Hoechst Aktiengesellschaft v. Quigg
| Decision Date | 26 October 1989 |
| Docket Number | Civ. A. No. 89-763-A. |
| Citation | 724 F. Supp. 398 |
| Court | U.S. District Court — Eastern District of Virginia |
| Parties | HOECHST AKTIENGESELLSCHAFT, Plaintiff, v. Donald J. QUIGG, Assistant Secretary of Commerce and Commissioner of the Patents & Trademarks, Defendant. |
Tipton D. Jennings, Basil J. Lewris, Finnegan, Henderson, Farabow, Garrett & Dunner, Washington, D.C., for plaintiff.
Fred E. McKelvey, Sol., U.S. Patent and Trademark Office, Arlington, Va., Robert C. Erickson, Asst. U.S. Atty., Alexandria, Va., for defendant.
This is a patent term extension case. It presents a novel question of statutory construction concerning Title II of the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Act"), 35 U.S.C. § 156.1 Plaintiff, owner of a human drug patent, seeks extension of the patent term pursuant to the Act, claiming that the product covered by the patent underwent a lengthy FDA approval process prior to commercial use. Defendant, the Commissioner of the Patents & Trademarks (the "Commissioner"), denied the request on the ground that plaintiff's patented product had not been the subject of a "regulatory review period" as defined in the Act, specifically § 156(g), and was therefore ineligible for a term extension.
The matter is properly before the Court2 on cross-motions for summary judgment as none of the material facts are disputed. While the Act's language is ambiguous, its structure and legislative history point ineluctably to the conclusion that plaintiff's patent does not fall within the universe of patents Congress intended to be eligible for term extensions. Given this, the Court concludes that summary judgment must be entered for the Commissioner.
Plaintiff owns United States Patent 3,737,433, the claims of which cover pentoxifylline, a pioneering drug useful in the treatment of vascular disorders. It is apparently the first of a new class of drugs known as hemorheologics and the first demonstrated to be effective for the treatment of intermittent claudification, a painful disorder associated with abnormal blood flow in the limbs. Plaintiff markets pentoxifylline as "TRENTAL", a registered trade name.
The TRENTAL patent was issued on June 5, 1973. Thereafter, plaintiff submitted a new human drug application to the Food and Drug Administration (FDA) for approval to market TRENTAL commercially. As is often the case with new drug applications, the process was lengthy.3 FDA finally issued approval more than 10 years later on August 30, 1984. 60 Fed. Reg. 6052 (Feb. 13, 1985).4 Congress passed the Act less than one month later, on September 24, 1984. Shortly thereafter, and within the 60 days allowed by § 156(d), plaintiff filed for a patent term extension under the Act. The Patent and Trademark Office (PTO) denied this request, concluding that TRENTAL had not been subject to a "regulatory review period" within the meaning of the Act. The Commissioner subsequently denied plaintiff's request for reconsideration. In re Hoechst Aktiengesellschaft, 227 U.S.P.Q. 638 (Comm'r Pat. 1985).
Analysis properly begins with a consideration of the Act's eligibility requirements for patent term extensions. These requirements appear in Section 156(a).5 There is no dispute that plaintiff has satisfied all but one of this section's five requirements. Only the "regulatory review period" requirement of subsection (a)(4) is in dispute. Accordingly, the definition of the phrase "regulatory review period" is central. Various meanings of the phrase are given in Section 156(g) which has six subsections, each concerning a different type of drug or product. Subsection (g)(1) applies to human drugs such as TRENTAL. Subsections (g)(2)-(g)(5) apply, respectively, to food and color additives, medical devices, animal drugs, and veterinary biological products and are not directly relevant here. Subsection (g)(6), establishes certain caps or limitations on term extensions and applies to all five categories. Analysis here, therefore, focuses on subsections (g)(1) and (g)(6).
