Bristol-Myers Squibb Co. (“Bristol”) appeals the order of the United States District Court for the District of Columbia granting the motion for a preliminary injunction brought by Mylan Pharmaceuticals, Inc. (“Mylan”). See Mylan Pharms., Inc. v. Thompson,
Regulatory Background
This case turns on the statutory framework governing new and generic drug approvals and its mechanisms for patent enforcement. Under the FFDCA, a pharmaceutical company seeking to manufacture a new drug is required to file a New Drug Application (“NDA”) for consideration by the FDA. 21 U.S.C. § 355(a) (1994). Preparing an NDA is frequently a time-intensive and costly process, because among other things, it must contain detailed clinical studies of the drug’s safety and efficacy. See id. § 355(b)(1) (Supp. V 1999). The NDA must also include a list of patents which claim the drug:
The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such 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.... Upon approval of the application, the Secretary shall publish information submitted under [this section].
Id.
If the FDA approves the NDA, it publishes a listing of the drug and patents on the drug’s approved aspects in Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book.” Id. § 355(j)(7)(A)(iii) (1994); id. § 355(b)(1); see also 21 C.F.R. § 314.53(c)(2) (2001). Because an applicant may not receive original approval for all aspects of the drug as described in the original NDA submission, once the NDA is approved, the applicant must amend the patent submission to list only the patents that meet the listing criteria for the approved drug product. 21 C.F.R. § 314.53(c)(2)(ii) (2001).
Under the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. §§ 355, 360cc, and 35 U.S.C. §§ 156, 271, 282 (the “Hatch-Wax-man Amendments” to the FFDCA and to Title 35 of the U.S.Code relating to patents), a pharmaceutical manufacturer seeking approval to market a generic version of a previously approved drug may submit an abbreviated new drug application (“ANDA”) to the FDA. 21 U.S.C. § 355(j) (1994). An ANDA offers an expedited approval process for generic drug manufacturers. Instead of filing a full NDA with new safety and efficacy studies,
The Hatch-Waxman provisions concerning patent infringement are part of this balance. Under 35 U.S.C. § 271(e)(1), it is not infringement to conduct otherwise infringing acts necessary to prepare an ANDA. 35 U.S.C. § 271(e)(1) (Supp. V 1999) (“It shall not be an act of infringement to make, use, offer to sell, or sell ... a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”). Under section 271(e)(2), however, a generic drug manufacturer infringes by filing an ANDA to obtain FDA approval for the purpose of marketing a generic drug product claimed in a patent before the patent expires. 35 U.S.C. § 271(e)(2) (1994) (“It shall be an act of infringement to submit ... [an ANDA] ... if the purpose of such submission is to obtain [FDA] approval ... to engage in the commercial manufacture, use, or sale of a drug ... claimed in a patent before the expiration of such patent.”) (emphasis added). Despite this provision, not all ANDA applicants can be sued immediately for infringement; moreover, they cannot sue immediately for declaratory judgment with respect to the patent, as further discussed below.
As part of the ANDA process, an applicant seeking to market a generic version of a listed drug must make a certification as to each patent listed in the Orange Book which “claims the listed drug ... or which claims a use for such listed drug for which the applicant is seeking approval.” 21 U.S.C. § 355(j)(2)(A)(vii) (1994). Further, according to regulations enacted by the FDA, an applicant whose ANDA is pending when a pioneer drug manufacturer lists additional patents in the Orange Book must make certifications as to the new patents, unless the additional patents are submitted more than thirty days after they were issued. 21 C.F.R. § 314.94(a)(12)(vi) (2001).
In either case, the applicant must certify either that: (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) such patent is invalid or will not be infringed by the manufacture, use, or sale of the new generic drug for which the ANDA is submitted. 21 U.S.C. § 355(j)(2)(A)(vii)(I-IV) (1994). These are commonly referred to as Paragraph I, II, III, and IV certifications. Further, if one of the listed patents is a method-of-use patent which does not claim a use for which the applicant is seeking approval, the applicant must make
An ANDA containing a Paragraph I or II certification may be approved without additional delay. See 21 U.S.C. § 366(j)(5)(B)(i) (Supp. V 1999). An ANDA containing a Paragraph III certification indicates that the applicant does not intend to market the drug until after the expiration of the patent, and the approval of the ANDA cannot be made final until the patent expires. Id. § 355(j)(5)(B)(ii).
