PFIZER INC. v. APOTEX INC., Case No.: 08-cv-7231

• Citation: 726 F.Supp.2d 921
• Decision Date: 30 June 2010
• Docket Number: 09-cv-6053.,Case No.: 08-cv-7231
• Parties: PFIZER INC., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, and Warner-Lambert Company LLC, Plaintiffs, v. APOTEX INC. and Apotex Corp., Defendants.
• Court: U.S. District Court — Northern District of Illinois

726 F.Supp.2d 921

PFIZER INC., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, and Warner-Lambert Company LLC, Plaintiffs,

v.APOTEX INC. and Apotex Corp., Defendants.

Case Nos.: 08-cv-7231, 09-cv-6053.

United States District Court, N.D. Illinois,Eastern Division.

June 30, 2010.

Rudolf E. Hutz, Daniel C. Mulveny, Jeffrey B. Bove, Mary W. Bourke, William E. McShane, Connolly, Bove, Lodge & Hutz LLP, Wilmington, DE, Jeffrey Mark Drake, John S. Mortimer, Wood, Phillips, Katz, Clark & Mortimer, Chicago, IL, for Plaintiffs.

William Andrew Rakoczy, Andrew M. Alul, Deanne M. Mazzochi, Paul J. Molino, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, John C. Phillips, Jr., Brian E. Farnan, Phillips, Goldman & Spence, P.A., Wilmington, DE, for Defendants.

MEMORANDUM OPINION AND ORDER

ROBERT M. DOW, JR., District Judge.

Plaintiffs Pfizer Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, Warner-Lambert Company LLC (collectively “Pfizer”) filed this patent infringement action against Defendants Apotex Inc. and Apotex Corp. (collectively “Apotex”) for infringement of United States Patent No. 5,273,995 (“the '995 patent”). After Pfizer filed its initial complaint, the ' 995 patent was reissued in part as U.S. Patent No. 40,667 (“the ' 667 patent”). Pfizer has since amended its complaint to include a claim for infringement of the '667 patent.

Pfizer's suit was prompted by Apotex's filing of an Abbreviated New Drug Application (“ANDA”), in which it seeks permission from the Food and Drug Administration (“FDA”) to market a generic copy of Pfizer's pharmaceutical product, Lipitor®. Apotex answered and filed counterclaims [110] asserting non-infringement and invalidity of the '995 and '667 patents, as well as three other Pfizer patents: U.S. Patent Nos. 5,686,104 (“the '104 patent”), 5,969,156 (“the '156 patent”), and 6,126,971 (“the '971 patent”) (collectively “the Unasserted Patents”). Currently before the Court is Pfizer's motion to dismiss [113] Counts III-VIII of Apotex's counterclaims for lack of subject matter jurisdiction and for failure to state a claim pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). ¹ For the reasons stated below Pfizer's motion to dismiss [113] Apotex's counterclaims is denied. The dismissal is without prejudice as to Pfizer's motion to dismiss for failure to make the statutorily-required bona fide offer of confidential access.

I. Background A. Statutory Framework

The approval of prescription drugs is governed by the applicable provisions of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), 21 U.S.C. § 301 et seq., as amended by the Drug Price Competition and Patent Term Restoration Act of 1984 (known as the “HatchWaxman Act”), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”). The Hatch-Waxman Act requires pharmaceutical companies seeking to market new, previously unapproved drugs to file a New Drug Application (“NDA”) with the FDA. 21 U.S.C. § 355(a), (b). As part of its NDA, an applicant must provide certain information to the FDA about “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). The FDA publishes the patent information in the Approved Drug Products With Therapeutic Equivalence Evaluations, which is commonly referred to as the “Orange Book.” 21 U.S.C. § 355(j)(7)(A). Drugs approved by the FDA are known as “listed drugs.” 21 U.S.C. § 355(j)(2)(A)(i).

In 1984, with the enactment of the Hatch-Waxman Act, Congress created “an expedited approval process known as an Abbreviated New Drug Application (ANDA)” in order “[t]o encourage the development of generic versions of listed drugs.” Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1355-56 (Fed.Cir.2008); see also 21 U.S.C. § 355(j). The Hatch-Waxman Act allows generic drug companies to rely on the FDA's previous approval of a listed drug if the generic drug company demonstrates in its ANDA that its generic drug product is bioequivalent to the NDA drug. 21 U.S.C. § 355(j)(2)(A). An ANDA applicant also must include a certification to each patent listed in the Orange Book covering the listed drug. 21 U.S.C. § 355(j)(2)(A)(vii). There are four types of patent certifications: (I) no patent information has been filed with the FDA; (II) the patent has expired; (III) the patent will expire on a particular date and approval of the ANDA should be deferred until expiration; and (IV) in the opinion of the ANDA applicant, the patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug. See 21 U.S.C. § 355(j)(2)(A)(vii); Janssen, 540 F.3d at 1356.