Subsection (g)(1)(B) sets forth the formula for computing the length of the regulatory review period. In essence, the formula requires the summing of two time periods:
The parties do not dispute that this formula, when applied to TRENTAL, yields a period of 6.8 years. Instead, the dispute centers on how the "limitation described in paragraph (6) applies." 35 U.S.C. § 156(g)(1)(A). Paragraph (6) places caps on term extensions for three classes of patents:
As it happens, TRENTAL falls outside all three classes9 and therein lies the nub of this dispute.
The Commissioner contends that the three classes in paragraph (6) are integral to the statutory definition of "regulatory review period". And since the TRENTAL patent falls outside all three, it cannot meet the "regulatory review period" requirement of Section 156(a) and is therefore ineligible for a term extension. In support, the Commissioner argues that this result is compelled by the statute's language, whereas the opposite result would impermissibly read out of the statute and render superfluous the language "to which the limitation described in paragraph (6) applies." 35 U.S.C. § 156(g)(1)(A).10
Plaintiff's contention, on the other hand, is that paragraph (6) is not part and parcel of the definition of "regulatory review period," but only provides limitations that apply in the three specific classes of patents delineated there. For patents outside these three classes, the "regulatory review period" is defined or measured by the formula in § 156(g)(1)(B). Plaintiff, like the Commissioner, argues that the plain meaning of the statute compels the result it seeks. Specifically, plaintiff relies on the language in paragraph (6) stating that "a a period determined under any of the preceding paragraphs including (1)(B) pertaining to human drugs is subject to the following limitations." According to plaintiff, a plain reading of this language presumes the existence of a regulatory review period that has already been determined, in this instance, pursuant to (1)(B). This analysis, plaintiff contends, clearly shows that paragraph (6) is not definitional; it merely sets caps on term extensions for some, but not all classes of patents that may be eligible for a term extension.
Both positions based on the statutory language are plausible; neither is ultimately convincing. There is sufficient ambiguity in that language to accommodate and bear the weight of both positions. To choose between these competing positions the Court must answer the central question whether Congress intended the universe of eligible patents to be those defined in paragraph (6) or those that meet the application criteria of Section 156(d). As noted, the three classes of paragraph (6) reduce essentially to all unexpired patents issued after the Act's passage and those issued prior to the Act's passage, but which do not receive FDA approval until after that date. Paragraph (6) does not apply to the TRENTAL patent because it received FDA approval less than a month prior to the Act's passage. But the TRENTAL patent extension request satisfied all the remaining criteria of Section 156, including that of Section 156(d) which required that the term extension be filed within 60 days of FDA approval for the product. Put another way, therefore, the central question presented is whether Congress intended the entire universe of patents eligible for term extension to be subject to a cap on that extension of five or two years as set forth in paragraph (6) or, whether it intended for many, but not all, to be so capped and for the remainder, i.e., those that received FDA approval shortly before the Act's passage, to receive whatever term extension results from the application of the subsection (g)(1)(B) formula. The answer to this question must be sought in the Act's structure and legislative history.
The Act's legislative history is extensive. In general, it records Congress' recognition that the protracted FDA approval process often unfairly reduces a drug patent's effective life.11 This occurs, as a House Report noted, "because patents are often obtained before products are ready to be marketed."12 As a remedy, Congress chose, through the Act, to permit certain patents to be extended in specific circumstances. Significantly for the issue at bar, the focus of the Act was intended to be narrow, a reflection that it represented a hard-fought compromise between the generic drug industry and the research intensive pharmaceutical firms.13 There was recognition, accordingly, that not all new drug product patents would be covered.14 Even more significant, and indeed dispositive on the issue at bar, is that the legislative history is replete with evidence that Congress did not intend to allow the term of any patent to be extended by more than five years.
Thus, according to the various House Reports:
The Act places several...
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Hoechst Aktiengesellschaft v. Quigg
...appeals the decision of the United States District Court for the Eastern District of Virginia, Hoechst Aktiengesellschaft v. Quigg, 724 F.Supp. 398, 13 USPQ2d 1543 (E.D.Va.1989), upholding upon motion for summary judgment, a ruling by the Commissioner of Patents and Trademarks, Donald J. Qu......