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FDA’s draft Q&A guidance on patent submission forms: A few practical tips worth noting

17 June 2026

In June 2026, FDA's Center for Drug Evaluation and Research issued draft guidance addressing common questions about Forms FDA 3542a and FDA 3542—the forms NDA applicants and NDA holders use to submit patent information for listing in the Orange Book. The draft guidance is a clarifying Q&A, and most of its twenty-nine items restate and consolidate existing requirements and instructions. That said, a few practical tips are worth noting.

Method-of-use-only patents: Leave the drug substance and drug product sections blank

The forms include questions regarding drug substance (active ingredient), drug product (composition/formulation), and method-of-use claims. Where a patent claims only a method of use and does not claim the drug substance or drug product, the draft guidance instructs that the applicant or holder should not check any boxes, including the “No” boxes, in Section 2 (drug substance) or Section 3 (drug product) of the form. In other words, those sections are left entirely blank rather than affirmatively marked “No.”

Use-code removal: Cover-letter recommendation

Patent listing forms are submitted electronically to the NDA and typically include the Form 3542 or Form 3542a, a cover letter, and a Form 356h. The draft guidance addresses the procedure for removing a use code from an existing patent listing. This includes modifying a use code because FDA considers modifying a use code to involve removing and replacing the use code. Of note, the holder should state the intent to remove the use code in the cover letter accompanying the submission in addition to Field 1.h of the form.

Electronic signature: Required

Although this may not be a widespread issue, the draft guidance states that the forms must be signed electronically and not by hand. The draft guidance ties this to longstanding electronic-submission requirements under 21 CFR 314.53(d)(4) and section 745A(a) of the Food, Drug, and Cosmetic Act, implemented through the eCTD framework.

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There is an opportunity to submit comments regarding the draft guidance. Although comments may be submitted at any time, FDA recommends that comments be submitted within 60 days of the Federal Register notice of availability to ensure that they are adequately considered.

If you have questions or would like help preparing a comment, please contact the author of this alert or the Hogan Lovells attorney with whom you normally work.

Authored by Gary Veron.