The timing of ANDA approval by the FDA depends on the types of certifications contained in the ANDA. An ANDA with a Paragraph III certification cannot be approved until the expiration of the last to expire of any patent that is the subject of that certification. 21 U.S.C. § 355(j)(5)(B)(ii). Where an ANDA contains a Paragraph IV certification, the timing of approval depends on two events: (i) whether the holder of the listed patent brings an infringement suit within 45 days of receiving notice of the ANDA filing, and (ii) whether the company seeking approval was the first to file an ANDA with a Paragraph IV certification to the listed patent. 21 U.S.C. § 355(j)(5)(B)(iii).

With respect to the first potential event, the Hatch-Waxman Act provides that the filing of a Paragraph IV certification is an act of patent infringement. 35 U.S.C. § 271(e)(2)(A). If the patentee or NDA holder does not bring suit within 45 days of receiving notice of the Paragraph IV certification, the statute mandates that FDA “shall” approve the ANDA immediately. 21 U.S.C. § 355(j)(5)(B)(iii). If the brand name company does bring suit within 45 days, the FDA may not approve the ANDA for 30 months, unless a court decides that the patent(s)-in-suit are invalid or not infringed. 21 U.S.C. § 355(j)(5)(B)(iii).

With respect to the second potential event, to encourage generic pharmaceutical companies to challenge Orange Book listed patents, the Hatch-Waxman Act grants the first company to submit a Paragraph IV ANDA a 180-day period of generic marketing exclusivity during which time FDA will not approve a later-filed Paragraph IV ANDA based on the same NDA. 21 U.S.C. § 355(j)(5)(B)(iv). Under the version of Hatch-Waxman Act that is applicable to this case, the start of the 180-day exclusivity period is triggered by the earlier of two events: (1) the first-filer's commercial marketing of its generic drug product; or (2) a court decision of non-infringement or invalidity. Id. § 355(j)(5)(B)(iv)(I)-(II) (2000). ² A court decision of noninfringement or invalidity can come in any court action, including one involving a subsequent Paragraph IV ANDA applicant. Consequently, “subsequent Paragraph IV ANDA filers have a strong incentive to generate a triggering event allowing the FDA to approve their subsequent Paragraph IV ANDAs 181 days after the triggering event,” while “NDA holders have a strong incentive to prevent a triggering event, because subsequent Paragraph IV ANDAs cannot be approved until the exclusivity period [is triggered and] expires.” Caraco Pharm. Labs. v. Forest Labs., 527 F.3d 1278, 1284 (Fed.Cir.2008).

On December 8, 2003, the Hatch-Waxman Act was amended by Title XI of the MMA, which, among other things, includes a provision for a “civil action to obtain patent certainty.” 21 U.S.C. § 355(j)(5)(C). That provision “allows a Paragraph IV ANDA filer a right to bring a declaratory judgment action for non-infringement or invalidity of the relevant listed patents against the patentee and NDA holder, if the patentee has not brought an infringement action within the 45-day notice period.” Janssen, 540 F.3d at 1357. See also 21 U.S.C. § 355(j)(5)(C)(i)(II) (authorizing “a civil action to obtain patent certainty” under 28 U.S.C. § 2201 “for a declaratory judgment that the [listed] patent is invalid or will not be infringed by the drug for which the applicant seeks approval”). The MMA was enacted “to prevent NDA holders from ‘gaming’ the Hatch-Waxman Act by forestalling the resolution of patent disputes with ANDA filers.” Caraco, 527 F.3d at 1285. In addition, in 35 U.S.C. § 271(e)(5)-a 2003 amendment to the patent statute that works in conjunction with the 2003 amendment to the Hatch-Waxman Act-Congress extended federal court jurisdiction over declaratory judgment actions to obtain patent certainty “to the extent consistent with the Constitution.” See Teva Pharms. USA, Inc. v. Novartis Pharms. Corp., 482 F.3d 1330, 1335 (Fed.Cir.2007); Janssen, 540 F.3d at 1357. Therefore, federal courts have jurisdiction over ANDA declaratory judgment actions to the extent that they present an Article III case or controversy. Janssen, 540 F.3d at 1357.

B. Factual Background ³

At issue in this case is the prescription drug atorvastatin, which Pfizer markets under the brand-name Lipitor®. Pfizer holds an approved NDA for Lipitor®. The Orange Book originally listed five patents for Lipitor®: the '995 patent, the '971 patent, the '104 patent, the ' 156 patent, and U.S. Patent No. 4,681,893 (“the '893 patent”). On March 17, 2009, the '995 patent was reissued in part as U.S. Patent No. 40,667 (“the '667 patent”); Pfizer has since listed the '667 patent in the Orange Book as well.

The first generic drug company to seek FDA approval to market a generic version of Lipitor® was Ranbaxy, which filed its ANDA in August 2002. Ranbaxy's ANDA included Paragraph IV certifications as to all five patents listed at that time-the '893, '995 '104, '156, and '971 patents. In response, Pfizer sued Ranbaxy for infringement of only the '893 patent and the...