An Antitrust Economist's Perspective on Recent FTC Scrutiny towards Orange Book Patent Listing

In the last year, the Federal Trade Commission (FTC) has taken several actions to challenge patents listed in the Food and Drug Administration's (FDA) Orange Book, including publishing a policy statement regarding its intent to scrutinize improper patent listings as potentially unfair methods of competition, filing Amicus Curiae briefs in private litigation, and issuing warning letters in November 2023 and April 2024 to manufacturers disputing over 400 patents that these manufacturers listed in the Orange Book covering brand-name asthma and COPD inhalers, epinephrine autoinjectors, obesity and type-2 diabetes injectable drugs, and nasal spray drugs.

Read more in this piece, published recently in Bloomberg Law.