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December 16, 2002


The opinion of the court was delivered by: Ellen Segal Huvelle, United States District Judge


This case arises out of the Food and Drug Administration's ("FDA" or "the agency") denial of Abbreviated New Drug Applications for generic formulations of the drug gabapentin submitted by plaintiff Purepac Pharmaceutical Co. ("Purepac"). The agency denied plaintiff's ANDAs because those applications failed to include the proper certification (a "paragraph IV certification") regarding a method of use patent covering gabapentin owed by the Warner-Lambert Company ("Warner-Lambert"). Purepac has now moved for a preliminary injunction requiring the FDA to accept the alternative statement (a "section viii statement") that the company filed regarding that patent and, accordingly, to approve its application to market a generic version of gabapentin for the treatment of epilepsy. Plaintiff also requests that the agency be enjoined from approving any other gabapentin ANDAs for that same use, including an application filed by defendants-intervenors TorPharm, Inc. and Apotex Corp. ("TorPharm").
On December 6, 2002, pursuant to FED. R. CIV. P. 65(a)(2), the Court informed the parties of its decision to consolidate the preliminary injunction motion with a final decision on the merits. Plaintiff's motion will therefore be treated as a motion for summary judgment. Moreover, on December 12, 2002, in response to the Court's decision to consolidate, TorPharm submitted a motion for summary judgment asserting that plaintiff's claims for declaratory and injunctive relief are barred by the doctrine of laches. Plaintiff responded to this motion on December 13, 2002, the same day that the parties presented oral argument in this case.*fn1 Based on the pleadings and on the arguments of counsel, and for the reasons given below, the Court will enter judgment on behalf of plaintiff, deny TorPharm's motion for summary judgment, and order the FDA to accept Purepac's section viii statement. However, the Court will not enjoin the FDA from approving TorPharm's application, but will instead leave this decision to the agency in the first instance.


I. Statutory and Regulatory Framework

At issue in this case are the complex set of amendments to the Food, Drug, and Cosmetic Act ("FDCA") added by the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. See Pub.L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. § 355. These amendments were designed to simplify and expedite the process by which generic drugs are brought to market. Generally, a company seeking FDA approval to market a particular drug must file a lengthy document called a New Drug Application ("NDA"), which, among other things, must include detailed data establishing the drug's safety and effectiveness. The NDA must also contain information on each patent that claims the drug or a method of using the drug that is the subject of the application and with respect to which a patent infringement claim could reasonably be asserted against a unauthorized party. 21 U.S.C. § 355(b)(1); (c)(2).*fn2 The FDA publishes the patent information that it receives in a publication entitled "Approved Drug Products With Therapeutic Equivalence Evaluations," known in agency parlance as the "Orange Book." See Am. Bioscience, Inc. v. FDA, 269 F.3d 1077, 1079 (D.C. Cir. 2001); Terry G. Mahn, Patenting Drug Products: Anticipating Hatch-Waxman Issues During the Claims Drafting Process, 54 FOOD & DRUG L.J. 245, 249-50 (1999).
Before the Hatch-Waxman Amendments were enacted, a firm that hoped to manufacture and sell a generic version of an already-approved drug was required to submit a new NDA complete with new safety and effectiveness data. See Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C. Cir. 1998). Obviously, this requirement imposed considerable burdens on would-be generic manufacturers, delaying and increasing the cost of bringing generic drugs to market. In order to benefit consumers, the amendments altered this requirement, creating a streamlined procedure for the approval of generic drugs whereby the generic applicant is permitted to piggyback on the original NDA filed by the manufacturer of the brand-name drug (the so-called "pioneer" or "innovator" drug). Under this new system, generic drugs may be approved through an Abbreviated New Drug Application ("ANDA"), which relies on the FDA's previous determination that the pioneer drug is safe and effective. See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675 (1990) ("The ANDA applicant can substitute bioequivalence data for the extensive animal and human studies of safety and effectiveness that must accompany a full new drug application."). This allows applicants to avoid the costly and time-consuming process associated with NDAs, thus facilitating the approval and dissemination of low-costs generic drugs. See H.R. Rep. No. 98-857 (Part I) at 14 (June 21, 1984).
At the same time, Congress sought to protect patent holders whose rights could be threatened by the marketing of generic versions of their patented innovations. See Am. Bioscience, Inc. v. Thompson, 243 F.3d 579, 580 (D.C. Cir. 2001). To this end, the Hatch-Waxman Amendments require that ANDAs contain specified information about the patents protecting the pioneer drug, including "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." 21 U.S.C. § 355(b)(1). There are two means by which applicants may satisfy this requirement; this case turns on the difference between the two approaches and a determination as to whether the FDA properly rejected plaintiff's use of one instead of the other.

