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In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap

 
• By Brenda Sandburg

Agency sends letters to 10 companies saying they improperly listed patents in US FDA’s Orange Book covering drug-device combination products. FTC does not specify why it believes the patents were improperly listed.

FTC building
FTC objects to listing of drug-device combo patents in FDA's Orange Book • Source: Shutterstock

The US Federal Trade Commission broke new ground in sending letters to 10 drug manufacturers claiming they improperly listed patents in the US Food and Drug Administration’s Orange Book. The agency did not give any explanation for its assessments or offer an opportunity for comment.

Key Takeaways
  • FTC is using the FDA Orange Book dispute process to try to get the patents removed.
  • The approach allows for swift action by FTC, but the lack of guidance could put the agency on shakier legal ground if it eventually pursues enforcement

The patents pertain to drug-device combination products, including asthma inhalers, epinephrine autoinjectors, and Restasis

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