FTC Advocates for Competition in Biologic Drug Markets Against Amgen
The Federal Trade Commission has filed an amicus brief in a case against Amgen, arguing that the company's acquisition of patent applications for Enbrel violates antitrust laws and harms competition.
20.08.2026 | Federal Trade Commission
The Federal Trade Commission (FTC) has taken a significant step by filing an amicus brief in an antitrust case involving Amgen, a major drug manufacturer. The case centers around allegations that Amgen illegally acquired exclusive rights to patent applications related to Enbrel, a drug used for treating rheumatoid arthritis and other inflammatory conditions. This acquisition is claimed to have allowed Amgen to extend its monopoly over the biologic drug, thereby limiting access to lower-cost alternatives for consumers.
CareFirst of Maryland Inc. and its affiliates have sued Amgen, asserting that the acquisition of these pending patent applications violates Section 2 of the Sherman Act. They argue that Amgen's actions not only covered Enbrel but also blocked potential competitors from entering the market, thereby maintaining its monopolistic position.
After the U.S. District Court for the Eastern District of Virginia denied Amgen's motion to dismiss the case, the company appealed, claiming that acquiring patent applications cannot be deemed anticompetitive under the Sherman Act. Amgen also contended that its actions are protected under the Noerr-Pennington doctrine, which shields certain conduct aimed at influencing government decisions from antitrust liability.
In its amicus brief, the FTC emphasizes that the acquisition of patent applications should be scrutinized under antitrust laws, similar to patent acquisitions. The brief outlines how control over pending patent applications can lead to anticompetitive harms, allowing monopolists to shape the scope of eventual patents to further entrench their market position.
Furthermore, the FTC argues that Amgen's prosecution of the patent applications before the U.S. Patent and Trademark Office (USPTO) and subsequent enforcement of the patents do not exempt the acquisition from antitrust scrutiny. The Commission's stance is that while the Noerr-Pennington doctrine may protect certain petitioning activities, it does not extend to private commercial transactions like the acquisition of patent rights.
The FTC's involvement underscores its commitment to ensuring the effective application of federal antitrust laws and its goal of making prescription drugs more affordable for Americans by fostering competition in the market.
