US Supreme Court Denies Sandoz's Appeal in Enbrel Biosimilar Patent Dispute

Compiled and Translated | Fan Dongdong

Recently, the U.S. Supreme Court has decided to reject the appeal petition regarding the patent case for Erelzi, a biosimilar of Enbrel, filed by Sandoz, the generics subsidiary of Novartis.

Enbrel is one of Amgen’s blockbuster products, and Novartis’s Erelzi is the biosimilar version of Enbrel. Novartis aims to provide U.S. patients with a “more affordable” treatment option through this biosimilar of Enbrel. In August 2016, Sandoz’s biosimilar to Enbrel was approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple inflammatory diseases, becoming the third biosimilar approved by the FDA.

However, due to ongoing patent litigation, Novartis has yet to introduce the drug to the U.S. market. Previously, a U.S. court ruled in favor of Amgen, finding that Sandoz had "failed to demonstrate by clear and convincing evidence that the patents covering marketed Enbrel are invalid." In August 2019, a U.S. court ruled on the patent dispute between Amgen and Sandoz, affirming that the Enbrel patents validly protect the product from biosimilar competition.

However, the U.S. Supreme Court's latest ruling appears unfavorable to Sandoz, as the U.S. Court of Appeals for the Federal Circuit has chosen to uphold two of Amgen's patents for Enbrel. Sandoz had previously argued that "Amgen's asserted patents are invalid and should not be used to extend the drug's market exclusivity." Compounding Sandoz's frustration, ongoing patent litigation has prevented the company from commercializing Erelzi nearly four years after it received FDA approval. At present, Sandoz can only anticipate launching Erelzi once Amgen's patents for Enbrel expire in 2029.

In response to this, Keren Haruvi, President of Sandoz US and Head of North America, stated, “Sandoz is disappointed by the Supreme Court's decision not to review the appeal. The U.S. Supreme Court's decision today means that the lower-cost biosimilar Erelzi will not be available to U.S. patients with autoimmune and inflammatory diseases until 2029. Nevertheless, Sandoz remains committed to providing important treatment options for patients affected by these diseases.”

Enbrel was first approved in 1998 and generated approximately $5 billion in sales in 2020. It is indicated for the treatment of various autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis. In a statement acknowledging the court's decision, Amgen said, "The Supreme Court's refusal to hear Sandoz's appeal in the Enbrel patent case finally brings this dispute to a close. As demonstrated by the rulings of both the trial and appellate courts, Enbrel's patents are valid on both factual and legal grounds, and will continue to protect Enbrel until their expiration in 2029."

References:

1.Amgen wins Enbrel patent case, knocking back Sandoz's biosimilar plan

2.US Supreme Court rebuffs Sandoz’s Enbrel biosimilar patent case