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
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.
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:
§ 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 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. § 355(j)(2)(B), and the patent holder has 45 days from the receipt of notice to bring suit against the applicant. § 355(j)(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 §§ 355(j)(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 § 355(j)(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 § 355(j)(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(j)(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:
§ 355(j)(5)(D)(i)(I)(bb).
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.
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
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. § 355(j)(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 ANDA 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, which ordered, adjudged and decreed:
Ex. 2 to Compl. [Dkt. # 1-3] ¶ 3 ("Consent Judgment and Decree"); see also Compl. ¶ 12. Perrigo did not become aware of this order until October 10, 2017 because it had originally been filed under seal. See Compl. ¶ 9.
On October 18, 2017, Perrigo sent FDA a letter, requesting a "formal — and prompt — decision from FDA with respect to forfeiture of eligibility of 180-day exclusivity under the so-called `failure-to-market provisions.'" Ex. 3 to Compl. [Dkt. # 1-4] ("Perrigo Letter") at 1. It asked the agency to confirm that the Consent Judgment and Decree obtained by Aurobindo "is wholly insufficient to trigger the 75-day period under" the FDCA, and that Perrigo would not forfeit its exclusivity eligibility 75 days after the date of the Consent Judgment and Decree (on or about December 4, 2017) if it failed to begin commercial marketing of the drug product approved under its ANDA. Perrigo Letter at 1-2; Compl. ¶ 13. Given the urgency of the situation, Perrigo asked FDA to respond to its letter within two weeks. See Perrigo Letter at 2.
FDA responded on November 17, 2017. Ex. 1 to Compl. [Dkt. # 1-2] ("FDA Letter") at 1. Citing its "longstanding policy and practice," FDA told Perrigo that it "does not intend to decide [Perrigo's] forfeiture question at this time, and will do so, if necessary, if and when [FDA is] ready to approve a subsequent [ANDA] for omeprazole magnesium." Id. FDA explained:
FDA Letter at 2 (internal citations omitted).
On November 21, 2017, Perrigo filed this lawsuit against FDA. See Compl. Plaintiff also filed a motion for a temporary restraining order that would (1) enjoin FDA from finding that based on the September 20, 2017 Consent Judgment and Decree, Perrigo could forfeit its eligibility for a 180-day period of generic drug marketing exclusivity on December 4, 2017, and (2) enjoin FDA from granting final approval to Aurobindo's ANDA for Omeprazole Magnesium Delayed-release Tablets, or any other ANDA from a generic drug applicant with a pending application for omeprazole magnesium tablets. Appl. for TRO [Dkt. # 2]. The Court held a telephonic conference on November 22, 2017 with Perrigo, FDA, and Aurobindo, a potential intervenor in the case, to discuss a briefing schedule. After the telephonic conference, the Court consolidated the application for injunctive relief with the merits under Federal Rule of Civil Procedure 65(a)(2) and it denied the motion for temporary restraining order as moot. See Min. Order (Nov. 22, 2017).
Plaintiff's complaint contains two counts. Count I alleges that "FDA has unlawfully failed to render a determination whether the September 20 Consent Judgment meets the statutory requirements to trigger the 75-day failure-to-market period." Compl. ¶ 33. Count II seeks a declaratory judgment from the Court that the Consent
On November 28, 2017, FDA filed a motion to dismiss both counts in the complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6), and to dismiss Count II for lack of subject matter jurisdiction pursuant to Federal Rule of Civil Procedure 12(b)(1). Def.'s Mot. to Dismiss [Dkt. # 5] ("Def.'s Mot."); Mem. in Supp. of Def.'s Mot. & Opp. to Pl.'s Req. for Injunctive & Declaratory Relief [Dkt. # 5-1] ("Def.'s Mem."). On the same day, Aurobindo filed a motion to intervene in the case, which the Court granted, as well as an opposition to Perrigo's application for temporary restraining order. See Notice of Mot. to Intervene [Dkt. # 6]; Min. Order (Nov. 28, 2017); Aurobindo's Mem. of Law in Opp. to Pl.'s Appl. for TRO [Dkt. # 9] ("Aurobindo's Mem.").
