FTC Challenges Pharma Patent Listings to Lower Drug Prices

The move comes as the FTC intensifies its efforts to combat tactics employed by drug manufacturers to delay generic competition, as reported by the Wall Street Journal.

Central to the issue is the Orange Book, a publication by the Food and Drug Administration (FDA) that catalogues patents relevant to brand-name pharmaceuticals. According to a law designed to promote generics, successful challenges to listed patents can grant generic manufacturers a period of exclusivity. However, if a brand-name manufacturer chooses to litigate a challenge to an Orange Book patent, it triggers a 30-month delay in generic approval.

The FTC alleges that pharmaceutical companies excessively list patents in the Orange Book, leading to unnecessary delays in the approval of generic alternatives and artificially inflating drug prices. FTC Chair Lina Khan emphasized the impact of these practices on consumers, stating, “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on.” According to the FDA, the introduction of just one generic competitor for a brand-name drug can reduce prices by approximately 40%.

In a recent move, the FTC issued warnings to 10 companies, notifying them that their patent listings were invalid. Additionally, the agency informed the FDA of its objections to the patent listings. The targeted companies, which include AstraZeneca, Boehringer Ingelheim, Covis Pharma, GSK, Novartis Pharmaceuticals, Novo Nordisk, Teva Pharmaceutical Industries, Amphastar Pharmaceuticals and some of their subsidiaries, were identified for what the FTC described as “junk listings” on patents for 20 drug products, including the diabetes drug Ozempic, as well as inhalers and other diabetes treatments.

Source: WSJ