Amgen Wins Enbrel Patent Suit Preventing Sandoz Biosimilar Launch

Regulatory NewsRegulatory News | 12 August 2019 |  By 

A US District Court Judge in New Jersey on Friday upheld the validity of two of Amgen’s patents for its blockbuster arthritis treatment Enbrel (etanercept), preventing the launch of a biosimilar developed by Novartis’ Sandoz division.
So far, the US Food and Drug Administration (FDA) has approved two Enbrel biosimilars, Sandoz’ Erelzi (etanercept-szzs) in August 2016 and Samsung Bioepis’ Eticovo (etanercept-ykro) last April, but neither have launched commercially due to ongoing litigation. Enbrel was first approved by FDA in 1998.
While FDA has approved more than 20 biosimilars since approving its first in 2015, only about one-third have launched, in large part due to complicated intellectual property litigation that often takes years to resolve.
The case was brought by Amgen’s Immunex subsidiary against Sandoz, with Amgen alleging that Sandoz infringed on two of its patents covering Enbrel, patent nos. 8,063,182 and 8,163,522. While Sandoz did not dispute that its biosimilar infringed on those patents, Sandoz challenged the validity of seven claims made in the two patents.
Amgen has also launched a suit against Samsung Bioepis alleging the company infringed on five patents covering Enbrel, including the two at issue in its suit against Sandoz.
In the ruling, Judge Claire Cecchi found that Sandoz “failed to show by clear and convincing evidence that the Patents-in-Suit are invalid.”
After the ruling was announced Friday, Sandoz said it will appeal the decision to the US Court of Appeals for the Federal Circuit.
“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,” said Carol Lynch, President of Sandoz US.
Amgen CEO Robert Bradway responded to the ruling Friday saying: “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.”


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