MEMORANDUM OPINION

ELLIS, District Judge.

Introduction

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"). 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).

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 ester 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:

[t]hus, 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.

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, 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.)

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.

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. 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 because the ester cefuroxime axetil may be derived from the acid cefuroxime through esterification is no basis for concluding that cefuroxime is some how an "ingredient." One might as well say that a caterpillar is an ingredient of a butterfly. This is palpably not so. To be sure, a butterfly comes from, or derives from, a caterpillar in metamorphosis as does the ester from the acid in esterification. But there is no caterpillar that is part of a butterfly, just as the acid itself is not a part of or found in the ester.

The Commissioner seeks to avoid this result by advancing a new rationale. In essence, the Commissioner's new rationale argues that cefuroxime is an active ingredient in Cefrin Tablets because it is, ultimately, the therapeutically effective agent. The explanation is as follows: Cefuroxime axetil, active on oral administration, is absorbed from the gastrointestinal track and then hydrologized in the blood and intestinal track to release cefuroxime into the circulation. And it is cefuroxime that is the effective anti-bacterial agent. Because the therapeutic effect of cefuroxime axetil is ultimately related to the cefuroxime released in the digestive tract, the Commissioner argues that cefuroxime is "the active moiety" of Ceftin Tablets and thereby falls within (a)(5)(A). This rationale is untenable, its flaw manifest. The statute says "ingredient," not "moiety." And, as noted, an "ingredient" must be present in the drug product when administered. This is an insurmountable obstacle for the Commissioner's proposed rationale given that he concedes, as he must, that "Cefuroxime itself is not an ingredient of Ceftin Tablets." Commissioner's Supplemental Brief at 17. Even if a "moiety," in pharmaceutical parlance, is something that results from chemical changes occurring after the drug is administered and need not itself be present in the drug product at the time of administration, this is not the plain meaning of "ingredient." And, neither this Court, nor the Commissioner is at liberty to ignore this plain meaning and the fact that the statute uses "ingredient," not "moiety." Equating "active moiety" with "active ingredient," as the Commissioner urges, results in reading out of the statute the plain meaning of the phrase Congress chose. This is unwarranted for "`[a] fundamental canon of statutory construction is that, unless otherwise defined, words will be interpreted as taking their ordinary, contemporary, common meaning.'" Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1426 (Fed. Cir. 1988) [quoting Perrin v. United States, 444 U.S. 37, 42, 100 S.Ct. 311, 314, 62 L.Ed.2d 199 (1979)].

Nor does the legislative history furnish any basis for ignoring the plain and unambiguous meaning of "active ingredient." The Commissioner attached to his supplemental brief several volumes of the Act's legislative history. Yet he forthrightly concedes that this extensive history contains no specific discussion of the definitions of the statutory term "active ingredient," the non-statutory term "active moiety" or any of the specific issues raised here. And, indeed, this is the case. Even so, the Commissioner attempts to fashion an argument based on the legislative history's discussions of "new chemical entities." The attempt fails. At worst, the Commissioner misconstrues this history. At best, the history is ambiguous, in which case, as noted in United States v. Canadian Vinyl Indus., Inc., 555 F.2d 806, 811 (C.C.P.A. 1977), this Court should not "alter the clear meaning of the statute because of ambiguous legislative history." Indeed, the operative rule here is as follows:

If the statutory language is unambiguous, in the absence of "a clearly expressed legislative intent to the contrary, that language must ordinarily be regarded as conclusive."

Both parties cite Abbott Laboratories v. Young, 691 F. Supp. 462 (D.D.C. 1988). That case concerns the interpretation of "active ingredient" as the phrase is used in the Act's Title I market exclusivity provisions. See 21 U.S.C. § 355(j)(4)(D). The FDA argued there, as the Commissioner does here, that "active ingredient" should be equated with "active moiety." Abbott disagreed, taking the position that an "ingredient" is different from a "moiety" because the former, but not the latter, must actually be present in the drug at the time it is administered. Ultimately, the court did not definitively decide this issue because it concluded, incorrectly it appears, that both definitions led to the same result: the applicability of the two year market exclusivity period. It does appear, however, that the Abbott court recognized a distinction between the plain meaning of "active ingredient" and the FDA's use of active moiety." In any event, because the court apparently misread one of the provisions, it appeared to equate them. Thus, any sympathy it may have expressed for the FDA's equation of the terms is unpersuasive. A more complete treatment of the decision illustrates this.

