in favor of Amgen as Sandoz had not met its burden to prove all seven asserted patent claims invalid.
Robert Bradway, chairman and CEO of Amgen responded to the court ruling in a statement, “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.”
Immunex, Amgen and Sandoz entered into an agreement to respect the preliminary injunction regarding Sandoz’s etanercept that was set out in the Court’s order as of June 2018.
Following a previous ruling from the US Court of Appeals for the Federal Circuit in 2016, Sandoz must provide Amgen with at least 180-days’ notice before it launches its biosimilar commercially.
The US Food and Drug Administration (FDA) stated when Erelzi was approved that it is a biosimilar, but it is not interchangeable with Enbrel.
This statement from the FDA means that it may not be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.
Samsung Bioepis, a biopharmaceutical company based in Korea, has an approved etanercept biosimilar, Benepali.