Pharmachemie B.V. v. Barr Laboratories

Decision Date18 January 2002
Docket NumberNo. 00-5206,No. 00-5207,00-5206,00-5207
Citation276 F.3d 627
Parties(D.C. Cir. 2002) Pharmachemie B.V., Appellee v. Barr Laboratories, Inc., Appellant Consolidated with
CourtU.S. Court of Appeals — District of Columbia Circuit

Appeals from the United States District Court for the District of Columbia (No. 99cv00801) (No. 99cv00862)

James F. Hurst argued the cause for appellant. With him on the briefs was Christine J. Siwik.

John F. Cooney argued the cause and filed the brief for appellee.

Before: Sentelle and Rogers, Circuit Judges, and Williams, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge Rogers.

Rogers, Circuit Judge:

Barr Laboratories, Inc. ("Barr") appeals the district court's grant of summary judgment, interpreting the Hatch-Waxman Amendments of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., and regulations promulgated thereunder, 21 C.F.R. 314.94, 314.107, to Pharmachemie, B.V., a potential competitor of Barr's. Barr contends that the district court erred in vacating an administrative ruling of the Food and Drug Administration ("FDA") that Barr, as the first company to file a paragraph IV certification for tamoxifen, a breast cancer drug, as part of its application for FDA review and approval of its generic version of tamoxifen, had a statutory right to 180 days of generic exclusivity. After the district court granted summary judgment, Pharmachemie lost its court challenge to the underlying patent of the pioneer drug manufacturer's tamoxifen. As a result, Pharmachemie cannot market its generic version of tamoxifen until the patent expires. Because the FDA's ruling no longer causes any redressible harm to Pharmachemie, we conclude that the case is moot and, accordingly, we dismiss the appeal for lack of jurisdiction, vacate the judgment of the district court, and remand the case to the district court with instructions to dismiss the complaint.

I.

The Hatch-Waxman Amendments simplified the procedure for obtaining approval of generic drugs. See Pub. L. No. 98-417, 98 Stat. 1585 (1984). While a pioneer drug manufacturer must file a New Drug Application with safety and effectiveness data, subsequent applicants who want to manufacture generic versions of the original drug need only file an Abbreviated New Drug Application ("ANDA"), which relies on the FDA's previous determination that the drug is safe and effective. See 21 U.S.C. 355(a), (j). As relevant here, the Hatch-Waxman Amendments establish an ANDA certification process that enables generic drug manufacturers to obtain expedited approval of their ANDAs before expiration of the pioneer's patent. See id. 355(j)(2)(A)(vii), (5)(b). The ANDA must include a paragraph certification that (I) no patent information has been filed, (II) the patent has expired, (III) the patent will expire on a date certain, or (IV) the patent is invalid or will not be infringed by the drug for which the applicant seeks approval. See id. 355(j)(2)(A)(vii). Relevant here is the paragraph IV certification, which triggers a complex process that potentially allows the ANDA applicant to market its generic drug before the pioneer's patent expires. See id. 355(j)(5)(b). The FDA can approve a paragraph IV certification ANDA immediately unless the patent holder files suit within forty-five days of receiving notice of the paragraph IV certification. See id. 355(j)(5)(B)(iii); 21 C.F.R. 314.107(f)(2). If a patent infringement action is timely brought, the ANDA can be approved only upon the expiration of a thirty-month period, unless this period is altered by the court or a decision of that court. See 21 U.S.C. 355(j)(5)(B)(iii). As an incentive to the first generic maker to risk costly patent litigation by filing an ANDA with a paragraph IV certification, the Hatch-Waxman Amendments provide that the first to file a paragraph IV certification for a particular drug is eligible for a 180-day period of marketing protection (i.e., exclusivity from competition from subsequent generic drug manufacturers), beginning from the earlier of the first filer's commercial marketing of the drug or a decision of a court holding the patent invalid or not infringed. See id. 355(j)(5)(B)(iv).

In 1985, Barr submitted an ANDA containing a paragraph III certification for the drug tamoxifen, which was patented by Imperial Chemical Industries, PLC ("Imperial") under U.S. Patent No. 4,536,516 (" '516 patent"), which is due to expire on August 20, 2002. Barr amended its ANDA in 1987 to a paragraph IV certification, making it the first company to file an ANDA with a paragraph IV certification for tamoxifen. Imperial sued Barr for patent infringement, triggering the thirty-month statutory stay. In 1992, a district court ruled in favor of Barr. Imperial Chem. Indus., PLC v. Barr Labs., 795 F. Supp. 619 (S.D.N.Y. 1992), appeal dismissed and vacated pursuant to settlement sub nom. Imperial Chem. Indus., PLC v. Heumann Pharma GmbH & Co., 991 F.2d 811, No. 92-1403, 1993 WL 118931 (Fed. Cir. Mar. 19, 1993) (Table). While Imperial's appeal to the United States Court of Appeals for the Federal Circuit was pending, Imperial and Barr entered into a settlement agreement, in which Imperial licensed Barr to sell its tamoxifen product and Barr agreed not to pursue efforts to obtain final approval of its ANDA prior to the expiration of the '516 patent. As a result of the settlement, on March 19, 1993, the Federal Circuit dismissed Imperial's appeal and vacated the district court's judgment. Imperial Chem. Indus., PLC v. Heumann Pharma GmbH & Co., 991 F.2d 811, No. 92-1403, 1993 WL 118931 (Fed. Cir. Mar. 19, 1993) (Table). Barr subsequently amended its ANDA from a paragraph IV certification to a paragraph III certification, delaying approval of its ANDA until the expiration of the '516 patent.

