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April 25, 2003


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


This is the latest installment in the long-running battle to determine which will be the first company permitted to market a generic version of the drug gabapentin. Competing for this privilege — and, more importantly, for the statutory right to sell the drug for 180 days free from generic competition — are plaintiff TorPharm, Inc. ("TorPharm") and intervenor-defendant Purepac Pharmaceutical Co. ("Purepac"). Originally, the Food and Drug Administration ("FDA") refused to approve Purepac's application because it failed to include what the agency believed to be the proper certification (a "paragraph IV certification") regarding a method-of-use patent covering gabapentin owned by the Warner-Lambert Company ("Warner-Lambert"). However, on December 16, 2002, this Court vacated that decision, and ordered the FDA to accept the alternative patent statement (a "section viii statement") that Purepac had submitted with its application. See Purepac Pharmaceutical Co. v. Thompson, 238 F. Supp.2d 191 (D.D.C. 2002). At the same time, the Court declined to go further and to forbid the agency from approving the application submitted by TorPharm, which did not contain the section viii statement filed by Purepac, but instead included a paragraph IV certification. The Court left the FDA free to resolve the "delicate question" of whether to approve TorPharm's application, and thus potentially to allow the company to share with Purepac the limited period of exclusivity for the sale of generic gabapentin. See id. at 211-12.

On remand, TorPharm urged the FDA to do just that, but the agency was not persuaded. The FDA ruled instead that — in light of its understanding of the statute, this Court's decision in Purepac, and other factual developments — a paragraph IV certification was inappropriate for the patent in question. The agency further concluded that Purepac was the first gabapentin applicant to have submitted a generic application with a valid paragraph IV certification (which related to another patent covering the drug). Based on these findings, the FDA announced that Purepac, and only Purepac, would be entitled to the 180-day exclusivity period. Arguing that these decisions are unreasonable and illegal, TorPharm brought this action, seeking a preliminary injunction to block the FDA's grant of exclusivity to Purepac and to compel the agency to bestow that privilege on TorPharm instead.

Pursuant to FED. R. CIV. P. 65(a)(2), the Court has consolidated the preliminary injunction motion with a final decision on the merits. TorPharm's motion, and the FDA's response thereto, will thus be treated as cross motions for summary judgment. Based on the pleadings, and for the reasons given below, the Court will deny plaintiff's motion, and enter judgment on behalf of the agency. In concluding that Purepac was the first company to present an effective paragraph IV certification, the FDA did not, as TorPharm insists, disregard clear statutory language, but rather reasonably filled in a textual gap. Moreover, the agency's rejection of TorPharm's certification represented an appropriate application of administrative discretion that cannot be characterized as arbitrary and capricious.


The complex legal and factual background to this case is set out at length in the Court's previous Memorandum Opinion and need not be exhaustively retold here. See Purepac, 238 F. Supp.2d at 193-201. Like its predecessor, this case involves the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act ("FDCA"), which have been codified at 21 U.S.C. § 355. These amendments were designed to streamline the process by which generic versions of drugs already approved by the FDA are brought to market. They allow a generic drug manufacturer to piggyback on the detailed "New Drug Application" ("NDA") filed by the manufacturer of the brand-name version of the drug (the so-called "pioneer" or "innovator") during the original approval process. Under the Hatch-Waxman Amendments, a would-be generic manufacturer can file a much less elaborate document, called an Abbreviated New Drug Application ("ANDA"), which relies on the FDA's previous determination that the drug is safe and effective.

While the ANDA process makes it significantly less expensive and time-consuming to gain approval of generic drugs, the Hatch-Waxman Amendments also sought to protect the interests of patent owners, whose valuable rights in the pioneer drug could be threatened by the marketing of cheaper, generic versions of their patented innovations. To this end, every ANDA must contain information about the patents protecting the brand-name drug, and the expected effect of the generic drug on those patents. One important purpose of this requirement is to give notice, if necessary, to the patent holder so that any legal disputes regarding the scope of the patent and the possibility of infringement can be resolved as quickly as possible. The source for this patent information is typically the "Orange Book" (a shorthand name for the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations"), in which the agency publishes the patent information it receives from brand manufacturers in their NDAs. See 21 U.S.C. § 355(b)(1) (requiring those seeking approval for new drugs to file with the FDA "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" and requiring the agency to publish this information).

