A U.S. judge ruled in favor of Amgen on the validity of two patents pertaining to the company’s drug Enbrel (etanercept), indicated for the treatment of rheumatic conditions including rheumatoid arthritis (RA).
Amgen was in a battle with Sandoz, a subsidiary of Novartis, which in 2016 received approval from the Food and Drug Administration (FDA) for a biosimilar of Amgen’s drug. However, Sandoz has not been able to market its drug, Erelzi, because of Amgen’s extended patent protection. The active ingredient in Enbrel is patent-protected until 2029.
“We are pleased with today’s decision recognizing the validity of these patents. 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,” said Robert A. Bradway, Amgen’s chairman and CEO, in a press release.
Enbrel earned FDA approval in 1998. The drug was manufactured by Immunex Corporation, which Amgen acquired several years after Enbrel was approved.
Sandoz plans to appeal the ruling.
“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 President of Sandoz US and Head of North America Carol Lynch in a press release. “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.”
Biosimilars of Enbrel are available in Europe.
According to a Reuters report, “The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year. Shares of Amgen closed up about 6% at $196.25 after the ruling.”
The FDA approved Enbrel biosimilar Eticovo (etanercept-ykro), manufactured by Samsung Bioepis, earlier this year.
In addition to RA, Enbrel is also indicated to treat polyarticular juvenile idiopathic arthritis (JIA) in patients aged two years or older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and plaque psoriasis (PsO) in patients aged four years or older.
In adults with RA and PsA, Enbrel is recommended in 50 mg once weekly with or without methotrexate. In AS, it is recommended in a 50 mg dose once weekly. In adults with PsO, it is recommended at 50 mg twice weekly for three months and then 50 mg once weekly thereafter. Pediatric PsO and JIA patients are recommended to take 0.8 mg/kg weekly with no more than 50 mg weekly.