Andrx Pharmaceuticals Inc v. Biovail Corp

• Decision Date: 17 January 2002
• Citation: 61 USPQ2d 1414,276 F.3d 1368
• Parties: (Fed. Cir. 2002) ANDRX PHARMACEUTICALS, INC., Plaintiff-Cross Appellant, v. BIOVAIL CORPORATION, Defendant-Appellant, v. TOMMY G. THOMPSON, Secretary of Health and Human Services, BERNARD A. SCHWETZ, Acting Principal Deputy Commissioner, U.S. Food and Drug Administration, and U.S. FOOD AND DRUG ADMINISTRATION, Defendants-Appellees. BIOVAIL LABORATORIES, INC., Plaintiff/Counterclaim Defendant, and BIOVAIL CORPORATION, Counterclaim Defendant-Appellant, v. ANDRX PHARMACEUTICALS, INC., Defendant/Counter claimant-Cross Appellant. 01-1650, 02-1025 DECIDED:
• Court: U.S. Court of Appeals — Federal Circuit

Page 1368

276 F.3d 1368 (Fed. Cir. 2002)

ANDRX PHARMACEUTICALS, INC., Plaintiff-Cross Appellant, v. BIOVAIL CORPORATION, Defendant-Appellant, v. TOMMY G. THOMPSON, Secretary of Health and Human Services, BERNARD A. SCHWETZ, Acting Principal Deputy Commissioner, U.S. Food and Drug Administration, and U.S. FOOD AND DRUG ADMINISTRATION, Defendants-Appellees.

BIOVAIL LABORATORIES, INC., Plaintiff/Counterclaim Defendant and BIOVAIL CORPORATION, Counterclaim Defendant-Appellant, v. ANDRX PHARMACEUTICALS, INC., Defendant/Counter claimant-Cross Appellant.

01-1650, 02-1025

United States Court of Appeals for the Federal Circuit

DECIDED: January 17, 2002

Appeals from: United States District Court for the Southern District of Florida, Judge William P. Dimitrouleas

[Copyrighted Material Omitted] Louis M. Solomon, Solomon, Zauderer, Ellenhorn, Frischer & Sharp, of New York, New York, argued for plaintiff-cross appellant 01-1650, and for defendant/Counter claimant-cross appellant in 02-1025, Andrx Pharmaceuticals, Inc. Of counsel were Colin A. Underwood, Teresa A. Consalves, and Jennifer R. Scullion. Also of counsel was Gerald J. Houlihan, Houlihan & Partners, P.A., of Miami, Florida.

Michael A. Cardozo, Proskauer Rose LLP, of New York, New York, argued for defendant-appellant in 01-1650, and plaintiff/counterclaim defendant, and counterclaim defendant-appellant in 02-1025, Biovail Corporation and Biovail Laboratories, Inc. Of counsel were Ronald S. Rauchberg, Nancy A. Kilson; and Alec W. Farr, Proskauer Rose LLP, of Washington, DC.

Howard S. Scher, Attorney, Appellate Staff, Civil Division, Department of Justice, of Washington, DC, argued for defendants-appellees, Tommy G. Thompson, Secretary of Health and Human Services, et al. Of counsel was Douglas N. Letter, Attorney.

Before BRYSON, LINN, and DYK, Circuit Judges.

DYK, Circuit Judge.

Biovail Corporation ("Biovail") appeals an order of the United States District Court for the Southern District of Florida. Pursuant to 21 U.S.C. 355(j)(5)(B)(iii), the district court (1) shortened the statutory thirty-month delay of approval of Andrx Pharmaceuticals, Inc.'s ("Andrx") pending Abbreviated New Drug Application ("ANDA") by the Food and Drug Administration ("FDA") and (2) ordered that the ANDA be approved by the FDA. Andrx Pharms., Inc. v. Biovail Corp., No. 01-6194, 2001 U.S. Dist. LEXIS 16904 (S.D. Fla. Sept. 19, 2001). We hold that the district court exceeded its authority under 21 U.S.C. 355(j)(5)(B)(iii). Accordingly, we vacate the district court's order and remand for further proceedings.

I

This case requires an interpretation of the statute which governs new and generic drug approvals and the enforcement of patents related to such drugs. This court has recently described the background and operation of this statute in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323, 1325-27, 60 USPQ2d 1576, 1577-79 (Fed. Cir. 2001). We briefly review it again here.

Under 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, (the "Hatch-Waxman Amendments" to the Federal Food, Drug and Cosmetic Act ("FFDCA")), Congress struck a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market. Under the Hatch-Waxman Amendments, a manufacturer that seeks to market a generic drug may submit an ANDA for approval by the FDA, rather than submitting a full New Drug Application ("NDA") concerning the safety and efficacy of the generic drug, and it may rely on safety and efficacy studies previously submitted by the pioneer manufacturer by submitting information showing the generic drug's bioequivalence with the previously approved drug product. See 21 U.S.C. 355(j)(2)(A).