In Abbott, the FDA in 1978 had previously approved Depakene, an anticonvulsant for treatment of seizures. Depakene's active ingredient, everyone acknowledged, is valporic acid. This agent frequently caused undesirable gastrointestinal side effects. Three years later, in 1981, Abbott developed Depakote, a specially coated tablet anticonvulsant. In this form, the tablet does not dissolve in the stomach and thus causes no adverse side effects. To achieve this result, Abbott replaced the valporic acid with divalproex sodium, a derivative salt of the acid. When Depakote reaches a certain point in the digestive tract, the divalproex sodium is converted to valporic acid and the same anticonvulsant therapeutic effect is ultimately achieved. Like cefuroxime, valporic acid is not an ingredient of the drug as it is administered, but comes about after administration as a result of chemical changes and is ultimately the effective therapeutic agent.

On these facts, Abbott sought a 10-year period of market exclusivity pursuant to 21 U.S.C. § 355(j)(4)(D)(i). In essence, this subsection grants 10 years of market exclusivity to a drug that was approved by FDA between January 1, 1982 and September 24, 1984 provided that neither the drug's active ingredient, nor any salt or ester of that active ingredient, had been previously approved by the FDA. As the court noted, acceptance of Abbotts' plain language definition of "active ingredient" would lead to granting the 10 year period of market exclusivity because neither divalproex sodium, nor any salt or ester of it had previously received FDA approval. The court went on, however, to consider whether the case also fit under the two-year market exclusivity provision, 21 U.S.C. § 355(j)(D)(v), as FDA urged. That subsection essentially provides for an exclusive marketing privilege until September 24, 1986 for any drug approved pursuant to the complete new drug application process, provided that the drug's active ingredient, or the salt or ester of that active ingredient, had received prior FDA approval during the period January 1, 1982 to September 24, 1984. Acceptance of Abbotts' position here leads to the conclusion that this subsection (and hence the two year market exclusivity period) is inapplicable because neither the active ingredient, nor any salt or ester of it, had received prior FDA approval. The court in Abbott concluded otherwise, apparently because it misread the subsection to mean that the two year market exclusivity period applied where the active ingredient in the applicant drug was a salt or ester of some other approved ingredient not present in the product. Subsection (v) applies where the active ingredient in the applicant drug or a salt or ester of that active ingredient received prior FDA approval. It does not apply where the active ingredient in the applicant drug is the salt or ester of some other approved ingredient. In essence, while the Abbott court recognized that subsections (i) and (v) are complementary, it then failed to recognize that they are also necessarily mutually exclusive. A product that qualifies under (i) cannot qualify under (v) and vice versa. Given this misreading of the subsection, the court incorrectly concluded that Abbotts' position led to the application of both the two and ten year periods, a result it termed an "irreconcilable statutory conflict." 691 F. Supp. at 472. In fact, no such conflict exists; if there is no prior approval of the active ingredient under review, or its salt or ester, then (assuming other requirements are met) the ten year period applies. If, by contrast, there is prior approval for the active ingredient, or its salt or ester, then (assuming other requirements are met) the two year period applies.

Though not dispositive here, Abbott is useful for the light it casts on the distinction between the plain meaning of "active ingredient" and the pharmaceutical meaning "active moiety." Thus, the Abbott opinion notes specifically that in the context of the Abbreviated New Drug Application (ANDA) portions of Title I, the FDA construes "active ingredient" as this Court does here, namely in accordance with its plain meaning.

On several occasions, the FDA has determined a drug to be ineligible for the ANDA process because this requirement was not satisfied. In making this determination, the Agency has stated that "[t]he term active ingredient in the Act refers to the active ingredient found in the final dosage form prior to the administration of [the] product to the patient, rather than to any resultant form the drug may take following administration.

[i]n the absence of an express congressional statement or other evidence of congressional purpose, the Agency's diametrically conflicting interpretations of "active ingredient" cannot be accepted. . . . Such statutory construction simply is unreasonable.