The ANDA applicant has several possible vehicles by which to discharge its patent notification responsibilities. With respect to "each patent which claims the listed [i.e. FDA-approved] drug . . . or which claims a use for such listed drug for which the applicant is seeking approval," the ANDA must "certify" (I) that no patent has been filed with the FDA; (II) that the patent has expired; (III) that the patent will expire on a date certain; (IV) that the patent is invalid or will not be infringed by the generic drug. 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV); 21 C.F.R. § 314.94(a)(12)(i). The last of these — the so-called "paragraph IV certification" — is the most complicated. Given its importance to the present case, several points about this certification require further elaboration. The first is its notice requirement. The statute mandates that a generic drug applicant who uses a paragraph IV certification "shall include in the application a statement that the applicant will give the notice required by clause (ii)"*fn1 both to the patent owner and to the holder of the NDA. 21 U.S.C. § 355(j)(2)(B)(i). Where an ANDA is amended to include a paragraph IV certification, the statute requires that this notice "shall be given when the amended application is submitted." 21 U.S.C. § 355(j)(2)(B)(iii) (hereinafter, "the notice provision").

Once notice is received, the patent owner has 45 days in which to bring an infringement action against the ANDA applicant. Such actions are brought under 35 U.S.C. § 271(e)(2)(A), which makes it an act of infringement to submit an ANDA "for a drug claimed in a patent or the use of which is claimed in a patent." Thus, whenever a generic applicant includes a paragraph IV certification in its ANDA, that act itself permits the brand manufacturer to initiate an immediate patent infringement suit even though the generic manufacturer has not yet marketed the drug. See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676 (1990). If no action has been commenced at the end of this 45-day period, the FDA may approve the application effective immediately. See 21 U.S.C. § 355(j)(5)(B)(iii). If an infringement action is filed, however, the agency may not approve the application for 30 months from the date the notice was received, or until the patent dispute is judicially resolved, whichever is shorter. Id.; see generally Am. Bioscience, Inc. v. Thompson, 243 F.3d 579, 580 (D.C. Cir. 2001).

Finally, as an incentive to generic drug applicants willing to risk litigation in order to challenge a pioneer manufacturer's patent, the statute provides that the first applicant whose ANDA included a paragraph IV certification is entitled to a 180-day period of market exclusivity. The onset of this period is triggered by either the first commercial marketing of the drug or by a decision of a court finding the patent that is the subject of the paragraph IV certification invalid, unenforceable, or not infringed, whichever comes first. See 21 U.S.C. § 355(j)(5)(B)(iv); 21 C.F.R. § 314.107(c). During this window, the FDA may not make effective the approval of any other ANDA for the drug in question that contains a paragraph IV certification. See 21 U.S.C. § 355(j)(5)(B)(iv) (hereinafter "the exclusivity provision").*fn2 This provision allows the first mover to enjoy a brief duopoly in which the only other authorized seller of the drug is the brand manufacturer. See SmithKline Beecham Corp. v. Apotex Corp., 2003 WL 728889, at *10 (N.D.Ill. March 3, 2003).

There is, however, an alternative to the paragraph IV certification, known as a "section viii statement," which an ANDA applicant may use 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).*fn3 A section viii statement avers that the patent in question has been listed, but does not claim a use for which the applicant seeks FDA approval. An applicant proceeding by way of section viii need not provide formal notice to the patent owner and NDA holder, does not necessarily face an infringement action under 35 U.S.C. § 271(e)(2)(A),*fn4 and does not face a mandatory 30-month stay should the patent owner sue. At the same time, however, section viii does not entitle the successful generic applicant to any period of exclusivity. Accordingly, as an alternative to paragraph IV certifications, section viii statements offer generic drug manufacturers a diminished set of both risks and rewards.

Of great significance to the present case is the FDA's long-held position that the circumstances in which a section viii statement may be used and those in which a paragraph IV certification is appropriate do not overlap. See Abbreviated New Drug Application Regulations, Patent and Exclusivity Provisions, 59 FED. REG. 50,338, 50,347 (Oct. 3, 1994) (hereinafter "ANDA Rulemaking") (noting that "the two provisions . . . are not overlapping, and an applicant does not have the option of making a certification under [paragraph IV] in lieu of, or in addition to, a statement under [section viii]."). Therefore, in the agency's view, a paragraph IV certification and a section viii statement are mutually exclusive alternatives. The factor that determines which is proper is whether the use patent at issue actually claims a use for which the generic applicant is seeking approval. If it does, a paragraph certification is required; if not, the ANDA should include a section viii statement. (Administrative Record ["A.R."], tab 18 at 4.)

