A federal district court judge has ruled against Sandoz, the generics business of Novartis, in patent litigation relating to Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug, Enbrel (etanercept), an anti-inflammatory drug with 2018 global sales of $5.0 billion. The ruling, which Sandoz says it will appeal, prevents Sandoz from bringing Erelzi to market at this time.

The US Food and Drug Administration (FDA) approved Erelzi for multiple inflammatory diseases in 2016. “Erelzi has been approved for nearly three years [;] however, Sandoz has been unable to launch the medicine due to the ongoing patent litigation from Amgen,” said Sandoz in an August 9, 2019 statement commenting on the ruling.

The recent ruling pertains to the validity of two patents that describe and claim Enbrel (etanercept) and the methods for making it. Affiliates of Amgen, Immunex Corporation (which Amgen acquired in 2002) and Amgen Manufacturing Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche, had previously brought patent-infringement action in federal court against Sandoz, which challenged the validity of two US patents (Nos. 8,063,182 and 8,163,522) that cover Enbrel’s active ingredient.

In a ruling on August 9, 2019, the US District Court for the District of New Jersey ruled in Amgen’s favor on the validity of the two patents that describe and claim Enbrel (etanercept) and methods for making it.

“Sandoz respectfully disagrees with the Court’s ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases,” said Carol Lynch, President of Sandoz US and Head of North America, in the company’s August 9, 2019 company statement. “Valid intellectual property should be respected[;] however, we continue to consider the patents in this case to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible.”

“We are pleased with today’s decision recognizing the validity of these patents,” said Amgen’s Chairman and Chief Executive Officer Robert A. Bradway, in an August 9, 2019 company 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.”

Sandoz says it will appeal the ruling to the US Court of Appeals for the Federal Circuit, and that the parties have agreed to an expedited appeal.

Source: Novartis/Sandoz, Amgen