Glaxo Operations UK Ltd. v. Quigg

• Decision Date: 17 February 1989
• Docket Number: Civ. A. No. 88-1487-A.
• Citation: 706 F. Supp. 1224,10 USPQ 2d 1100
• Parties: GLAXO OPERATIONS UK LIMITED, Plaintiff, v. Donald J. QUIGG, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks, Defendant.
• Court: U.S. District Court — Eastern District of Virginia

706 F. Supp. 1224

10 USPQ 2d 1100

GLAXO OPERATIONS UK LIMITED, Plaintiff, v. Donald J. QUIGG, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks, Defendant.

Civ. A. No. 88-1487-A.

United States District Court, E.D. Virginia, Alexandria Division.

February 17, 1989.

Paula M. Potoczak, Asst. U.S. Atty., Alexandria, Va. (Fred E. McKelvey, Sol., John C. Martin, Assoc. Sol., Arlington, Va., of counsel), for defendant.

Richard E. Fichter, Bacon & Thomas, Alexandria, Stuart J. Land, Donald O. Beers, John Agar, David E. Korn, Arnold & Porter, Washington, D.C., for plaintiff.

MEMORANDUM OPINION

ELLIS, District Judge.

Introduction¹

In this suit for declaratory and injunctive relief, plaintiff, the holder of a patent for an orally-administered antibiotic drug, challenges the denial of its application for a patent term extension pursuant to the Drug Price Competition and Patent Restoration Act of 1984 (the "Act").² Title II of the Act, 35 U.S.C. § 156, permits extensions of the patent term for certain patented new drugs required to undergo the Food and Drug Administration's (FDA) rigorous and often time-consuming new drug approval procedures. Such procedures often require years to complete, thereby diminishing the commercial rights provided by the patent. Acutely aware of this, Congress acted to permit extensions of the patent terms to make up some of the time consumed in the FDA approval process.

The parties' dispute in this case presents a straightforward question of statutory interpretation. Specifically, the question presented is whether plaintiff's patented product meets the requirement of Section 156(a)(5)(A) that the use of the product following FDA approval constitute the first commercial marketing or use. Because the essential, dispositive facts are undisputed, summary judgment is appropriate. Rule 56, Fed.R.Civ.P. For the reasons stated, the Court grants plaintiff summary judgment as to Count I and awards declaratory and injunctive relief.

Facts

Plaintiff holds Patent No. 4267320 claiming cefuroxime axetil, an orally administered antibiotic drug. It markets this patented compound as Ceftin Tablets, a registered trademark. The patent issued on May 12, 1981. As often happens, however, the New Drug Application (NDA) for Ceftin Tablets was not approved by FDA under Section 507 of the Federal Food, Drug and Cosmetic Act until December 28, 1987. To obtain this NDA approval, plaintiff was required to complete a range of tests and procedures, including toxicity tests on animals and clinical tests on humans. See generally 21 CFR §§ 312 & 314. After receiving approval from NDA, plaintiff sought an extension of the patent term. Because more than four (4) years were consumed in proceedings before the FDA, plaintiff sought the maximum two year extension of the patent term permitted by the Act. See 35 U.S.C. § 156(c).³

The active ingredient of Ceftin Tablets is cefuroxime axetil. Unique properties of this distinct pharmaceutical compound make it therapeutically active and effective when administered orally. Cefuroxime axetil is an ester⁴ of cefuroxime, an organic acid. This acid and its salts are claimed by plaintiff's United States Patent No. 3,974,153. Cefuroxime and its salt, cefuroxime sodium, are both antibiotics that are therapeutically active only when administered intramuscularly or intravenously. Neither is effective if administered orally. The FDA has previously approved NDA's for two sodium salts of cefuroxime. Zinacef was approved in 1983 and Kefurox in 1986 and 1987. No approval has ever issued for the acid cefuroxime.

Plaintiff filed the term extension application in issue here on September 9, 1988. The Commissioner denied the approval, asserting that cefuroxime axetil was not eligible for patent term extension because the 1987 FDA approval of Ceftin Tablets was not the first permitted commercial marketing or use of the product. In support of this rejection of the application, the Commissioner stated that:

thus, for the purpose of eligibility for patent term extension, an active ingredient in the acid, salt or ester form is treated as the same drug product.

