Since President Biden's July 2021 executive order directing the FDA Commissioner to collaborate with the PTO on potential misuse of the patent system, I've been skeptical as to whether such efforts will have any impact on the number and quality of the patents that are issued by the PTO or any corresponding benefit to reduce drug pricing. After all, don't PTO Examiners already have access to all of the public prior art that would be relevant when reviewing patent applications, and hasn't FDA sworn off all but a ministerial role in evaluating patents? A recent FDLI webinar addressing the collaboration indicates that the answers to my questions are “maybe” and, unfortunately, still “yes.”
Taking my second question first, despite public pressure seeking to have FDA police Orange Book patent listings, FDA has remained firm in its position that it has no more than a ministerial role in listing patents in the Orange Book. This means that FDA receives the patent information from NDA holders, ensures that the forms are completely filled out, and then lists the submitted patent information in the Orange Book without conducting any analysis as to whether the patents are properly listed. Although FTC has announced plans to be more active in policing Orange Book listings, it appears that FDA is firmly committed to its ministerial role for the foreseeable future.
As to my first question, I was surprised to learn that PTO Examiners are often not confident in establishing publication dates for approved drug labels and other FDA-related documents when evaluating such documents for prior art purposes. So, one of the more enlightening cross-training events has apparently involved FDA personnel explaining their publication practices to the PTO and providing a review of available databases. The hope, of course, is that PTO Examiners improve their evaluation of prior art and scrutinize patent applications more closely in order to prevent patents that would otherwise be invalid from issuing. It has long been recognized that just the mere listing of these patents in the Orange Book often gives rise to multi-million dollar litigation and the automatic 30-month stay of FDA approval of generic products, ultimately delaying competition and driving up costs to the generic drug industry even if such patents are ultimately found invalid by the courts.
Only time will tell whether the collaboration between FDA and the PTO will have any impact on the quality of patents issuing and drug prices. But, the continuing discussions between these two important agencies will certainly be interesting to watch.
“Are there other areas of engagement that would be more beneficial in terms of getting to the prized goal of bringing down drug costs instead of perhaps looking at these sort of one-offs, like the provision of inconsistent statements?” Sitlani said. “We don’t have the raw data to see how pervasive this problem is.”
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