Apotex, Inc. v. Thompson

• Decision Date: 27 October 2003
• Docket Number: No. 02-1295.,02-1295.
• Parties: APOTEX, INC., Plaintiff-Appellant, v. Tommy G. THOMPSON, Secretary of Health and Human Services, U.S. Food and Drug Administration, and Lester M. Crawford, Deputy Commissioner, U.S. Food and Drug Administration, Defendants-Appellees, and Smithkline Beecham Corporation, Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

347 F.3d 1335

APOTEX, INC., Plaintiff-Appellant, v. Tommy G. THOMPSON, Secretary of Health and Human Services, U.S. Food and Drug Administration, and Lester M. Crawford, Deputy Commissioner, U.S. Food and Drug Administration, Defendants-Appellees, and Smithkline Beecham Corporation, Defendant-Appellee.

No. 02-1295.

United States Court of Appeals, Federal Circuit.

Decided October 27, 2003.

COPYRIGHT MATERIAL OMITTED

Hugh L. Moore, Lord, Bissell & Brook, of Chicago, Illinois, argued for plaintiff-appellant. With him on the brief were Terrence P. Canade and Hugh S. Balsam. Of counsel on the brief was Arthur Y. Tsien, Olsson, Frank and Weeda, P.C., of Washington, DC.

Daniel E. Troy, Chief Counsel, Office of the Chief Counsel, Food and Drug Administration, of Rockville, Maryland, argued for defendants-appellees Tommy G. Thompson, Secretary of Health and Human Services, et al. With him on the brief were Eric M. Blumberg, Deputy Chief Counsel for Litigation; and Karen E. Schifter, Associate Chief Counsel, Food and Drug Administration, and Alex M. Azar II, General Counsel, Department of Health and Human Services, of Washington, DC. On the brief for defendants-appellees were Douglas N. Letter and Howard S. Scher, Attorneys, Appellate Staff, Civil Division, United States Department of Justice, of Washington, DC.

E. Edward Bruce, Covington & Burling, of Washington, DC, argued for defendant-appellee Smithkline Beecham Corporation. On the brief were Bruce N. Kuhlik, Christopher N. Sipes, and Elizabeth S. Weiswasser. Of counsel was Stephen T. Kaminski.

Before NEWMAN, Circuit Judge, PLAGER, Senior Circuit Judge, and BRYSON, Circuit Judge.

Opinion of the Court filed by Circuit Judge BRYSON. Concurring opinion filed by Senior Circuit Judge PLAGER. Dissenting opinion filed by Circuit Judge PAULINE NEWMAN.

BRYSON, Circuit Judge.

A company that seeks to market a pharmaceutical drug in the United States must first obtain approval from the Food and Drug Administration ("FDA"). Ordinarily, a pharmaceutical company initiates that process by filing a New Drug Application ("NDA"), demonstrating through the presentation of test data that the drug in question is safe and effective. 21 U.S.C. § 355(b)(1)(A).

Before 1984, a pharmaceutical company that wished to make a generic version of an approved drug needed to file a separate NDA, which had to include that company's own safety and effectiveness data. In that year, however, Congress changed the process for obtaining FDA permission to market generic versions of approved drugs by enacting the Drug Price Competition and Patent Term Restoration Act of 1984, known as the "Hatch-Waxman Act," Pub.L. No. 98-417, 98 Stat. 1585. The Hatch-Waxman Act authorized a company to obtain FDA permission to market a generic version of an approved drug by filing an Abbreviated New Drug Application ("ANDA"). If the ANDA establishes both that the active ingredient in the proposed drug product is the same as the active ingredient in the previously approved drug and that the proposed product is bioequivalent to the approved drug, the ANDA applicant may rely on the safety and effectiveness data contained in the original NDA. 21 U.S.C. §§ 355(j)(2)(A)(ii), (iv). In addition, the Act permitted a company wishing to develop a generic version of an approved drug to manufacture and use the drug for development purposes without infringing any patent claiming the approved drug. 35 U.S.C. § 271(e)(1).

At the same time, the Hatch-Waxman Act sought to strengthen the incentives for pharmaceutical development by extending the terms of certain drug patents, 35 U.S.C. § 156, and by providing a 180-day period of nonpatent market exclusivity for approved drugs during which no ANDA may be filed or approved, 21 U.S.C. § 355(j)(5)(B)(iv). The Act also sought to facilitate the resolution of patent-related disputes over pharmaceutical drugs by creating a streamlined mechanism for identifying and resolving patent issues related to the proposed generic products. In particular, the Act required NDA applicants to identify any patent that claims the drug that is the subject of the NDA or that claims "a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted" against a party who made, used, or sold the drug. Id. § 355(b)(1). The statute directs the FDA to list the disclosed patents, id., which the FDA does in a publication entitled "Approved Drug Products With Therapeutic Equivalence Evaluations," more commonly known as the "Orange Book." In addition, the Act requires an NDA holder to file for listing in the Orange Book any such patents that issue after the NDA is approved. Id. § 355(c)(2).

