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ARTICLE · 08 MAY 2024

FTC Expands Orange Book Patent Listing Challenges

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As discussed in November and December, the FTC has placed improper Orange Book patent listings squarely in its crosshairs. Initially, based on its September 2023 policy statement...

United StatesIntellectual Property
Axinn Veltrop & Harkrider
Axinn Veltrop & Harkrider
Matthew S. Murphy
Matthew S. Murphy
Ross Blau
Ross Blau

As discussed in November and December, the FTC has placed improper Orange Book patent listings squarely in its crosshairs. Initially, based on its September 2023 policy statement, FTC announced that it would "scrutinize improper Orange Book listings" and "use its full legal authority" to "tak[e] actions against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria." Towards the end of last year, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in the FDA's Orange Book for a variety of products is improper, in addition to notifying the FDA of what it believed were improper listings.

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