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.

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