FDA Receives a 4th Citizen Petition on QI Act and 30-Month Stay Issues; Latest Petition Concerns EVOCLIN

March 5, 2009

By Kurt R. Karst –      

Last week, we reported on the third 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 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 QI Program Supplemental Funding Act of 2008 (“QI Act”).  Now another citizen petition has been added to the mix. 

The latest petition, submitted on behalf of Stiefel Laboratories, Inc. (“Stiefel”), concerns the old antibiotic drug product EVOCLIN (clindamycin phosphate) Topical Aerosol Foam, 1%.  We previously reported that FDA’s Paragraph IV Certification List shows that an ANDA containing a Paragraph IV certification to a QI Act Orange Book-listed patent was submitted to FDA with respect to EVOCLIN.  Unlike the previously submitted citizen petitions, the Stiefel petition does not argue that the 30-month stay provisions of the original Hatch-Waxman Amendments apply, rather than the version of the statute amended by the Medicare Modernization Act (“MMA”), 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 subject to a 30-month stay in connection with that certification.  Instead, Stiefel argues that:

The February 5, 2009 first applicant date is effectively the filing date under the unusual circumstances covered by the transitional rules.  This date, and not the actual date of the ANDA submission, is the most logical date to apply for purposes of determining the application of the 30-month stay.  Under this approach, the patents timely listed for covered old antibiotic drugs will predate the constructive application date for the Paragraph IV certifications.  As a result, the 30-month stay would be available, even under the restrictions imposed by the MMA. Only this interpretation provides necessary protection to old antibiotic drug NDA holders.  The availability of the 30-month stay should not be dependant solely on the arbitrary date of enactment of the QI Act.  Any interpretation and conclusion other than the one reached above unfairly singles out holders of NDAs for old antibiotic drug products that were approved prior to enactment of the QI Act and denies them the right to the 30-month stay provision to protect their intellectual property – a right that all other NDA holders of non-antibiotic drug products currently enjoy.  Application of ordinary Waxman-Hatch analysis, including restriction of the 30-month stay because of late listed patents, is not appropriate in this case as such analysis would fail to consider the unique factual and policy considerations raised in the isolated situation of the QI Act transitional rules.

The reference to February 5, 2009 is derived from QI Act § 4(b), which 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. 

The Stiefel petition goes on to argue that “[t]here is FDA precedence for developing and implementing unique transitional provisions that interpret statutory provisions in a manner that best reflects statutory intent.”  Specifically, Stiefel cites to FDA’s October 11, 1984 guidance for industry letter in which the Agency discussed its policies for converting and prioritizing “paper NDAs” into applications submitted under FDC Act § 505(j) in light of the enactment of the Hatch-Waxman Amendments.  In that letter, FDA provided a single date for ANDA conversion filings – i.e., November 26, 1984, when the then new ANDA provisions in the FDC Act became effective. 

Categories: Hatch-Waxman