Etanercept is a biological drug used to treat a number of autoimmune diseases caused by activity of the inflammatory molecule tumour necrosis factor-alpha (TNF-α), including rheumatoid arthritis, psoriasis and ankylosing spondylitis. It is sold under the brand name Enbrel by the originator company Amgen, which has reportedly filed 68 patent applications related to Enbrel, its top-selling drug.

The cost of Enbrel in the US has increased since its launch, averaging US$2,225 per month in 2013. Although the original patent on etanercept was due to expire in 2012, a second patent extended exclusivity until 2029. There are therefore no biosimilar versions available in the US, although several are available in the EU.

Sandoz, the generics division of Novartis, has developed a biosimilar etanercept named Erelzi. Erelzi has been on the EU market since 2017 and has been approved by the US Food and Drug Administration (FDA) but is unable to launch in the US due to patent infringement disputes.

Sandoz has been challenging Amgen’s patents on etanercept in the US since 2019 in an attempt to get Erelzi on the US market earlier than patent expiry, however, none have been successful. In August 2019 for example, a US District Court ruled against Sandoz that Amgen patents covering Enbrel and methods of producing it were valid [1].

In May 2021, the US Supreme Court rejected a further challenge from Sandoz. The ruling goes back to July 2020, when the US Court of Appeals for the Federal Circuit ruled that Erelzi infringed on two of Amgen’s patents.

Sandoz filed a petition requesting review of the judgment, arguing that ‘patentees may not obtain two patents on the same invention’. However, the Supreme Court has now declined to hear the appeal, finally bringing the dispute to an end.
The decision means that Sandoz will not be able to launch its biosimilar on the US market until 2029.

Keren Haruvi, President of Sandoz US and Head of North America, said in a press release: ‘We are disappointed the Supreme Court decided not to review our case. Today’s decision means Erelzi, a more affordable biosimilar, will not be available to U.S. patients with autoimmune and inflammatory diseases until 2029; nonetheless we remain committed to providing important treatment options for patients affected by these diseases.’

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 11]. Available from: www.gabionline.net/Biosimilars/General/Court-rules-Amgen-s-patents-on-Enbrel-are-valid-Sandoz-to-appeal

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