Patents listed in the Orange Book must claim the reference listed drug or a method of using it. The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information.FDA regulations describe to brand name drug companies (sponsors) the patent information that should be submitted for listing in the Orange Book. In response to the FTC's push, FDA promised to issue updated guidance to companies about which patents to list in the Orange Book. While you can file a patent application as an unregistered user, you will not benefit from the tools available to registered users. The disclosure provides support for the claim section.