Amgen Wins Enbrel Patent Case, Securing U.S. Market Exclusivity Until 2029

Compiled by S.Li

On July 2 local time, Amgen won a patent lawsuit for Enbrel in the U.S. Court of Appeals, with the court supporting an extension of Enbrel's patent term until 2029. According to the ruling, this anti-inflammatory drug will enjoy a market advantage of up to 31 years in the U.S. market. At the close of trading on July 2, Amgen’s stock price rose by 8% to $255.12.

In recent years, biosimilars of Amgen’s flagship products (such as Epogen and Neulasta) have successively entered the market, raising significant concerns that Enbrel, its best-selling anti-inflammatory drug, may lose its market exclusivity advantage.

In August last year, Sandoz, a division of Novartis, challenged two patents on Enbrel, but unfortunately failed. Although Sandoz’s Erlezi was approved by the FDA in 2016 as the first biosimilar to Enbrel, it could not be marketed due to patent litigation. In 2019, the FDA approved Eticovo, the second biosimilar to Enbrel, developed by Samsung Bioepis. Amgen again challenged this drug through similar litigation. In the European Union, however, Erlezi and Benepali (developed by Biogen/Samsung Bioepis) have been on the market for many years.

“While we respect valid intellectual property, Sandoz continues to believe that the patents asserted by Amgen are invalid and should not be used to extend drug exclusivity,” said Carol Lynch, President of Sandoz U.S. and Head of North America. The company stated in a release that it is considering appealing the ruling to the Supreme Court.

Meanwhile, Amgen is also seeking new strategies to maintain Enbrel’s market share. In 2017, Amgen reached an agreement with Harvard Pilgrim Healthcare stipulating that the company would reduce reimbursement for the drug if patient adherence fell below a certain threshold or if other factors were present, such as the need for additional medications to control pain. Last December, Amgen signed an agreement with the pharmacy benefit manager Abarca, under which Amgen agreed to provide discounts for all patients who discontinued use of the drug after three months.

Amgen’s victory in the patent dispute is not its first. Previously, Amgen and Regeneron engaged in a patent battle over PCSK9 inhibitors, with Amgen successfully persuading a jury to uphold the patents for Repatha and securing a patent protection victory in Germany.

Enbrel is the world’s first TNF inhibitor approved for rheumatoid arthritis and ankylosing spondylitis. Originally developed by Amgen and Pfizer, it has received approval for at least five inflammation-related indications. The drug was approved for marketing in China in 2010. Evaluate Pharma predicted last year that Enbrel could become one of the best-selling drugs of all time. It is estimated that by 2024, Enbrel’s lifetime sales will reach $139.8 billion, propelling it to third place on the list of blockbuster drug legends, surpassed only by AbbVie’s Humira and Pfizer’s Lipitor.

Reference Source: Amgen's Enbrel Fends Off Biosimilar Threat—and Heads Toward Blockbuster Superstardom