Under the procedure set forth in the Act, a company that submits an ANDA for a proposed generic drug must certify as to each patent that claims the approved drug either (1) that no patent information has been filed with the FDA; (2) that the patent has expired; (3) that the patent will expire on a particular date; or (4) that the patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug. 21 U.S.C. § 355(j)(2)(A)(vii). Under FDA policy, an ANDA applicant must make a certification for every patent listed in the Orange Book for the particular approved drug to which the ANDA relates. When an ANDA applicant certifies that the patent is invalid or will not be infringed (a so-called "paragraph IV certification"), it must provide notice to the patentee and the holder of the approved NDA that it has submitted such a certification. Id. § 355(j)(2)(B)(i). In addition, the ANDA applicant must supply a detailed statement of the factual and legal basis for its opinion of invalidity or noninfringement. Id. § 355(j)(2)(B)(ii). The ANDA applicant must also provide such a statement if it amends its ANDA to include a paragraph IV certification. Id. § 355(j)(2)(B)(iii).

Once the patent holder receives notice that an ANDA applicant has filed a paragraph IV certification with respect to an approved drug, the patent holder has 45 days within which to file a patent infringement action. 21 U.S.C. § 355(j)(5)(B)(iii). To facilitate judicial resolution of the question whether the generic drug would infringe a pertinent patent, the Hatch-Waxman Act treats the act of filing a paragraph IV certification as an act of patent infringement. 35 U.S.C. § 271(e)(2)(A). If the patentee files an infringement action within the designated 45-day period, the FDA may not approve the ANDA until 30 months have passed, unless the case is decided before then or the 30-month period is modified by the court before which the infringement action is pending. 21 U.S.C. § 355(j)(5)(B)(iii).

I

Appellee SmithKline Beecham Corporation ("SmithKline") is the holder of an NDA for the pharmaceutical Paxil, the active ingredient in which is paroxetine hydrochloride hemihydrate. On December 29, 1992, the FDA approved SmithKline's NDA for the use of Paxil to treat depression. Pursuant to 21 U.S.C. § 355(b)(1), SmithKline referred in its NDA to its U.S. Patent No. 4,721,723 ("the '723 patent"), which claims crystalline paroxetine hydrochloride hemihydrate. Accordingly, the FDA listed the '723 patent in the Orange Book when it approved SmithKline's NDA.

In March 1998, appellant Apotex, Inc., filed an ANDA for a generic bioequivalent of Paxil. At that time, the '723 patent was the only patent listed in the Orange Book relating to the NDA for Paxil. Because the active ingredient in Apotex's proposed generic drug was an anhydrous form of paroxetine hydrochloride, which Apotex asserted would not infringe the '723 patent, Apotex filed a paragraph IV certification. After receiving notice of Apotex's paragraph IV certification, SmithKline filed a patent infringement action in the United States District Court for the Northern District of Illinois. SmithKline alleged that, contrary to Apotex's certification, Apotex's drug would infringe the '723 patent. The filing of that suit triggered the automatic 30-month stay during which the FDA could not approve Apotex's ANDA. That stay expired on November 21, 2000.

Meanwhile, in February and May 1999, SmithKline was issued two patents, U.S. Patent No. 5,872,132 ("the '132 patent") and U.S. Patent No. 5,900,423 ("the '423 patent"), which claim two forms of paroxetine hydrochloride anhydrate. SmithKline filed notices asserting that both of those patents claim the drug that was the subject of its 1992 NDA. The FDA then listed those two patents in the Orange Book. Because Apotex's ANDA was still pending, the FDA required Apotex to file certifications for them. After Apotex filed paragraph IV certifications for the '132 and '423 patents, SmithKline sued Apotex in the United States District Court for the Eastern District of Pennsylvania for allegedly infringing the '423 patent. The FDA treated that lawsuit as triggering a second 30-month stay of approval of Apotex's ANDA, a stay that expired in January 2002. SmithKline has not sued Apotex for infringement of the '132 patent.

In February 2000, Apotex filed an administrative petition known as a citizen petition with the FDA. Apotex challenged the FDA's refusal to grant final approval of its ANDA and sought to have the '132 and '423 patents removed from the Orange Book on the ground that those patents did not claim Paxil, the drug that was the subject of the 1992 NDA. By April 2000, the FDA had neither approved Apotex's 1998 ANDA nor de-listed the '132 or '423 patents. Apotex therefore filed this action in the United States District Court for the District of Columbia, challenging the FDA's refusal to grant final approval of Apotex's ANDA.

After Apotex initiated this lawsuit, SmithKline was issued the following patents: (1) U.S. Patent No. 6,080,759 ("the '759 patent"), which claims a process for making one form of paroxetine hydrochloride anhydrate; (2) U.S. Patent No. 6,113,944 ("the '944 patent"), which is directed to a...