Minnesota Mining and Mfg. v. Barr Laboratories

• Decision Date: 01 May 2002
• Docket Number: No. 01-1369.,No. 01-1370.,01-1369.,01-1370.
• Citation: 289 F.3d 775
• Parties: MINNESOTA MINING AND MANUFACTURING COMPANY and Riker Laboratories, Inc., Plaintiffs-Appellants, and Alphapharm Pty. Ltd., Plaintiff-Appellant, v. BARR LABORATORIES, INC., Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

Page 775

289 F.3d 775

MINNESOTA MINING AND MANUFACTURING COMPANY and Riker Laboratories, Inc., Plaintiffs-Appellants, and Alphapharm Pty. Ltd., Plaintiff-Appellant, v. BARR LABORATORIES, INC., Defendant-Appellee.

No. 01-1369.

No. 01-1370.

United States Court of Appeals, Federal Circuit.

May 1, 2002.

Donald R. Dunner, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for plaintiffs-appellants. On the brief were Allen M. Sokal, Charles E. Lipsey, David S. Forman, and Gregory A. Chopskie. Of counsel on the brief were Kevin H. Rhodes, and MarySusan Howard, Office of Intellectual Property Counsel, of St. Paul, MN.

James K. Stronski, Frommer Lawrence & Haug LLP, of New York, NY, argued for plaintiff-appellant. With him on the brief was Edgar H. Haug. Of counsel on the brief was Bruce H. Little, Lindquist & Vennum, P.L.L.P., of Minneapolis, MN.

James F. Hurst, Winston & Strawn, of Chicago, IL, argued for defendant-appellee. With him on the brief were Christine J. Siwik and Christopher Shearer.

Before MICHEL, GAJARSA, and DYK, Circuit Judges.

DYK, Circuit Judge.

This case presents a question under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act ("FFDCA"), which were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. §§ 355, 360cc, and 35 U.S.C. §§ 156, 271, 282. Appellants, Minnesota Mining and Manufacturing Co. ("3M") and Alphapharm Pty. Ltd. ("Alphapharm"), urge that the district court should have dismissed 3M's infringement action against appellee, Barr Laboratories, Inc. ("Barr"), without prejudice pursuant to Rule 41(a)(2) of the Federal Rules of Civil Procedure, so that the dismissal of that suit would not have triggered the running of a 180-day waiting period under 21 U.S.C. § 355(j)(5)(B)(iv)(II) for approval of Barr's Abbreviated New Drug Application ("ANDA"). Appellants urge that a dismissal without prejudice was required because Barr improperly caused the 3M suit to be brought. Barr allegedly did so by failing to provide 3M with information (before 3M filed suit) showing that Barr did not infringe. In particular appellants alleged that Barr failed to comply with the requirement of 21 U.S.C. § 355(j)(2)(B)(ii) that it provide "a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed." Pursuant to our decisions in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323, 60 USPQ2d 1576 (Fed.Cir.2001) and Andrx Pharmaceuticals, Inc. v. Biovail Corp., 276 F.3d 1368, 61 USPQ2d 1414 (Fed.Cir.2002), we hold that § 355(j)(2)(B) cannot be enforced by a private party in a patent infringement action, but must be enforced, if at all, only in the context of an action under the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 702-706. We also conclude that the district court did not lack subject matter jurisdiction to determine the form of dismissal or otherwise abuse its discretion in declining to dismiss without prejudice. We accordingly affirm the judgment of the district court.

I

The overall scheme of the Hatch-Waxman Amendments is described in detail in our decisions in Mylan and Andrx and need not be repeated here. The facts of this case are relatively simple considering the complexity of the statutory scheme.

3M is the assignee of U.S. Patent No. 4,642,384 (the "'384 patent"). The '384 patent claims intermediate compounds that result from a process for producing a drug product containing the active ingredient flecainide acetate.¹ As required by 21 U.S.C. §§ 355(b)(1) and 355(c)(2), 3M notified the Food and Drug Administration ("FDA") that the '384 patent claims a drug for which 3M had filed a New Drug Application ("NDA"). The FDA then listed the '384 patent in the so-called Orange Book. 3M's NDA was approved on October 31, 1985, and 3M currently markets the drug under the trade name TAMBOCOR. Alphapharm, as permitted by the statute, sought to piggyback on the approval of 3M's NDA, and filed an ANDA on July 16, 1998. Pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), on November 20, 1998, Alphapharm provided a paragraph IV notice to 3M, and stated that even if Alphapharm's proposed product is manufactured from any of the intermediate compounds claimed in the '384 patent, Alphapharm would not infringe the '384 patent because manufacturing of the product would occur outside the United States.

