The FTC is stepping up its actions against what they see as questionable patent practices by drugmakers that impede the entry of generic alternatives into the pharmaceutical market. This strategy is rooted in challenges to patents listed in the Orange Book, a publication by the Food and Drug Administration that contains pertinent patents for brand-name drugs. Successfully disputing these patents can allow generic manufacturers a period of exclusivity before other generics are approved, as per regulations aimed at fostering generic competition.
The crux of the issue lies in the potential delays caused by brand-name drug manufacturers contesting challenges to Orange Book patents in court, which can extend the approval timeline for generics by 30 months. The FTC's recent move involves issuing warning letters to 10 companies and disputing the accuracy or relevance of over 300 Orange Book patent listings across various brand-name products, highlighting concerns about "junk patent listings" that obstruct competition and keep drug prices high.
FTC Chair Lina Khan emphasized that by confronting these "bogus patent filings," the FTC is combating illegal tactics that inflate drug prices, thereby ensuring Americans can access innovative and affordable medications. However, critics have raised apprehensions about potential consequences of the FTC's actions, expressing concerns that delisted patents could lead to increased risks for generics entering the market and potential post-approval patent litigation. Meanwhile, the U.S. Patent and Trademark Office has also faced criticism for allegedly issuing weak or redundant patents, contributing to the challenges faced in promoting generic competition.