FDA Launches Review of Orange Book Patent Listing Practices

Citing its priority to facilitate the timely development and approval of generic drugs, the U.S. Food and Drug Administration ("FDA") solicits stakeholder input on the types of patents that should be listed in the Orange Book.

With specific reference to the Drug Competition Action Plan, which is intended to encourage market competition and help facilitate efficiency and transparency in generic drug review without sacrificing scientific standards, the FDA has established a public docket to collect comments on the listing of patent information in the "Approved Drug Products With Therapeutic Equivalence Evaluations" (the "Orange Book"). 

The FDA is undertaking an agency-wide effort to modernize the Orange Book, including examining whether it should further evaluate or provide additional clarity regarding the types of patent information listed in the Orange Book. While the FDA is interested in any pertinent information, it is specifically requesting comments on the submission and listing of certain patent information, including: 

  • The listing of additional categories of patents in the Orange Book
  • The listing of patents that claim a device constituent part of a combination product (e.g., a drug delivery device) 
  • The listing of patents that claim a device whose use is referenced in approved drug labeling 
  • The listing of patents associated with an established risk evaluation and mitigation strategy 
  • The listing of patents associated with digital applications (e.g., clinical decision support software, software as a medical device)

Simultaneous with the release of the notice establishing a public docket regarding the listing of patent information in the Orange Book, the FDA took two related actions. The FDA opened a docket posing general questions and requesting comments on how stakeholders and the public use the Orange Book and whether it can be improved. The FDA also released and is accepting comments on a draft guidance for industry entitled, "Orange Book: Questions and Answers," which addresses commonly asked questions the FDA has received from interested parties. The FDA requests comments to all dockets by August 31, 2020. 

While the FDA specifies that the efforts are not intended to communicate regulatory expectations, given the cited origin, the nature and tone of the specific questions posed, and the storied history of Orange Book patent listing regulatory and litigation issues, it behooves clients to consider the requests and comment as warranted, monitor FDA activity, and develop engagement and response strategies.

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