Sandoz to appeal against Amgen biosimilar ruling
Sandoz has confirmed that it plans to appeal against a decision that upheld the validity of two of Amgen’s patents for its arthritis treatment Enbrel (etanercept), effectively blocking the launch of Sandoz’s biosimilar version.
On Friday, August 9, the US District Court for the District of New Jersey rejected Sandoz’s attempt to invalidate two patents and clear the path for its biosimilar Erelzi (etanercept-szzs).
Erelzi, which was approved by the Food and Drug Administration nearly three years ago, is the first approved biosimilar etanercept.
Before a two-week bench trial in September last year, Sandoz didn’t contest infringement of the two patents, US numbers 8,063,182 and 8,163,522, but did ask the court to find them invalid.
However, last week, District Judge Claire Cecchi concluded that Sandoz had failed to show that two of Amgen’s patents were invalid.
Carol Lynch, president of Sandoz US and head of North America, said: “Sandoz respectfully disagrees with the court’s ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases.
Lynch added that Amgen asserted two patents that it obtained from Roche, in what Sandoz believes is an attempt to extend its US compound patent protection for etanercept to 2029.
Sandoz will appeal against the ruling to the US Court of Appeals for the Federal Circuit, and both parties have agreed to an expedited appeal.
Robert Bradway, chairman and CEO at Amgen, said: “We are pleased with [the] decision recognising the validity of these patents. Protecting IP is critical to incentivise 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.”
Back in 2013, Novartis’s generic arm Sandoz sought a judgment that its planned biosimilar version of Enbrel wouldn’t infringe the two Amgen patents because they should be declared invalid.
The district court rejected Sandoz’s claims, after finding that it had filed the lawsuit. On appeal, the Federal Circuit upheld the decision.
In the subsequent dispute at issue, Amgen filed its suit at the New Jersey court in 2016, accusing Sandoz of infringement through its biosimilar version.
According to a press release from Sandoz, estimates suggest that a biosimilar etanercept could save the US healthcare system around $1 billion a year.
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