FDA Denies All Four QI Act Citizen Petitions; Determines that No 30-Month Stay Applies to Pending ANDAs; Is a Lawsuit Soon to Follow?

By Kurt R. Karst –      

FDA has issued its highly anticipated decision concerning whether the QI Program Supplemental Funding Act of 2008 (“QI Act”) imposes a 30-month stay of approval of an ANDA referencing an old antibiotic drug product if that ANDA contains a Paragraph IV certification to a patent that was listed in the Orange Book in accordance with § 4(b)(1) of the QI Act.  FDA received four citizen petitions arguing that a 30-month stay should apply – see our previous posts here, here, here, and here.  FDA denied all four citizen petitions in a 20-page response and determined that:

under the QI Act, no 30-month stay of approval will apply to an ANDA referencing an old antibiotic based on the grounds that the ANDA contains a paragraph IV certification to a later-listed patent and the NDA holder or patent owner has sued the ANDA applicant for patent infringement as a result of notice of the paragraph IV certification.  We note that, under current law, a 30-month stay will apply to an ANDA referencing an old antibiotic if that ANDA contains a paragraph IV certification to a patent submitted to the Agency before the ANDA was submitted, and the NDA holder or patent owner sues the ANDA applicant for patent infringement as a result of notice of the paragraph IV certification.

The four citizen petitions raised three general grounds as to why a 30-month stay should apply: (1) the plain language of the QI Act requires application of the 30-month stay provisions of the original Hatch-Waxman Amendments, rather than the version of the statute amended by the Medicare Modernization Act (“MMA”), which limits 30-month stays such that a generic applicant with a pending ANDA that amends its application to add a Paragraph IV certification to a later-listed patent is not subject to a 30-month stay in connection with that certification; (2) the patents at issue should be treated as having been submitted to FDA with the original NDA, thus providing for 30-month stay availability; and (3) the patents at issue should be treated as having been filed in the original ANDA, instead of in an amendment, thus providing for 30-month stay availability.  FDA’s petition response analyzed and dismissed all three bases.

With respect to the applicability of the original Hatch-Waxman Amendments, FDA determined that Congress “did not require FDA to turn back the clock to 1984,” and that such an “outcome is inconsistent with the purpose of the QI Act.”  FDA further explained that:

Upon consideration of the reference in the QI Act to the original 1984 Act in light of additional statutory text, legislative history, and other regulatory considerations, it is apparent that neither this bare statutory reference, nor other statutory considerations require the Agency to apply the original 1984 Act to the ANDAs referencing petitioners’ old antibiotics.  Congress’s reference to the 1984 Act did not impose a 30-month stay of applicants who had already submitted ANDAs when the QI Act was enacted, nor did it create a class of old antibiotic applications that will be subject to long-term differential treatment . . . .  Rather, the reference to “Drug Price Competition and Patent Term Restoration Act of 1984” was a means to identify, as a general matter, the statutory provisions that would apply for the first time to old antibiotics (i.e., those provisions that comprise the generic drug approval program first enacted in 1984).  The term “Drug Price Competition and Patent Term Restoration Act of 1984” is merely a more formal shorthand than the more common reference to “the Hatch-Waxman Amendments.”

FDA similarly dismissed the remaining two bases raised in the petitions.  First, after explaining that “FDA does not interpret the MMA exclusivity provisions to grant 180-day exclusivity only when an ANDA contains a paragraph IV certification to a listed patent on the date the ANDA is originally submitted to FDA,” FDA stated that:

[b]y rendering all applicants with pending ANDAs that timely submit paragraph IV certifications to a listed patent for an old antibiotic “first applicants,” the QI Act effectively treats the applicants’ amendments containing paragraph IV certifications as having been submitted on the first day on which any ANDA applicant submitted a substantially complete application that contains a paragraph IV certification to a patent for the listed drug.  The QI Act does not, however, recalculate the date on which the ANDAs were submitted to FDA.

Second, with respect to the argument that the patents at issue should be treated as having been submitted to FDA with the original NDA, FDA stated that:

This is a tortured reading of a statutory provision that is more reasonably read to mean that patent information of the type required to be filed under 505(b)(1) and (c)(2) is to be submitted to FDA by the identified date. . . .  There is no need to adopt the strained reading proposed by petitioners to give the reference to sections 505(b)(1) and (c)(2) meaning; they already have a reasonable and well established regulatory meaning.

FDA’s petition response also addresses some general arguments that it would be unfair not to apply a 30-month stay.  FDA commented that “[w]hether petitioners consider the legislative choice made in the QI Act regarding 30-month stays as ‘fair’ to their interests is irrelevant.  FDA is implementing the statute based on its interpretation of the plain language, and on the basis of its experience with the complex generic drug approval program as described over the years in the Hatch-Waxman Amendments.”  FDA then goes on to note:

In [the 1997 FDA Modernization Act], Congress expressly enumerated the statutory benefits that would not apply to old antibiotic drugs (section 12S(d)(2)).  And in the QI Act, Congress appears to have made 3- and 5-year exclusivity available only to certain applications for old antibiotics when the application was submitted to FDA after enactment of the QI Act; any NDA for an old antibiotic submitted before the QI Act appears to be ineligible for the exclusivity protections.  Each legislative action reflects particular public policy judgments regarding the appropriate balance of incentives and protections needed to encourage development of antibiotic drugs and the prompt approval of generic drug products.

FDA’s comments might shed some light on the Agency’s possible position on other issues concerning QI Act implementation raised in a letter submitted to FDA earlier this year by the American Intellectual Property Law Association. 

There has been a lot of speculation as to whether or not one or more of the companies on whose behalf the QI Act citizen petitions were submitted will sue FDA in the wake of the Agency’s decision.  Given the storied history of Hatch-Waxman litigation, it would not be surprising if such a lawsuit is filed shortly.  Your loyal and intepid bloggers will continue to update you about this issue.