Dreams Do Come True: The Purple Book is getting patent listings!
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) did not contain any provisions for patent listings for the products covered by the Act. That was a big difference between the BPCIA and Hatch-Waxman. As an Orange Book patents aficionado and the creator of the Orange Book Companion® (OBC), I had dreamed over the years of somehow collecting patents on biologics and creating a Purple Book Companion™(PBC). My plan would be for the PBC to provide enhanced info for biologics patents in the same way that my Orange Book Companion provides enhanced info for small molecule drug patents. You can see samples of the OBC’s enhanced format on the OBC public homepage.
Well, my dream may be about to come true! A January 15, 2021 alert from the Arent Fox firm described a three-page section of the 2,124-page “Consolidated Appropriations Act, 2021” (“the Act,” enacted December 27, 2020) which is entitled “Sec. 325 Biological Product Patent Transparency”. At pages 1755-1757 of the Act, Sec. 325 requires the FDA to create, within 180 days, what looks like a Purple Book equivalent of the Electronic Orange Book.
But the most exciting part of Sec. 325 requires reference product sponsors who provide a list of patents to a “subsection (k) applicant” as part of the so-called Patent Dance to provide that list of patents and their respective expiration dates to the FDA within 30 days of the giving that list to the subsection (k) applicant. The FDA is then required to add those patents to the Purple Book at its next regularly scheduled update. Yipee!
Unfortunately, the text of Sec. 325 appears to be prospective, only. So biologics already in the Purple Book will not receive patent listings unless a reference product sponsor adds a new patent. There is also the issue of subsection (k) applicants who choose to forgo the Patent Dance entirely. That would result in no patents being listed. Well, anything is better than nothing!
Even if you are not interested in the Purple Book, the Arent Fox alert starts off with a description of the “Orange Book Transparency Act of 2020” (enacted January 5, 2021). So if you are interested in the Orange Book it would be very worthwhile to read their alert just for that. But continue reading until, near the end, you find their description of what they call the “Purple Book Act.” And if you have dreamed about biologics patents being listed in the Purple Book you can rejoice!