In evaluating a motion to dismiss under either Rule 12(b)(1) or 12(b)(6), the Court must "treat the complaint's factual allegations as true and must grant plaintiff `the benefit of all inferences that can be derived from the facts alleged.'" Sparrow v. United Air Lines, Inc., 216 F.3d 1111, 1113 (D.C. Cir. 2000) (internal citations omitted), quoting Schuler v. United States, 617 F.2d 605, 608 (D.C. Cir. 1979); see also Am. Nat'l Ins. Co. v. FDIC, 642 F.3d 1137, 1139 (D.C. Cir. 2011). Nevertheless, the Court need not accept inferences drawn by the plaintiff if those inferences are unsupported by facts alleged in the complaint, nor must the Court accept plaintiff's legal conclusions. Browning v. Clinton, 292 F.3d 235, 242 (D.C. Cir. 2002).
Under Rule 12(b)(1), the plaintiff bears the burden of establishing jurisdiction by a preponderance of the evidence. See Lujan v. Defs. of Wildlife, 504 U.S. 555, 561, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992); Shekoyan v. Sibley Int'l Corp., 217 F.Supp.2d 59, 63 (D.D.C. 2002). Federal courts are courts of limited jurisdiction and the law presumes that "a cause lies outside this limited jurisdiction." Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994); see also Gen. Motors Corp. v. EPA, 363 F.3d 442, 448 (D.C. Cir. 2004) ("As a court of limited jurisdiction, we begin, and end, with an examination of our jurisdiction."). "[B]ecause subject-matter jurisdiction is `an Art[icle] III as well as a statutory requirement ... no action of the
When considering a motion to dismiss for lack of jurisdiction, unlike when deciding a motion to dismiss under Rule 12(b)(6), the court "is not limited to the allegations of the complaint." Hohri v. United States, 782 F.2d 227, 241 (D.C. Cir. 1986), vacated on other grounds, 482 U.S. 64, 107 S.Ct. 2246, 96 L.Ed.2d 51 (1987). Rather, "a court may consider such materials outside the pleadings as it deems appropriate to resolve the question [of] whether it has jurisdiction to hear the case." Scolaro v. D.C. Bd. of Elections & Ethics, 104 F.Supp.2d 18, 22 (D.D.C. 2000), citing Herbert v. Nat'l Acad. of Scis., 974 F.2d 192, 197 (D.C. Cir. 1992); see also Jerome Stevens Pharms., Inc. v. FDA, 402 F.3d 1249, 1253 (D.C. Cir. 2005).
"To survive a [Rule 12(b)(6)] motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009), quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). In Iqbal, the Supreme Court reiterated the two principles underlying its decision in Twombly. "First, the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions," and "[s]econd, only a complaint that states a plausible claim for relief survives a motion to dismiss." Id. at 678-79, 129 S.Ct. 1937.
A claim is facially plausible when the pleaded factual content "allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. at 678, 129 S.Ct. 1937, citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955. "The plausibility standard is not akin to a `probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully." Id., quoting Twombly, 550 U.S. at 556, 127 S.Ct. 1955. A pleading must offer more than "labels and conclusions" or a "formulaic recitation of the elements of a cause of action," id., quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955, and "[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Id., citing Twombly, 550 U.S. at 555, 127 S.Ct. 1955.
When considering a motion to dismiss under Rule 12(b)(6), the Court is bound to construe a complaint liberally in the plaintiff's favor, and it should grant the plaintiff "the benefit of all inferences that can be derived from the facts alleged." Kowal v. MCI Commc'ns Corp., 16 F.3d 1271, 1276 (D.C. Cir. 1994). Nevertheless, the Court need not accept inferences drawn by the plaintiff if those inferences are unsupported by facts alleged in the complaint, nor must the Court accept plaintiff's legal conclusions. See id.; see also Browning v. Clinton, 292 F.3d 235, 242 (D.C. Cir. 2002). In ruling upon a motion to dismiss for failure to state a claim, a court may ordinarily consider only "the facts alleged in the complaint, documents attached as exhibits or incorporated by reference in the complaint, and matters about which the Court may take judicial notice." Gustave-Schmidt v. Chao, 226 F.Supp.2d 191, 196 (D.D.C. 2002), citing EEOC v. St. Francis Xavier Parochial Sch., 117 F.3d 621, 624-25 (D.C. Cir. 1997).