In 1996, Pharmachemie filed its own ANDA for tamoxifen with a paragraph IV certification, amending its 1994 paragraph III certification ANDA. Zeneca Limited ("Zeneca"), which obtained the patent rights of the '516 patent from Imperial, its former parent company, filed a paragraph IV patent infringement suit against Pharmachemie, triggering the thirty-month statutory stay. Zeneca Ltd. v. Pharmachemie B.V. (No. 96-12413). On April 3, 1997, the FDA tentatively approved Pharmachemie's ANDA, to be effective at the earlier of the expiration of the statutory thirty-month stay period (or the period set forth by the court), the date of a final court decision, or the date of the expiration of the patent. On March 2, 1999, the FDA granted Barr's June 26, 1998 petition, which was filed shortly before the thirty-month statutory stay of Pharmachemie's ANDA was to expire and which sought enforcement of Barr's 180-day exclusivity period. The FDA imposed a stay on approval of all other ANDAs for tamoxifen until 180 days after the date of Barr's first commercial marketing of the drug or the date of a final decision of a court holding the '516 patent invalid or not infringed.

Pharmachemie then sought injunctive and declaratory relief in the district court, challenging the FDA's March 2, 1999 decision as contrary to the statute and FDA regulations. Barr intervened. On March 31, 2000, the district court (after consolidating the case with a similar suit brought by Mylan Pharmaceuticals, Inc.) granted summary judgment to Pharmachemie. Mylan Pharm. Inc. v. Henney, 94 F. Supp. 2d 36 (D.D.C. 2000).

Thereafter, two relevant events occurred. First, the FDA did not appeal the district court's decision, but rather, on July 13, 2000, issued an interim rule amending its regulations that interpreted the meaning of "court decision," 21 C.F.R. 314.107(e)(1)-(2)(iii), on which it had relied in granting Barr's petition. Court Decisions, ANDA Approvals, and 180-Day Exclusivity, 65 Fed. Reg. 43,233, 43,233 (2000). In view of recent judicial decisions, the FDA defined a "decision of a court" to include a district court opinion regardless of whether that opinion is appealed. Id. at 43,234. This rule is prospective only. FDA, Guidance for Industry, Court Decisions, ANDA Approvals and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act 4 (2000). Second, Pharmachemie lost its patent suit against Zeneca, and the district court in that case ordered that Pharmachemie's ANDA would become effective no earlier than the expiration of the '516 patent. Zeneca Ltd. v. Pharmachemie, B.V., Order (Oct. 27, 2000).

II.

Pharmachemie contends that the case is moot on appeal because it can no longer obtain the relief it sought in its complaint in light of the adverse final judgment on the validity of the patent. Barr responds that the appeal is not moot because the district court's decision stripping Barr of its statutory right to generic exclusivity continues to harm Barr. Alternatively, pointing to Teva Pharmaceuticals, USA, Inc. v. FDA, No. 99-5287, 2000 WL 1838303, at *1 (D.C. Cir. Nov. 15, 2000), Barr contends that the issues on appeal are capable of repetition, yet evade review because there are only 180 days in which to obtain judicial review of challenges to the statutory exclusivity period.

The mootness doctrine limits Article III courts to deciding "actual, ongoing controversies." Clarke v. United States, 915 F.2d 699, 700-01 (D.C. Cir. 1990) (quoting Honig v. Doe, 484 U.S. 305, 317 (1988)). A case is moot if "events have so transpired that the decision will neither presently affect the parties' rights nor have a more-than-speculative chance of affecting them in the future." Id. at 701 (quoting Transwestern Pipeline Co. v. FERC, 897 F.2d 570, 575 (D.C. Cir. 1990)); accord Pub. Util. Comm'n of the St. of Cal. v. FERC, 236 F.3d 708, 714 (D.C. Cir. 2001). Thus, "Article III denies federal courts the power to decide questions that cannot affect the rights of litigants in the case before them, and confines them to resolving real and substantial...

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