This case involves rival ANDAs submitted for the drug gapapentin, which is sold under the brand name Neurontin®. Pfizer, by assignment from Warner-Lambert, holds the NDAs for this drug, which the FDA approved in 1993 (in capsule form) and in 1998 (in tablet form) for the treatment of epilepsy.*fn5 In connection with these applications, Warner-Lambert submitted a variety of patent information regarding gabapentin, including two method-of-use patents covering the drug. The first is U.S. Patent No. 4,087,544 ("the `544 patent"), which claims a method of using gabapentin to treat epilepsy, and has now expired. The second, U.S. Patent No. 4,084,479 ("the `479 patent"), claims a method of using the drug to treat neurodegenerative diseases.*fn6 This patent is set to expire on January 2, 2010. A third patent relevant to this case, a drug composition patent, is U.S. Patent No. 6,054,482 ("the `482 patent"), which Warner-Lambert submitted to the FDA on April 25, 2000. All three of these patents, along with one other covering the drug,*fn7 were listed in the Orange Book. In keeping with FDA practice, however, the `544 patent was removed from the book when it expired on July 16, 2000.

In March 1998, Purepac submitted an ANDA seeking permission to market generic versions of gabapentin capsules for the treatment of epilepsy. In this application, Purepac included a section viii statement regarding the `479 patent, which appeared to claim a use (the treatment of neurodegenerative diseases) for which the company was not seeking approval, and indeed could not have sought approval through the ANDA process. This application also contained a paragraph IV certification to the `476 patent and a paragraph III certification to the `544 patent. On May 26, 2000, FDA received from Purepac an amendment to its application that included a paragraph IV certification for the newly submitted `482 patent.

The rival gabapentin ANDA at issue in this case was filed by TorPharm on April 20, 1998. Like Purepac's, this application contained a paragraph IV certification to the `476 patent and a paragraph III regarding the `544 patent. However, with respect to the `479 patent, TorPharm hedged its bets and included both a section viii statement and a paragraph IV certification. On June 16, 2000, the FDA received TorPharm's amended paragraph IV certification regarding the `482 patent.

These applications have triggered several rounds of patent litigation. First, Warner-Lambert brought suit against Purepac in New Jersey alleging infringement of both the `476 and `479 patents. That case is still pending, though the 30-month stay triggered by this suit has long since expired. Then, on July 14, 1998, Warner-Lambert sued TorPharm in Illinois, alleging infringement of the same patents. In March 2001 and September 2001, the district court granted summary judgment in favor of TorPharm on both patents respectively; Warner-Lambert appealed only the decision regarding the `479 patent to the Federal Circuit. On January 16, 2003, that Court affirmed, holding that because the `479 patent did not claim an approved use of gabapentin, Warner-Lambert could not sue for infringement under 35 U.S.C. § 271(e)(2)(A). See Warner-Lambert, 316 F.3d at 1362. Finally, on July 20, 2000, Warner-Lambert sued both Purepac and TorPharm in connection with their paragraph IV certifications to the `482 patent. The Judicial Panel on Multidistrict Litigation has consolidated these suits for pretrial proceedings in New Jersey, and they are ongoing. While no decision regarding the `482 patent has issued, the 30-month stays relating to this litigation have now expired. Accordingly, at present, no litigation-related stays prevent the FDA from approving the ANDAs submitted by Purepac or by TorPharm.

The confusion about whether a section viii statement or a paragraph IV certification was appropriate for the `479 patent spawned separate litigation, which continues in the present case. As noted, Purepac and TorPharm took different approaches to this patent in their ANDAs, the former using only a section viii statement, while the latter used both. Initially, the FDA took the position that only a paragraph IV certification was proper, and therefore disregarded TorPharm's section viii statement. Furthermore, in April 2002, the FDA wrote two letters to Purepac informing the company that a section viii statement was improper for the `479 patent and that to secure agency approval for its ANDAs, it would have to submit a revised certification under either paragraph III or IV. ...

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