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.