FTC is­sues pol­i­cy con­demn­ing the im­prop­er list­ing of patents in FDA's Or­ange Book

The Fed­er­al Trade Com­mis­sion vot­ed 3-0 on Thurs­day to is­sue a pol­i­cy state­ment to in­crease scruti­ny of im­prop­er list­ing of patents in the FDA’s Or­ange Book.

Phar­ma com­pa­nies cur­rent­ly can “weaponize” the Or­ange Book, FTC chair Lina Khan said at an open FTC meet­ing on Thurs­day, keep­ing prices high for Amer­i­can pa­tients.

The 6-page pol­i­cy state­ment ex­plains how by list­ing patents in the Or­ange Book, brand drug man­u­fac­tur­ers may ben­e­fit from a 30-month stay of FDA ap­proval of gener­ic com­peti­tors, re­gard­less of whether a court finds the patent valid or in­fringed by a com­peti­tor.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER