An amendment to the description of approved method(s) of use claimed by the patent will be considered timely if it is submitted within 30 days of: (1) patent issuance, (2) approval of a corresponding change to product labeling, or (3) a decision by the U.S. Patent and Trademark Office or a Federal court that is specific to the patent and alters the construction of a method-of-use claim(s) of the patent (and the amendment contains a copy of the decision). Outside of these circumstances and except as provided in the patent listing dispute regulation (21 CFR 314.53(f)(1)), an amendment to the description of the approved method(s) of use claimed by the patent will not be considered timely filed.
If the amendment to the description of the approved method(s) of use claimed by the patent is filed within an acceptable time frame but is incomplete or shows that the patent is not eligible for listing, the NDA holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s notification to be considered timely filed as of the date of the submission of amended patent information.
