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Federal Court

The Federal Trade Commission filed an amicus brief with the U.S. District Court for the District of Delaware in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals. The Brief highlights the significant harm to consumers when a brand company improperly lists a patent on a distribution system in the Food and Drug Administration’s “Orange Book” of approved drugs and thereby blocks generic or follow-on competition. The FTC’s amicus brief explains how the Orange Book listing process can be abused and emphasizes the harm to competition and consumers that can result from that abuse, including depriving consumers of potential price competition and the ability to choose between products. The FTC’s amicus brief further argues that distribution patents should not be listed in the FDA Orange Book because they do not meet the statutory requirement that a listed patent claim either the drug itself or a method of using the drug.