Glaxo Operations UK Ltd. v. Quigg

Decision Date24 January 1990
Docket NumberNo. 89-1407,89-1407
Citation13 USPQ2d 1628,894 F.2d 392
Parties, 13 U.S.P.Q.2d 1628 GLAXO OPERATIONS UK LIMITED, Plaintiff-Appellee, v. Donald J. QUIGG, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks, Defendant-Appellant.
CourtU.S. Court of Appeals — Federal Circuit

Donald O. Beers, Arnold & Porter, Washington, D.C., argued for plaintiff-appellee. With him on the brief were Stuart J. Land, John Agar and David E. Korn. Also on the brief was Richard E. Fichter, Bacon & Thomas, Alexandria, Va., of counsel.

Irene M. Solet, Dept. of Justice, Washington, D.C., argued for defendant-appellant. With her on the brief were Stuart E. Schiffer, Acting Asst. Atty. Gen., Henry E. Hudson, U.S. Atty. and John F. Cordes. Also on the brief were Fred E. McKelvey, Sol., Charles E. Van Horn, Deputy Sol. and John C. Martin, Associate Sol., Patent and Trademark Office, Arlington, Va., of counsel.

Before ARCHER and MICHEL, Circuit Judges, and BALDWIN, Senior Circuit Judge.

MICHEL, Circuit Judge.

Donald J. Quigg, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks (Commissioner), appeals the Order of the United States District Court for the Eastern District of Virginia, dated February 28, 1989, granting summary declaratory judgment to Glaxo Operations U.K. Ltd. (Glaxo). See Glaxo Operations UK Ltd. v. Quigg, 706 F.Supp. 1224, 10 USPQ2d 1100 (E.D.Va.1989). The court declared in its Order that Glaxo's application for patent term extension for U.S. Patent No. 4,267,320 satisfies the requirements of 35 U.S.C. Sec. 156(a) (Supp. V 1987), a provision of the Drug Price Competition and Patent Term Restoration Act of 1984 (the Act), tit. II, Sec. 201(a), 98 Stat. 1598. Because the district court correctly construed and properly applied the operative terms of the Act, we affirm.

Background

Glaxo is the assignee of U.S. Patent No. 4,267,320 ('320), issued May 12, 1981, which claims cefuroxime axetil, an antibiotic drug. In 1985, Glaxo sought approval from the Food and Drug Administration (FDA) to market a form of this drug, CEFTIN 1 tablets, and received approval on December 28, 1987. The active ingredient of CEFTIN tablets is cefuroxime axetil. The properties of this compound are such that it becomes therapeutically active and effective when orally administered. Cefuroxime axetil is an ester 2 of cefuroxime, an organic acid.

Cefuroxime and its salts 3 are claimed in Glaxo's U.S. Patent No. 3,974,153. Cefuroxime and two of its salts, marketed as ZINACEF and KEFUROX, are therapeutically active antibiotics only when administered intramuscularly or intravenously. None of these compounds are effective if orally administered. FDA approved ZINACEF in 1983 and various dosage strengths of KEFUROX in 1986 and 1987, but the acid cefuroxime has not been approved.

Glaxo sought a patent term extension for its '320 patent (cefuroxime axetil) because of the lost marketing time due to the lengthy FDA review process. The Commissioner denied the extension asserting that the 1987 FDA approval of CEFTIN was not the first permitted commercial marketing or use of the "product" because ZINACEF and KEFUROX had previously been approved, and therefore the '320 patent was not eligible for a term extension under the Act. See In re Glaxo Operations UK Ltd., Request for Patent Term Extension Under 35 U.S.C. Sec. 156 for U.S. Patent No. 4,267,320 (Sept. 9, 1988).

Glaxo sought declaratory and injunctive relief under the Administrative Procedures Act (APA), 5 U.S.C. Sec. 702 (1988), for which the federal district court had jurisdiction under 28 U.S.C. Sec. 1338(a) (1982). Glaxo then filed a motion for summary judgment. In responding to that motion, the Commissioner modified his grounds for rejection of Glaxo's patent term extension application. See Glaxo, 706 F.Supp. at 1226, 10 USPQ2d at 1102. The dispute between Glaxo and the Commissioner, however, remains focused entirely on the proper interpretation of one statutory eligibility requirement for patent term extension. Its application in this case, once properly construed, is not in dispute.

For a patent to be eligible for a term extension, among other things the product must have been "subject to a regulatory review period" and "the permission for the commercial marketing or use of the product after such regulatory review period [must have been] the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred." 35 U.S.C. Sec. 156(a)(4) & (5) (Supp. V 1987) (emphasis added). Moreover, the Act explicitly defines "product" as "the active ingredient of a new drug, ... including any salt or ester of the active ingredient...." Id. Sec. 156(f)(2).

