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Perrigo Research & Development Co. v. United States Food and Drug Administration

United States District Court, District of Columbia

December 1, 2017

PERRIGO RESEARCH & DEVELOPMENT COMPANY, Plaintiff,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION Defendant, and AUROBINDOPHARMALTD., et al . Intervener Defendants.

          MEMORANDUM 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 redress 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 3550). 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. §§ 355G)(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, use, or sale of the new drug for which the application is submitted.

§ 355G)(2)(A)(vii)(I)-(IV). FDA may approve an ANDA containing either of the first two certifications effective immediately, § 355(])(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(])(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 35 U.S.C. § 271(e)(2)(A), and it can trigger patent infringement litigation. The FDCA requires an ANDA applicant to notify the patent holder of the filing of a paragraph IV certification, 21 U.S.C. § 355G)(2)(B), and the patent holder has 45 days from the receipt of notice to bring suit against the applicant. § 355G)(5)(B)(iii). If the patent holder does not file a lawsuit within that time period, the ANDA will become effective immediately. Id.

         The FDCA provides an incentive and reward to generic drug applicants willing to expose themselves to the litigation risk. It grants the "first applicant" - the applicant that is first to file a substantially complete ANDA that contains and lawfully maintains a paragraph IV certification to a listed patent - an opportunity to be the only generic product in the market competing with the listed drug for a period of time. See §§ 3550)(5)(B)(iv)(II)(aa), (bb). During this 180-day period of marketing exclusivity, FDA may not approve any competing generic version of the drug if the ANDA for the subsequent applicant also contains a paragraph IV certification. See § 355G)(5)(B)(iv)(I). The 180-day period begins to run when the first applicant begins marketing the product. See id.

         But an applicant can forfeit its 180-day exclusivity period, thereby opening the market to other generic drug manufacturers. See § 3550)(5)(D). A first applicant forfeits its eligibility for 180-day generic exclusivity if it fails to market the drug within certain time periods prescribed in the statute. § 355(])(5)(D)(i)(I). Under the FDCA, a forfeiture event occurs if a first applicant fails to market the drug by the later of two dates. The parties agree that the only date relevant to this dispute is the second "bookend" date, which is defined as follows:

(bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), [1] 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 certification qualifying the first applicant for the 180-day exclusivity period ... at least 1 of the following has occurred:
(AA) In an infringement action brought against the applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.
(BB) In an infringement action or a declaratory judgment action described in subitem (AA), a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.

§ 355(j)(5)(D)(i)(I)(bb).[2]

         The specific provision at issue in this dispute is (bb)(BB), under which a first generic applicant can forfeit its 180-day exclusivity period if it fails to market the drug within 75 days of a consent decree in the second applicant's lawsuit against the patent holder.

         II. Factual Background

         On March 30, 2012, Perrigo submitted an ANDA for approval to market a generic version of AstraZeneca's Prilosec OTC Delayed-Release Tablets. Compl. ¶ 4. Perrigo's ANDA included paragraph IV certifications for both U.S. patents listed in the Orange Book[3] for AstraZeneca's drug. Id. ¶ 5. FDA approved Perrigo's ANDA on July 30, 2015, and it informed Perrigo that it was eligible for 180-day marketing exclusivity because it was the first company to file a substantially complete ANDA for the product with a paragraph IV certification. Id. ¶ 6. While more than two years have gone by, Perrigo has not yet marketed its generic omeprazole magnesium drug product. Id.¶ 7.

         On June 16, 2016, FDA granted tentative approval to a second ANDA filed by Aurobindo Pharma Limited and Aurobindo Pharma Inc. (collectively, "Aurobindo") for Omeprazole Magnesium Tablets (OTC). Compl. ¶ 8. Aurobindo's application cannot receive final approval "until the expiration of Perrigo's 180-day generic exclusivity, unless Perrigo forfeits that exclusivity." Id.

         On August 18, 2016, Aurobindo filed an action against AstraZeneca in the United States District Court for the District of New Jersey under 21 U.S.C. § 3550)(5)(C), the FDCA provision authorizing civil actions for patent certainty. See Aurobindo Pharma Ltd. v. AstraZeneca AB, No. 3:16-cv-05079 (D.N.J. Aug. 18, 2016). It sought a declaratory judgment that Aurobindo's omeprazole magnesium product does not infringe the two unexpired patents listed in the Orange Book for Prilosec OTC, or that those patents are invalid. See id; Certification of Marc D. Youngelson [Dkt. # 8] ("Youngelson Certification") ¶ 3; Ex. A to Youngelson Certification [Dkt. # 8] ("Aurobindo Compl."). In its complaint, Aurobindo specifically referenced its need to obtain a judgment that would trigger the 75-day period in which Perrigo would have to begin marketing its omeprazole magnesium AND A product to avoid forfeiture of its eligibility for 180-day exclusivity. See Aurobindo Compl. ¶¶ 34, 48, 50, 53.

         The court entered a Consent Judgment and Decree in the Aurobindo lawsuit on September 20, 2017, ...


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