Novartis loses biosimilar appeal as court upholds a 31-year monopoly by Amgen’s Enbrel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.

But Novartis argues that it’s long past due for a lower-cost knockoff to enter the market.

The original patent of Enbrel, which launched in 1998, expired in 2012. What Novartis is challenging is the patents covering the active protein, etanercept, and the process of making the anti-TNF pill.

“Our company respects valid intellectual property, however Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity,” Carol Lynch, president of Sandoz US and head of North America, said in a statement.

The US District Court of New Jersey first ruled against that line last August, and while many analysts consider the case closed with the judge’s “carefully crafted” decision, Novartis went on to file an appeal with the Federal Circuit.

Erelzi is also approved in Canada and Europe (both in 2017).

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