Medicis Citizen Petition Argues For 30-Month Stay Under the QI Act

By Kurt R. Karst –      

We previously reported on a citizen petition submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of DORYX (doxycycline hyclate) Delayed-Release Tablets, an old antibiotic drug, which ANDA contains a Paragraph IV certification to a patent listed in the Orange Book in accordance with § 4(b)(1) of the recently-enacted QI Program Supplemental Funding Act of 2008 (the “QI Act”).  (The "QI" stands for Qualifying Individual.) 

The petition argues that 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.  In support of this position, the petition cites QI Act § 4(a) (to be codified at FDC Act § 505(v)(4)), which states:

Notwithstanding section 125, or any other provision, of the Food and Drug Administration Modernization Act of 1997, or any other provision of law, and subject to the limitations in [new FDC Act §§ 505(v)(1)-(3)], the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 shall apply to any drug subject to [new FDC Act § 505(v)(1)] or any drug with respect to which an election is made under [new FDC Act § 505(v)(2)(A)]. [(emphasis added)]

A similar citizen petition was recently submitted to FDA on behalf of Medicis Pharmaceutical Corporation (“Medicis”) concerning SOLODYN (minocycline HCl) Extended Release Tablets, another old antibiotic drug.  According to FDA’s Paragraph IV Certification List, ANDAs containing a Paragraph IV certification to a QI Act Orange Book-listed patent have been submitted to FDA with respect to DORYX and SOLODYN, as well as to a third drug, EVOCLIN (clindamycin phosphate) Foam, 1%.  The Orange Book patent listings and Paragraph IV certifications for these three products were made in accordance with the transition provisions in § 4(b) of the QI Act and FDA’s November 2008 draft guidance document, which describes the Agency’s current thinking on the implementation of § 4(b)(1).  QI Act § 4(b) includes three transition provisions on Orange Book patent listing, certification, and 180-day exclusivity for each ANDA applicant that not later than 120 dates after enactment of the QI Act (i.e., February 5, 2009) amends a pending application to contain a Paragraph IV certification to a newly listed old antibiotic drug patent.  FDA has already approved one ANDA for a generic version of SOLODYN that qualifies for 180-day exclusivity; however, FDA did not have to resolve the 30-month stay issue because the applicant was not sued for patent infringement within the statutory 45-day period.  (In fact, the generic applicant entered into a settlement and license agreement with Medicis under which Medicis agreed not to sue for patent infringement within the statutory 45-day period.)

In addition to arguing that the original Hatch-Waxman Amendments apply, such that a 30-month stay is available if a generic applicant with an ANDA pending before October 8, 2008 (when the QI Act was enacted) amends that application to include a Paragraph IV certification to a patent listed in the Orange Book pursuant to the QI Act’s transition provisions, the Medicis petition argues that even if the MMA’s 30-month stay rules apply, then Medicis is entitled to a 30-month stay.  First, Medicis argues that ANDAs amended to contain a Paragraph IV certification pursuant to the QI Act should be treated as having been submitted after the patent information was filed.  According to Medicis, under this interpretation, the QI Act “recalculates the submission date of a covered ANDA to the first day on which the first possible application containing a Paragraph IV certification could have been submitted” so that a 30-month stay is available.  Second, Medicis argues that patents covering old antibiotics listed in the Orange Book in accordance with that transition provision at QI Act § 4(b)(1) should be treated as having been filed in the original ANDA, instead of in an amendment, thus providing for 30-month stay availability.  Medicis contends that this interpretation “strikes a fair balance . . . between innovator and generic interests by providing innovators with the opportunity for adjudication of patent infringement claims before approval of an ANDA, while achieving the MMA’s purpose of preventing multiple 30-month stays against the same ANDA.”   

It is unclear how soon FDA will respond to the two petitions or will otherwise take action on pending ANDAs affected by the petitions.  Under FDC Act § 505(q), FDA is required to respond within 180-days after receiving the petitions; however, a petition that does not raise public health issues is not supposed to delay generic drug approval.  Therefore, it is possible that if FDA internally decides that it will not grant the two petitions, the Agency could make approval decisions and later respond to the petitions.  Indeed, this is the path FDA took in early 2008, when the Agency approved ANDAs for generic CAMPTOSAR (irinotecan HCl) notwithstanding a pending citizen petition that FDA ultimately denied in July 2008.