The opinion of the court was delivered by: Rosemary M. Collyer United States District Judge
Actavis Elizabeth LLC seeks judicial review of a decision of the United States Food and Drug Administration awarding five years of market exclusivity to Intervenor-Defendant Shire Pharmaceuticals Inc. for the manufacture of lisdexamfetamine dimesylate ("LDX"), currently marketed by Shire's subsidiary in the United States under the trade name Vyvanse(r). Actavis disagrees with the agency's conclusion that LDX is a "new chemical entity" within the meaning of the Federal Food, Drug, and Cosmetic Act ("Act"), 21 U.S.C. § 301 et seq., as amended. Actavis, FDA, and Shire each moves for summary judgment.*fn1 For the reasons explained herein, the Court will grant summary judgment to FDA and Shire, and will deny summary judgment to Actavis.
On February 23, 2007, FDA approved Shire's new drug application for LDX to treat Attention Deficit Hyperactivity Disorder. FDA awarded Shire five years of market exclusivity pursuant to § 355(j)(5)(F)(ii) of the Act and FDA's interpreting regulations, 21 C.F.R. § 314.108. FDA determined that LDX is a "new chemical entity" within the meaning of the Act because LDX contains a previously approved molecule with a covalent, non-ester amide derivative.*fn2 With certain limited exceptions, FDA's determination precludes it from accepting abbreviated new drug applications for generic versions of LDX for five years following February 23, 2007, that is, until February 23, 2012.
On January 29, 2009, Actavis submitted an abbreviated new drug application for a generic version of LDX. FDA declined receipt of Actavis's application on February 6, 2009, based on its grant of five years of market exclusivity to Shire. That same day, Actavis submitted a position paper to FDA arguing that the agency should reconsider its decision that LDX is a "new chemical entity." On February 24, 2009, Actavis filed this lawsuit alleging that FDA had erroneously determined that LDX is a "new chemical entity" and that FDA should not have refused its application for a generic version of LDX.
FDA determined that the issues raised by Actavis should be considered administratively and opened a public docket on April 13, 2009, to receive comments from interested parties on the relevant legal and regulatory issues. On October 23, 2009, FDA issued a final decision affirming its original determination to grant Shire five years of market exclusivity. FDA concluded that the LDX molecule in Vyvanse(r) was a "new chemical entity" because:
Lisdexamfetamine consists of dextroamphetamine bonded covalently to lysine through an amide bond. Lisdexamfetamine is a prodrug that is metabolically converted to produce dextroamphetamine, which is responsible for the drug's activity. Under FDA's regulation at 21 CFR § 314.108, a non-ester covalently bonded molecule is considered the active moiety of a drug and, if not previously approved, it will be considered a new chemical entity entitled to 5 years of exclusivity. A non-ester that requires metabolic conversion to produce a previously approved active moiety is considered a new chemical entity. Because lisdexamfetamine is a non-ester covalently bonded molecule, and because it requires metabolic conversion to produce dextroamphetamine, lisdexamfetamine is a new chemical entity and is thus entitled to 5 years of exclusivity.
On October 6, 2009, Actavis amended its complaint to challenge FDA's October 23, 2009, final decision. All parties move for summary judgment. Oral argument on the motions was held on February 17, 2010.
Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment must be granted when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). Moreover, summary judgment is properly granted against a party who "after adequate time for discovery and upon motion . . . fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986).
In ruling on a motion for summary judgment, the court must draw all justifiable inferences in the nonmoving party's favor and accept the nonmoving party's evidence as true. Anderson, 477 U.S. at 255. A nonmoving party, however, must establish more than "the mere existence of a scintilla of evidence" in support of its position. Id. at 252. In addition, the nonmoving party may not rely solely on allegations or conclusory statements. Greene v. Dalton, 164 F.3d 671, 675 (D.C. Cir. 1999). Rather, the nonmoving party must present specific facts that would enable a reasonable jury to find in its favor. Id. at 675. ...