FTC Files Amicus Brief to Protect Competition in Biologic Drug Markets

The Federal Trade Commission filed an amicus brief in an antitrust case alleging that drug manufacturer Amgen illegally acquired exclusive rights to patent applications that it shaped to cover Enbrel—a drug used to treat rheumatoid arthritis and other inflammatory conditions—allowing Amgen to extend its monopoly over the biologic drug. As part of its efforts to ensure Americans have greater access to low-cost prescription drugs, the FTC argues in the brief that acquisitions of patent applications, like Amgen’s acquisition, are subject to antitrust scrutiny. 

CareFirst of Maryland Inc. and its affiliates sued Amgen, alleging that the drug manufacturer’s acquisition of pending patent applications violated Section 2 of the Sherman Act. CareFirst alleges that Amgen acquired exclusive rights to patent applications with the potential to cover Enbrel and then used those applications to obtain patent claims covering Enbrel, which it leveraged to extend its monopoly over the drug and block lower-cost competitors from entering the market. 

After the U.S. District Court for the Eastern District of Virginia denied Amgen’s motion to dismiss the case, Amgen appealed. It argued that the acquisition of patent applications can never constitute anticompetitive conduct under Section 2 of the Sherman Act. And it further contended that its acquisition is immune from antitrust liability under the Noerr-Pennington doctrine because it later prosecuted the patent applications before the U.S. Patent and Trademark Office (USPTO) and enforced the issued patents in federal court. 

The FTC’s amicus brief, filed in the U.S. Court of Appeals for the Fourth Circuit, argues that private commercial agreements acquiring the rights to patent applications, just like patent acquisitions, are subject to antitrust scrutiny. The brief identifies several ways in which control of a pending patent application—even before it becomes a granted patent—can result in unique anticompetitive harms and help a company exclude competitors from the market. The brief further describes how these aspects of patent applications may give a monopolist greater control to shape the exclusionary scope of the eventual patent to increase its monopoly.

The FTC’s brief also argues that neither Amgen’s prosecution of the applications before the USPTO nor its enforcement of the issued patents via litigation immunizes the underlying commercial transaction—the acquisition of those applications—from antitrust scrutiny. Under the Noerr-Pennington doctrine, defendants are immune from antitrust liability for engaging in conduct aimed at influencing government decision-making. The FTC argues that while this immunity may protect petitioning, it does not extend to private commercial transactions.

The Commission filed the amicus brief given its strong interest in ensuring the proper application of federal antitrust laws and its focus on making prescription drugs more affordable for Americans by promoting competition. 

The Commission vote authorizing the issuance of the amicus brief was 2-0.