Sponsors are required to submit information in their NDA filings to include “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” If no patent was available for listing at the time of NDA submission but a patent subsequently issues after the NDA is filed, after approval of the NDA or or at the time that a supplement is filed to the NDA, the sponsor must comply with the regulatory requirements to list such patents. The sponsors must make certain declarations regarding their patent listings. FDA is required to obtain approval from the Office of Management and Budget (OMB) for the collection of data by the FDA.
In a recent Federal Register (FR) Notice (here) announcing the extension of approval for the collection of patent information dealing with the FDA forms 3542 and 3542A (patent declaration forms), the FDA noted that the numbers of patents submitted to FDA for listing in the Orange Book (OB) in 2012, 2013 and 2014 were 458, 509 and 617, respectively, for an average of 528/year. Before reading this FR, I have to admit that I had no idea how many patents had been submitted to the FDA for inclusion in the Orange Book (OB).
Some interesting factoids that appear in the FR notice are:
- FDA recognizes that multiple patents may be submitted to multiple applications and estimates that occurs in about 14% of the time.
- FDA “approved 86, 94, and 107 NDAs in calendar years 2012, 2013, and 2014, respectively, of which we estimate 71 percent submitted patent information for listing in the Orange Book.”
- FDA also approved approximately 101, 101, and 110 NDA supplements in FYs 2012, 2013, and 2014, respectively, for which submission of a patent declaration would be required.
The FR Notice further explains the burden on the industry for filling out the forms and reporting the information to the Agency. It is certainly interesting what you can find in some of these seemingly simple information collection notices. It is also noteworthy that a significant portion of my life is being absorbed by these FR notices. I find they are also very good for inducing sleep, even though I have not seen any clinical studies that can support the safety or efficacy of FR Notices for this indication.