It’s been 22 years since Amgen Inc. obtained exclusive rights to two etanercept patent applications. No one seemed to pay much attention at the time. Not even the U.S. FTC, which reviews patent acquisitions and exclusive patent licenses under the Hart-Scott-Rodino Act. But when the patents issued several years later, extending the protection for Amgen’s blockbuster inflammatory disease drug, Enbrel, until 2029, eyebrows shot up. After all, up until then, Enbrel would have lost patent protection in 2012, making it fair game for early biosimilar competition. Now with the Sherman Act’s four-year statute of limitations long over, the FTC is trying to make up for lost time with an amicus brief it filed in the U.S. Court of Appeals for the Fourth Circuit.
Licensing of pending patents can be an antitrust threat, FTC says