FDA’s Orange Book Dispute Resolution Process May Grow Teeth With FTC Patent Listing Challenges
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.
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US Senator Baldwin’s letters to four inhaler manufacturers come after the FTC challenged their patents last year, but the companies rejected patent amendment claims.
Deputy director of the Bureau of Competition notes in an interview that the FTC focused on older products it felt should have more generic competition in its letters to companies citing improper patent listings. He says it is clear which drug-device combo patents should not be listed.
Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.