Hi-Tech Pharmacal Co. v. U.S. Food and Drug Admin.

• Decision Date: 10 October 2008
• Docket Number: Civil Action No. 08-01495 (JDB).
• Citation: 587 F.Supp.2d 1
• Parties: HI-TECH PHARMACAL CO., INC., Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendants, and Apotex, Inc., Intervenor-Defendant.
• Court: U.S. District Court — District of Columbia

Page 1

587 F.Supp.2d 1

HI-TECH PHARMACAL CO., INC., Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendants, and Apotex, Inc., Intervenor-Defendant.

Civil Action No. 08-01495 (JDB).

United States District Court, District of Columbia.

October 10, 2008.

COPYRIGHT MATERIAL OMITTED

James Philip Ellison, Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.

Drake S. Cutini, Department of Justice Office of Consumer Litigation, Steven Y. Bressler, U.S. Department of Justice, Washington, DC, for Defendant.

Carmen Mercedes Shepard, Kate Cumming Beardsley Buc & Beardsley, Washington, DC, for Intervenor Defendant.

MEMORANDUM OPINION

JOHN D. BATES, 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®. 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® 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.¹ 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.

BACKGROUND

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), affd, 226 Fed.Appx. 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 withdrawn by the [NDA-holder].

21 U.S.C. § 355(j)(5)(D)(i)(I).

The FDA has made very few exclusivity determinations since the Medicare Modernization Act was enacted in 2003. See Pl.'s Exs. 2 (Acarbose decision) & 4 (Granisetron decision). The FDA asserts that its general practice is to decide issues of exclusivity and forfeiture only when an ANDA is ready for final approval, and that it does so "because [there are] many factors that may influence eligibility for exclusivity up to the time an application is ready for approval (e.g., patent expiration, patent delisting, failure to obtain tentative approval within 30 months, withdrawal of ANDA) and could thus render a premature eligibility determination incorrect." Pl.'s Ex. 2 at 1 n. 1; see also Def.'s Opp'n & Mot. Dismiss ("Def.'s Opp'n") at 6.

II. Factual Background

Hi-Tech submitted an ANDA to the FDA in August 2005, seeking approval to market a generic version of COSOPT®, an ophthalmic drug product used to treat glaucoma, which is marketed by Merck & Co., Inc. See Compl. ¶ 7. Hi-Tech's ANDA contained a paragraph IV certification challenging the validity of three patents listed in the Orange Book covering CSOPT®: U.S. Patent Nos. 4,797,413 ("the '413 patent"), 6,248,735 ("the '735 patent"), and 6,316,443 ("the '443 patent"). See Pl.'s Mot. Prelim. Inj. ("Pl.'s Mot.") at 11. The FDA "received" Hi-Tech's ANDA on October 11, 2005.² Id. at 11-12.

In early December 2005, Hi-Tech sent the required notice to Merck challenging the validity of the three listed patents that cover COSOPT®. See id. at 12; 21 U.S.C. § 355(j)(2)(B). In response, Merck elected to bring a suit for infringement against Hi-Tech on only one of the patents—the '413 patent. The validity and enforceability of the '413 patent was ultimately upheld by the United States Court of Appeals for the Federal Circuit. See Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317 (Fed.Cir.2007). As a result, final approval of Hi-Tech's ANDA was enjoined until October 28, 2008, when the '413 patent and its related period of pediatric exclusivity expire. See Pl.'s Mot. at 12. Hi-Tech received tentative approval of its ANDA from the FDA on April 10, 2008. See id.; Pl.'s Ex. 5.

Merck elected not to sue Hi-Tech for infringement with regard to either the '735 or '443 patents.³ Instead, on April 18, 2006, Merck disclaimed its interests in the '735 and the '443 patents. See McIntire Decl., Ex. A. Just days later, on April 26, 2006, Merck requested the FDA to delist the '735 and '443 patents from the Orange Book. See McIntire Decl., Ex. C. On December 18, 2006, Merck sent a second letter to the FDA requesting that the patents be delisted. See McIntire Decl., Ex. E. Merck's delisting...