IPO Recommendations for Changes to the Orange Book Listing Form 3542

The FDA sought comments as part of its wide effort to modernize the Orange Book in Docket FDA-2020-N-1127 regarding the types of patent information listed in the Orange Book. Specifically, the FDA sought input for specific questions regarding:

1. the listing of patents that claim a device constituent part of a combination product approved under section 505 of the FD&C Act;
2. the listing of patents that claim a device whose use is referenced in approved drug labeling;
3. the listing of patents associated with an established Risk Evaluation Mitigation Strategy (“REMS”); and
4. the listing of patents associated with digital applications.

In addition, the FDA also asked for general comments regarding potential improvements to the Orange Book patent listing process.

The IPO Pharmaceutical and Biotechnology Issues Committee formed a subcommittee to draft a response to the FDA. Finnegan's Tom Irving and Stacy Lewis, members of the IPO Pharmaceutical and Biotechnology Issues Committee, joined the subcommittee and, with the help of Finnegan's Jill MacAlpine, drafted detailed recommendations for changes to the Orange Book Listing Form 3542, found in the Appendix to the IPO response. Tom Irving and Stacy Lewis also participated in the subcommittee's drafting of substantive responses to the FDA's request for comments and specific questions.

The complete IPO response letter to the FDA may be found here, and further details on the proposed recommendations for changes to Form 3542 can be found here.