Amgen’s Stealth Enbrel Patent May Block Biosimilars; Scenario May Apply To Other Biologics

Amgen’s patent may keep Enbrel biosimilars off the market until at least 2028. Other biosimilar sponsors could face similar submarine patents that derail their commercialization plans.

Amgen Inc. asserted at an analyst meeting in April that it would be able to block biosimilars of Enbrel (etanercept) after a manufacturing patent expired in October 2012. But no one knew it had a crucial patent application pending in the Patent and Trademark Office that could provide 17 years of additional patent protection.

The company’s announcement that the patent had issued on Nov. 22, 11 years after the application was filed, stunned those...

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