Mylan Pharmaceuticals, Inc. v. Thompson

• Citation: 139 F.Supp.2d 1
• Decision Date: 13 March 2001
• Docket Number: No. CIV. A. 00-2876(RMU).,CIV. A. 00-2876(RMU).
• Parties: MYLAN PHARMACEUTICALS, INC., Plaintiff, v. Tommy G. THOMPSON, Secretary, United States Department of Health and Human Services, United States Food and Drug Administration, and Bristol-Myers Squibb Co., Defendants.
• Court: U.S. District Court — District of Columbia

Page 1

139 F.Supp.2d 1

MYLAN PHARMACEUTICALS, INC., Plaintiff, v. Tommy G. THOMPSON, Secretary, United States Department of Health and Human Services, United States Food and Drug Administration, and Bristol-Myers Squibb Co., Defendants.

No. CIV. A. 00-2876(RMU).

United States District Court, District of Columbia.

March 13, 2001.

COPYRIGHT MATERIAL OMITTED

Edward Anthony Figg, Steven Lieberman, Rothwell, Figg, Ernst & Kurz, Washington, DC, for Mylan Pharmaceuticals, Inc.

Andrew E. Clark, U.S. Dept. of Justice, Office of Consumer Litigation, Washington, DC, for Secretary, U.S. Dept. of Health and Human Service, Jane E. Henney, Food & Drug Admin.

Michael B. Waitzkin, John D. Kiser, Matthew David Peterson, Foxkiser, Washington, DC, for Bristol-Myers Squibb Co.

MEMORANDUM OPINION

URBINA, District Judge.

GRANTING THE PLAINTIFF'S REQUEST FOR A PRELIMINARY INJUNCTION

                Table of Contents
                  I.  Introduction .................................................................4
                 II.  Statutory Framework—the Hatch-Waxman Act ...............................4
                      A.  Pioneer Makers and New Drug Applications (NDA) ...........................4
                      B.  Generic Makers and the Abbreviated-New-Drug-Application (ANDA)
                            Process ................................................................5
                III.  Factual Background ...........................................................7
                 IV.  The Maryland Litigation .....................................................10
                  V.  Discussion ..................................................................11
                      A.  Subject-Matter Jurisdiction .............................................11
                          1. The Declaratory Judgment Act .........................................12
                          2. Is This a "Patent Case"? .............................................16
                      B.  Preliminary Injunction Standard .........................................17
                      C.  Preliminary Injunction Analysis .........................................18
                          1. Prong 1: Whether Mylan is Likely to Succeed on the Merits ............18
                             a.  The '365 Patent Does Not Claim a Method of Using BuSpar® .....19
                             b.  The '365 Patent is Not One With Respect to Which a Claim of
                                  Patent Infringement Could Reasonably be Asserted ................21
                                 (1)  Claim Construction—The '365 Patent Expressly Disclaims
                                      Coverage of the Administration of Buspirone in the Manner
                                      Currently Approved ..........................................22
                                 (2)  Claim Construction-Bristol Surrendered the Coverage of
                                      the Administration of Buspirone During the Prosecution
                                      of the '365 Patent ..........................................24
                

                          2. Prong 2: Whether Mylan Will Suffer Irreparable Harm if the
                              Injunction is Not Granted ...........................................26
                          3. Prong 3: Whether Bristol or the FDA Will Be Injured by the
                              Granting of the Injunction ..........................................28
                          4. Prong 4: Whether the Public Interest Favors Granting a Preliminary
                              Injunction ..........................................................28
                      D.  Motion for Preliminary Injunction Granted ...............................29
                 VI.  Conclusion ..................................................................29
                

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. 6,150,365 ("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).¹

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, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983); 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, 502 U.S. 819, 112 S.Ct. 76, 116 L.Ed.2d 49 (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), U.S.Code Cong. & Admin.News 1984, p. 2647. 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, 103 S.Ct. 1298.

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...