The APA authorizes judicial review where "[a] person suffer[s] legal wrong
The APA provides two methods by which a plaintiff may seek relief. A court may (1) "compel agency action unlawfully withheld or unreasonably delayed," 5 U.S.C. § 706(1), or (2) "hold unlawful and set aside agency action" that is, among other things, "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law." 5 U.S.C. § 706(2). Although Perrigo points out in Count I that section 702 authorizes a party wronged by agency action to seek review, see Compl. ¶ 32, it does not identify the specific APA provision under which it purports to bring its claim. See id. ¶¶ 31-34. The complaint is replete with references to "unreasonable delay," see, e.g., id. ¶ 30; id. at 7-8 (headings), but plaintiff's memorandum in opposition to the motion to dismiss advances an argument that the FDA letter constitutes final agency action that was arbitrary and capricious. Pl.'s Opp. at 6-8. Perrigo states in its opposition that Count I is grounded on both sections 706(1) and 706(2), but it fails to state a claim under either section.
To state a claim under section 706(1), a plaintiff must ask the Court to "compel agency action," and the agency must be statutorily required to take that action. Plaintiff has not alleged sufficient facts to meet either requirement here.
As an initial matter, the complaint does not contain any request that the Court "compel agency action," but instead it asks the Court to step into FDA's shoes and decide the exclusivity issue itself. See Compl. ¶ 34 ("Because FDA has failed to render a timely decision, this Court should address the issue that FDA will not — and has refused to — address."). So plaintiff's claim under section 706(1) fails on this ground alone.
Moreover, a claim under section 706(1) "can proceed only where a plaintiff asserts that an agency failed to take a discrete agency action that it is required to take." Norton, 542 U.S. at 64, 124 S.Ct. 2373 (emphasis in original). Perrigo does not allege that FDA was required by statute or regulation to answer its inquiry regarding its exclusivity eligibility at all, much less that it was bound to do so by any particular date. See Hi-Tech Pharmacal Co. v. FDA, 587 F.Supp.2d 1, 9 (D.D.C. 2008) (holding that the company failed to demonstrate any success on the merits because under section 706(1), "resolving Hi-Tech's entitlement to exclusivity is not a discrete agency action that the FDA is required to take, pursuant to statute or regulation, by a time certain"). Nor does Perrigo provide any authority for this proposition in its opposition.
The Supreme Court established a two-part test for determining whether an agency action qualifies as final so as to be subject to judicial review:
Bennett v. Spear, 520 U.S. 154, 177-78, 117 S.Ct. 1154, 137 L.Ed.2d 281 (1997) (internal quotation marks and citations omitted). Plaintiff's complaint does not contain sufficient facts to allege that FDA's failure to "render a timely decision" was a final agency action. See Compl. ¶¶ 33-34.
FDA's letter to Perrigo itself illustrates that FDA's refusal to decide the exclusivity issue did not qualify as final agency action under the Supreme Court's two-part test. When the agency gives an indication that its decision is subject to further consideration or possible modification, its action is not final. See FTC v. Standard Oil Co., 449 U.S. 232, 241, 101 S.Ct. 488, 66 L.Ed.2d 416 (1980); Sw. Airlines Co. v. DOT, 832 F.3d 270, 275 (D.C. Cir. 2016) (finding DOT's letter, which initiated a proceeding to deal with issues described in the letter, did not qualify as final agency action). Here, FDA stated that it would not decide the forfeiture question in response to Perrigo's inquiry, but it would "do so, if necessary, if and when [it is] ready to approve a subsequent abbreviated new drug application ("ANDA") for omeprazole magnesium." FDA Letter at 1. FDA also told Perrigo that it was "in the process of asking any other applicants with an ANDA for omeprazole magnesium for their views," and that it would "consider their views in making [a] decision." Id. at 2. Putting off a decision is certainly not a consummation of the agency's decisionmaking process. See Bennett, 520 U.S. at 177-78, 117 S.Ct. 1154.
More important, FDA's failure to answer Perrigo's question on the forfeiture issue did not determine either party's legal rights or obligations. See Bennett, 520 U.S.
Absent final agency action to review, any claim under section 706(2) is premature. Therefore, the Court will grant defendant's motion and dismiss Count I.
Perrigo also seeks a declaration that the "Consent Judgment and Decree does not meet the requirements of the [FDCA] and did not trigger the 75-day period under the statute for Perrigo to commence marketing by December 3 or forfeit eligibility for 180-day generic exclusivity." Compl. ¶ 37. However, plaintiffs have not alleged a cognizable cause of action and therefore have no basis upon which to seek declaratory relief. See Ali v. Rumsfeld, 649 F.3d 762, 778 (D.C. Cir. 2011).
