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Mylan Pharmaceuticals, Inc. v. Thompson

March 13, 2001

MYLAN PHARMACEUTICALS, INC., PLAINTIFF,
v.
TOMMY G. THOMPSON, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND DRUG ADMINISTRATION, DOCUMENT NOS.: 3, 4 AND BRISTOL-MYERS SQUIBB CO., DEFENDANTS.



The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

As amended March 14, 2001.

MYLAN PHARMACEUTICALS, INC., PLAINTIFF,
v.
TOMMY G. THOMPSON, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND DRUG ADMINISTRATION, DOCUMENT NOS.: 3, 4 AND BRISTOL-MYERS SQUIBB CO., DEFENDANTS.

The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

MEMORANDUM OPINION

GRANTING THE PLAINTIFF'S REQUEST FOR A PRELIMINARY INJUNCTION

 I. INTRODUCTION

Mylan Pharmaceuticals, Inc., a generic drug manufacturer, moves for a preliminary injunction ordering defendant Bristol-Myers Squibb Co. ("Bristol" or "BMS") to de-list U.S. Patent No. 5,150,365 ("the '365 patent") from the United States Food and Drug Administration ("FDA")'s "Orange Book" and directing the FDA to approve immediately Mylan's Abbreviated New Drug Application ("ANDA") No. 75-252. Bristol's '365 patent covers a method of using BuSpar®, Bristol's brand-name buspirone hydrochloride ("buspirone") product. Mylan seeks this preliminary injunction so that it may proceed with plans to sell its generic buspirone product. For the reasons that follow, the court will grant Mylan's request for a preliminary injunction.

II. STATUTORY FRAMEWORK: THE HATCH-WAXMAN ACT

A. PIONEER MAKERS AND NEW DRUG APPLICATIONS (NDAS)

An understanding of the statutory and regulatory framework governing the approval of generic drugs is critical to assessing the merits of the parties' claims. The Federal Food, Drug, and Cosmetic Act ("FFDCA"), as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, authorizes the FDA to regulate the production, distribution, and sale of drugs in the United States. See 21 U.S.C. §§ 321-397. An applicant seeking to market a new brand-name drug ("a pioneer maker") must prepare a rigorous New Drug Application ("NDA") for FDA consideration. See 21 U.S.C. § 355. The NDA contains reports of the drug's safety and effectiveness, a list of the articles used as components in the drug, a statement of the composition of the drug, a description of the methods, facilities and controls used in the manufacture, processing and packaging of the drug, samples of the drug or components, if necessary, and samples of the proposed labeling. See 21 U.S.C. § 355(b)(1). In addition, the NDA must contain information on any patents that claim the drug or a method of using the drug and for which a claim of patent infringement could reasonably be asserted against an unauthorized party. See 21 U.S.C. §§ 355(b)(1), (c)(2). *fn1

Upon approval of the NDA, the FDA publishes any claimed patents for the approved drug in "Approved Drug Products with Therapeutic Equivalence Evaluations," also known as the "Orange Book." See 21 U.S.C. § 355(j)(7)(A)(iii). Pioneer makers have considerable incentive to cause the FDA to list patents in the Orange Book. See Mylan's Memorandum of Law in Support of its Motion for Preliminary Injunction ("Mot. for Prelim. Inj.") at 12 (citing Bristol- Myers Squibb Co. v. Ben Venue Labs., 90 F. Supp.2d 522, 524 (D.N.J. 2000)). When the FDA lists a patent for an approved drug, generic makers often have to wait an additional thirty months to obtain FDA approval of their competing generic drugs. See Mot. for Prelim. Inj. at 12.

B. Generic Makers and the Abbreviated-New-Drug-Application (ANDA) Process

Generic drugs are versions of brand-name prescription drugs that typically contain the same active ingredients but not necessarily the same inactive ingredients as the brand-name original. See United States v. Generix Drug Corp., 460 U.S. 453, 454-55 (1980); Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1062 (D.C. Cir. 1998). Before 1984, a company that wished to make a generic version of an FDA-approved brand-name drug ("a generic maker") had to file another NDA. Preparation of the second NDA was as time-consuming and costly as the original, because the applicant had to include new studies showing the drug's safety and effectiveness. See Mova, 140 F.3d at 1063. In 1984, however, Congress enacted the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, which simplified the procedure for obtaining approval of generic drugs. See Pub. L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. § 355 and 25 U.S.C. §§ 156 and 271(e).

