Foley Hoag Event

Why is the FTC Seeing Red over FDA's Orange Book Listings?

December 20, 2023

On November 7, 2023, the FTC challenged over 100 patents that it says were improperly listed in the FDA’s Orange Book, asserting that the listings could “drive up the prices Americans must pay for medicines and drug product while undermining fair and honest competition” (according to one Commissioner). These actions were not a surprise, however, because the FTC previewed them in its September Policy Statement specifically addressing the “Improper Listing of Patents in the Orange Book.”

Foley Hoag presented an informative legal webinar when we looked at this and related issues. Specifically, our webinar addressed:

  • The standards for listing patents in the Orange Book; 
  • What it means for a patent to be listed in the Orange Book – and its real world impact;  
  • FDA’s mechanisms for dealing with patent listing challenges, both historically and today;
  • FTC’s September Policy Statement about Orange Book listings; and
  • How the FTC looks at competition issues under Section 5 of the FTC Act, 15 U.S.C. § 45, and as described in its Policy Statement.
Download presentation materials here.

Please note that CLE credit is only valid for live attendance. At this time, we are not able to provide credit for recorded views. Please contact us for details.