Amarin Pharm. Ir. Ltd. v. Food & Drug Admin.

• Decision Date: 15 October 2015
• Docket Number: Civil Action No. 14–324 (RDM)
• Citation: 139 F.Supp.3d 437
• Parties: Amarin Pharmaceuticals Ireland Limited, Plaintiff, v. Food and Drug Administration; Margaret A. Hamburg, M.D., Commissioner of Food and Drugs; Kathleen Sebelius, Secretary of Health & Human Services, Defendants.
• Court: U.S. District Court — District of Columbia

139 F.Supp.3d 437

Amarin Pharmaceuticals Ireland Limited, Plaintiff,

v.Food and Drug Administration; Margaret A. Hamburg, M.D., Commissioner of Food and Drugs; Kathleen Sebelius, Secretary of Health & Human Services, Defendants.

Civil Action No. 14–324 (RDM)

United States District Court, District of Columbia.

Signed October 15, 2015

Christopher N. Sipes, Benjamin Conrad Block, Bradley K. Ervin, Covington & Burling LLP, Matthew Joseph Berns, U.S. Department of Justice, Washington, DC, for Plaintiff.

Ann Frances Entwistle, Gerald Cooper Kell, Andrew E. Clark, Cindy Jane Cho, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION AND ORDER

RANDOLPH D. MOSS, United States District Judge

In this action brought under the Administrative Procedure Act, 5 U.S.C. § 702 et seq., Plaintiff Amarin Pharmaceuticals Ireland Limited ("Amarin") challenged the Food and Drug Administration's determination that Amarin's new drug, Vascepa (icosapent ethyl) Capsules ("Vascepa") was not entitled to a five-year period of market exclusivity under the Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98–417, 98 Stat. 1585 (1984) ("Hatch–Waxman Amendments"). As the Court has previously explained, the Hatch–Waxman Amendments entitle a drug manufacturer to a five-year exclusivity period only if "no active ingredient (including any ester or salt of the active ingredient)" of the new drug has been previously approved. 21 U.S.C. §§ 355(c)(3)(E)(ii), 355(j)(5)(F)(ii). Here, the Food and Drug Administration ("FDA") had concluded that Vascepa was not entitled to the five-year exclusivity period because it contained a molecule that was a component of a previously-approved drug. On May 28, 2015, this Court issued an opinion concluding that the interpretation of the Hatch–Waxman Amendments set forth in the FDA's determination failed under both steps of the Chevron framework, see Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), and was arbitrary and capricious, see 5 U.S.C. § 706(2)(A). Amarin Pharm. Ireland Ltd. v. FDA, No. 14–cv–00324, 106 F.Supp.3d 196, 2015 WL 3407061 (D.D.C. May 28, 2015).

Watson Laboratories Inc. ("Watson") is a pharmaceutical company that hopes someday to market a generic version of Vascepa. It was not a party to the proceedings before the Court issued its May 28, 2015 Order. On July 22, 2015, however—55 days after the Court's opinion issued, and five days before the FDA's time to file a notice of appeal expired—Watson filed a motion to intervene (Dkt.33) for the purpose of appealing the Court's Order. On the same day, Watson filed a notice of appeal. Dkt. 37. Watson explains that it moved to intervene upon learning that the FDA did not plan to appeal the Court's Order. Dkt. 33 at 7. Amarin and the FDA both oppose Watson's motion to intervene. Dkts. 40, 41. The time to file a notice of appeal has now elapsed, and neither Plaintiff nor Defendants has done so.

Although Watson's motion to intervene is still pending before the Court, its notice of appeal caused the pending action to be transmitted to the Court of Appeals, which docketed the appeal on July 30, 2015. See Amarin Pharm. Ireland Ltd. v. FDA, No. 15–5214 (D.C.Cir.). On September 14, 2015, Amarin and the FDA moved the Court of Appeals to dismiss the appeal for lack of jurisdiction. Briefing on their motions before that Court is almost complete.

Watson's motion to intervene (Dkt.33) is now before this Court. The filing of Watson's notice of appeal, however, raises a procedural question that remains unresolved in this Circuit: whether the filing of a notice of appeal deprives a district court of jurisdiction over a motion to intervene. For the reasons discussed below, the Court concludes that it does and that the Court therefore lacks jurisdiction to adjudicate Watson's motion to intervene. The Court, however, exercises its discretion under Federal Rule of Civil Procedure 62.1(a) to render an indicative ruling addressing some, but not all, of the issues posed by the motion to intervene. Putting aside the question whether the Court's May 28, 2015 Order is a final, appealable order, the Court concludes that Watson has satisfied the Rule 24 prerequisites for intervention as of right, and the Court would grant Watson's motion to intervene were the Court of Appeals to deny the pending motions to dismiss and remand the matter. The Court declines to offer an indicative ruling, however, on the question whether the May 28, 2015 Order is final and appealable. Because that question implicates appellate jurisdiction and has already been briefed in the Court of Appeals, the Court concludes it is more appropriately addressed by the Court of Appeals.