The Hatch-Waxman Act represented Congress's efforts to strike a compromise between the competing interests of pioneer pharmaceutical companies and generic manufacturers. As Chief Judge (then Judge) Edwards of the Court of Appeals for this Circuit explained, the Hatch- Waxman Act "emerged from Congress' efforts to balance two conflicting policy objectives: to induce name-brand pharmaceutical firms to make the investments necessary to research and develop new drug products, while simultaneously enabling competitors to bring cheaper, generic copies of those drugs to market." Abbott Labs. v. Young, 920 F.2d 984, 991 (D.C. Cir. 1990) (Edwards, J., dissenting on other grounds) (citations omitted), cert. denied, 402 U.S. 819 (1991). To this end, Title I of the Act aimed "to make available more low cost generic drugs by establishing a generic drug approval procedure for pioneer drugs first approved after 1962." H.R. Rep. No. 857 (Part I), 98th Cong., 2d Sess. at 14 (1984). Title II of the Act, by contrast, favored the interests of pioneer makers by granting patent-term extensions and guaranteeing market exclusivity for innovative drug products. See id. at 15.

Under the Hatch-Waxman Act, Congress continues to require the pioneer maker to file an NDA, complete with safety and effectiveness data. Subsequent applicants who wish to manufacture generic versions of the original drug, however, are required to file only an Abbreviated New Drug Application ("ANDA"). See 21 U.S.C. § 355(j). Unlike the stringent requirements for an NDA, an ANDA applicant need not show independent evidence of the safety and efficacy of its generic drug, but instead can rely on the FDA's previous determination that the drug is safe and effective. See 21 U.S.C. § 355(j); 21 C.F.R. § 314.94(a)(3); Mead Johnson Pharm. Group v. Bowen, 838 F.2d 1332, 1333 (D.C. Cir. 1988). The ANDA innovation thus allows manufacturers to market generic copies of pioneer drugs without repeating the expensive and lengthy clinical trials otherwise required by federal law. For this reason, among others, generic drugs are generally much cheaper to the consumer than brand-name drugs. See Ben Venue Labs., Inc. v. Novartis Pharm. Corp., 10 F. Supp.2d 446, 449 (D.N.J. 1998); see also Generix Drug Corp., 460 U.S. at 455 n.1.

To receive approval of its ANDA, an applicant must show that its generic drug is "bioequivalent" to the listed reference drug. See 21 U.S.C. § 355(j)(4)(F). Bioequivalence refers to the rate at which, and the extent to which, the body absorbs the active ingredient(s) in the drug. See id. § 355(j)(8)(A); 21 C.F.R. § 320.1(e). In this case, the reference drug is BuSpar®, the brand of buspirone marketed by Bristol. The applicant must also show that the generic drug has the same route of administration, strength, and dosage form as the reference drug. See 21 U.S.C. §§ 355(j)(2)(A)(iii), (j)(4)(D)(i)-(ii); see also 21 C.F.R. § 314.92(a)(1) (1999) (indicating the categories of drug products for which an ANDA may be filed).

In addition, when a generic maker files an ANDA seeking approval of a generic version of a drug that is listed in the Orange Book, the applicant must certify that any patent information listed in the Orange Book does not bar FDA approval of a generic version of the drug. See 21 U.S.C. § 355(j)(2)(A)(vii); 21 C.F.R. § 314.94(a)(12). The Hatch-Waxman Act provides ANDA applicants with four certification options: (I) that no patent information on the drug product that is the subject of the ANDA has been submitted to the FDA; (II) that the patent has expired; (III) that the patent will expire on a stated date; or (IV) that the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug for which the ANDA applicant seeks approval. See 21 U.S.C. §§ 355(j)(2)(A)(vii)(I) to (IV). The court will refer to these certification clauses as Paragraph I, II, III and IV certifications, respectively. In the case of a patent that has not yet expired (such as the '365 patent), the ANDA applicant's only certification options are Paragraph III or IV certifications. See id.

The Hatch-Waxman Act also permits ANDA applicants to avoid certifying to a method- of- use patent if they are not seeking approval for any of the uses claimed in the patent. In that circumstance, the Act requires the ANDA applicant to make a statement to the FDA that the existing method-of-use patent does not relate to the use(s) for which the ANDA applicant seeks approval. See 21 U.S.C. § 355(j)(2)(A)(viii); 21 C.F.R. § 314.94(a)(12)(iii). This statement is known as a "Section viii Statement."

