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Amgen Inc. v. Hargan

United States District Court, District of Columbia

October 24, 2017

AMGEN INC., Plaintiff,
ERIC D. HARGAN, Acting Secretary, Department of Health and Human Services, et al., Defendants, and TEVA PHARMACEUTICALS USA, INC., et al., Intervenor-Defendants .



         The matter is before the Court on two motions: Amgen Inc.'s motion to complete or to supplement the administrative record, Dkt. 38, and Amneal Pharmaceuticals LLC's (“Amneal”) unopposed motion to intervene as a defendant, Dkt. 33. For the reasons that follow, the Court will deny Amgen's motion and will grant Amneal's motion, subject to one condition. In addition, the Court reaffirms its earlier decision granting Watson Laboratories, Inc. (“Watson”) leave to intervene, subject to that same condition. See Minute Order (Aug. 15, 2017).

         I. BACKGROUND

         The Court recites only those facts relevant to the pending motions.

         A. Facts Relevant to Amgen's Motion To Supplement the Administrative Record

         In March 2004, the Food and Drug Administration (“FDA”) approved a New Drug Application (“NDA”) for Sensipar (cinacalcet hydrochloride) for the treatment of (1) secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis; (2) hypercalcemia in adult patients with parathyroid carcinoma; and (3) severe hypercalcemia in adult patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. Dkt. 1 at 10 (Compl. ¶ 26). Amgen, the sponsor of the NDA, holds several patents for Sensipar. One of those patents, which Amgen describes as a “key patent[] covering Sensipar, ” is due to expire on March 8, 2018. Id. at 4-5 (Compl. ¶ 9).

         The present dispute centers on whether Amgen is entitled to an additional six months of market exclusivity for Sensipar (and other drugs containing the same active moiety) under 21 U.S.C. § 355a, an amendment to the Federal Food, Drug, and Cosmetic Act that Congress enacted to “provide[] an incentive for a drug patent holder to conduct pediatric studies of a drug which the FDA believes may have beneficial pediatric use.” Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 1276 (D.C. Cir. 2004). Subject to certain exceptions not relevant to the pending motion, § 355a provides an additional six-month period of “pediatric exclusivity” for qualifying drugs. It does so by, among other things, precluding the FDA from approving any Abbreviated New Drug Application (“ANDA”) for a follow-on drug for “a period of six months after the date the patent expires (including any patent extensions), ” subject to detailed rules relating to the timing of the pediatric studies and the term, scope, and validity of the patent. 21 U.S.C. § 355a(b)(1)(B)(i); see also 21 U.S.C. § 355(b)(2)(A)(ii)-(iv) (describing certification of ANDA applicant that the patent has expired, will expire, is invalid, or will not be infringed); 21 U.S.C. § 355(j)(2)(A)(vii)(II)-(IV) (same).

         Before an applicant may qualify for this additional period of exclusivity, however, five events must occur: (1) the FDA must determine “that information relating to the use of [the] drug in the pediatric population may produce health benefits in that population;” (2) the FDA must make a “written request for pediatric studies;” (3) the applicant must agree to that request; (4) the studies must be “completed using appropriate formulations for each age group for which the study is requested within [the specified] timeframe;” and-most importantly for present purposes-(5) the reports from those studies must be “submitted [to] and accepted” by the FDA. 21 U.S.C. § 355a(b)(1) (emphasis added). In deciding whether to accept or reject the studies, the FDA's “only responsibility [is] to determine . . . whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with” the FDA's filing requirements. 21 U.S.C. § 355a(d)(4) (emphasis added).

         Amgen submitted a proposed pediatric study request for Sensipar in May 2007, and after extensive back and forth, the FDA finally issued a written request for pediatric studies of the drug in May 2010. Dkt. 1 at 11 (Compl. ¶ 28); Dkt. 1-2 at 4. The back and forth then continued over the next several years, while Amgen performed-or attempted to perform-various studies. Dkt. 1 at 11 (Compl. ¶ 28). Ultimately, however, the FDA concluded in May 2017 that Amgen's studies failed to “fairly respond” to the agency's written request. Id. at 20-21 (Compl. ¶ 49). Amgen, then, brought this action to challenge that decision, asserting claims under the Administrative Procedure Act (“APA”), 5 U.S.C. § 706(2), and the Due Process Clause of the Fifth Amendment. Id. at 29-31 (Compl. ¶¶ 76-90). Amgen simultaneously moved for a temporary restraining order (“TRO”) and preliminary injunction, Dkt. 3, and the Court held a hearing on Amgen's motion, see Minute Entry (June 2, 2017). At the same time that Amgen brought suit, it also sought formal dispute resolution before the FDA. Dkt. 52-2 at 154 (FDA reconsideration decision). The FDA declined to accept Amgen's request for formal dispute resolution while the company was actively pursuing litigation on the same matter. Id. Following the TRO hearing, however, the parties stipulated to stay this action pending completion of the administrative process and further agreed that, in light of their stipulation, Amgen's motion for a TRO was moot. Dkt. 14.

