FDA Seeking Comments on Orange Book Patent Listing

June 29, 2020 – Article

The FDA has published a public notice requesting comments on the submission and listing of patent information. See the notice here. The information requested could lead to the implementation of changes having a significant impact on pharma, including combination products in the future, especially on combination products.

The FDA Has 5 categories of questions:

1. General Questions: including whether the FDA should clarify the types of patent that may be listed. This may be a reaction to the decision in In re: Lantus Direct Purchaser Antitrust Litigation, No. 18-2086, D. Mass. February 13, 2020, where the court found that an antitrust action may be based on an improperly listed patent on a syringe component where the patent nor its claims identified any specific drug. See https://www.lifesciencesipblog.com/listing-the-medical-device-part-of-a-combination-product-in-the-orange-book-may-trigger-antitrust-liability-

2.     Drug Product Patents: including what factors should FDA consider in providing any clarifications related to whether device-related patents need to be submitted for listing as a patent that claims the drug? An example is, “what are the advantages and disadvantages of requiring patents that claim a device constituent part of a combination product approved under section 505 of the FD&C Act to also claim and/or disclose the active ingredient or formulation of the approved drug product (or the drug product class) to fall within the type of patent information that is required to be submitted to FDA for listing in the Orange Book?

3.     Method-of-Use Patents: Primarily directed at combination products where the claims are directed to using a device to administer the drug. Of interest is the question:

What information should FDA consider regarding whether there are circumstances in which a method-of-use patent claiming the way an approved drug product is administered that is not described in FDA-approved product labeling would meet the statutory standard for listing in the Orange Book?

4.     REMS-Related Patents [require a risk evaluation and mitigation strategy]: The agency is particularly interest in the impact of listing such patents in the Orange Book on the development of generic versions.

5.     Patents for Digital Applications: Primarily seeking input on the factors should be considered in determining whether a patent that claims an aspect of that digital application meets the standards for listing in the Orange Book?

Whether these inquiries will result in any FDA rule making remains to be seen. Depending on what the FDA decides could have a significant impact on Pharma life cycle strategies. Industry has been seeking answers to these question since 2002. It appears that the FDA is now advancing down the path to providing some clarity.