The timing of FDA approval of the ANDA depends in part on the type of certification. If the ANDA contains a Paragraph I or II certification, the FDA may approve the ANDA as soon as it is satisfied that the product is safe and effective. See 21 U.S.C. § 355(j)(5)(B)(i). If the ANDA contains a Paragraph III certification, the FDA cannot make the approval effective until the patent expires. See 21 U.S.C. § 355(j)(5)(B)(ii). If the ANDA contains a Paragraph IV certification, the date of approval is determined by a complicated statutory scheme under which the ANDA applicant must provide notice to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA refers. See 21 U.S.C. § 355(j)(2)(B)(i). This notice must include a detailed statement of the factual and legal basis for the ANDA applicant's assertion that the patent is not valid or will not be infringed by its generic product. See id.; 21 C.F.R. § 314.95.

A Paragraph IV certification has significant legal effects. See Ben Venue Labs., 10 F. Supp.2d at 449. The patent law provides that submitting an application for an infringing product is itself an act of infringement. See id. (citing 35 U.S.C. § 271(e)(2)(A)). Thus, a Paragraph IV certification automatically creates a cause of action for patent infringement. *fn2 See id. Upon receiving notice of a Paragraph IV certification, the patent holder has 45 days in which to file suit against the generic manufacturer. See 21 U.S.C. § 355(j)(5)(B)(iii). *fn3 If the patent-holder brings such an action, the FDA is prohibited from approving the generic maker's ANDA for a period of 30 months. See id. This 30-month stay allows the parties to litigate the patent infringement action in court. If the court hearing the infringement action decides the patent would be infringed by the product proposed in the ANDA, the FDA will not approve the ANDA until the patent expires. If, however, the court hearing the infringement action rules before the expiration of the 30-month period that the patent is invalid or not infringed, the FDA must approve the ANDA effective on the date of the court's decision. See id.

The statutory framework of the Hatch-Waxman Act creates the potential for costly patent litigation against the generic maker that files a Paragraph IV-certified ANDA. As an incentive to the first generic maker to expose itself to the risk of costly patent litigation, Hatch-Waxman provides that the first to file a Paragraph-IV certified ANDA ("the first filer") is eligible for a 180- day period of exclusivity ("the Exclusivity Incentive"). See 21 U.S.C. § 255(j)(5)(B)(iv), as amended by Pub. Law. No. 105-115, 111 Stat. 2296 (1997); Mova v. Shalala, 140 F.3d 1060, 1064 (D.C. Cir. 1998). That is, during those 180 days, the FDA will not approve any other ANDA for the same generic product. By its terms, the Exclusivity Incentive affords the first filer protection from competition from subsequent generic makers for 180 days beginning from the earlier of a commercial marketing or a court decision. See 21 U.S.C. § 355(j)(5)(B)(iv)(I), (II).

III. FACTUAL BACKGROUND

At the center of this dispute is a white, ovoid-rectangular, scored tablet called BuSpar®. See Mem. of Bristol-Myers Squibb Co. in Opp'n to Pl.'s Request for a Prelim. Inj. ("Bristol Opp'n"), Ex. 9 at 12; Fed. Defs.' Mem. in Opp'n to Pl.'s Mot. for Prelim. Inj. ("FDA Opp'n") at 8. Since 1986, Bristol has sold BuSpar®--which contains the active ingredient buspirone--as a medication to treat patients suffering from generalized anxiety disorder. See Mot. for Prelim. Inj. at 1. In 1999, Bristol sold more than $600 million of BuSpar®. See id. According to Bristol, BuSpar® "is one of those rare successes that provide[s] profits to its developer's shareholders and fund[s] research and development of new drugs--most of which are never successfully brought to market." Bristol Opp'n at 6.

Bristol received a patent covering the administration of buspirone to treat anxiety disorders in 1980, and obtained FDA approval of BuSpar® in 1986. See Mot. for Prelim. Inj. at 1. In addition, Bristol received a two-year extension to its 17-year patent term to compensate for the delays in regulatory approval of BuSpar®. See id. More recently, Bristol extended its exclusive rights over buspirone for an additional six months under the pediatric exclusivity provisions of the FFDCA, 21 U.S.C. § 355a. See id.; FDA Opp'n at 9. Bristol's term of exclusivity, which was set to expire at 11:59 p.m. on November 21, 2000, has enabled it to sell BuSpar® for almost fifteen years without any competition from generic buspirone makers. See Mot. for Prelim. Inj. at 1.

