FDA Denies Galderma Petition on QI Act 30-Month Stay Issue

November 20, 2009

By Kurt R. Karst –

In June, we reported on a citizen petition Galderma Laboratories L.P. (“Galderma”) submitted to FDA requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval on an ANDA referencing the old antibiotic drug product ORACEA (doxycycline) 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.  The QI Act amended the FDC Act to add § 505(v) to create Hatch-Waxman benefits for “old” antibiotics.  FDA previously denied several petitions (see our previous post here) that argued a 30-month stay should apply.

Galderma states that its citizen petition is “entirely distinguishable” from the previous QI Act 30-month stay citizen petitions submitted to FDA: “Unlike prior petitioners, Galderma does not contend that Congress, via the QI Act, directed FDA to apply the applicable statutory provisions of the original Hatch-Waxman Amendments as enacted in 1984, rather than as subsequently amended by Congress.”  Furthermore, Galderma states that the company “agrees with FDA’s Denial Letter that ‘it is reasonable, both as a matter of statutory construction and sound public policy, to interpret section 505(v)(4) [of the QI Act] to require the application of the current law to old antibiotics . . . there is a strong argument that Congress intended this result.’” 

Indeed, according to Galderma, “this is precisely Galderma’s position – that Congress clearly intended to treat ‘old antibiotics’ consistent with ‘new antibiotics’ pursuant to current law, and that a single 30-month stay should apply to both classes of products.”  Galderma summarizes its argument as follows:

[N]o previous petitioner argued, as this petitioner does, that the intent of Congress, embodied in the terms of the transition provisions of the QI Act, was to grant the opportunity to obtain both a single 30-month stay of ANDA approval and 180-day generic exclusivity to the holders of NDAs and ANDAs covered by the Q1 Act.  Although FDA addressed certain issues related to this petition in its recent Denial Letter, FDA has not directly addressed the issues raised herein as applicable to ORACEA.

Earlier this month, FDA denied Galderma’s petition.  FDA’s response indicates that the Agency did not, in fact, consider Galderma’s arguments to be “entirely distinguishable” from those raised in the previous QI Act 30-month stay petitions:

There is no evidence that Congress intended to link the QI Act’s 60-day transitional requirement for patent submissions to the availability of a 30-month stay. . . .  After consideration of the Petitioner’s arguments, comments thereto, statutory language, and legislative history associated with the development of antibiotic regulation, the Agency has concluded that the transition provisions of the QI Act do not impose a 30-month stay of approval on an ANDA as to which the NDA holder or patent owner has initiated patent litigation as a result of the ANDA applicant’s notice of paragraph IV certification, when the ANDA was pending with FDA at the time the patent claiming the old antibiotic drug was submitted to the Agency for listing. 

Now that FDA has responded to 5 citizen petitions concerning QI Act 30-month stay issues, the issue has presumably been put to rest.  Other QI Act implementation issues remain, however, including those raised in a January 2009 letter from the American Intellectual Property Law Association to FDA.

Categories: Hatch-Waxman