Nature of the Case
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Facts
Bristol-Myers Squibb Co. (Bristol) appealed an order granting the motion for a preliminary injunction brought by P. The injunction directed Bristol to take measures to delist the '365 patent from the FDA's 'Orange Book,' and directed the FDA to grant final approval of P's abbreviated new drug application for a generic version of buspirone. 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. §355(a). The NDA must contain detailed clinical studies of the drug's safety and efficacy. The NDA must also include a list of patents that claim the drug. 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.' 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. §314.53(c)(2)(ii). 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. An ANDA offers an expedited approval process for generic drug manufacturers. 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. The Hatch-Waxman Amendments concerning patent infringement are part of the equation. Under Section 271(e)(1), it is not infringement to conduct otherwise infringing acts necessary to prepare an ANDA. Under section 271(e)(2) 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. Not all ANDA applicants can be sued immediately for infringement; moreover, they cannot sue immediately for declaratory judgment with respect to the patent. The ANDA applicant 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.' §355(j)(2)(A)(vii). 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. §314.94(a)(12)(vi). 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. An ANDA containing a Paragraph I or II certification may be approved without additional delay. 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. A Paragraph IV certification requires that 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. The patentee is then given forty-five days to sue the ANDA applicant for infringement. 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. The availability of declaratory judgment actions is limited: 'Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under section 2201 of Title 28, for a declaratory judgment with respect to the patent.' Hatch-Waxman does not include any explicit provisions either enabling or prohibiting an action to challenge a patentee's listing of a patent in the Orange Book. Bristol the '763 patent. It is listed in the Orange Book as covering Bristol's FDA-approved drug 'BuSpar.' Bristol's patent was set to expire at the end of the day on November 21, 2000. P had filed and received tentative approval of an ANDA for its buspirone product under a Paragraph III certification. Mylan manufactured and was ready to ship its product at 12:00 a.m. on November 22, 2000, the moment the '763 patent was to have expired. Eleven hours before the '763 patent's expiration, Bristol hand-delivered to the FDA copies of the '365 patent which issued earlier that day. Bristol sought to have the '365 patent listed in the Orange Book as covering buspirone. The FDA suspended approval of P's ANDA and the ANDAs filed by other prospective generic manufacturers of buspirone. P wrote to the FDA to challenge the listing of the '365 patent on the grounds that it only covered a metabolite of buspirone and therefore should not be listed because it did not claim the drug. Instead of filing a Paragraph IV certification with respect to the ANDA P commenced the present action against Bristol and the FDA on the same day, November 30, 2000. It sought a declaratory judgment that Bristol improperly listed the '365 patent, and a preliminary injunction requiring Bristol to take steps to delist the '365 patent and directing the FDA to approve P's ANDA. The court held that P was entitled to declaratory relief that the '365 patent was improperly listed in the Orange Book under the patent laws and the Declaratory Judgment Act, as a defense to the infringement suit Bristol could have brought against Mylan under 35 U.S.C. § 271(e)(2). The court found that the '365 patent did not claim the drug for which the applicant submitted the application or claim a method of using such drug upon which a claim of patent infringement could reasonably be asserted. The court granted P's requested injunction. Bristol appealed.
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