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FDA’s Orange Book Dispute Resolution Process May Grow Teeth With FTC Patent Listing Challenges

 
• By Brenda Sandburg

People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.

Dispute book
FTC invokes new use of FDA process to challenge Orange Book patent listings • Source: Shutterstock

The US Federal Trade Commission put a spotlight on the US Food and Drug Administration’s process for disputing listings in its Orange Book when it claimed manufacturers of drug-device combination products improperly listed their patents. The FTC’s use of the process differs from that of others as its enforcement power could compel companies to actually delist.

The FTC sent notice letters to 10 companies objecting to patent listings for asthma and chronic obstructive pulmonary disease inhalers and epinephrine auto-injectors. The agency said it was utilizing FDA’s dispute process while retaining the right to take further action, including investigating the manufacturers’ conduct as a violation of FTC laws

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