Mylan Pharmaceuticals Inc. v. Henney

Decision Date31 March 2000
Docket NumberCivil Action No. 99-cv-862(RMU).,Civil Action No. 99-cv-801 (RMU).
Citation94 F.Supp.2d 36
PartiesMYLAN PHARMACEUTICALS INC., Plaintiff, v. Jane E. HENNEY and Donna E. Shalala, Defendants, Barr Laboratories, Inc., Intervenor-Defendant. Pharmachemie B.V., Plaintiff, v. Jane E. Henney and Donna E. Shalala, Defendants, Barr Laboratories, Inc., Intervenor-Defendant.
CourtU.S. District Court — District of Columbia

James Harold Wallace, Jr., Wiley, Rein & Fielding, Washington, DC, for Mylan Pharmaceuticals, Inc.

Mark E. Nagle, Wilma Antoinette Lewis, Meredith Manning, U.S. Attorney's Office, Washington, DC, for Jane E. Henney, Donna E. Shalala.

Michael K. Atkinson, Charles Bennett Klein, Winston & Strawn, Washington, DC, for Barr Laboratories, Inc.

Geoffrey M. Levitt, James N. Czaban, Venable, Baetjer, Howard & Civiletti, L.L.P., Washington, DC, for Pharmachemie B.V.

MEMORANDUM OPINION

URBINA, District Judge.

ORDERING CONSOLIDATION OF CASES; DENYING MYLAN'S AND PHARMACHEMIE'S MOTIONS FOR INJUNCTIVE RELIEF; DENYING MYLAN'S AND PHARMACHEMIE'S MOTIONS TO INTERVENE; REMANDING TO FDA FOR PERMISSIBLE INTERPRETATION OF 21 U.S.C. § 355(j)(5)(B)(iv) AND REGULATION 314.94(a)(12)(viii)

I. INTRODUCTION

Pharmachemie, B.V. ("Pharmachemie") and Mylan Pharmaceuticals, Inc. ("Mylan"), generic manufacturers of the drug tamoxifen (together, the "Parties"), bring separate actions against Defendant Jane E. Henney, M.D., in her official capacity as Commissioner of the United States Food and Drug Administration, and against Defendant Donna E. Shalala, in her official capacity as Secretary of the United States Department of Health and Human Services (collectively referred to as the "FDA"). The Parties, whose tamoxifen drugs are used in the treatment of breast cancer, bring their actions under the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. and the Administrative Procedure Act ("APA"), 5 U.S.C. § 706. (Mylan's Compl. at 2; Pharmachemie's Compl. ("Pharm.'s Compl.") ¶ 9.) Barr Laboratories ("Barr") is a manufacturer of the generic drug tamoxifen, currently exclusively licensed by the owner of the patent to market the drug. (Pharm.Mot. for Prelim.Inj., Ex. 4.)

Mylan and Pharmachemie both assert that the FDA acted arbitrarily and capriciously in rendering by letter dated March 2, 1999 (the "March Letter"), its decision to grant Barr's request that the FDA stay approval of any version of the drug tamoxifen other than Barr's version. (Mylan's Compl. at 2; Pharm.'s Compl. ¶ 5.) The effect of the March Letter is that neither Mylan nor Pharmachemie has the opportunity to market their generic version of tamoxifen until the patent for tamoxifen expires on August 20, 2002. In essence, both maintain that the March Letter violates the FDCA and runs contrary to the agency's own regulations. See id.

Before reaching the merits of the underlying dispute, the court makes the following preliminary determinations, which will assist in the efficacious management and just resolution of this case. First, the court orders the cases, Mylan v. Henney et al. and Pharmachemie v. Henney et al. consolidated for the reasons discussed infra at II.C. Second, the court denies both parties' outstanding motions to intervene for the reasons articulated infra at III.C. Before elaborating on the reasons for these preliminary determinations, the court turns to consider the statutory and regulatory framework that gives rise to the parties' common claims in this now consolidated action.

II. BACKGROUND

A. The Hatch-Waxman Amendments

I. NDA, ANDA and Expedited Generic Approvals

An understanding of the statutory and regulatory framework applicable to the marketing of generic drugs is critical to assessing the merits of the parties' claims. Generic drugs are versions of brand-name prescription drugs that typically contain the same active ingredients as the brand-name original. See United States v. Generix Drug Corp., 460 U.S. 453, 455, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1980); Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1062 (D.C.Cir.1998). Ordinarily, an applicant seeking to market a new brand-name drug ("a pioneer maker") must prepare a rigorous New Drug Application ("NDA") for FDA approval, which includes data showing the new drug's safety and effectiveness. 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 application had to include new studies showing the drug's safety and effectiveness. See Mova, 140 F.3d at 1063.

