Mylan Pharmaceuticals, Inc. v. Thompson

• Decision Date: 12 October 2001
• Docket Number: DEFENDANTS-APPELLEES,BRISTOL-MYERS,PLAINTIFF-APPELLEE,DEFENDANT-APPELLANT,No. 01-1257,01-1257
• Citation: 60 USPQ2d 1576,268 F.3d 1323
• Parties: (Fed. Cir. 2001) MYLAN PHARMACEUTICALS, INC.,, v. TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES, BERNARD A. SCHWETZ, D.V.M., PH.D, ACTING PRINCIPAL DEPUTY COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION, AND U.S. FOOD AND DRUG ADMINISTRATION,, AND SQUIBB COMPANY,
• Court: U.S. Court of Appeals — Federal Circuit

Page 1323

268 F.3d 1323 (Fed. Cir. 2001)

MYLAN PHARMACEUTICALS, INC., PLAINTIFF-APPELLEE, v. TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES, BERNARD A. SCHWETZ, D.V.M., PH.D, ACTING PRINCIPAL DEPUTY COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION, AND U.S. FOOD AND DRUG ADMINISTRATION, DEFENDANTS-APPELLEES, AND BRISTOL-MYERS SQUIBB COMPANY, DEFENDANT-APPELLANT.

No. 01-1257

U.S. Court of Appeals, Federal Circuit

October 12, 2001

As amended October 17, 2001.

Appealed from: United States District Court for the District of Columbia, Judge Ricardo M. Urbina

E. Anthony Figg, Rothwell, Figg, Ernst & Manbeck, P.C. of Washington, DC, argued for plaintiff-appellee. With him on the brief were Steven M. Lieberman and Elizabeth A. Leff.

Howard S. Scher, Attorney, Appellate Staff, Civil Division, Department of Justice, of Washington, DC, argued for defendants-appellees. With him on the brief were Stuart E. Schiffer, Acting Assistant Attorney General; and Douglas N. Letter, Attorney. Of counsel on the brief were Michael M. Landa, Acting Chief Counsel; and Kevin M. Fain, Associate Chief Counsel, Office of the Chief Counsel, U.S. Food and Drug Administration, of Rockville, Maryland.

Evan R. Chesler, Cravath, Swaine & Moore, of New York, New York, argued for defendant-appellant. With him on the brief was Richard J. Stark. Of counsel were David R. Marriott, Swaine & Moore; and Mathew D. Peterson, FoxKiser, of Washington, DC.

Richard A. Samp, Washington, Legal Foundation, of Washington, DC, for amicus curiae Washington Legal Foundation. With him on the brief was Daniel J. Popeo.

Before Mayer, Chief Judge, Newman and Michel, Circuit Judges.

Mayer, Chief Judge.

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, No. 00-2876 (D.D.C. Mar. 14, 2001). The injunction directed Bristol to take measures to delist United States Patent No. 6,150,365 from the U.S. Food and Drug Administration's "Orange Book," and directed the FDA to grant final approval of Mylan's abbreviated new drug application for a generic version of buspirone. Id. Because we find that such a declaratory relief action against Bristol was not available to Mylan under the patent laws and was not created by the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act ("FFDCA") and to Title 35 of the United States Code, we reverse.

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-Waxman 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 in an ANDA a generic manufacturer may rely in part on the pioneer manufacturer's work by submitting data demonstrating the generic product's bioequivalence with the previously approved drug. See id. § 355 (j)(2)(A) (Supp. V 1999). These provisions of the Hatch-Waxman Amendments "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). Thus, Title I of the Act was intended 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. 98-857, pt. 1 at 14 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647. Title II, on the other side of the scale, was intended to benefit pioneer drug manufacturers by "restor[ing] . . . some of the time lost on patent life while the product is awaiting pre-market approval." H.R. Rep. No. 98-857, pt. 1 at 15, 1984 U.S.C.C.A.N. at 2648.

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 a statement to that effect (a "Section viii Statement"). Id. § 355(j)(2)(A)(viii).

An ANDA containing a Paragraph I or II certification may be approved without additional delay. See 21 U.S.C. § 355(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)(1)(iv) (2001)....