When an ANDA contains a Paragraph IV certification, the ANDA applicant must give notice to the patentee and must provide detailed bases for its belief that the patent is invalid, unenforceable, or not infringed. Id. § 355(j)(2)(B)(i); 21 C.F.R. § 314.95(c)(6) (2001). The patentee is then given forty-five days to sue the ANDA applicant for infringement. 21 U.S.C. § 355(j)(5)(B)(iii) (Supp. V 1999). If the patentee does not file suit, the application may be approved. If the patentee files suit within that period, the FDA may not approve the ANDA until the expiration of the patent, judicial resolution of the infringement suit, a judicial determination that the patent is invalid or unenforceable, or thirty months from the patentee’s receipt of notice, whichever is earliest. Id.; 21 C.F.R. § 314.107(b)(l)(iv) (2001). The court in which the suit is pending may order a shorter or longer stay on the approval time if “either party to the action fail[s] to reasonably cooperate in expediting the action.” 21 U.S.C. § 355(j)(5)(B)(iii) (Supp. V 1999). Moreover, the availability of declaratory judgment actions is limited: “Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under section 2201 of Title 28, for a declaratory judgment with respect to the patent.” Id. These provisions give the pioneer manufacturer the first opportunity to file suit against the ANDA applicant for infringement, and may substantially delay the ANDA approval during the pendency of the litigation.
The Hatch-Waxman Amendments, however, do not include any explicit, provisions either enabling or prohibiting an action to challenge a patentee’s listing of a patent in the Orange Book. By regulation, the FDA has provided a limited process for disputing the accuracy or relevance of patent information submitted to the FDA and listed in the Orange Book. 21 C.F.R. § 314.53(f) (2001). One who questions the accuracy of the patent information may write to the FDA, and the FDA will request that the applicant confirm the information. Id. According to the FDA’s regulations, however, “[ujnless the application holder withdraws or amends its patent information in response to FDA’s request, the agency will not change the patent information in the list” and an ANDA applicant must still make certifications for each patent despite its disagreement. Id.
Factual Background
Bristol owns U.S. Patent No. 4,182,763 (“'763 patent”) directed to the treatment of anxiety through the administration of bus-pirone hydrochloride. The '763 patent is listed in the Orange Book as covering Bristol’s FDA-approved drug “BuSpar.” Bristol’s patent was set to expire at the end of the day on November 21, 2000. In anticipation of its expiration, Mylan, a generic manufacturer, had filed and received tentative approval of an ANDA for its buspirone product under a Paragraph III certification. Mylan manufactured and was ready to ship its product at 12:00 a.m. on November 22, 2000, the moment the '763 patent was to have expired.
Approximately eleven hours before the '763 patent’s expiration, Bristol hand-delivered to the FDA copies of U.S. Patent No.
A process for ameliorating an undesirable anxiety state in a mammal comprising systemic administration to the mammal of an effective but non-toxic anxiolytic dose of ... [BMY 28674 (the active metabolite of buspirone) ] or a pharmaceutically acceptable acid addition salt or hydrate thereof.
'365 patent, col. 16, 11. 27-32. Bristol sought to have the '365 patent listed in the Orange Book as covering buspirone.
Upon receiving the '365 patent from Bristol, the FDA suspended approval of Mylan’s ANDA and the ANDAs filed by other prospective generic manufacturers of buspirone. Mylan and other ANDA applicants wrote to the FDA to challenge the listing of the '365 patent on the grounds that it only covered a metabolite of buspi-rone and therefore should not be listed because it did not claim the drug, citing our ruling in Hoechst-Roussel Pharmaceuticals, Inc. v. Lehman,
The FDA responded on November 30, 2000, by asking Bristol to provide a clarification as to whether the '365 patent claimed only a metabolite of buspirone. The FDA also requested additional information from the ANDA applicants concerning the effect of our Hoechst-Roussel ruling on the '365 patent claim. Bristol responded that the '365 patent did not simply claim a method of using the metabolite, but also a method of using buspi-rone itself. The FDA informed Bristol that its response was adequate and that the '365 patent would be deemed listed in the Orange Book.