Mylan is the nation's largest generic drug manufacturer. See Bristol Opp'n at 1. On September 29, 1998, Mylan submitted an ANDA to the FDA for a generic version of buspirone tablets. See FDA Opp'n at 9. Mylan's ANDA contained a Paragraph III certification stating that it would not market its generic product until the expiration of Bristol's patent 4,182,763 ("the '763 patent"). See id. The FDA "tentatively approved" Mylan's ANDA, with final approval contingent only on the expiration of Bristol's exclusivity on November 22, 2000. See id.; Mot. for Prelim. Inj. at 2. Anticipating the expiration of Bristol's exclusivity, Mylan took the steps necessary to put its buspirone product on the market, even loading its trucks with generic buspirone tablets for shipment beginning at 12:00 a.m. on November 22, 2000. See Mot. for Prelim. Inj. at 2.

Only twelve hours before Bristol's exclusivity was to expire, however, the U.S. Patent and Trademark Office ("PTO") issued patent 6,150,365 ("the '365 patent") to Bristol, *fn4 which Bristol immediately delivered to the FDA for listing in the Orange Book. See id. at 2; FDA Opp'n at 9; Bristol Opp'n at 14. Bristol also submitted a declaration to the FDA stating that the '365 patent "is a method-of-use patent covering, among other things, a method of using BuSpar® for all of its approved indications." See FDA Opp'n at 9 (citing Bristol Declaration dated Nov. 21, 2000, Ex. B). *fn5 Bristol's submission to the FDA contained all the information required by the FDA's regulations, including the patent number, date of expiration, type of patent, a declaration that the '365 patent "covers the formulation, composition and/or method of use of BuSpar®," and an identification of the approved BuSpar® uses that are covered by the patent. See Bristol Opp'n at 14. As a result of the FDA's receipt of the '365 patent and accompanying declaration, the FDA did not give final approval to Mylan's ANDA (or to any other ANDAs) for generic buspirone tablets. See FDA Opp'n at 9-10.

The FDA's listing sparked a flurry of activity among Bristol, Mylan and other companies seeking to market a generic version of buspirone. On November 21, 2000, Bristol issued a press release regarding the '365 patent. See Bristol Press Release dated Nov. 21, 2000 (FDA Opp'n, Ex. C). As described in Bristol's press release, the '365 patent covers "a method of use of a metabolite produced by the administration of [buspirone]." *fn6 Id. Shortly after the FDA received the '365 patent, Mylan and Danbury Pharmacal, Inc. ("Danbury"), another company with a pending ANDA for buspirone, provided copies of the press release to the FDA. The FDA also received correspondence from Danbury, in which Danbury argued that under the Federal Circuit's ruling in Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756 (Fed. Cir. 1997), a patent for a metabolite could not "claim a listed drug" within the meaning of the statute. See FDA Opp'n at 11 (citing Danbury Correspondence to FDA dated Nov. 24 & 27, 2000, Ex. B). In addition, on November 22, 2000, Mylan filed a Section viii Statement with the FDA stating that the labeling of its drug in the ANDA did not claim the method-of-use covered by the '365 patent. *fn7 See FDA Opp'n at 10 (citing Mylan Correspondence to FDA dated Nov. 22, 2000, Ex. D). Mylan requested that the FDA accept its Section viii Statement and approve its ANDA immediately. See Mot. for Prelim. Inj. at 9.

In light of these submissions, and faced with contradictory information about the '365 patent, the FDA requested additional input from Mylan, Danbury, and Bristol. See FDA Opp'n at 11. According to the FDA, it read the Bristol press release as suggesting that the '365 patent covered a metabolite of buspirone. See id. At the same time, the Federal Circuit's Hoechst- Roussel decision suggested to the FDA that patents for a drug's metabolites do not "claim" the listed drug itself. See id. The FDA therefore turned to Bristol for clarification as to whether the patent claimed only a metabolite of buspirone. Specifically, in a letter dated November 30, 2000, the FDA asked Bristol to provide "a declaration that the '365 patent issued by the PTO on November 21, 2000 contains a claim for an approved use of buspirone hydrochloride [the approved drug] that is separate from the claim for 6-hydroxy-buspirone [the metabolite] described in the November 21, 2000, Bristol-Myers Squibb press release." See id. at 11-12 (citing FDA Letter to Bristol dated Nov. 30, 2000, Ex. F). The FDA also asked Mylan and Danbury to submit additional legal analysis "to help the agency determine the impact of this Federal Circuit opinion [Hoechst-Roussel] on the patent listing process." See FDA Opp'n at 12.