First, in a situation in which the patent potentially implicated by the generic drug "claims the listed [i.e. FDA-approved*fn3] drug . . . or which claims a use for such listed drug for which the applicant is seeking approval," the ANDA applicant is required to certify that the new drug will not infringe the patent and explain why it will not. 21 U.S.C. § 355(j)(2)(A)(vii). The statute provides four bases on which this certification may be made: (I) that the required patent information has not been filed; (II) that the patent has expired; (III) that the patent will expire on a date certain; or (IV) that the patent is invalid or will not be infringed by the drug for which approval is sought. Id. Because the fourth option — called a "paragraph IV certification" — is the most complicated and the only one at issue in this case, it demands further explanation.

When an ANDA includes a paragraph IV certification, the applicant must give notice of the filing both to the owner of the patent and to the holder of the NDA for the approved drug. The statute then provides a 45-day window during which the patent owner may bring suit against the generic applicant.*fn4 If a suit is initiated, the FDA's approval of the ANDA is automatically stayed for 30 months, a period that can be lengthened or shorted by the court hearing the case if either party fails to "reasonably cooperate in expediting the action." 21 U.S.C. § 355(j)(5)(B)(iii). If, before the expiration of the 30-month stay, the court finds that the patent is invalid or would not be infringed by the new drug, the FDA's approval of the ANDA becomes effective on the date of that ruling. See Andrx Pharm., Inc. v. Biovail Corp. Int'l, 256 F.3d 799, 802 (D.C. Cir. 2001). As an incentive to generic manufacturers willing to run the risk of defending against patent infringement actions, the statute provides that the first party to gain approval of an ANDA containing a paragraph IV certification is entitled to a 180-day period of market exclusivity. 21 U.S.C. § 355(j)(5)(B)(iv). During this "[e]denic moment of freedom from the pressures of the market," Mova Pharm., 140 F.3d at 1064, the FDA may not allow any subsequent ANDAs for the drug in question to become effective, thus allowing the first mover to sell its drug without competition from other generic manufacturers. See Mylan Pharm., Inc. v. Shalala, 81 F. Supp.2d 30, 33 (D.D.C. 2000) ("In other words, no ANDA for the same generic drug product will be approved during those 180 days.").
As noted, however, the statute provides an alternative to a paragraph IV certification, known as a "section viii statement," which applies where the patent in question is a "method of use patent which does not claim a use for which the applicant is seeking approval under this subsection." 21 U.S.C. § 355(j)(2)(A)(viii) (emphasis added). By regulation, the FDA has provided that these statements are to be used when "the labeling for the drug product for which the applicant is seeking approval does not include any indications that are covered by the use patent" that has been submitted by the NDA holder. 21 C.F.R. § 314.94(b)(12)(iii)(A). In such circumstances, the ANDA applicant need not file a patent certification under paragraphs I-IV; instead, the ANDA must include a statement that the method of use patent at issue does not claim the use of the drug for which the applicant is seeking approval. Id; see also Mylan Pharm., Inc. v. Thompson, 139 F. Supp.2d 1, 6 (D.D.C. 2001), rev'd on other grounds, 268 F.3d 1323 (Fed. Cir. 2001). An applicant proceeding by means of a section viii statement need not inform the patent owner of its application, and does not face an infringement action under 35 U.S.C. § 271(e)(2)(A) (see supra note 4) or the automatic 30-month stay applicable to paragraph IV certifications should the owner decide to file an infringement action. Thus, the FDA may approve a section viii application immediately, making it an attractive route for generic manufacturers, even though a section viii statement does not entitle a successful applicant to the 180-day period of exclusivity bestowed on paragraph IV applicants.
Two points about the Orange Book are especially important. The first is the FDA's insistence that method of use patents can be listed and remain in the book only if such patents actually claim a use that has been approved by the agency. Thus, a patent that claims an unapproved method of using an approved drug should not be submitted, and if such a listing appears in the Orange Book, the holder of the NDA is obliged to submit information to correct the error. These are not statutory requirements, but rather have been imposed by regulation. See 21 C.F.R. § 314.53(b); Proposed Rules, Abbreviated New Drug Application Regulations, 54 Fed. Reg. 28,872, 28,908 (July 10, 1989) (hereinafter "Proposed ANDA Rules") ("[I]nformation will be published in the list only on patents that claim approved drug products or that claim approved indications or other conditions of use.").
