The ANDA and 505(b)(2) Proposed Rule, that (due to its length) we like to call Moby Dick, addresses a plethora of issues of importance to the generic industry, and we are trying to tackle many of them in multiple posts. This is a continuation of that effort.
The submission of proper and accurate descriptions of the Use Code submitted by the NDA holder is important for the smooth functioning of the Act. The Agency’s goal is to prohibit an overly broad description of the use that would preclude ANDA applicants from making a little viii statement (they do not intend to seek approval for a specific use of the product), otherwise known as a “carve out” provision. FDA explains that this regulatory clarification and enhancement is required based on a Supreme Court decision as FDA states: “As the U.S. Supreme Court noted in Caraco Pharm. Labs. v. Novo Nordisk A/S: ‘An overbroad use code… throws a wrench into the FDA’s ability to approve generic drugs as the statute contemplates’.”
In a bit of a surprise, FDA is maintaining its position on reissued patents for purposes of the 30-month stay or for 180-day exclusivity purposes, even in the face of a court decision that took a different view. FDA’s position in the Proposed Rule states, “Although we recognize that the original patent is surrendered upon patent reissuance (see 37 CFR 1.178(a)), we are proposing to treat the original patent and the reissued patent as a “single bundle” of patent rights, albeit patent rights that may have changed with reissuance, for purposes of administering the patent certification requirements of the FD&C Act and any 30-month stay of approval or 180-day exclusivity that relates to a paragraph IV certification to the original patent (see discussion in section II.E.4).” The FDA has appealed the Fourth Circuit’s reversal of the United States District Court for the Northern District of West Virginia, where the Fourth District Court told FDA to treat each reissue patent as a new and separate patent and not a “single bundle” of patent rights. I guess the FDA believes its position is correct. But recognize that if the FDA appeal fails, then the Proposed Rule will likely be revised prior to finalization.
FDA is also proposing that if the original patent was untimely filed (submitted to the FDA after 30 days from the patent’s issuance), then the reissue patent would also be considered to be untimely filed even if the reissue patent was submitted to the Agency within the 30-day period. This approach, FDA says, “recognizes that the original and reissued patents comprise a ‘single bundle’ of patent rights, which first became relevant to approval of 505(b)(2) applications and ANDAs with the submission of the patent information prior to reissuance.”
Have a Product in the Discontinued Section of the Orange Book?
FDA advises NDA holders that if they have a product in the discontinued section of the Orange Book that has not been withdrawn from the market for safety or efficacy reasons to “encourage NDA holders to ensure that they continue to comply with the statutory requirements for patent listing for products that have been discontinued from marketing.” If they fail to do so, if an ANDA or 505(b)(2) applicant relies on one of these discontinued products and a reference listed drug, and the patent information is not timely listed with the FDA, the applicant would not have to certify to those patents.
Well, that’s it for today, there is still a lot more to cover so stay tuned.