The FDA requested this additional input from the parties on November 30, 2000. That same day, without responding to the FDA's request, both Mylan and Danbury filed suit in federal court. Mylan filed the instant action, naming both the FDA and Bristol as defendants. Danbury filed suit in the U.S. District Court for the District of Maryland, naming FDA Commissioner Jane Henney as the sole defendant. In both suits, the plaintiffs requested preliminary injunctive relief that would prevent the listing of the '365 patent and require the FDA to approve their buspirone ANDAs immediately. (The Maryland litigation is discussed in greater length below).

On December 4, 2000, Bristol submitted the clarification that the FDA had requested four days earlier. See Second Bristol Decl., dated Dec. 4, 2000 (FDA Opp'n, Ex. I). In its clarification, Bristol declared that the sole claim of the '365 patent was: a method for ameliorating an undesirable anxiety state comprising the direct administration of 6-hydrox-busprione [the metabolite] or oral administration of a prodrug *fn8 [buspirone] of 6-hydrox-busprione such as buspirone hydrochloride to provide an effective but non-toxic anxiolytic dose of 6-hydrox-busprione. Id.

Bristol also explained that the Bristol press release that Mylan and Danbury had provided to the FDA was "a short-hand, layperson's description of the patent." See Bristol Opp'n at 15. Finally, in a letter accompanying the declaration, Bristol reiterated that "the '365 patent does not simply claim a method of using [the metabolite], but also claims a method of using [buspirone itself]." Id. (Dec. 4, 2000 Letter) at 2.

Based on Bristol's clarification, and "consistent with [the FDA's] long-standing policy of accepting at face value the accuracy of such patent declarations, [the] FDA concluded that the Federal Circuit's ruling in Hoechst-Roussel was inapplicable because the '365 patent did not solely claim a metabolite." FDA Opp'n at 13. For this reason, the FDA informed Bristol that the clarification had "adequately responded" to the agency's concerns, and that the '365 patent would therefore be deemed to have been listed in the Orange Book on November 21, 2000. See id. (citing FDA Letter to Bristol dated Dec. 6, 2000, Ex. J).

IV. THE MARYLAND LITIGATION

On November 30, 2000, the very day that Mylan instituted litigation in this court, two other generic drug companies, Watson Pharmaceuticals and Danbury Pharmacal (hereinafter "Danbury") *fn9 filed suit in the U.S. District Court for the District of Maryland. Like Mylan, Danbury sought an injunction ordering the de-listing of Bristol's '365 patent from the Orange Book. On January 18, 2001, U.S. District Judge Frederic N. Smalkin issued a Memorandum Opinion denying the plaintiffs' request for preliminary injunctive relief. See Watson Pharm., Inc. and Danbury Pharmacal, Inc. v. Henney, Civil Action No. 00-3516, (D. Md. Jan. 17, 2001). In his Opinion, Judge Smalkin described Danbury's suit as, "at base, a quest for judicial review of a federal agency's final decision" under the Administrative Procedure Act ("APA"), 5 U.S.C. § 706. See id. at 4. It is, of course, well-established that agency determinations are entitled to deference under Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984).

Noting that the FDA plays a limited, "ministerial" role in the patent fights between patent holders and generic makers, and in light of the traditional deference accorded to agency determinations, Judge Smalkin ruled that it was "not the business of the FDA or of this Court in an APA review, to adjudicate the merits of the scope and/or validity of the claims covered by the '365 patent." See id. at 5 (emphasis in original). Accordingly, Judge Smalkin ruled that since the FDA's action was not "unreasonable, arbitrary, or capricious," the federal defendants were entitled to summary judgment on the merits. See id.

Because Bristol and the FDA have urged this court to adopt Judge Smalkin's reasoning, it is worth examining how this case differs from the Maryland litigation. First, Danbury did not sue Bristol. See id. at 7. In fact, although Bristol ultimately intervened as a defendant in the Maryland litigation, Danbury did not request any relief against Bristol. See id. Second, Danbury did not raise the issue of whether Bristol's '365 patent was one as to which a claim of patent infringement could reasonably be asserted. See id. Finally, Danbury did not submit a Section viii Statement to the FDA, and therefore did not argue, as did Mylan, that the FDA was required to accept its Section viii Statement. See id.

