Modernization Of The Orange Book

In a previous post, we discussed FDA's request for comments on "Listing of Patent Information in the Orange Book" in online public Docket FDA-2020-N-1127. In that request, FDA sought comments as part of its effort to modernize the Orange Book on the type of patent information listed in the Orange Book. Comments were accepted from June 1, 2020 through August 31, 2020, electronically and in writing.

Specifically, FDA requested comments on the submission and listing of certain patents, including:

1. patents claiming a device constituent part of a combination product approved under section 505 of the FD&C Act;
2. patents that claim a device whose use is referenced in approved drug labeling;