Amneal Pharm. LLC v. Food & Drug Admin.

• Decision Date: 23 January 2018
• Docket Number: Civil Action No. 17–18(RDM)
• Citation: 285 F.Supp.3d 328
• Court: U.S. District Court — District of Columbia
• Parties: AMNEAL PHARMACEUTICALS LLC, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants, and Lupin Pharmaceuticals, Inc., et al., Intervenor–Defendants.

285 F.Supp.3d 328

AMNEAL PHARMACEUTICALS LLC, Plaintiff,

v. FOOD AND DRUG ADMINISTRATION, et al., Defendants,andLupin Pharmaceuticals, Inc., et al., Intervenor–Defendants.

Civil Action No. 17–18(RDM)

United States District Court, District of Columbia.

Signed January 23, 2018

Filed January 24, 2018

Dean Richlin, Pro Hac Vice, Marco J. Quina, Pro Hac Vice, Foley Hoag, LLP, Boston, MA, Areta L. Kupchyk, Foley Hoag LLP, Washington, DC, for Plaintiff.

James William Harlow, Kathleen M. Konopka, U.S. Department of Justice, Washington, DC, for Defendant.

William M. Jay, Brian Burgess, Joshua James Bone, Prescott Moore Lassman, Sarah K. Frederick, Goodwin Procter, LLP, Janine A. Carlan, Richard Jason Berman, Taniel Ermano Anderson, Arent Fox, LLP, Washington, DC, for Intervenor–Defendant.

MEMORANDUM OPINION

RANDOLPH D. MOSS, United States District Judge

The Federal Food, Drug, and Cosmetic Act ("FDCA"), as amended by the Drug Price Competition and Patent Restoration Act of 1984 ("Hatch–Waxman Act") and the Medicare Prescription Drug Improvement and Modernization Act of 2003 ("Medicare Modernization Act"), grants 180 days of market exclusivity to the first generic manufacturer to file an abbreviated new drug application ("ANDA") that challenges a patent covering the brand-name version of the drug. But that right is not absolute and is subject to various statutorily defined "forfeiture events." As relevant here, an applicant who fails "to obtain tentative approval of [its ANDA] within 30 months after the date on which the [ANDA] is filed" forfeits its right to the 180 days of market exclusivity, "unless th[at] failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed." 21 U.S.C. § 355(j)(5)(D)(i)(IV).

The plaintiff in this case, Amneal Pharmaceuticals LLC ("Amneal"), was the first manufacturer to file an ANDA to market a generic version of Namenda

XR (memantine hydrochloride extended release capsules), and its ANDA challenged a patent held by the manufacturer of the brand-name version of the drug. Amneal did not, however, obtain tentative approval for its ANDA within the 30–month window. As a result, Amneal's eligibility for the 180 days of generic market exclusivity turns on whether its failure to obtain timely approval was "caused by a change in or a review of the requirements for approval of the" ANDA. In proceedings before the Food and Drug Administration ("FDA"), Amneal argued (1) that the delay was caused by the FDA's demand for data from a commercial-scale batch of the drug and (2) that this demand constituted a change in a requirement for approval of the ANDA. The FDA disagreed on both counts. Amneal, in response, brought the present action pursuant to the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 701 et seq. , challenging the FDA's decision.

The case is now before the Court on Amneal's motions for summary judgment, Dkt. 25, and for a preliminary injunction or, in the alternative, a temporary restraining order, Dkt. 62, and the cross-motions for summary judgment filed by the FDA, Dkt. 34, and intervenor-defendant Lupin Pharmaceuticals ("Lupin"), Dkt. 30. Although Amneal raises a host of other issues, the heart of the dispute is whether the FDA's request that Amneal supplement its ANDA with data from a commercial-scale batch, as opposed to data from the pilot-scale batches that Amneal originally submitted, constituted a "change in ... the requirements for approval of" Amneal's ANDA—or, more precisely, whether the FDA's decision that the request did not was contrary to law or otherwise unreasonable. As explained below, the Court concludes that the FDA acted within its authority and reasonably in rejecting Amneal's claim to market exclusivity. The Court will, accordingly, deny Amneal's motion for summary judgment, Dkt. 25, and will grant the FDA's and Lupin's cross-motions for summary judgment, Dkt. 30; Dkt. 34. Moreover, having resolved the case on the merits, the Court will deny Amneal's motion for a preliminary injunction or, the alternative, a temporary restraining order, Dkt. 62, as moot.

