Sandoz Is 0-3 in Enbrel Patent Case

In an action that comes at a key time in the debate over product exclusivity and patient access, Sandoz, a Novartis division, has lost a Supreme Court bid to bring its etanercept biosimilar Erelzi to market before 2029, as the high court declined to review the company’s petition to invalidate 2 patents held by the originator company Amgen for the reference drug, Enbrel.

The originator product has garnered billions of dollars in yearly revenues over 22 years of product exclusivity in the United States so far.

Enbrel is a tumor necrosis factor inhibitor that was first approved in 1998. It is currently indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. The product brought in $4.9 billion in revenues for Amgen in 2020, down from $5.2 billion in 2019. There are 3 approved etanercept biosimilars in the European Union, the earliest of which (Benepali) was launched in January 2016.

In the United States, Erelzi got FDA approval in August 2016 and Samsung Bioepis received approval for its etanercept biosimilar (Eticovo) in April 2019, but patent exclusivities are holding that off the market, too.

Patent Objections

In its legal effort, Sandoz had targeted patents asserted by Amgen in defense of Enbrel’s exclusivity, namely US Patent 8,063,182, covering the fusion protein etanercept, and US Patent 8,163,522, covering a manufacturing process. The patents are set to expire in 2028 and 2029, respectively.

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

Sandoz was the first company to receive FDA approval for an etanercept biosimilar. The other was Samsung Bioepis, which saw its Eticovo product approved in April 2019.

The Supreme Court bid by Sandoz was an appeal of a Federal Circuit court 2-1 ruling in mid-2020 that upheld the 2 patents in question. Previously, a US District Court judge found that Sandoz had failed to demonstrate that the patents were invalid.

Whatever the merits of the case, the highest court’s decision not to review the etanercept patents intensifies the spotlight already on originator products that enjoy lengthy periods of exclusivity and that prevent competitors’ products from entering market at lower cost and thereby improving access to health care for patients.

AbbVie's CEO to Testify

On Tuesday, May 18, 2021, Richard Gonzalez, CEO of AbbVie, is scheduled to testify before the House Oversight Committee on his company’s exclusivity protections for adalimumab (Humira), a blockbuster drug that has been available in the European Union since 2018, but not in the United States, where the first of 6 adalimumab biosimilars was approved in 2016. Each of the 6 adalimumab biosimilar developers has settled out of court with AbbVie rather than pursue a patent battle with the company, which according to Gonzalez has at least 136 patents protecting its lucrative adalimumab franchise.

Most recently, Alvotech of Reykjavik, Iceland, has locked horns with AbbVie over a high-concentration formulation of adalimumab. AbbVie filed suit against Alvotech alleging the company stole trade secrets regarding the manufacturing process for this formulation, and Alvotech sued in return, alleging that AbbVie’s patents are invalid.

Return to The Center for Biosimilars® website later this week for further coverage of these issues.