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 for the newly listed patents in Supplement 6 did not contain any data! That text file was for the ‘771 patent. The USPTO’s “Patent Public Search” described the ‘711 patent as “withdrawn” without any text or image pages. My Google search for the number “11638711” turned up a USPTO list of “withdrawn patent numbers.” So it looks like MC2 may have jumped the gun by submitting a 3542 form for the ‘711 patent soon after the projected issue date without first confirming that the patent had actually issued.

I used the USPTO’s Patent Center to confirm that the ‘711 patent was not issued on the projected issue date. In fact, the Patent Center showed that on June 21, 2023 the USPTO issued a second Issue Notification for MC2’s application. That second Issue Notification contained a projected patent number of 11696919 (‘919 patent) with a projected issue date of July 11. The ‘919 patent, showing MC2 as the applicant and assignee, was, in fact, issued on the projected issue date of July 11.

The moral of this story? Don’t base an Orange Book patent information submission on an Issue Notification. While it might be very rare for a patent number to be withdrawn by the USPTO, I suggest that you wait until the patent can actually be shown to have issued before submitting your 3452 form to the FDA.