Second, the FDA does not take it upon itself to review the patent submissions it receives from NDA applicants and holders in order to determine whether they actually relate to approved drugs and uses. Instead, the agency views of its role as purely ministerial. Lacking the resources or the expertise to determine the validity or scope of patent claims, the FDA simply lists the patent information that it receives from brand manufacturers, expecting those parties to understand and abide by the regulatory mandates. See Abbreviated New Drug Application Regulations, Patent and Exclusivity Provisions, 59 Fed. Reg. 50,338, 50,345 (Oct. 3, 1994) (hereinafter "ANDA Rulemaking"); Mahn, supra, at 250 (noting the FDA's "willingness to list in the Orange Book virtually any patent submitted by an NDA holder").
Indeed, in formulating its regulations governing patent submissions, the FDA explicitly declined to establish "a mechanism for review of submitted patent information to determine, at least on a very general basis, applicability to the particular NDA in question." ANDA Rulemaking, 59 Fed. Reg. at 50,343; see aaiPharm Inc. v. Thompson, 296 F.3d 227, 243 (4th Cir. 2002) (upholding the FDA's "purely ministerial approach to the Orange Book listing process" as a reasonable interpretation of its statutory responsibilities). The duty to ensure that the Orange Book only lists patents that actually claim approved drugs thus lies with NDA holders. See Watson Pharm., Inc. v. Henney, 194 F. Supp.2d 442, 445-46 (D.Md. 2001) ("In making its decision to list a patent . . . it is entirely appropriate and reasonable for the FDA to rely on the patentee's declaration as to coverage, and to let the patent infringement issues play out in other, proper arenas, as is the clear intent of the Hatch-Waxman Amendments.").
Despite the FDA's hands-off approach, its rules do provide an internal procedure whereby parties — including ANDA applicants — can dispute the accuracy or relevance of patent information listed in the Orange Book. That party must first notify the agency of its basis for disagreeing with the listing. The agency will then request that the NDA holder confirm the correctness of the patent information. However, unless that application holder "withdraws or amends its patent information in response to FDA's request, the agency will not change the patent information in the list." 21 C.F.R. § 314.53(f). If the holder of the NDA does not do so, any ANDA application "submitted for a drug that is claimed by a patent for which information has been submitted must, despite any disagreement as to the correctness of the patent information, contain an appropriate certification for each listed patent." Id.; Am. Bioscience, 269 F.3d at 1080; see also aaiPharma, 296 F.3d at 237 ("In short, FDA's position is that if the NDA holder stands on its Orange Book listing, aggrieved parties are out of luck."). The FDA has concluded that such disputes about the scope of particular patents are best resolved by private litigation between the pioneer manufacturer and the generic applicant, rather than by agency action. See ANDA Rulemaking, 59 Fed. Reg. at 50,348.*fn5

II. Factual Background

A. New Drug Applications for Gabapentin

The drug product at issue is gabapentin, which is currently marketed by Warner-Lambert (now a division of Pfizer, Inc.) under the brand name Neurontin®. Until mid-2002, the only FDA-approved use for gabapentin was for the treatment of epilepsy.*fn6 The FDA approved Warner-Lambert's NDAs for gabapentin in December 1993 (capsule form) and October 1998 (tablet form). In connection with these applications, Warner-Lambert submitted information to the agency on a variety of patents connected with the drug. Of these, two were method of use patents and are thus important to the Court's analysis.*fn7 First, U.S. Patent No. 4,087,544 ("the `544 patent") claims a method of using gabapentin to treat epilepsy. This patent expired on July 16, 2000. The second, and in this litigation, more important patent is U.S. Patent No. 4,084,479 ("the `479 patent"), which is not set to expire until January 2010. Determining the use claimed by the `479 patent is at the heart of this case.

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