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Hi-Tech Pharmacal Co., Inc. v. United States Food and Drug Administration

October 10, 2008


The opinion of the court was delivered by: John D. Bates United States District Judge


Plaintiff Hi-Tech Pharmacal Co., Inc. ("Hi-Tech") brings this action pursuant to the Administrative Procedures Act ("APA") asserting a statutory right under the Drug Price Competition and Patent Term Restoration Act of 1984 (known as the "Hatch-Waxman Act"), as amended by the Medicare Modernization Act of 2003, to a 180-day period of marketing exclusivity for the generic version of the branded drug COSOPT(r). Currently before the Court is Hi-Tech's motion for a preliminary injunction to prevent defendant Food and Drug Administration ("FDA") from granting final marketing approval to intervenor-defendant Apotex, Inc., or any other drug manufacturer, for a generic version of COSOPT(r) while Hi-Tech enjoys marketing exclusivity. In response, the FDA has filed a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(1) and 12(b)(6), arguing that Hi-Tech's claims are not ripe for judicial review and that Hi-Tech has failed to state a claim upon which relief can be granted.*fn1 Upon careful consideration of the motions, the parties' several memoranda, the arguments advanced at the motions hearing held on October 2, 2008, the applicable law, and the entire record, the Court will deny Hi-Tech's motion for a preliminary injunction.


I. Statutory and Regulatory Framework

In order to market an original pharmaceutical product, a company must file a New Drug Application ("NDA") with the FDA, providing technical information regarding the drug's composition, clinical trial results as to safety and effectiveness, the method of manufacture, and proposed labeling for the drug's use. See 21 U.S.C. § 355(b)(1). The FDA must approve the NDA, and the applicant must also submit information concerning patents that "claim[ ] the drug . . . or which claim[ ] a method of using such drug . . . ." 21 U.S.C. §§ 355(b)(1), (c)(2). The FDA then "lists" this information, once approved, in a publication called "Approved Drug Products With Therapeutic Equivalence Evaluations" (also known as "the Orange Book"). See 21 U.S.C. § 355(c)(2); 21 C.F.R. § 314.53(a).

The Hatch-Waxman Act, codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, 282, as amended by the Medicare Modernization Act, Pub. L. No. 108-173, §§ 1101-23, 117 Stat. 2066 (2003), codified at 21 U.S.C. § 355 and 35 U.S.C. § 271, governs the marketing of generic versions of drugs that are covered by pre-existing NDAs. See 21 U.S.C. § 355(j). The generic pharmaceutical company must submit an Abbreviated New Drug Application ("ANDA"), which is a truncated version of the original NDA, enabling the generic applicant to avoid the considerable expense of repeating the detailed clinical studies originally conducted in connection with the NDA. See Dr. Reddy's Labs., Inc. v. Thompson, 302 F. Supp. 2d 340, 343 (D.N.J. 2003). The ANDA must include one of four certifications as to each patent that is listed in the Orange Book in connection with the NDA-product. See 21 U.S.C. § 355(j)(2)(A)(vii). The four available certifications state that: (1) there is no patent information; (2) the listed patent has expired; (3) the ANDA-applicant will not market its generic drug until the listed patent expires ("paragraph III certification"); or (4) the listed patent is invalid and/or will not be infringed by the ANDA-drug ("paragraph IV certification"). See 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV).

An ANDA-applicant seeking to market its drug before the NDA-drug's patent has expired must make a paragraph IV certification with respect to the relevant listed patents (i.e., the patents that claim the NDA-drug and are listed in the Orange Book). See 21 U.S.C. § 355(j)(2)(B). An ANDA-applicant must also give notice of its paragraph IV certification to the NDA-holder and the patent owner, including a description of the legal and factual basis for the assertion that the patent is invalid or not infringed. See id. Under the law, as soon as an ANDA-applicant makes a paragraph IV certification as to a patent that claims the NDA-drug, the ANDA-applicant has infringed that patent, and the NDA-holder may immediately sue the ANDA-applicant for infringement. See 35 U.S.C. § 271(e)(2)(A).

As an incentive for generic pharmaceutical companies to undertake the risk of litigation and further the statutory purpose of accelerating public access to lower-cost drugs, the first ANDA-applicant that files a paragraph IV certification is entitled to a 180-day period of generic marketing exclusivity. See 21 U.S.C. § 355 (j)(5)(B)(iv). During this 180-day exclusivity period, no other generic competition is permitted. Id. The 180-day exclusivity period is a highly-coveted and lucrative benefit, as evidenced by the recurrence of litigation regarding the entitlement to it. See, e.g., Apotex Inc. v. FDA, 414 F. Supp. 2d 61 (D.D.C. 2006), aff'd, 226 F. App'x 4 (D.C. Cir. 2007); Teva Pharms. v. FDA, 355 F. Supp. 2d 111 (D.D.C. 2004), aff'd, 410 F.3d 51 (D.C. Cir. 2005); TorPharm, Inc. v. Thompson, 260 F. Supp. 2d 69 (D.D.C. 2003), aff'd, 354 F.3d 877 (D.C. Cir. 2004).

Entitlement to the 180-day exclusivity period can be forfeited, however, if a first ANDA-applicant fails to market the drug within a specified time period. See 21 U.S.C. § 355(j)(5)(D). Congress enacted the forfeiture provisions to "ensure that the 180-day exclusivity period enjoyed by the first generic to challenge a patent cannot be used as a bottleneck to prevent additional generic competition." 149 Cong. Rec. S15746 (daily ed. Nov. 24, 2003) (statement of Sen. Schumer). Thus, a first ANDA-applicant must go to market in a timely manner or risk forfeiting its entitlement to exclusivity by virtue of a "failure to market," as defined under the statute. Id. In pertinent part, the statute provides that the first applicant fails to market the generic drug by the later of--

(aa) the earlier of the date that is--

(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or

(BB) 30 months after the date of submission of the application of the first applicant; or

(bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a [paragraph IV] certification qualifying the first applicant for the 180-day exclusivity period [ ], at least 1 of the following has occurred:

(CC) The patent information submitted under subsection (b) or (c) of this section is ...

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