DISCUSSION

I. Jurisdiction

Before addressing the merits of the motion to intervene, the Court must first "satisfy itself of its authority" to decide the motion. Prakash v. Am. Univ., 727 F.2d 1174, 1179 (D.C.Cir.1984). In particular, the Court must decide whether the filing of a notice of appeal by a would-be intervenor deprives the Court of jurisdiction over the case—including jurisdiction to decide the motion to intervene itself. The answer to that question is not self-evident. The courts are divided on "whether the district court loses jurisdiction to grant intervention to appeal after a notice of appeal has been filed," 15A Charles A. Wright et al., Federal Practice and Procedure § 3902.1 (2d ed. 2008 & Supp.2015), and, to date, the D.C. Circuit has expressly declined to resolve the issue, Associated Builders & Contractors, Inc. v. Herman, 166 F.3d 1248, 1256 (D.C.Cir.1999). As explained below, the Court agrees with the majority of courts that have addressed the question and concludes that it lacks jurisdiction to adjudicate Watson's motion to intervene.

As a general rule, "[t]he filing of a notice of appeal is an event of jurisdictional significance—it confers jurisdiction on the court of appeals and divests the district court of its control over those aspects of the case involved in the appeal." Griggs v. Provident Consumer Discount Co., 459 U.S. 56, 58, 103 S.Ct. 400, 74 L.Ed.2d 225 (1982) (per curiam). The reason for this rule is a practical one: it prevents that "broad class of situations ... in which district courts and courts of appeals would both have had the power to modify the same judgment," id. at 59–60, 103 S.Ct. 400, by "implementing a commonsensical division of labor between the district court and the court of appeals," Wright et al., supra, § 3949.1. As Judge Posner has explained, the rule is intended "to keep the district court and the court of appeals out of each other's hair." In re Jones, 768 F.2d 923, 931 (7th Cir.1985) (Posner, J., concurring).

The rule, however, is subject to exceptions. The most notable of these exceptions is set out in Federal Rule of Appellate Procedure 4(a)(4), which tolls the deadline in which to file a notice of appeal while certain motions are pending. See Fed. R. App. P. 4(a)(4). As the Supreme Court noted in Griggs, Rule 4(a)(4) does not merely toll the deadline for filing a notice of appeal upon the filing of certain motions; it "clarif[ies] ... the courts' respective jurisdictions" when such a motion is made by "depriving the courts of appeals of jurisdiction" and explicitly providing that the district court will retain jurisdiction over case and motion alike.¹ See Griggs, 459 U.S. at 59–60, 103 S.Ct. 400. Today, the list of motions specified in Rule 4(a)(4) includes a motion for judgment under Rule 50(b), a motion to alter or amend the judgment under Rule 59, and a motion for relief under Rule 60, but not a motion to intervene under Rule 24. See Fed. R. App. P. 4(a)(4).

Rule 4(a)(4) is not the only exception to the rule that a properly filed notice of appeal divests the district court of jurisdiction. The district court retains jurisdiction, for example, "where the defendant frivolously appeals, or takes an interlocutory appeal from a non-appealable order." United States v. DeFries, 129 F.3d 1293, 1303–04 (D.C.Cir.1997) (citation omitted). In addition, the courts have recognized that a district court may take actions "in aid of the appeal" even after the appeal has been noticed. See, e.g., Wolfe v. Clarke, 718 F.3d 277, 281 n. 3 (4th Cir.2013) ; Inland Bulk Transfer Co. v. Cummins Engine Co., 332 F.3d 1007, 1013 (6th Cir.2003) ; Local P–171, Amalgamated Meat Cutters & Butcher Workmen of N. Am. v. Thompson Farms Co., 642 F.2d 1065, 1073 (7th Cir.1981). Thus, a district court may memorialize an oral opinion in writing even when an appeal has been taken from the oral opinion, see Inland Bulk Transfer Co., 332 F.3d at 1013 ; Jones, 768 F.2d at 924 n. 2, or enter clerical corrections to the order on appeal, see Doe v. Public Citizen, 749 F.3d 246, 258 (4th Cir.2014). But, as the Court of Appeals for the Fourth Circuit has observed, a district court "does not act in aid of the appeal when it ‘alter[s] the status of the case as it rests before the court of appeals.’ " Id. at 259 (quoting Coastal Corp. v. Tx. E. Corp., 869 F.2d 817, 820 (5th Cir.1989) ).

Against this backdrop, the courts of appeals in most of the circuits have concluded that "an effective notice of appeal divests a district court of jurisdiction to entertain an intervention motion." Doe, 749 F.3d at 258 (collecting cases); see also Taylor v. KeyCorp, 680 F.3d 609, 617 (6th Cir.2012) ; Drywall Tapers & Pointers of Greater New York, Local Union 1974 v. Nastasi & Assocs., Inc., 488 F.3d 88, 94–95 (2d Cir.2007) ; Roe v. Town of Highland, 909 F.2d 1097, 1100 (7th Cir.1990) ; Avoyelles Sportsmen's League, Inc. v. Marsh, 715 F.2d 897, 928 (5th Cir.1983). Only the Court of Appeals for the Third Circuit has "rejected the ... view" that a would-be intervenor's notice of appeal deprives the district court of "authority to consider the motion to intervene." Halderman v. Pennhurst State Sch. & Hosp., 612 F.2d 131, 134 (3d Cir.1979) (en banc). For...