Perrigo Research & Dev. Co. v. U.S. Food & Drug Admin.

290 F. Supp. 3d 51
CourtCourt of Appeals for the D.C. Circuit
DecidedDecember 1, 2017
DocketCivil Action No. 17–2517 (ABJ)
StatusPublished
Cited by2 cases

This text of 290 F. Supp. 3d 51 (Perrigo Research & Dev. Co. v. U.S. Food & Drug Admin.) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Perrigo Research & Dev. Co. v. U.S. Food & Drug Admin., 290 F. Supp. 3d 51 (D.C. Cir. 2017).

Opinion

AMY BERMAN JACKSON, United States District Judge

Plaintiff Perrigo Research & Development Company ("Perrigo") brings this action against defendant United States Food and Drug Administration ("FDA") under the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 501 - 706, the Food, Drug & Cosmetic Act ("FDCA"), 21 U.S.C. § 301, et seq. , and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 - 02. It seeks *55redress for FDA's refusal to answer Perrigo's request to confirm that a Consent Judgment and Decree entered on September 20, 2017 is legally insufficient to trigger the running of a 75-day period during which Perrigo must begin marketing its product or risk forfeiting its eligibility for a 180-day period of generic drug marketing exclusivity. See Compl. [Dkt. # 1] ¶¶ 2-3. Perrigo claims in Count I that the FDA has violated the APA by "fail[ing] to act," and that therefore, this Court should step in and rule on the question Perrigo posed to the agency. Id. ¶¶ 32-34. In Count II, it asks the Court to enter a declaratory judgment stating that the Consent Judgment and Decree did not trigger the 75-day period under the statute. Id. ¶ 37.

Because Perrigo has failed to allege a violation of the APA, defendant's motion to dismiss Count I will be granted. And without a viable claim under the APA and in the absence of a case or controversy, the Court lacks subject matter jurisdiction to issue a declaratory judgment under Count II, so that count will also be dismissed.

BACKGROUND

I. Statutory Background

The FDCA requires all new drugs to be approved by the FDA before they are introduced into interstate commerce. 21 U.S.C. § 355(a). It provides two primary pathways for obtaining approval: (1) the new drug application ("NDA"), described in section 355(b) ; and (2) the abbreviated new drug application ("ANDA") for generic products, set forth in section 355(j). The NDA procedure requires the applicant to conduct a spectrum of safety and effectiveness tests and to inform FDA of the results. See 21 U.S.C. § 355(b)(1). It also requires the applicant to file information about any patents filed in connection with the drug. See id. Once the drug is approved, it is referred to as a "listed drug." See 21 C.F.R. § 314.3(b).

Congress added the truncated ANDA approval process to the FDCA as part of the 1984 Hatch-Waxman amendments, which sought "to make available more low cost generic drugs" by providing a pathway that was less costly and time consuming than the NDA process. Serono Labs., Inc. v. Shalala , 158 F.3d 1313, 1316 (D.C. Cir. 1998), quoting H.R. Rep. No. 98-857, pt. 1, at 14 (1984). A drug manufacturer that follows the ANDA pathway may rely on research conducted by a third party-the maker of the listed drug-in order to meet the approval requirements. See 21 U.S.C. §§ 355(b)(2), j(2)(A). ANDA applicants must file information showing that the conditions of use, active ingredient, route of administration, dosage form, strength, and labeling of the generic drug are "the same as" those of the listed drug that was previously approved. 21 U.S.C. §§ 355(j)(2)(A)(i)-(iii), (v). They are thereby relieved of the obligation to perform the extensive testing to demonstrate safety and effectiveness that is the hallmark of the NDA process. See § 355(b)(1)(A).

To protect the patent rights of the makers of the listed drugs, ANDA applicants must provide one of four "certifications" for "each patent which claims the listed drug ... or which claims a use for such listed drug for which the application is seeking approval." § 355(j)(2)(A)(vii) ; see also Andrx Pharms., Inc. v. Biovail Corp. Int'l , 256 F.3d 799, 802 (D.C. Cir. 2001). Thus, for each relevant patent, ANDA applicants must certify either:

(I) that such patent information has not been filed,
(II) that such patent has expired,
(III) of the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the manufacture, *56use, or sale of the new drug for which the application is submitted.

§ 355(j)(2)(A)(vii)(I)-(IV). FDA may approve an ANDA containing either of the first two certifications effective immediately, § 355(j)(5)(B)(i), and it may approve an ANDA containing the third type of certification to be effective as of the relevant patent's expiration date. § 355(j)(5)(B)(ii). But the filing of the fourth type of certification-referred to as a "paragraph IV certification"-is an act of patent infringement on the part of the ANDA applicant, see

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290 F. Supp. 3d 51, Counsel Stack Legal Research, https://law.counselstack.com/opinion/perrigo-research-dev-co-v-us-food-drug-admin-cadc-2017.