Also under the Hatch-Waxman Amendments, a pioneer drug manufacturer that holds an approved NDA is required to notify the FDA of all patents that "claim[] the drug for which the [NDA] applicant submitted the application . . . ." 21 U.S.C. 355(b)(1), (c)(2). The FDA lists such patents in its Approved Drug Products With Therapeutic Equivalence Evaluations (otherwise known as the "Orange Book"). Under 35 U.S.C. section 71(e)(1), it is not patent infringement to conduct otherwise infringing acts necessary to prepare an ANDA. Under section 271(e)(2), however, a generic drug manufacturer infringes a patent by filing an ANDA to obtain approval for a generic drug product claimed by a valid and unexpired patent.

As part of the approval process, an ANDA applicant must make a certification addressing each patent listed in the Orange Book that claims the drug. 21 U.S.C. 355(j)(2)(A)(vii). An applicant whose ANDA is pending when a pioneer drug manufacturer lists additional patents in the Orange Book must make amended certifications addressing the newly listed patents claiming the drug, unless the patents are listed more than thirty days after they were issued. 21 C.F.R. 314.94(a)(12)(vi). In either case, the ANDA applicant must certify that (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be infringed by the manufacture, use, or sale of the new generic drug for which the ANDA is submitted. 21 U.S.C. 355(j)(2)(A)(vii)(I-IV). These are commonly referred to as paragraph I, II, III, and IV certifications.

When an ANDA contains a paragraph IV certification, the ANDA applicant must give notice to the patentee and the NDA holder and provide a detailed basis for its belief that the patent is not infringed, invalid, or unenforceable. 21 U.S.C. 355(j)(2)(B)(i); 21 C.F.R. 314.95(c)(6). The patentee then has forty-five days to sue the ANDA applicant for patent infringement, and the ANDA applicant may not file a declaratory judgment during this time (based on the filing of the ANDA application). 21 U.S.C. 355(j)(5)(B)(iii). If the patentee does not sue, the ANDA will be approved. If the patentee does file suit, the FDA may not approve the ANDA until expiration of the patent, resolution of the suit, or thirty months after the patentee's receipt of notice, whichever is earlier. Id. The court in which the suit is pending may order a shorter or longer stay if "either party to the action fail[s] to reasonably cooperate in expediting the action . . . ." Id.

II

The present controversy arose against this statutory background. Biovail's affiliate Biovail Laboratories, Inc.,¹ currently holds an approved New Drug Application for a drug used to treat hypertension and angina, which it markets as Tiazac. The active ingredient in Tiazac is diltiazem hydrochloride. Andrx has filed an ANDA with the FDA for approval of a generic version of Tiazac.

The parties have been litigating patent infringement issues related to Andrx's ANDA for some time now. Biovail received approval for its NDA on September 11, 1995. Subsequent to FDA approval of the NDA, Biovail certified to the FDA that U.S. Patent No. 5,529,791 (the "'791 patent"), which issued on June 25, 1996, claimed the drug for which Biovail submitted the NDA. The FDA listed the '791 patent in the Orange Book as claiming Tiazac.

On June 22, 1998, Andrx filed its ANDA application, which included a paragraph IV certification addressing the '791 patent. The certification stated that Andrx did not infringe the patent and that the patent was invalid. Andrx notified Biovail of its paragraph IV certification and, on October 7, 1998, Biovail sued Andrx in district court for infringement of the '791 patent. Pursuant to 21 U.S.C. 355(j)(5)(B)(iii), the filing of the patent infringement action triggered an automatic stay of the approval of Andrx's ANDA for thirty months after Biovail received notice of Andrx's paragraph IV certification (i.e., until February 25, 2001) or until the patent litigation was resolved. After a bench trial, the district court entered a judgment of noninfringement in favor of Andrx, and this court affirmed on February 13, 2001. Biovail Corp. Int'l v. Andrx Pharms., Inc., 239 F.3d 1297, 57 USPQ2d 1813 (Fed. Cir. 2001). Thus, but for the present dispute, the FDA would have approved Andrx's ANDA on or shortly after February 13, 2001.² However, the present dispute intervened.

On May 1, 1997, non-party Arnold Lippa filed a provisional application in the United States Patent and Trademark Office. On April 28, 1998, within the one-year window available to claim priority to the provisional application, Mr. Lippa filed a utility patent application. That application resulted in the issuance on December 19, 2000, of U.S. Patent No. 6,162,463 (the "'463 patent"), which claims an extended release formulation of diltiazem, the active ingredient in Tiazac. The parties apparently agree that Biovail did not participate in the prosecution of applications leading to the '463 patent, but in January 2001 Biovail acquired an exclusive license for the patent.

On January 8, 2001, Biovail filed a certification with the FDA supporting the listing of the '463 patent in the Orange Book. In a February 2, 2001, letter to Andrx the FDA stated that because of the listing of the '463 patent, it no longer intended to approve Andrx's ANDA upon the expiration of the thirty-month stay triggered by the infringement dispute concerning the '791 patent. In a letter to the FDA dated February 1, 2001, Andrx protested the listing of the '463 patent, claiming that the patent did not claim Tiazac, and requested that the FDA delist the patent from the Orange Book. The FDA twice sought a response from Biovail concerning Andrx's protest to the listing of the '463 patent in the Orange Book. On March 26, 2001, Biovail recertified that the '463 patent claims the drug for which it submitted its original NDA. This alone was apparently sufficient for the...