Instead of filing a Paragraph IV certification with respect to the ANDA at issue here, Mylan commenced the present action against Bristol and the FDA on the same day, November 30, 2000. It sought a declaratory judgment that Bristol improperly listed the '365 patent, and a preliminary injunction requiring Bristol to take steps to delist the '365 patent and directing the FDA to approve Mylan’s ANDA. Mylan also filed an action in the United States District Court for the District of West Virginia for a declaration of noninfringement and invalidity, and Bristol sued My-lan for infringement in the Southern District of New York.
In the present action, the United States District Court for the District of Columbia held that Mylan was entitled to declaratory relief that the '365 patent was improperly listed in the Orange Book under the patent laws and the Declaratory Judgment Act, as a defense to the infringement suit Bristol could have brought against Mylan under 35 U.S.C. § 271(e)(2). Mylan,
Discussion
The grant or denial of a preliminary injunction under 35 U.S.C. § 283 is within the sound discretion of the district court. Purdue Pharma L.P. v. Boehringer Ingelheim GMBH,
As the moving party, Mylan was required to establish its right to a preliminary injunction in light of four factors: “(1) a reasonable likelihood of success on the merits; (2) irreparable harm if the injunction were not granted; (3) the balance of the hardships and (4) the impact of the injunction on the public interest.” Purdue,
With respect to the first factor, Bristol argues that the district court erred because Mylan did not assert a cognizable cause of action. According to Bristol, My-lan’s claim seeks to delist a patent from
Mylan and the FDA concede that there is no cause of action to delist a patent from the Orange Book. They also concede that such an action would be a private right of action barred by the FFDCA. They submit, however, that Mylan’s cause of action, and the basis for our jurisdiction and declaratory relief, arises under the patent laws as a defense to patent infringement.
This is a matter of first impression for this court. The Declaratory Judgment Act, 28 U.S.C. § 2201, is remedial only. It “enlarged the range of remedies available in the federal courts but did not extend their jurisdiction.” Shelly Oil v. Phillips Petroleum Co.,
Applying the “well-pleaded complaint rule” for analyzing a purported declaratory judgment, we do not look to the plaintiffs complaint to determine which federal law is the basis of the declaratory plaintiffs cause of action, “but to the action that the declaratory defendant would have brought” to enforce its rights. Speedco, Inc. v. Estes,
Mylan argues that the action Bristol, the declaratory judgment defendant, would have brought is an action for patent infringement under 35 U.S.C. § 271(e)(2). This section provides that an applicant infringes a patent if it submits an ANDA “for a drug claimed in a patent or the use of which is claimed in a patent ... before the expiration of such patent.” 35 U.S.C. § 271(e)(2) (1994). Mylan argues that had it filed an ANDA with a Paragraph IV certification, it would have been charged with infringing the '365 patent. One of the defenses, which Mylan argues would
This assertion, however, is not a recognized defense to patent infringement. Defenses to allegations of patent infringement fall into two broad groups: statutory and equitable. The statutory defenses are set forth in 35 U.S.C. § 282 and include non-infringement, absence of liability for infringement, unenforceability, and invalidity (for failure to meet the conditions of patentability or to comply with any requirement of sections 112 or 251). 35 U.S.C. § 282 (Supp. V 1999). The equitable defenses include unclean hands, unen-forceability of the patent for fraud and inequitable conduct, misuse, and delay in filing suit resulting in laches or estoppel. See E.B. Lipscomb III, Lipscomb’s Walker on Patents, § 261:1 (3d. ed. 1988); cf. J.P. Stevens & Co. v. Lex Tex, Ltd.,
Mylan does not tie its argument to any of these defenses. The issue that Mylan seeks to litigate under this declaratory judgment action is not infringement of the '365 patent, i.e., that Mylan did not infringe under 35 U.S.C. § 271(e)(2)(A) because its ANDA was not “for a drug claimed in the patent or the use of which is claimed in a patent.” Instead, it seeks to litigate whether Bristol is barred from asserting the '365 patent against any ANDA applicant because Bristol did not properly comply with the listing requirements set forth in the FFDCA. Although this -issue may be akin to an estoppel defense or an unenforceability defense for a patentee’s inequitable conduct in prosecuting a patent in the Patent and Trademark Office, My-lan has not asserted any such link.