The FDA has endorsed Judge Smalkin's ruling, reiterating to this court that its role in listing patents is "purely ministerial" and that it "does not have the expertise nor the resources to resolve complex patent coverage issues." See FDA Opp'n at 19 (citing 54 Fed. Reg. 28872, 28909-10 (July 10, 1989)). For this reason, among others, the FDA argues that Mylan's remedy is not to sue the agency, but rather to ask the court hearing its patent claims to modify the presumptive 30- month statutory stay on FDA approval of Mylan's ANDA. See FDA Opp'n at 23; see also 21 U.S.C. § 355(j)(5)(B)(iii) (providing that 30-month stay may be modified by the court hearing the patent litigation).

Mylan responds that it is not asking the FDA to perform anything but a ministerial act. As Mylan explained at oral argument, the FDA is "an important player here because if we were to sue Bristol alone and not the FDA and there were to be an order directed to Bristol asking Bristol to request [that] the patent be delisted from the Orange Book, we might still need relief against the FDA if the FDA, for whatever reason, declined to do so." See Tr. of Oral Argument dated Jan. 24, 2001 ("Tr.") at 8. In other words, Mylan has placed the "substantive burden" in this matter on Bristol. See id. at 7. Indeed, with the exception of the Section-viii-Statement issue, Mylan is challenging only Bristol's actions, not the FDA's. See Pl.'s Reply Mem. In Support of Mot. for Prelim. Inj. ("Pl.'s Reply") at 3-4. Specifically, Mylan asks the court to declare that Bristol improperly submitted the '365 patent to the FDA for inclusion in the Orange Book. See id. at 4. In this way, Mylan has cleverly avoided the problem that Danbury faced in its suit, namely that the FDA's decision to list the '365 patent was entitled to a presumption of validity under Chevron and its progeny.

V. DISCUSSION

A. Subject-Matter Jurisdiction

Before proceeding to the preliminary-injunction analysis, the court must address Bristol's argument that Mylan does not identify any recognized cause of action in support of its request for relief. See Bristol Opp'n at 22-23. According to Bristol, Mylan's lawsuit is not the appropriate vehicle for challenging Bristol's submission of the '365 patent for inclusion in the Orange Book. See id. This is so, Bristol argues, because Mylan seeks to enforce the FFDCA--a statute which by its terms does not allow for a private right of action. See id. at 22; see also 21 U.S.C. § 337(a) ("proceedings for the enforcement, or to restrain violations, of the [statute] shall be by and in the name of the United States"). Indeed, as Bristol points out, "every federal court that has addressed the issue has held that the FFDCA does not create a private right of action." See Bristol Opp'n at 22 (citing Eli Lilly & Co. v. Roussel Corp., 23 F. Supp.2d 460, 476 (D.N.J. 1998)); see also In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781, 788 (3d Cir. 1999); PDK Labs., Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997); Bailey v. Johnson, 48 F.3d 965, 966-68 (6th Cir. 1995); Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993), cert. denied, 510 U.S. 1097 (1994); Rodriguez v. SK & F Co., 833 F.2d 8, 9 (1st Cir. 1987) (per curiam). For this reason, Bristol urges the court to hold that Mylan has failed to state a claim upon which relief can be granted. See Bristol Opp'n at 22.

Mylan, however, does not seek to enforce the FFDCA against Bristol. See Pl.'s Reply at 4. Rather, Mylan asks the court to declare that Bristol improperly submitted the '365 patent to the FDA for inclusion in the Orange Book because that patent did not meet 21 U.S.C. § 355(c)(2)'s requirements for such a listing. See id. Mylan also asks that the court, upon making this determination, order Bristol to withdraw its submission of the '365 patent, and instruct the FDA to perform the "ministerial" task of de-listing the '365 patent from the Orange Book. See id. Mylan contends--and the court agrees--that these requests are proper under the Declaratory Judgment Act, 28 U.S.C. § 2201. See id. at 4-5.

1. The Declaratory Judgment Act

The Declaratory Judgment Act permits federal courts to "declare the rights and other legal relations" of parties to "a case or actual controversy." See 28 U.S.C. § 2201. The Act does not enlarge the jurisdiction of federal courts beyond what is constitutionally permissible, but widens the range of remedies that federal courts have at their disposal. See Skelly Oil Co. v. Phillips Petroleum Co., 339 U.S. 667, 771-72 (1950). The sole requirement for jurisdiction under the Act is that the conflict be "real and immediate, i.e., that there be a true, actual 'controversy.'" See Arrowhead Indus. Water, Inc. v. Ecolochem, Inc., 846 F.2d 731, 735 (Fed. Cir. 1988). The "actual controversy" requirement, in turn, mirrors the "case or controversy" requirement of Article III of the United States ...


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