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

 
• By Brenda Sandburg
  
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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.

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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 patents pertain to drug-device combination products, including asthma inhalers, epinephrine autoinjectors, and Restasis Multidose eye drops. (See table below).

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