Teva Pharmaceutical Industries Ltd. v. Crawford, No. 05-5004.
| Court | United States Courts of Appeals. United States Court of Appeals (District of Columbia) |
| Writing for the Court | Ginsburg |
| Citation | 410 F.3d 51 |
| Docket Number | No. 05-5004. |
| Decision Date | 03 June 2005 |
| Parties | TEVA PHARMACEUTICAL INDUSTRIES LTD. and TEVA PHARMACEUTICALS, USA, INC., Appellants v. Lester M. CRAWFORD, Jr., Acting Commissioner of Food and Drugs, et al., Appellees |
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v.
Lester M. CRAWFORD, Jr., Acting Commissioner of Food and Drugs, et al., Appellees
Appeal from the United States District Court for the District of Columbia. (No. 04cv01416).
William H. Rooney argued the cause for appellants. With him on the briefs were Theodore C. Whitehouse and James N. Czaban.
William A. Rakoczy, Christine J. Siwik, Amy D. Brody, and Lara E. Monroe-Sampson were on the brief for amicus curiae Mylan Pharmaceuticals, Inc. in support of appellants.
Jeffrey S. Bucholtz, Deputy Assistant Attorney General, U.S. Department of Justice, argued the cause for federal appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General, Eugene M. Thirolf, Director, Andrew E. Clark, Attorney, Alex M. Azar, II, General Counsel, Food & Drug Administration, and Eric M. Blumberg, Deputy Chief Counsel.
Bert W. Rein argued the cause for appellees Pfizer Inc., et al. With him on the brief were Karyn K. Ablin and Jeffrey B. Chasnow.
Before: GINSBURG, Chief Judge, and SENTELLE and ROGERS, Circuit Judges.
GINSBURG, Chief Judge.
Teva Pharmaceutical Industries has sued to overturn the Food and Drug Administration's denial of its "citizen petition" requesting that the agency prohibit Pfizer, Inc., the holder of the approved New Drug Application (NDA) for gabapentin, from marketing that drug in "generic" form during the 180-day exclusivity period provided by the Drug Price Competition
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and Patent Term Restoration Act, also known as the "Hatch-Waxman Amendments" to the Food, Drug, & Cosmetic Act. Because the exclusivity provision does not apply to the holder of an approved NDA, the district court entered a summary judgment for the FDA, which we now affirm.
Section 355(j) of 21 U.S.C. provides that a drug manufacturer may submit an "Abbreviated New Drug Application" (ANDA) for approval to market a so-called "generic" drug, which is the bioequivalent to a "branded" drug previously approved pursuant to a NDA filed under 21 U.S.C. § 355(b). Unlike a NDA, an ANDA need not contain clinical evidence of the safety or efficacy of the drug.
The ANDA must certify either that the approved product is not protected by a patent or "that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted." 21 U.S.C. § 355(j)(2)(A)(vii)(para.IV). The statute rewards the first generic applicant successfully to challenge the patent on an approved drug with a 180-day exclusivity period during which no other ANDA for the same drug may be approved. Id. at § 355(j)(5)(B)(iv).*
Teva entered into an agreement by which Purepac Pharmaceutical Co ., the first ANDA filer to challenge the patent for gabapentin, agreed to share its exclusivity period with Teva in exchange for a portion of Teva's revenues. During that period, which ends on June 6, 2005, Pfizer has marketed its own "generic" version of gabapentin, which it has priced substantially below its name-brand equivalent (Neurontin), packaged in "generic" trade dress, and distributed through many of the same channels Teva uses for its generic product. Pfizer's so-called "brand-generic" or "authorized-generic" gabapentin qualifies for "generic substitution" under state laws and third-party purchasing plans, such as HMO formularies, and thus has competed directly with Teva's product during its period of exclusivity.
Teva petitioned the FDA first simply to "prohibit the marketing and distribution of `authorized generic' versions of brand name products until after the expiration of any '180-day exclusivity period' applicable to an [ANDA] for the drug product." Teva argued in the alternative that the FDA should "require Pfizer to submit a pre-approval supplemental new drug application (sNDA) [under 21 U.S.C. § 356a(d)] before marketing or distributing any version of [a name-brand drug] changed in any way such that the product purports to be, resembles, or could be
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confused with, a generic (unbranded) version of [the drug]."
By letter of July 2, 2004 the FDA denied Teva's petition, concluding § 355(j)(5)(B)(iv) "does not contemplate or countenance delaying the marketing of authorized generics." The Agency further held "there is no statutory basis for imposing categorical approval requirements for the marketing of authorized generics, as a means to prevent their marketing during a 180-day exclusivity period applicable to the drug under an ANDA."
Teva then brought this action in the district court, which, like the Agency, concluded that "[n]othing in the statute provides any support for the argument that the FDA can prohibit NDA holders from entering the market with [an authorized] generic drug during the exclusivity period." Teva Pharm. Indus. v. FDA, 355 F.Supp.2d 111, 117 (D.D.C.2004). The court granted summary judgment for the FDA and Intervenor-defendant Pfizer, from which Teva now appeals.
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...look to what Congress enacted—specifically, the MMA provisions that reset the statutory balance. See Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 54 (D.C.Cir.2005) (“Because the balance struck between these competing goals is quintessentially a matter for legislative judgment, the cour......
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...of a statute are unambiguous ... this first canon is also the last: judicial inquiry is complete.'" Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 53 (D.C.Cir.2005) (quoting Conn. Nat'l Bank v. Germain, 503 U.S. 249, 253-54, 112 S.Ct. 1146, 117 L.Ed.2d 391 (1992)) (omissions in Unswayed ......
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...general rulemaking authority cannot be used to expand a congressionally imposed restriction, see Teva Pharm. Indus. Ltd. v. Crawford , 410 F.3d 51, 55 (D.C. Cir. 2005) ; Nat. Res. Def. Council, Inc. v. Reilly , 976 F.2d 36, 41 (D.C. Cir. 1992), and "Congress's more specific enactment contro......
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Citizens for Responsibility & Ethics in Wash. v. Fed. Election Comm'n, Civil Action No. 16-259 (BAH)
...deference is unnecessary. See SAS Inst. , 138 S.Ct. at 1358 ; Pereira , 138 S.Ct. at 2113 ; see also Teva Pharm. Indus. Ltd. v. Crawford , 410 F.3d 51, 53 (D.C. Cir. 2005) ("We do not reach step two ... if the court, ‘employing traditional tools of statutory construction, ascertains that Co......
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Apotex, Inc. v. Daiichi Sankyo, Inc., Nos. 2014–1282
...look to what Congress enacted—specifically, the MMA provisions that reset the statutory balance. See Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 54 (D.C.Cir.2005) (“Because the balance struck between these competing goals is quintessentially a matter for legislative judgment, the cour......
-
Mass. v. E.P.A., No. 03-1361.
...of a statute are unambiguous ... this first canon is also the last: judicial inquiry is complete.'" Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 53 (D.C.Cir.2005) (quoting Conn. Nat'l Bank v. Germain, 503 U.S. 249, 253-54, 112 S.Ct. 1146, 117 L.Ed.2d 391 (1992)) (omissions in Unswayed ......
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Ciox Health, LLC v. Azar, Case No. 18-cv-00040 (APM)
...general rulemaking authority cannot be used to expand a congressionally imposed restriction, see Teva Pharm. Indus. Ltd. v. Crawford , 410 F.3d 51, 55 (D.C. Cir. 2005) ; Nat. Res. Def. Council, Inc. v. Reilly , 976 F.2d 36, 41 (D.C. Cir. 1992), and "Congress's more specific enactment contro......