Law360 Quotes Chicago Locke Lord Partner Jonathan Turpin on FTC’s Potential Next Steps After Challenging Patents in FDA’s Orange Book

June 3, 2024

Chicago Partner Jonathan Turpin was quoted by Law360 on the Federal Trade Commission’s (FTC) challenge of “improper or inaccurate” patents listed by pharmaceutical manufacturers in the Food and Drug Administration’s (FDA) Orange Book, which lists drug products approved by the FDA as safe and effective. The FTC first sent warning letters to 10 drugmakers challenging the listing of over 100 patents in November and sent additional letters in April, challenging more than 300 patents owned by more than 10 companies. Turpin explains that the FTC has already outlined possible next steps the agency could take, but “how exactly they go about that I think is the unanswered question.”

Turpin adds that the FTC isn’t the only party who has taken action against patent listings in the Orange Book. “Generic-drug makers have also filed suits targeting Orange Book patent listings, and until the FTC got involved, ‘that was kind of where all the action was,’” he says. “Since the FDA does not police listings, ‘it’s up to third parties, typically generic companies, to challenge improperly listed patents. FTC taking an interest has, I think, accelerated things, but it’s not a completely untested area.’”

Read the full Law360 article (subscription may be required), and read Turpin’s QuickStudy on the topic The FTC Strikes Again – Challenging the Listing of 300+ Patents in FDA’s Orange Book.