The U.S. Federal Trade Commission flagged that licensing of pending patents can create antitrust risk, filing an amicus brief in the Fourth Circuit tied to Amgen’s long-running exclusive rights to etanercept-related patent applications. The issue centers on when patent protection can effectively delay biosimilar entry, with the FTC arguing the structure of licensing could be problematic under antitrust principles. The filing’s context includes Enbrel’s patent protection extension, which would have enabled earlier biosimilar competition absent the patent timeline. While the brief does not pre-decide outcomes, it signals that regulators are paying close attention to how intellectual property strategies can shape competition in biologics. For biotech companies, the case underscores that patent licensing strategy is increasingly scrutinized not only by courts but also by competition authorities, affecting how future deals are structured for biologics and biosimilars.