It is undisputed that cefuroxime axetil is the active ingredient of CEFTIN tablets. Moreover, the Commissioner does not appear to contest that ZINACEF and KEFUROX are neither salts nor esters of cefuroxime axetil. Consequently, Glaxo argues that the "product" as defined by the Act has not been previously approved or used before CEFTIN tablets were approved because neither ZINACEF nor KEFUROX fell within the definition. Accordingly, Glaxo contends that because CEFTIN is the "first permitted commercial marketing or use" of the product patented, the '320 patent is eligible for term extension.

The Commissioner, on the other hand, argues that "product" was not intended by Congress to have a literal meaning, only encompassing three categories of compounds: (1) an active ingredient; (2) a salt of an active ingredient; or (3) an ester of an active ingredient. He asserts that Congress intended the definition to mean any "new chemical entity," i.e., "new active moiety," which would encompass all acid, salt, or ester forms of a single therapeutically active substance even if the drug before being administered contained only other substances. In this case, because after being orally administered CEFTIN tablets combine with digestive substances in the human body to produce the same therapeutically active substance contained in both ZINACEF and KEFUROX, then under the Commissioner's interpretation, Glaxo has already had a prior approval of the "product" before it sought a term extension for its '320 patent.

The trial court reviewed the Commissioner's interpretation of section 156 under the standard enunciated in the APA, 5 U.S.C. Sec. 706(2)(A) (1988), 4 and concluded that his action was "contrary to law." Accordingly, the trial court granted Glaxo summary judgment. We hear the Commissioner's appeal under 28 U.S.C. Sec. 1295(a)(1) (1982).

OPINION
I.

In reviewing a grant of summary judgment, an appellate court must determine whether the strict standard set forth in Rule 56(c) of the Federal Rules of Civil Procedure has been satisfied. Chula Vista City School Dist. v. Bennett, 824 F.2d 1573, 1579 (Fed.Cir.1987), cert. denied, 484 U.S. 1042, 108 S.Ct. 774, 98 L.Ed.2d 861 (1988). In the instant case, both parties concede that there are no genuine issues of material fact. Consequently, this court need only decide the same question of law decided by the district court on summary judgment. That question is one of statutory interpretation, one that an appellate court can independently determine without deference to the trial court's interpretation. See Madison Galleries, Ltd. v. United States, 870 F.2d 627, 629 (Fed.Cir.1989). 5

II.

"When ... the terms of a statute [are] unambiguous, judicial inquiry is complete, except in rare and exceptional circumstances." United States v. James, 478 U.S. 597, 606, 106 S.Ct. 3116, 3121, 92 L.Ed.2d 483 (1986) (quoting Rubin v. United States, 449 U.S. 424, 430, 101 S.Ct. 698, 701, 66 L.Ed.2d 633 (1981) (internal quotation marks omitted)). Moreover, absent a "clearly expressed legislative intention to the contrary," a statute's plain meaning "must ordinarily be regarded as conclusive." Consumer Prod. Safety Comm'n v. GTE Sylvania, Inc., 447 U.S. 102, 108, 100 S.Ct. 2051, 2056, 64 L.Ed.2d 766 (1980).

We conclude that section 156(f)(2)'s terms, "active ingredient of a new drug ... including any salt or ester of the active ingredient," all have a plain meaning. We reach this conclusion because we must interpret statutory words as " 'taking their ordinary, contemporary, common meaning,' " unless otherwise defined by Congress. Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1426, 7 USPQ2d 1152, 1155 (Fed.Cir.1988) (quoting Perrin v. United States, 444 U.S. 37, 42, 100 S.Ct. 311, 314, 62 L.Ed.2d 199 (1979)). In particular, the terms "active ingredient," "salt," and "ester" had well-defined, ordinary, common meanings when Congress enacted the Act. See, e.g., 45 Fed.Reg. 72,582; 72,591 (1980); 44 Fed.Reg. 2932, 2937-38 (1979); Chemical Dictionary, supra note 3, at 418, 907. The Commissioner, however, suggests that Congress "inartfully" and "awkwardly" selected this combination of terms intending something other than their combined, common and ordinary meanings. Brief for Defendant-Appellant Quigg at 10, 24, Glaxo Operations UK Ltd. v. Quigg, No. 89-1407 (Fed.Cir. filed July 19, 1989) [hereinafter Commissioner's Brief]. This approach is unpersuasive because it simply overlooks the legal consequence that ordinarily attaches whenever statutory language has a clear and plain meaning. Instead, the Commissioner simply ignores the plain meaning of these terms and argues, as a totally unrelated question, that Congress intended a meaning contrary to the plain meaning.

Nonetheless, even when the plain meaning of the statutory language in question would resolve the issue before the court, the legislative history should usually be examined at least "to determine whether there is a clearly expressed legislative intention contrary to the statutory language." Madison Galleries, 870 F.2d at 629 (emphasis added); see LSI Computer Sys. v. United States Int'l Trade Comm'n, 832 F.2d 588, 590, 4 USPQ2d 1705, 1707 (Fed.Cir.1987). 6 Consequently, although we...

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