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How Orange Book Antitrust Scrutiny Is Intensifying

By  |  August 23, 2024

By: Elai Katz, Lisa P. Rumin & Betty Zhang (McDermott Will & Emery Antitrust Alert)

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    Pharmaceutical patent holders take note: Over the past year, antitrust enforcers have intensified their scrutiny of Orange Book listings, viewing them as potentially anticompetitive. The Federal Trade Commission has stated that improperly listing patents in the Orange Book can constitute an unfair method of competition, among other legal violations.

    In this article, Elai Katz, Lisa Rumin, and Betty Zhang examine this increased focus on Orange Book listings and outline the risks brand-name drug manufacturers should be mindful of regarding their listing practices. Moving forward, these manufacturers should adopt a proactive approach by thoroughly documenting their evaluation process and the rationale behind listing patents in the Orange Book to ensure compliance with statutory requirements…

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