By Kurt R. Karst –
In a decision handed down last week by Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia, the court may have finally put an end to ViroPharma Inc.’s (“ViroPharma’s”) litigation over FDA’s approval of generic versions of the company’s antibiotic drug VANCOCIN (vancomycin HCl) Capsules (approved under NDA No. 050606). In denying ViroPharma’s Motion for Summary Judgment and granting FDA’s Cross-Motion for Summary Judgment as well as Intervenor-Defendants’ Cross Motion for Summary Judgment (one of which – Akorn, Inc. – was represented by Hyman, Phelps & McNamara P.C.) (reply briefs here, here, and here), Judge Huvelle upheld FDA’s decision not to grant a period of 3-year Hatch-Waxman exclusivity in connection with the Agency’s approval of a December 2011 supplemental NDA because of the limitation on such exclusivity for a so-called “old antibiotic” like vancomycin set forth in FDC Act § 505(v) as added by Section 4 of the 2008 QI Act. Judge Huvelle also affirmed FDA’s decision to approve generic VANCOCIN based on in vitro dissolution data demonstrating bioequivalence. Both issues were addressed by FDA in an April 9, 2012 response to a March 17, 2006 petition for stay of action submitted by ViroPharma (Docket No. FDA-2006-P-0007).
As we previously reported, ViroPharma sued FDA on April 13, 2012 after the Agency approved generic VANCOCIN. (That lawsuit was preceded by other lawsuits related to VANCOCIN – see here and here.) In an April 23, 2012 decision, Judge Huvelle denied ViroPharma’s Motion for a Preliminary Injunction after having determined that the company had not demonstrated a likelihood of success on the merits of either its exclusivity claim or its bioequivalence claim. Nevertheless, ViroPharma pressed ahead for a decision on the merits of its claims against FDA and urged the court in its Motion for Summary Judgment to reconsider its arguments “with the benefit of the additional elaboration herein and additional time to consider the law and arguments.” Judge Huvelle, despite the “additional elaboration” and “additional time,” refused to change her mind and stated:
[N]othing in the parties’ submissions convinces the Court to reach a different conclusion today. ViroPharma all but admits that it has presented no substantially new arguments, but rather it relies on “additional elaboration,” none of which persuades the Court to reverse itself. Moreover, no new facts have been presented that would dictate a different result. Although the parties have submitted additional excerpts from the administrative record, which the Court has reviewed, these submissions do not alter the Court’s judgment. To the extent that any portion of the supplemented record affects the Court’s opinion, it serves only to bolster it. Therefore, the Court incorporates by reference the conclusions that it reached in its prior Memorandum Opinion, and will limit its discussion to the few additional points that are arguably being raised for the first time. [(Internal citations omitted)]
With respect to the December 2011 labeling changes that ViroPharma alleged supported an FDA decision to award 3-year exclusivity, FDA had ruled (in the Agency’s petition decision and in a memorandum prepared by FDA’s CDER Exclusivity Board) that the labeling changes merely “related to and refined the already-approved indication for treatment of [Clostridium difficile], and included a dosing regimen that was encompassed within, and at most refined, the prior regimen,” and therefore, precluded a grant of exclusivity pursuant to FDA Act § 505(v)(3)(B). In addition to “rehashing the same arguments that the Court has already rejected,” ViroPharma suggested in the company’s Motion for Summary Judgment that “[i]f the labeling changes approved in the Vancocin sNDA constituted previously approved conditions of use, then the structure of innovator drug regulation under the FDCA would be seriously compromised,” because “manufacturers could make labeling changes without prior FDA approval because the changes would be considered ‘previously approved.’” Judge Huvelle did not bite:
ViroPharma seriously misconstrues the FDA’s position. The FDA does not claim that the labeling changes were “previously approved.” Rather, “the conditions of use for the drug – how, to whom, and for what purpose the drug is administered – were previously approved.” The FDA has been very clear, from its response to ViroPharma’s Citizen Petition through its briefing of the present motions, that it considered the new Vancocin labeling to have “merely refined and added new details to describe the previously approved conditions of use.” The FDA has used the same definition of “condition of use” in applying subsection (v)(3)(B) that it has used in applying other subsections of the statute, such as subsection (j)(2)(A)(i), which requires ANDAs to have the same conditions of use as the innovator.
As the Court explained at length in its prior Memorandum Opinion, the agency acted within its discretion to determine that “the revision of the Vancocin label to incorporate clinical data that supports and refines labeling regarding already approved conditions of use, does not constitute approval for a condition of use that has not been ‘approved before the enactment’ within the meaning of section 505(v)(3)(B).” The Court reaffirms this conclusion here, especially given the “high level of deference” accorded to the agency where the agency’s decision “involve[s] a subject matter [that] is technical, complex, and dynamic,” and “rests on the ‘agency’s evaluations of scientific data within its area of expertise.’” [(Internal citations omitted; italics in original)]
After reviewing certain portions of the administrative record, Judge Huvelle also noted that the studies supporting the approval of ViroPharma’s December 2011 Supplemental NDA approval – and the studies upon which ViroPharma staked its claim to 3-year exclusivity – were not essential to the approval of the Supplemental NDA. The “essential to approval” criterion is one of the three criteria that must be met for FDA to grant 3-year exclusivity.
Similar to ViroPharma’s challenge to FDA’s exclusivity decision, Judge Huvelle found with respect to ViroPharma’s allegation that FDA violated its own regulations when the Agency approved generic VANCOCIN based on in vitro rather than in vivo bioequivalence testing data because FDA’s regulations establish an in vivo testing default requirement, that ViroPharma “[failed] to present any new arguments or facts to support its bioequivalence claim[, but rather,] has merely added two additional examples to support its previously articulated argument, neither of which compels a different result.” Specifically, ViroPharma alleged that certain changes to FDA’s ANDA bioequivalence regulations at 21 C.F.R. Part 320 served to “expressly relinquish” the Agency’s authority under the FDC Act to determine on a case-by-case basis the appropriate method for demonstrating bioequivalence to a brand-name Reference Listed Drug. Not so, wrote Judge Huvelle, who found no express relinquishment of statutory authority and stated her satisfaction that FDA did not abuse its authority in waiving a showing of in vivo bioequivalence to approve generic VANCOCIN.
In sum, wrote Judge Huvelle, “[g]iven the absence of changed facts or new legal arguments or authority, the Court’s judgment remains the same: the FDA acted well within its discretion in denying three-year exclusivity to ViroPharma and in approving the ANDAs of intervenor-defendants.”
For those Hatch-Waxman watchers, we note that the ViroPharma case is one of two recent cases involving 3-year exclusivity. Currently on appeal to the U.S. Court of Appeals for the District of Columbia Circuit is the DC District Court’s July 2012 decision (see our previous post here) concerning the scope of 3-year exclusivity applicable to SEROQUEL (quetiapine fumarate). One particularly enlightening document that has come out of that litigation is FDA’s March 27, 2012 letter decision, which lays out the Agency’s approach to 3-year exclusivity. The letter decision discusses the scope of 3-year exclusivity as it relates to the scope of new clinical investigations conducted by the NDA sponsor. According to FDA, the FDC Act sets up a “logical relationship between the change in the product for which the new clinical investigations were essential to approval of the supplement, and the scope of any resulting three-year exclusivity.” Oral argument in the SEROQUEL case (Case No. 12-5227) is scheduled for March 21, 2013. Copies of FDA’s Opening Brief and AstraZeneca’s Opening Brief and Reply Brief are available here, here, and here.