Pharmaceutical patent holders beware: Over the past year, antitrust enforcers have taken a more aggressive approach challenging Orange Book listings as an anticompetitive practice. According to the Federal Trade Commission, improperly listing patents in the Orange Book constitutes an unfair method of competition, among other violations.

In this article, Elai Katz, Lisa Rumin and Betty Zhang discuss the recent heightened scrutiny of Orange Book listings and highlight risks brand manufacturers should be aware of with respect to their Orange Book listing practices. Going forward, brand manufacturers should think proactively and consider carefully documenting their evaluation process and reasoning for listing patents in the Orange Book to satisfy the statutory requirements.

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