Purepac Pharmaceutical Co. v. Thompson

• Decision Date: 16 December 2002
• Docket Number: No. CIV.A. 02-1657(ESH).,CIV.A. 02-1657(ESH).
• Citation: 238 F.Supp.2d 191
• Parties: PUREPAC PHARMACEUTICAL CO. Plaintiff, v. Tommy G. THOMPSON, Secretary of Health & Human Services, and Lester M. Crawford, Jr., Deputy Commissioner of Food and Drugs, Defendants, and Apotex, Inc., and Torpharm, Inc., Intervenors-Defendants
• Court: U.S. District Court — District of Columbia

238 F.Supp.2d 191

PUREPAC PHARMACEUTICAL CO. Plaintiff, v. Tommy G. THOMPSON, Secretary of Health & Human Services, and Lester M. Crawford, Jr., Deputy Commissioner of Food and Drugs, Defendants, and Apotex, Inc., and Torpharm, Inc., Intervenors-Defendants

No. CIV.A. 02-1657(ESH).

United States District Court, District of Columbia.

December 16, 2002.

Andrew M. Berdon, Frommer Lawrence & Haug, LLP, New York, NY, Joseph S. Hall, Mark C. Hansen, Richard H. Stern, Kellogg Huber Hansen Todd & Evans, PLLC, Washington, DC, for Plaintiff.

Andrew E. Clark, U.S. Dept. of Justice, Office of Consumer Litigation, Washington, DC, Peter Blumberg, U.S Attorney's Office, Civ. Div., Washington, DC, Arthur Y. Tsien, Olsson, Frank and Weeda, P.C., Washington, DC, Hugh L. Moore, William A. Rakoczy, Lord, Bissell and Brook, Chicago, IL, for Defendants.

Jeremy M. Jay, Leydig, Voit & Mayer, Washington, DC, Pamela J. Ruschau, Robert F. Green, Steven H. Sklar, Leydig, Voit & Mayer, Chicago, IL, for Amicus.

MEMORANDUM OPINION

HUVELLE, 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.¹ 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.

BACKGROUND

I. Statutory and Regulatory Frame-work

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).² 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. Thompson, 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, 110 S.Ct. 2683, 110 L.Ed.2d 605 (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-approved³] 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.⁴ 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 Pharms., 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...