For those parties required to submit patent information to the U.S. Food and Drug Administration, the Agency has published updated forms: Form 3542 and Form 3542a. FDA updated the patent information forms as part of final regulations implementing portions of the 2003 Medicare Modernization Act. The regulations, which FDA issued on October 6, 2016, took effect on Monday, December 5, 2016. FDA will no longer accept old Form 3542 and 3542a, but it is not necessary to resubmit old forms if they were submitted before December 5, 2016.
The new rules amend 21 CFR 314.53, which governs the submission of patent information to FDA. Under the new rules, the NDA holder’s proposed use code(s) must describe only specific approved methods of use claimed by a patent for which a claim of patent infringement could reasonably be asserted. Use codes should not be so broad as to cover indications or other approved conditions of use that are not covered in their entirety by a patent. In other words, FDA clarified in the new rules that the use code must not extend beyond the patent claim(s) and, within the boundary established by the patent claim(s), the use code must only describe a patented method of use that FDA has approved as reflected in approved product label. Consistent with these revisions, section 4.2b of Form FDA 3542 now states that the NDA holder must submit the description of the specific approved method of use claimed by the patent that is proposed for inclusion as the “use code” in the Orange Book. The Forms also require that submission specify the section(s) and subsection(s) of the approved labeling that describe the method(s) of use claimed by the patent.
Another notable change is that FDA will no longer require NDA holders with an NDA supplement to resubmit all previously submitted patent information. Instead, the new regulation only requires submission of patent forms in certain circumstances, including: (i) to add or change the dosage form or route of administration; (ii) to add or change the strength; (iii) to change the drug product from prescription use to over-the-counter use; (iv) or if “the published description of the patented method of use would change upon approval of the supplement.” See 21 CFR 314.53(d)(2).