Today, the FDA published a draft guidance titled Forms FDA 3542a and FDA 3542: Questions and Answers (here) that provides NDA sponsors with more information on patent submission than perhaps you ever even thought possible. The document identifies twenty-nine different questions and corresponding answers to clarify who needs to submit patent information, what patent information needs to be submitted, why it needs to be submitted, where it needs to be submitted, and exactly how it must be submitted.
Questions range from how to obtain the required forms, how to make corrections for forms submitted, and which form to use for pending applications and supplements, to which form to use for approved applications or supplements. The document is comprehensive and instructive, and should provide NDA filers and holders with sufficient information to help them navigate the patent submission and listing process required by the regulations.
Have fun reading the draft guidance! I bet you’ll learn at least one thing that you didn’t know about the patent listing process!