It is important to note that in insisting upon the plain meaning of the statute, the Court here in no way seeks to substitute its judgment on highly technical or factual matters for that of the Commissioner, nor does it limit or preclude the legitimate, defined exercise of policymaking discretion that Congress may delegate to administrative agencies. See 5 U.S.C. § 701(a)(2) (judicial review under Administrative Procedure Act inappropriate where agency action committed to agency discretion by law). Similarly, this is not a case where this Court has declined to accord deference to a range of permissible agency choices. See Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415, 91 S.Ct. 814, 823, 28 L.Ed.2d 136 (1971); Baltimore Gas Elec. Co. v. N.R.D.C., Inc., 462 U.S. 87, 103, 103 S.Ct. 2246, 2255, 76 L.Ed.2d 437 (1983); United Transportation v. Lewis, 711 F.2d 233, 252 (D.C. Cir. 1983). Rather, this is an instance where an agency has made a policy judgment at odds with the statute's plain meaning and now seeks to implement this judgment. However sound the Commissioner's policy judgment may be, neither he nor this Court may implement it against the statute's plain meaning. To hold otherwise impermissibly transfers policymaking power from Congress to the administrative agencies and the judiciary. The Commissioner's remedy is with Congress.

In summary, it is undisputed that cefuroxime axetil is the active ingredient of Ceftin Tablets, not cefuroxime, which is not present at all in the tablets. Further, it is undisputed that no prior FDA approval exists for cefuroxime axetil, or any ester or acid of it. From this, it follows that (a)(5)(A) is satisfied and that the Commissioner's contrary decision is arbitrary and capricious.

B. Count II

Plaintiff's Count II theory is fundamentally inconsistent with its Count I position. In Count I, plaintiff proceeded on the premise that the definition of "drug product" in Section 156(f) is controlling in Section 156(a)(5)(A). Count II, by contrast, denies that Section 156(f) controls (a)(5)(A). Plaintiff argues that because the last sentence of 156(a) states that the "product" referred to in (a)(5)(A) is referred to as "approved product," the "product" in (a)(5)(A) is different from that defined in 156(f). An "approved product," plaintiff claims, is self-evidently the product FDA approved. Since FDA had never previously approved the product Ceftin Tablets, (a)(5)(A) is satisfied and a patent term extension warranted. Under plaintiff's Count II theory, it is irrelevant whether FDA had previously approved an active ingredient or a salt or ester of it.

Count II's theory is unsound. Section 156(f) states that its definition of "product" applies "for purposes of this [156] section." No separate definition of "approved product" is provided. Nor is one needed; it plainly means a "product," as defined in Section 156(f), that has received FDA approval, as set forth in Section 156(a)(4) and (5). In short, the plain meaning of the statutory language is as dispositive of Count II as it is of Count I. That language unambiguously requires that the paragraph (f) definition be applied through the Section.

Plaintiff argues that applying the Section 156(f) definition of "product" to (a)(5)(A) renders Section 156(c)(4), which allows only one patent to be extended per FDA approval, "difficult to explain." According to plaintiff, Section 156's definition applied to (c)(4) suggests (i) that there may be more than one regulatory review period for a single product or active ingredient and (ii) that different patents can be extended for those different periods. Plaintiff's suggested inferences are only half right. As to the first, there may well be (and appropriately so) more than one regulatory review period for a single "product" or "active ingredient." But this does not follow from applying 156(f) to (c)(4); rather it is simply the result of including alternative forms of the active ingredient (i.e., the salt or ester) within the "product definition." The second inference is wrong; patent term extensions are limited to one per product; (a)(5)(A) achieves this result in most instances and subsection (c)(4) operates to preclude multiple patent terms extensions in those few instances that escape the reach of (a)(5)(A). For example, a product patent, a method of use patent and a method of manufacturing patent may all relate to the same drug subjected to a single regulatory review period. Applications for extensions of the three patents would be based on the same FDA approval. Given this, (a)(5)(A) may not preclude extension of all three patents, but (c)(4) would limit the extension to one of the three. In sum, plaintiff's arguments do not overcome the statute's plain language, which compels the conclusion that the definition of "product" in (f) applies to the entire section. Accordingly, Count II fails.

Conclusion

For the reasons set forth here, the Court grants summary judgment for plaintiff on Count I. The Commissioner's decision denying patent term extension is based on an incorrect construction of the Act. Were it necessary to reach Count II, the Court would dismiss it, for here it is plaintiff who misconstrues the statute.

An appropriate order will enter.