Make sure that your patent exists before submitting a 3542 form for the patent to the FDA
So, you received an “Issue Notification” from the USPTO for an allowed patent application. Yay! But be careful! The “Issue Notification” document that the USPTO sent you says that it merely contains a “ projected ” patent number and issue date. In the case of MC2 Therapeutics’ WYNZORA, a patent with the projected patent number that the Issue Notification contained did not issue on the projected issue date, and, in fact, never issued! However, MC2 must have submitted a 3542 form to the FDA for patent number 11638711 (‘711 patent) that was contained in an Issue Notification that had been sent to them on April 12, 2023. That Issue Notification said that the patent would issue on May 2, 2023. The Electronic Orange Book shows that information for the ‘711 patent was received by the FDA for WYNZORA on May 31. However, in my preparation for the Vol. 43/ Supplement 6 version of my Orange Book Companion® I discovered that one of the text files of basic data that my algorithms had generated fo