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ViroPharma, Inc. v. Hamburg

United States District Court, District of Columbia

January 9, 2013

VIROPHARMA, INC., Plaintiff,
v.
Margaret A. HAMBURG, M.D., in her official capacity as Commissioner, Food and Drug Administration, et al., Defendants, and Akorn, Inc., et al., Intervenor-Defendants.

Christian G. Vergonis, Jacob M. Roth, Rosanna K. McCalips, Thomas F. Cullen, Jr., Jones Day, Matthew David Peterson, Peterson Wil Marth and Robertson, LLP, Washington, DC, for Plaintiff.

Page 77

Andrew E. Clark, U.S. Department of Justice, Washington, DC, for Defendants.

John Robert Fleder, Jennifer McVey Thomas, Hyman, Phelps & McNamara, PC Washington, DC, for Intervenor-Defendant, Akorn, Incorporated.

Chad A. Landmon, Axinn, Veltrop & Harkrider LLP, Washington, DC, for Intervenor-Defendants, Akorn, Incorporated, Alvogen, Inc., and Watson Laboratories, Inc.

Elizabeth Pesses Retersdorf, Axinn, Veltrop & Harkrider LLP, Hartford, CT, Evan S. Storm, Nicholas E.O. Gaglio, Suchira Ghosh, Axinn, Veltrop & Harkrider LLP, New York, NY, for Intervenor-Defendant, Alvogen, Inc.

Edward Anthony Figg, Glenn E. Karta, Sharon Lynch Davis, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC, for Intervenor-Defendant, Watson Laboratories, Inc.

MEMORANDUM OPINION

ELLEN SEGAL HUVELLE, District Judge.

ViroPharma, Inc. manufactures the antibiotic Vancocin® . On April 13, 2012, ViroPharma sued Margaret Hamburg, in her official capacity as the Commissioner of the Food and Drug Administration; Kathleen Sebelius, in her official capacity as the Secretary of the Department of Health and Human Services; and the agencies themselves (collectively, the " FDA" ) to challenge the FDA's approval, on April 9, 2012, of three Abbreviated New Drug Applications (" ANDAs" ) permitting the marketing of generic versions of Vancocin (vancomycin hydrochloride capsules or " vancomycin" ). ( See Complaint (Apr. 13, 2012) [ECF No. 1] (" Compl." ).) ViroPharma alleges that the FDA approved the three ANDAs (1) in violation of ViroPharma's statutory right under the Federal Food, Drug, and Cosmetic Act (" FFDCA" ), 21 U.S.C. §§ 301 et seq., to a three-year period of exclusivity for Vancocin, extending through December 15, 2014; and (2) based solely on in vitro (laboratory) bioequivalence testing in violation of the FDA's own regulations requiring in vivo (human) bioequivalence testing. ( Id. ¶ 2.) The Court will refer to these as ViroPharma's " statutory exclusivity claim" ( see id. ¶¶ 75-78 (Count II)) and its " bioequivalence claim." ( See id. ¶¶ 69-74 (Count I).) The three generic manufacturers whose vancomycin ANDAs were approved— Akorn, Inc., Alvogen, Inc., and Watson Laboratories, Inc.— have also joined the suit as intervenor-defendants.

On April 23, 2012, this Court denied ViroPharma's motion for a preliminary injunction to require the FDA to withdraw its approval of the three vancomycin ANDAs and to refuse to approve any additional vancomycin ANDAs until ViroPharma's claims were adjudicated on the merits. See ViroPharma, Inc. v. Hamburg, 898 F.Supp.2d 1, No. 12-584, 2012 WL 1388183 (D.D.C. Apr. 23, 2012) (" Memorandum Opinion" ). Now seeking adjudication on the merits, ViroPharma has filed a motion for summary judgment ( see Plaintiff's Motion for Summary Judgment (July 20, 2012) [ECF No. 51] (" Pl. Mot." )), urging the Court to reconsider its arguments " with the benefit of the additional elaboration herein and additional time to consider the law and arguments." ( Id. at 10.) Defendants have also filed a motion to dismiss, or, in the alternative, for summary judgment ( see Federal Defendants' Motion to Dismiss or, in the Alternative, for Summary Judgment (Sept. 4, 2012) [ECF No. 53] (" Def. Mot." )), and intervenor-defendants have likewise filed a motion to dismiss, or, in the alternative, for summary judgment. ( See Intervenor-Defendants' Motion to Dismiss, or, in the Alternative,

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for Summary Judgment (Sept. 4, 2012) [ECF No. 56] (" Inter.-Def. Mot." ).)

ViroPharma is correct that a court's determinations regarding a motion for preliminary relief are not considered to be the law of the case. ( See Pl. Mot. at 9 (quoting Belbacha v. Bush, 520 F.3d 452, 458 (D.C.Cir.2008) and citing Kuzinich v. Cnty. of Santa Clara, 689 F.2d 1345, 1350-51 (9th Cir.1982) and Nat'l Football League Players Ass'n v. Pro-Football, Inc., 857 F.Supp. 71, 79 (D.D.C.1994).)) However, nothing 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" (Pl. Mot. at 10), 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. ( See, e.g., Memo from Lorenz re: Consult Response on ViroPharma December 22, 2011 Submission (Apr. 9, 2012), Part H to Joint Appendix, FDA004629-4637 (outlining reasons that data from ...


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