Because the Hatch-Waxman Amendments create the statutory act of infringement here, however, we should also examine them to determine whether they add an additional defense.
The only explicit statement in the amendments concerning an applicant’s rights to seek judicial relief against the patentee is in 21 U.S.C. § 355(j)(5)(B)(iii)(III). This section provides that no one, including the ANDA holder, may commence “an action ... for declaratory judgment with respect to the [listed] patent” before the expiration of forty-five days from the date the patent owner receives notice of the ANDA holder’s Paragraph IV certification. 21 U.S.C. § 355(j)(5)(B)(iii) (Supp. V 1999). Mylan and the FDA argue that this rule does not apply to Mylan’s declaratory judgment action. They argue that section 355(j)(5)(B)(iii)’s reference to an “action” must be read in a manner consistent with
Mylan’s arguments further bolster our conclusion that its claim is not a recognized defense to patent infringement. There is no indication in 21 U.S.C. § 355(j)(5)(B)(iii)(III) that Congress intended to provide an additional defense. Instead it indicates that Congress only envisioned that recognized defenses could be raised in declaratory judgments in patent infringement actions. See 21 C.F.R. § 314.107(b)(3) (2001) (expanding Paragraph IV certification to include “unen-forceability” defense in addition to the invalidity and noninfringement defenses stated in 21 U.S.C. § 355(j)(2)(A)(vii)(IV), because unenforceability is a recognized reason why a generic drug product would not violate a patent holder’s rights); see also Merck v. Danbury Pharmacal, Inc.,
Therefore, we are forced to conclude that Mylan’s action here against Bristol is in essence an attempt to assert a private right of action for “delisting” under the FFDCA. We see nothing in the Hatch-Waxman Amendments to alter the statement in section 337(a) of the FFDCA that “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C § 337(a) (1994). “In a case in which neither the statute nor the legislative history reveals a congressional intent to create a private right of action for the benefit of the plaintiff,” the inquiry is at an end. Northwest Airlines, Inc. v. Transp. Workers,
Our cases do not suggest a different result. In Abbott Laboratories v. Novopharm Ltd.,
Notably, Congress has considered legislation to amend the FFDCA to loosen the restrictions on generic ANDA applicants under 21 U.S.C. § 355(j)(5). See Greater Access to Affordable Pharmaceuticals Act of 2001, S. Res. 812, 107th Cong. (2001). The bill proposes, among other things, amending the forty-five day rule to allow a declaratory judgment with respect to the patent such that “if information on a patent for a listed drug has been published under subsection (c)(2) for at least 1 year after the date on which an abbreviated application for approval of a new drug was filed under this subsection in relation to the listed drug, the person that filed the abbreviated application or the holder of the approved application for the listed drug may immediately bring a civil action to determine the legal status of the patent for the listed drug.” This provision appears to recognize Mylan’s cause of action, subject to a one-year time delay from the publication of the patent information. It reinforces our conclusion that neither the general patent laws nor the Hatch-Wax-man Amendments now permit Mylan’s asserted action against Bristol in this case.
Conclusion
Accordingly, the judgment of the United States District Court for the District of Columbia is reversed.
REVERSED.
Notes
. We apply the law of the regional circuit to which the district court appeal normally lies unless "the issue pertains to or is unique to patent law,” in which case we will apply our own law to both substantive and procedural issues “intimately involved in the substance of enforcement of the patent right.” Amana Refrigeration, Inc. v. Quadlux, Inc.,
. The Hatch-Waxman Amendments were made both to the FFDCA and to Title 35 of the United Stales Code relating to patents. As such, a number of the Hatch-Waxman Amendments constitute part of the patent laws, and are essential to defining whether a defense to infringement is available under 35 U.S.C. § 271(e)(2)(A).
. Our conclusion that a declaratory relief action to "delist” is unavailable under the patent laws does not preclude jurisdiction. The determination of whether federal patent law creates such a remedy invokes our jurisdiction per Christianson v. Colt Industries Operating, Corp.,
. Because our review of the above issues disposes of the case, we need not address the remainder of the arguments submitted by the parties.