Despite the paragraph IV certification, 3M brought suit for patent infringement against Alphapharm in the district of Minnesota on January 4, 1999. Under the Hatch-Waxman Amendments, a consequence of that filing was that the FDA could not approve Alphapharm's ANDA until thirty months after the date 3M received notification from Alphapharm or the termination of the infringement suit in favor of Alphapharm, whichever was earlier. 21 U.S.C. § 355(j)(5)(B)(iii). 3M's suit against Alphapharm is still pending, but the thirty-month period expired in May 2001. Accordingly, the FDA approved Alphapharm's ANDA, but Alphapharm apparently has not begun marketing its drug product, and intends to defer marketing until 3M's infringement suit against it is resolved.

Barr also sought to piggyback on the approval of 3M's NDA and filed an ANDA on May 22, 2000. Barr provided its paragraph IV certification that it did not infringe the '384 patent to 3M by letter dated July 12, 2000. As the second ANDA filer, Barr was not only potentially subject to the thirty-month stay under 21 U.S.C. § 355(j)(5)(B)(iii) (if 3M filed an infringement suit) but also to a 180-day stay pursuant to § 355(j)(5)(B)(iv) of the statute, which provides:

If the [ANDA] application contains a [paragraph IV certification] and is for a drug for which a previous application has been submitted under this subsection continuing [sic] such a certification, the application shall be made effective not earlier than one hundred and eighty days after —

(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or

(II) the date of a decision of a court in an action described in [21 U.S.C. § 355(j)(5)(B)(iii)] holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier.

(emphases added).

This provision is designed to provide an incentive, in the form of a 180-day period of marketing exclusivity, to an ANDA filer that is the first to challenge a patent listed in the Orange Book. The running of the 180-day period is triggered by "the Secretary['s] receiv[ing] notice from the [first ANDA applicant] of [its] first commercial marketing of the drug" or by "a decision of a court in an action described in [21 U.S.C. § 355(j)(5)(B)(iii)] holding the patent which is the subject of the certification to be invalid or not infringed." 21 U.S.C. § 355(j)(5)(B)(iv). Since Alphapharm has apparently not commenced marketing, we are concerned here with the second triggering condition a "decision of a court in an action described in [21 U.S.C. § 355(j)(5)(B)(iii)] holding the patent which is the subject of the certification to be invalid or not infringed." 21 U.S.C. § 355(j)(5)(B)(iv)(II). This provision has been construed by the District of Columbia Circuit to include not only a successful judgment of noninfringement or invalidity in a suit against the first ANDA filer but also a successful judgment of noninfringement or invalidity in a suit brought against a later ANDA filer. Teva Pharms., USA, Inc. v. United States FDA, 182 F.3d 1003, 1010, 51 USPQ2d 1432, 1437 (D.C.Cir.1999).

Following Barr's initial notice to 3M of its paragraph IV certification, 3M sought additional information from Barr regarding its noninfringement position and on August 10, 2000, Barr elaborated, stating that "[a]s detailed in our letter dated July 12, 2000, Barr's proposed product does not contain any of the compounds claimed in the '384 patent and, in fact, Barr's active ingredient was known well over a year before your client filed its earliest relevant patent application." Letter from Samuel L. Fox, Counsel to Barr, to Allen M. Sokal, Counsel to 3M (Aug. 10, 2000). Barr, however, declined to provide further information, which it regarded as proprietary.

Unsatisfied by Barr's claim of noninfringement, 3M filed an infringement suit against Barr in the district of Minnesota on August 25, 2000. Alphapharm intervened because of its interest in delaying approval of Barr's ANDA application. Because 3M filed this suit within 45 days of receiving notice of Barr's paragraph IV certification, the thirty-month or litigation termination stay period under 21 U.S.C. § 355(j)(5)(B)(iii) was triggered with respect to Barr. Barr brought counterclaims seeking, among other things, a declaration of noninfringement. Barr also moved for summary judgment of noninfringement.

In the course of discovery, information was disclosed by Barr that convinced 3M that Barr did not infringe the '384 patent. 3M sought to dismiss its suit without prejudice, because, it urged, a dismissal without prejudice would prevent the triggering of Alphapharm's 180-day period of exclusivity. In effect, 3M sought to prevent approval of Barr's ANDA until 180 days after Alphapharm began marketing its approved product. 3M urged that Barr had "hoodwinked" 3M into filing a suit by refusing to provide a more detailed statement as to why it did not infringe the '384 patent.

The district court declined to dismiss 3M's action without prejudice. The district court recognized that the decision whether to allow a party to voluntarily dismiss an action after filing, pursuant to Rule 41(a)(2), is generally within the discretion of the district court, and that under governing Eighth Circuit law factors to consider in exercising this discretion include: whether the party has presented a...