Mylan Laboratories, Inc. v. Leavitt
| Decision Date | 30 April 2007 |
| Docket Number | Civil Action No.: 07-579 (RMU).,Document No. 47.,Document No. 48.,Document No. 44. |
| Citation | 484 F.Supp.2d 109 |
| Parties | MYLAN LABORATORIES, INC. et al., Plaintiffs, v. Michael LEAVITT et al., Defendants, and Teva Pharmaceuticals USA., Apotex Inc., Mutual Pharmaceuticals Co., Intervenors. |
| Court | U.S. District Court — District of Columbia |
David James Harth, Heller Ehrman, LLP, Madison, WI, for Plaintiffs.
Drake S. Cutini, Department of Justice Office of Consumer Litigation, Washington, DC, for Defendants.
Jay P. Lefkowitz, Michael D. Shumsky, Kirkland & Ellis LLP, Arthur Y. Tsien, Olsson, Frank and Weeda, PC, John Will Ongman, Axinn Veltrop & Harkrider LLP, Washington, DC, Robert Breisblatt, Welsh & Katz, Limited, Chicago, IL, Steven E. Feldman, San Diego, CA, Chad A. Landmon, Jo Anne M. Kokoski, Axinn, Veltrop & Harkrider, L.L.P., Hartford, CT, for Intervenors.
In this case, four generic drug manufacturers of the drug amlodipine besylate each take issue with various portions of an FDA decision concerning their rights to market and sell their generic version of the drug under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act ("FDCA"). Each manufacturer seeks to clear the regulatory hurdles so that it can sell its generic version of amlodipine besylate and to do so as quickly as possible. Of these generic manufacturers only Mylan Laboratories, Inc. ("Mylan") is currently selling its generic drug on the market.
Before the court are motions for a preliminary injunction from Mylan, Apotex Inc. ("Apotex") and Teva Pharmaceuticals USA ("Teva"). Because none of the movants demonstrates a substantial likelihood of success on the merits, because all of the movants fail to show irreparable injury sufficient to warrant injunctive relief, and because a balancing of the harms and the public interest weigh against injunctive relief, the court denies their motions.
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. The Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. (1994), regulates the manufacture and distribution of pharmaceuticals.
Ordinarily under the FDCA, 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. In determining whether a product is sufficiently safe to warrant approval, the FDA reviews a large amount of clinical data submitted in the NDA, including the following: a listing of the drug's chemical or biological components; a statement of the drug's composition; a description of the drug company's manufacturing, processing, and packaging of the drug; drug samples; patent information; and proposed labeling for the drug. 21 U.S.C. § 355(b)(1).
Generic drugs are versions of brand-name prescription drugs that typically contain the same active ingredients as the brand-name original. United States v. Generix Drug Corp., 460 U.S. 453, 103 S.Ct. 1298, 75 L.Ed.2d 198 (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 often as time-consuming and costly as preparation of the original NDA, 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 wish to manufacture generic versions of the original drug, however, are only required to file an Abbreviated New Drug Application ("ANDA"). The generic manufacturer is allowed to essentially piggyback its ANDA on the FDA's previous findings that the pioneer drug is safe and effective. 21 U.S.C. § 355(a); Mead Johnson Pharm. Group v. Bowen, 838 F.2d 1332, 1333 (D.C.Cir.1988). As a result of 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 if the otherwise infringing activity is related to the development and submission of an ANDA. 35 U.S.C. § 271(e)(1). Hatch-Waxman also establishes an ANDA certification process, whereby generic makers can obtain expedited approval for their ANDAs before expiration of the pioneer maker's patent. 21 U.S.C. § 355(j)(5)(B). The overarching purpose of this abbreviated drug approval mechanism is to strike a "balance encouraging innovation in drug development with accelerating the availability of lower cost alternatives to approved brand-name drugs." H.R.Rep. No. 98-857 (Part I), at 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. at 2647-48.
Hatch-Waxman enables generic makers who adhere to certain requirements to obtain expedited ANDA approval as follows. 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. 21 U.S.C. § 355(j)(2)(A)(iv).
Critical to the instant motions, Hatch-Waxman requires an ANDA for a patented drug to 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." 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 refers to these certification clauses as Paragraphs I, II, III and IV, respectively.
Submission of an ANDA for a patented drug under a Paragraph IV certification constitutes an act of infringement if the generic maker intends to market its generic version before expiration of the original maker's patent. Notice of Filing, Ex. 1 (Apr. 18, 2007) ("FDA Decision") at 2. A generic maker seeking certification of its ANDA under Paragraph III, for example, must wait for the pioneer maker's patent to expire so as not to infringe the patent. But a generic maker seeking certification of its ANDA under Paragraph IV on the grounds that the pioneer maker's patent is invalid triggers a multi-tiered process that potentially enables it to obtain approval of its ANDA and market its generic drug before the pioneer maker's patent expires.
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. 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 FDA withholds approval of the ANDA until at least 30 months from the date the affected party (the pioneer maker) received notice of the action or certification.2 Thus, the potential exists 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, the Hatch-Waxman regime provides that the first generic manufacturer to file a Paragraph IV certified ANDA ("the first filer") is eligible for a 180-day exclusivity period. 21 U.S.C. § 355(j)(5)(B)(iv), Public Law No. 105-115, 111 Stat. 2296 (1997); Mova, 140 F.3d at 1064. 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 as prescribed by the statute. 21 U.S.C. § 355(j)(5)(B)(iv).
The statute also confers to the brand manufacturer a six-month period of exclusivity for complying with a request made by the FDA to conduct pediatric testing. See generally, 21 U.S.C. § 355a. This period of exclusivity, "pediatric exclusivity," can extend beyond the patent's expiration, and is tied to a court determination regarding validity of the patent in an infringement action. 21 U.S.C. § 355a(c)(2)(B).
This case centers around generic versions of amlodipine besylate. On July 31, 1992, the FDA approved Pfizer Inc.'s NDA for Norvasc. FDA Decision at 4. The FDA approved Norvasc for use in treating hypertension and angina. Id. The heart of this dispute is Patent 4,879,303 ("303 Patent") for Norvasc.3 FDA Decision at 4. This patent expired on March 25, 2007. FDA Decision at 1.
On May 22, 2002, Mylan filed an ANDA to the FDA for a generic version of amlodipine besylate. Id. at 4; Mylan's Application for a Prelim. Inj. (...
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