A US court has ruled in favour of Amgen in its dispute with Novartis’ Sandoz over patents protecting Enbrel (etanercept) from biosimilar competition.
Sandoz won US Food and Drug Administration (FDA) approval for a biosimilar version of Amgen’s blockbuster rheumatoid arthritis drug in 2016 but has been unable to introduce the drug because of ongoing patient litigation.
The Novartis subsidiary was looking to the case in the District Court of New Jersey to clear some of the barriers to the commercial launch of the biosimilar, called Erelzi (etanercept-szzs), by ruling that certain patents are invalid.
The case centred on two patents that Amgen obtained from Roche. Sandoz did not dispute that its biosimilar infringes on the patents, which cover the Enbrel active ingredient and manufacturing process, but argued that they were invalid.
As Sandoz sees it, the patents are invalid as their specifications lack a sufficient written description of the invention and for other reasons.
However, the US court sided with Amgen, concluding that Sandoz “failed to show by clear and convincing evidence that the Patents-in-Suit are invalid”.
The ruling could delay the arrival of biosimilar competition for Enbrel in the US by a decade. Sandoz thinks Amgen obtained the patients in “an attempt to extend its US compound patent protection for etanercept to 2029”.
If Enbrel remains free from biosimilar competition until 2029, the drug will have enjoyed more than 30 years of intellectual property protection. Enbrel won FDA approval in 1998.
Shares in Amgen rose 6% when news of the court ruling emerged. The increase reflects how reliant Amgen is on Enbrel. At $1.4bn, revenues from Enbrel accounted for almost one-quarter of Amgen’s total product sales in the company’s most recent set of results.
Sandoz wants the chance to try to take market share from Enbrel and has vowed to continue fighting Amgen in the courts.
“Sandoz respectfully disagrees with the Court’s ruling,” said Carol Lynch, president of Sandoz US. “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.”
Whatever the outcome of the appeal, the ruling of the New Jersey court will secure Amgen an additional period of sales free from biosimilar competition. The ruling also delays the date on which Sandoz and Samsung Bioepis, which became the second company to win FDA approval for an Enbrel biosimilar in April, can begin recouping returns on their investments.