The Declaratory Judgment Act provides that "[i]n a case of actual controversy within its jurisdiction," a court "may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought." 28 U.S.C. § 2201(a). But the Declaratory Judgment Act "is not an independent source of federal jurisdiction." C & E Servs., Inc. v. D.C. Water & Sewer Auth., 310 F.3d 197, 201 (D.C. Cir. 2002), quoting Schilling v. Rogers, 363 U.S. 666, 677, 80 S.Ct. 1288, 4 L.Ed.2d 1478 (1960). "Rather, `the availability of declaratory relief presupposes the existence of a judicially remediable right.'" Rumsfeld, 649 F.3d at 778, quoting C & E Servs., Inc., 310 F.3d at 201 (internal edits omitted).
Plaintiff insists nonetheless that it has alleged the existence of an actual controversy which the Court may resolve under the Declaratory Judgment Act. But the complaint does not articulate an actual controversy between the parties, see McManus v. Dist. of Columbia, 530 F.Supp.2d 46, 80 (D.D.C. 2007); plaintiff only states conclusorily that "[t]here is a case of actual controversy within the jurisdiction of this Court." Compl. ¶ 36. And the complaint does not specify any cause of action through which the Court may exercise subject matter jurisdiction since Perrigo has failed to state a claim under the APA. See Rumsfeld, 649 F.3d at 778. Perrigo is essentially asking the Court to issue
For the foregoing reasons, the Court will grant defendant FDA's motion to dismiss. A separate order will issue.
First of all, the conundrum is largely self-inflicted since there is no allegation that either the FDA or Aurobindo has interfered in any way with Perrigo's launch of its product under the terms of the ANDA it obtained twenty-eight months ago. And second, Perrigo's claimed lack of certainty about the legal landscape seems entirely inconsistent with the law and the facts.
On September 20, 2017, the United States District Court for the District of New Jersey signed a consent decree in a declaratory judgment action, Aurobindo Pharma Ltd. v. AstraZeneca AB, No. 3:16-cv-5079 (D.N.J. Aug. 18, 2016). It said:
Consent Judgment and Decree. This certainly appears to be a "consent decree that enters a final judgment that includes a finding that the patent is ... not infringed," see 21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(BB), and therefore this Court would not have been inclined to enter judgment in plaintiff's favor on Count II. The Consent Judgment and Decree dated September 20, 2017 is a consent decree, it entered final judgment, and it found that the patent is not infringed, whether it utilized the word "find" or not. The fact that the judgment was predicated on a license is immaterial — the definition of the forfeiture event in the statute does not make any distinction between patent cases resolved through licensing arrangements or other negotiated dispositions and those that require judicial analyses of the underlying patents.
Plaintiff alleges in its complaint:
Compl. ¶ 11. But this sort of judicial determination seems to be plainly covered by the section of the statute related to forfeiture of the 180-day exclusivity period. Subsection (D)(i)(I)(bb)(BB) specifically provides that a "settlement order or consent decree" in a declaratory judgment action, such as the one filed by Aurobindo in this case, may serve as the critical forfeiture event that starts the clock ticking; there is no legal requirement in that provision that the judgment include a ruling on the infringement question on the merits. This seems even more clear when one reads the previous provision, subsection (D)(i)(I)(bb)(AA), which states that the failure-to-market date could also fall 75 days after a court enters "a final decision ... that the patent is invalid or not infringed" in an infringement action brought against the other applicant or a declaratory judgment brought by that applicant. In other words, it is subsection (AA) that deals with final determinations on the merits and subsection (BB) that reflects Congress's recognition that patent actions are often resolved by agreement of the parties. Indeed, plaintiff cites no authority for its strained interpretation of the word "finding," other than Federal Rule of Civil Procedure 52, which deals with "an action tried on the facts without a jury," and has no bearing on a consent decree.
Plaintiff also suggests that the operative paragraph in the consent decree is too vague to constitute the necessary finding that a patent is not infringed since it does not specifically identify the patents involved but simply refers to them as "the AstraZeneca patents." But the consent decree was not handed down in a vacuum — it is the final document on the docket in a lawsuit concerning the only patents that could have any bearing on this case — the two patents listed in the Orange Book for the listed drug. See Aurobindo Compl. ¶ 1.
Thus, while Perrigo has urged the Court to give unambiguous language its plain meaning, it appears that it is Perrigo that is resisting the commonsense interpretation of the texts involved.