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Amendments ("Hatch-Waxman"), which simplified the procedure for obtaining approval of generic drugs. See Pub.L. No. 98-417, 98 Stat. 1585 (1984). Under Hatch-Waxman, the pioneer maker is still required to file an NDA, complete with safety and effectiveness data. Subsequent applicants who wished to manufacture generic versions of the original drug, however, were only required to file an Abbreviated New Drug Application ("ANDA"). The ANDA is allowed to rely on the FDA's previous determination that the drug is safe and effective. See 21 U.S.C. § 355(a); Mead Johnson Pharmaceutical Group v. Bowen, 838 F.2d 1332, 1333 (D.C.Cir.1988). As a result of the ANDA innovation under Hatch-Waxman, generic makers can obtain expedited approval to market generic versions of drugs that have undergone the rigors of "pioneer" approval under the NDA process.

Moreover, generic makers are permitted to manufacture and use drugs protected by a patent(s) if the otherwise infringing activity is related to the development and submission of an ANDA. See 35 U.S.C. § 271(e)(1). Finally, Hatch-Waxman establishes an ANDA certification process, whereby generic makers can obtain expedited approval for their ANDAs before expiration of the pioneer maker's patent. See 21 U.S.C. § 355(j)(5)(B).

III. ANDA Certification and Expedited Approval

Hatch-Waxman potentially enables generic makers who adhere to certain requirements to obtain expedited ANDA approval as follows. First, a generic maker seeking approval of its ANDA must demonstrate that (1) the generic version of the drug is "bio-equivalent" to the pioneer NDA version and (2) the generic maker is able to manufacture the drug to required specifications. See 21 U.S.C. § 355(j)(2)(A)(iv). Second, and of moment to this controversy, the ANDA must include a "certification, that for each of the patents applicable to the pioneer drug, the proposed generic drug would not infringe the patent because (I) the patent information has not been filed; (II) the patent has expired; (III) the patent will expire on a stated date; or (IV) the patent is invalid or will not be infringed by the manufacture, use or sale of the drug for which the abbreviated application applicant seeks approval." See 21 U.S.C. § 355(j)(2)(A)(vii); Purepac Pharm. Co. v. Friedman, 162 F.3d 1201, 1202 (D.C.Cir.1998). The court will refer to the above-referenced certification clauses as Paragraphs I, II, III and IV, respectively.

(i) Paragraph IV and Expedited Approval

Submission of an ANDA for a patented drug is an infringing act if the generic maker intends to market its generic version before expiration of the original maker's patent. (See Pharm.Mot for Prelim.Inj., Ex 4, Guidance for Industry, 180-Day Generic Drug Exclusivity ("Guidance"), at 2.) For example, a generic maker seeking certification of his ANDA under Paragraph III must wait for the pioneer maker's patent to expire and, consequently will not infringe the patent. But a generic maker seeking certification of his ANDA under Paragraph IV, on the grounds that the pioneer maker's patent is invalid, triggers a multi-tiered process that potentially enables him to obtain approval of his ANDA and market his generic drug before the pioneer maker's patent expires.

(ii) Paragraph IV and Infringement Actions

The FDA can approve a generic maker's Paragraph IV-certified ANDA immediately, unless the pioneer maker brings an action for patent infringement against the ANDA applicant within 45 days of the date the pioneer maker receives notice of the Paragraph IV certification. See 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2).1 If a patent action is brought within 45 days, however, the ANDA will not be approved until at least 30 months from the date the affected parties, i.e., pioneer makers, receive notice.2 Thus, the potential exists for costly patent litigation against the generic maker that files a Paragraph IV-certified ANDA.

(iii) The Exclusivity Incentive

As an incentive to the first generic maker to expose himself to the risk of costly patent litigation, the Hatch-Waxman regime provides that the first to file a Paragraph IV certified ANDA ("the first filer") is eligible for a 180-day period of marketing protection, commonly known as the 180-day exclusivity period ("the Exclusivity Incentive"). See 21 U.S.C. § 355(j)(5)(B)(iv), as amended by Public Law No. 105-115, 111 Stat. 2296 (1997); Mova v. Shalala, 140 F.3d 1060, 1064 (D.C.Cir.1998) ("Mova 1998"). 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 court decision. In explaining what is intended a court decision, the Exclusivity Incentive makes explicit reference to "clause (iii)" of the statute. See 21 U.S.C. § 355(j)(5)(B)(iii).

B. Factual Background

The facts material to disposition of this consolidated action date back to August, 1985, when a pioneer maker secured the original patent for brand-name tamoxifen, which is a drug used in the treatment of breast cancer. On August 20, 1985, Imperial Chemicals Industries, PLC ("Imperial") obtained U.S.Patent 4,536,516,...

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