         The Court agreed to stay the action and denied Amgen's motions for a TRO and preliminary injunction as moot in light of the FDA's agreement to reconsider its decision. Minute Order (June 5, 2017); Dkt. 15. In pursuing its request for reconsideration, Amgen challenged the FDA's initial denial of pediatric exclusivity on several grounds, including one ground that bears on the present motion: that the FDA ignored its own precedent in denying Amgen's application for pediatric exclusivity. Although far from exhaustive of the FDA's pediatric exclusivity decisions, the FDA and Amgen focused their analysis and arguments on eight “comparator” drugs. Dkt. 38-1 at 3-4, 7-9. The FDA rejected Amgen's contention that the agency had ignored its own precedent, and, indeed, concluded that its prior decisions were consistent with its decision denying Amgen's application for pediatric exclusivity. Dkt. 52-2 at 154-75.

         The dispute, then, returned to this Court. The Court lifted the stay and set an agreed-upon, expedited schedule for cross-motions for summary judgment. Dkt. 25. Pursuant to that schedule, the FDA proceeded to compile the administrative record. It did not, however, provide the full complement of pediatric exclusivity documents for each of the eight comparator drugs; rather, the FDA included only one document for most of those drugs. Dkt. 38-1 at 8. According to Amgen, although the relevant documentation may vary from case to case, a complete set of pediatric exclusivity documents for each drug generally should have included the Pediatric Exclusivity Board meeting minutes, the completed pediatric exclusivity checklist, Review Division memoranda, and the annotated Written Request. Id.

         In September, Amgen moved to complete or supplement the administrative record with “documents that were before [the] FDA and [were] necessarily considered by the agency in connection with its pediatric exclusivity decision for Sensipar.” Dkt. 38-1 at 2. Amgen argued that the FDA should be required to supplement the administrative record with three categories of documents: (1) “the Pediatric Review Board meeting minutes for Sensipar;” (2) “documents reflecting FDA's consideration of the requests for pediatric exclusivity for the eight comparator drugs;” and (3) “any other documents reflecting the ‘consistency' of FDA's application of its ‘fairly respond' standard.” Id. at 3-5. Amgen asked the Court to order the FDA to produce the missing documents or to “certify that no such documents exist.” Dkt. 38-2 at 2.

         Nine days after the parties completed briefing on the relevant issues, see Dkt. 38; Dkt. 40; Dkt. 41, the Court held a hearing in an effort to expedite resolution of the issue. As explained at the hearing and reflected in a minute order entered that same day, the Court denied Amgen's motion with respect to the first and third categories of documents. See Minute Order (Sept. 20, 2017). With respect to the first category, the Pediatric Review Board meeting minutes for Sensipar, the Court denied Amgen's request as moot. Id. In responding to Amgen's motion, the FDA represented that the minutes that Amgen sought did not exist, and it further asserted that any draft minutes that may have been prepared were deliberative and, thus, were properly excluded from the administrative record. See Dkt. 40 at 5. Because Amgen acknowledged that the FDA had included all of the relevant documents relating to Sensipar, all agreed that there was nothing further for the Court to decide with respect to Pediatric Review Board meeting minutes. Dkt. 58 at 4 (Transcript of Hearing).

         The Court also denied Amgen's request with respect to the third category-“any other documents reflecting the ‘consistency' of FDA's application of its ‘fairly respond' standard”- on the ground that Amgen had failed to carry its burden of demonstrating that these documents were before the FDA when it made its decision or that unusual circumstances otherwise justified inclusion of the documents in the administrative record. See Minute Order (Sept. 20, 2017); see also Dist. Hosp. Partners, L.P. v. Burwell, 786 F.3d 46, 55 (D.C. Cir. 2015). As the FDA clarified at the hearing, the agency “did not pull other files or . . . look at other files” beyond those pertaining to the eight comparators when it rendered its decision. Dkt. 58 at 7 (Transcript of Hearing). Nothing in the APA or in the case law requires an ...

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