I. BACKGROUND

A. Statutory and Regulatory Background

To obtain approval to market a new drug, the innovator-manufacturer must submit a new drug application ("NDA") to the FDA that contains extensive information and data, including "full reports of investigations which have been made to show" that the new drug is safe and effective, "a full statement of the composition" of the new drug, "a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packaging" of the new drug, and proposed labeling for the new drug. 21 U.S.C. § 355(b)(1). In addition, the NDA must include "the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the [NDA] or which claims a method of using [the new] drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug."Id. The FDA then lists this patent information in the "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations" or, as it is commonly known, simply the "Orange Book."¹ See also Mylan Labs. Ltd. v. FDA , 910 F.Supp.2d 299, 301 (D.D.C. 2012).

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98–417, 98 Stat. 1585 (1984), popularly known as the "Hatch–Waxman Act." The Act sought, among other things, to encourage the development of generic drugs to increase market competition and to lower prices for consumers. See Mead Johnson Pharm. Grp., Mead Johnson & Co. v. Bowen , 838 F.2d 1332, 1333 (D.C. Cir. 1988). To that end, the Hatch–Waxman Act streamlined the process for bringing new generic drugs to market by creating the abbreviated new drug application—or "ANDA"—process, under which a manufacturer can "piggyback[ ] on the original manufacturer's evidence of safety and efficacy." Teva Pharm., USA, Inc. v. Leavitt , 548 F.3d 103, 104 (D.C. Cir. 2008). To obtain FDA approval for a generic drug, the ANDA applicant must demonstrate (1) that it is "bioequivalent" to the brand-name drug (also referred to as the "listed drug"); (2) that the prescribed conditions of use have been approved for the listed drug, 21 U.S.C § 355(j)(2)(A) ; (3) that the generic drug satisfies certain chemistry and labeling requirements; (4) and that the proposed manufacturing and packaging processes and controls are adequate to "preserve its identity, strength, quality, and purity," id. § 355(j)(4)(A).

Although the Hatch–Waxman Act streamlined the process for bringing generic drugs to market, obtaining FDA approval for an ANDA remains a prolonged task. The process begins with the submission of an application, which must comply with FDA requirements for receipt. If an application is not "substantially complete," 21 C.F.R. § 314.101(b)(1), the FDA will issue a "refuse-to-receive decision" in which it rejects the ANDA without evaluating the substance of the application, id. § 314.101(b)(3). In response, an applicant may resubmit the ANDA with the required data or may withdraw the ANDA. Id. Only after the FDA has determined that the ANDA meets the receipt requirements does the agency begin to evaluate whether the applicant's product is bioequivalent, manufactured in an appropriate manner, and properly labeled. During this substantive review, there is "inevitably and invariably back and forth" between the agency and the applicant, see Dkt. 69 at 8 (Tr. 8:7), in which the agency generally requests additional data or information to determine whether the ANDA meets the requirements for approval, see 21 C.F.R. § 314.127. This process can take years to complete.

An ANDA must also include one of four certifications with respect to each of the Orange Book patents that claims the listed drug. 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). The four certifications are identified by the paragraph in which they appear: A "paragraph I" certification attests that, to the best of the applicant's knowledge, no such patent information has been filed. Id. § 355(j)(2)(A)(vii)(I). A "paragraph II" certification attests that any such patent has expired. Id. § 355(j)(2)(A)(vii)(II). A "paragraph III" certification identifies the date on which any such patent will expire. Id. § 355(j)(2)(A)(vii)(III). And, most importantly for present purposes, a "paragraph IV" certification asserts that any such patent is invalid or will not be infringed by the generic drug. Id. § 355(j)(2)(A)(vii)(IV). "If an ANDA applicant makes one of the first two certifications, [the] FDA may approve the ANDA immediately," and, if the "applicant makes a paragraph III certification, [the] FDA may grant tentative approval of the ANDA, to be made effective on the date the patent expires." Mylan Labs. , 910 F.Supp.2d at 301. The consequences of making a paragraph IV certification, however, are different in kind. Most significantly, a paragraph IV certification is treated as an act of patent infringement. 35 U.S.C. § 271(e)(2)(A). If the patent holder brings an infringement action within 45 days of receiving notice of the certification, moreover, the FDA's approval of the ANDA will not take effect for a period of 30 months, unless otherwise ordered by the district court in which the patent litigation is pending. Id. § 355(j)(5)(B)(iii).

Would-be generic drug manufacturers thus risk costly patent infringement litigation if they seek FDA approval before the brand-name drug's patent has expired or is invalidated—a risk that Congress feared would discourage market competition and delay bringing lower-priced generic drugs to market. See Teva Pharm. USA, Inc. v. Sebelius , 595 F.3d 1303, 1305 (D.C. Cir. 2010). To "compensate [generic] manufacturers for research and development costs as well as the risk of...