FTC’s new Orange Book listing complaints target drug delivery device patent issue that FDA has ignored for years

Lexology November 8, 2023
Loeb & Loeb LLP

The Federal Trade Commission (FTC) is at it again, jumping into the Food and Drug Administration’s sandbox with a splashy press release announcing a volley of letters to ten pharma companies and a notice to the FDA, accusing the companies of illegally listing more than 100 pharmaceutical patents in the FDA’s Orange Book.

Some readers may understandably be scratching their heads about what business FTC thinks it has in policing FDA’s Orange Book patent listing issues, especially in light of the Commission’s prior failure to persuade the Supreme Court that “reverse payment” settlements involving Orange Book listed patents were presumptively unlawful (FTC v. Actavis, Inc. (2013)). However, a closer look at the specific patents that FTC has challenged reveals a...

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