FTC Issues Policy Statement on Brand Pharmaceutical Manufacturers’ Improper Listing of Patents in the Food and Drug Administration’s ‘Orange Book’

Summary:

The Federal Trade Commission (FTC) has issued a policy statement warning pharmaceutical companies that improper listings of patents in the FDA's Orange Book may be investigated as potential violations of the FTC Act. Improperly listed patents can harm competition from generic alternatives and keep prices artificially high. The FTC will scrutinize such listings as potential unfair methods of competition in violation of Section 5 of the FTC Act. The policy statement emphasizes that improper patent listings can undermine competition and harm the American public, and the FTC will use all its tools to halt unlawful business practices that contribute to high drug prices.