Applying the explicit terms of the statute to the circumstances of this application for patent term extension, it must be concluded that the active ingredient in CEFTIN is an ester of cefuroxime. A sodium salt of cefuroxime has been approved for commercial marketing or use by the FDA prior to the approval of CEFTIN. Accordingly, the permission for commercial marketing or use of the product (i.e. the active ingredient cefuroxime axetil) after the regulatory review period was not the first permitted commercial marketing or use of the product (cefuroxime as a salt or ester) under the provision of law under which the regulatory review period occurred.

In re Glaxo Operations UK Limited, Request for Patent Term Extension Under 35 U.S.C. § 156 For U.S. Patent No. 4,267,320 at 3-4 (Sept. 9, 1988).

More recently, the Commissioner, in his initial brief on this issue, stated that upon further reflection Ceftin Tablet's active ingredient is cefuroxime the acid, not cefuroxime axetil the ester. The Commissioner requested a remand to add this finding to the record and to change accordingly the rationale for his decision. At oral argument, the need for a remand was unclear. Accordingly, the Court ordered further briefing to clarify the nature of the Commissioner's proposed rationale. The Court has now reviewed the supplemental brief and concludes, on the basis of the record as a whole, that a remand is neither necessary nor warranted. Remand for agency reconsideration may be appropriate if, on a correct reading of the law, questions of fact or policy remain unresolved. Agency reconsideration may also be appropriate where there is "such failure to explain agency action as to frustrate effective judicial review," Camp v. Pitts, 411 U.S. 138, 142-43, 93 S.Ct. 1241, 1244, 36 L.Ed.2d 106 (1972), or where the agency's factual findings cannot be sustained on the record. See Florida Power & Light v. Lorion, 470 U.S. 729, 744, 105 S.Ct. 1598, 1607, 84 L.Ed.2d 643 (1985); Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 549, 98 S.Ct. 1197, 1214, 55 L.Ed.2d 460 (1978). None of these conditions obtains here. On the contrary, the Commissioner's proposed rationale is adequately explained in his supplemental briefs. Simply put, this is a case in which undisputed material facts and unambiguous statutory language compel rejection of the Commissioner's second rationale, as well as his first. While the Court is not compelled to consider the Commissioner's proposed rationale,⁵ it does so in the interests of good judicial husbandry and the expeditious resolution of this dispute. Also in the interests of good judicial husbandry, the Court addresses Count II of plaintiff's complaint even though the Court's ruling with respect to the first count provides plaintiff with all the requested relief. As it happens, the plaintiff's legal position in connection with the second count is inconsistent with its position on the first count, with the result that the Commissioner would prevail in the second count if it became material to this case.

Analysis

A. Count I

A patent is eligible for a term extension under the Act if five conditions are met:

(1) the term of the patent has not expired before an application is submitted under subsection (d) for its extension;

(2) the term of the patent has never been extended;

(3) an application for extension is submitted by the owner of record of the patent or its agent and in accordance with the requirements of subsection (d);

(4) the product has been subject to a regulatory review period before its commercial marketing or use;

(5) (A) ... the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred. (Emphasis added.)

35 U.S.C. § 156(a).

Undisputed in this case is that plaintiff's application for extension of the plaintiff's cefuroxime axetil patent meets the first four conditions. Only the fifth, Section 156(a)(5)(A), is in issue here. Given this, the question sharply presented is whether the "product" referred to in (a)(5)(A) is cefuroxime axetil, on the one hand, or cefuroxime, the parent acid on the other. The answer to this question turns on the statutory definition of "product." Subsection (f) of Section 156 defines "product" as "a drug product," which, in turn, is defined as follows:

(2) The term "drug product" means the active ingredient of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.

35 U.S.C. § 156(f)(2). The central question then is whether the active ingredient of Ceftin Tablets is the ester cefuroxime axetil or the parent acid cefuroxime. If the former is true, plaintiff is entitled to an extension of its patent term.⁶ If the latter is true, then no extension would be warranted because the FDA has previously approved NDA's for Zinacef and Kefurox, two sodium salts of cefuroxime.

Undisputed record facts leave no doubt as to the answer to this question: It is cefuroxime axetil that is the "active ingredient" in Ceftin Tablets.⁷ Cefuroxime itself is not present at all in Ceftin Tablets; it is therefore not an "ingredient." This conclusion is inescapable given the plain and unambiguous language of the statute. An ingredient is a "constituent element of a mixture or compounds." Webster's Second University Dictionary (1984). It must be something found in the mixture or compound, not just something that can be derived from it or from which the mixture or compound can be derived. Simply...