Hoechst Aktiengesellschaft v. Quigg

• Decision Date: 16 October 1990
• Docket Number: No. 90-1088,90-1088
• Citation: 917 F.2d 522,16 USPQ2d 1549
• Parties: HOECHST AKTIENGESELLSCHAFT, Plaintiff-Appellant, v. Donald J. QUIGG, Assistant Secretary of Commerce and Commissioner of Patents & Trademarks, Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

Page 522

917 F.2d 522

16 U.S.P.Q.2d 1549

HOECHST AKTIENGESELLSCHAFT, Plaintiff-Appellant, v. Donald J. QUIGG, Assistant Secretary of Commerce and Commissioner of Patents & Trademarks, Defendant-Appellee.

No. 90-1088.

United States Court of Appeals, Federal Circuit.

Oct. 16, 1990.

Basil J. Lewris, Finnegan, Henderson, Farabow, Garrett & Dunner, Washington, D.C., argued, for plaintiff-appellant. With him on the brief were Jerry D. Voight, J. Michael Jakes and David S. Forman. Also on the brief was Jerome Rosenstock, Hoechst Celanese Corp., Somerville, N.J., of counsel.

Fred E. McKelvey, Sol., Office of the Sol., Arlington, Va., argued, for defendant-appellee. With him on the brief was Teddy S. Gron, Asst. Sol.

Before MICHEL, Circuit Judge, BALDWIN, Senior Circuit Judge, and WILLIAMS, Senior District Judge. ^*

BALDWIN, Senior Circuit Judge.

Hoechst Aktiengesellschaft ("Hoechst") 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. Quigg ("Commissioner"), that U.S. Patent No. 3,737,433 ('433) is not entitled to an extension of its term under 35 U.S.C. Sec. 156. We reverse and remand.

BACKGROUND

Hoechst owns the '433 patent claiming pentoxifylline, a pharmaceutical product for human use having the tradename Trental. The '433 patent issued on June 5, 1973 but the Food and Drug Administration ("FDA") did not approve Trental for commercial marketing until August 30, 1984. Thus, more than ten years elapsed between the time the '433 patent issued and the date Trental could be marketed.

Hoechst applied for a patent term extension under 35 U.S.C. Sec. 156 on October 29, 1984. The U.S. Patent and Trademark Office ("PTO") determined that Hoechst was not entitled to a term extension for the '433 patent because Trental had not been subject to a regulatory review period within the meaning of Section 156(a)(4) and the Commissioner denied Hoechst's request for reconsideration. In re Hoechst Aktiengesellschaft, 227 USPQ 638 (Comm'r Pat.1985).

Hoechst appealed the Commissioner's decision to the United States District Court for the Eastern District of Virginia and the parties submitted cross-motions for summary judgment. The district court determined that the language of Section 156 was ambiguous, consulted the legislative history and concluded that the '433 patent did not fall within the group of patents Congress intended to be eligible for patent extensions. It granted the Commissioner's motion for summary judgment and this appeal by Hoechst followed.

ISSUE

Did the district court err in determining that the '433 patent was ineligible for a term extension?

OPINION

I.

A. Eligibility Requirements for a Patent Term Extension

The eligibility requirements for a patent term extension, as set forth in 35 U.S.C Sec. 156(a) ¹, are as follows:

Sec. 156. Extension of patent term

(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent if-

(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) except as provided in subparagraph (B) [concerning recombinant DNA technology] or (C) [concerning new animal drugs and veterinary biological products], 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).

Section 156(d)(1) further states that in order to obtain an extension, the patent owner must submit an application "within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use."

According to the record, Hoechst has satisfied all of the requirements for a patent term extension under Section 156(a)(1)-(3) and (a)(5). It is also clear that Hoechst applied for the extension within 60 days after Trental received FDA approval, pursuant to Section 156(d)(1). The only question is whether Trental has undergone a "regulatory review period" pursuant to Section 156(a)(4).

B. Regulatory Review Period

The "regulatory review period" for a human drug such as Trental is defined in Section 156(g)(1) as follows:

(g) For purposes of this section, the term "regulatory review period" has the following meanings:

(1)(A) In the case of a product which is a new drug, ... the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies. (emphasis added)

Subparagraph (B) ² essentially provides that the length of the regulatory review period is the sum of (i) the testing phase period and (ii) the approval phase period for the drug. It is undisputed that the formula in subparagraph (B) yields a 9.5 year regulatory review period which is then reduced by Section 156(c) ³ to yield a 6.8 year term extension for the Trental patent. The primary dispute in this case concerns the meaning and effect of the emphasized language in Section 156(g)(1)(A) "to which the limitation described in paragraph (6) applies."

C. The Limitations of Paragraph (6)

Section 156(g)(6) provides, in relevant part:

(6) A period determined under any of the preceding paragraphs is subject to the following limitations:

(A) If the patent involved was issued after the date of enactment of this section, the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years.

(B) If the patent involved was issued before the date of the enactment of the section and--

(i) no request for an exemption described in (1)(B) ... was submitted,

....

before such date for the approved product the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years.

(C) If the patent involved was issued before the date of the enactment of this section and if an action described in subparagraph (B) was taken before the date of the enactment of this section with respect to the approved product and the commercial marketing or use of the product has not been approved before such date, the period of extension determined on the basis of the regulatory review period determined under such paragraph may not exceed two years....

None of the limitations in Section 156(g)(6) applies to the '433 patent. For instance, subparagraph (A), which limits the maximum term extension to five years for a patent which issues after the date of enactment of the Act, September 24, 1984, is inapplicable because the '433 patent issued prior to that date. Subparagraph (B), which limits the maximum extension to five years for patents that issued prior to the date of enactment, but for which no exemption had been applied for as of that date, is inapplicable because Hoechst applied for an exemption prior to the date of enactment. Subparagraph (C), which limits the maximum extension to two years for patents that issued before the date of enactment if the regulatory review period had commenced but commercial marketing or use had not yet been approved at the time of enactment, is inapplicable because Trental had already received such approval at the time of enactment.

II.

The Commissioner argues here as he did below that the language "to which the limitation described in paragraph (6) applies" in Section 156(g)(1)(A) incorporates the paragraph (6) limitations into the definition of a regulatory review period. Thus, if none of the limitations in paragraph (6) applies, no regulatory review period is established and no patent term extension is available. In support of this interpretation, the Commissioner notes the rule of statutory construction requiring the court to give effect to all portions of a statute and to avoid constructions rendering any language superfluous. He further relies upon legislative history indicating that Congress intended that no patent for a drug be given a term extension greater than five years and argues that any alternative interpretation would conflict with that intention.

Hoechst argues that a plain reading of the statute shows that the requirements of paragraph (6) are not a part of the definition of a regulatory review period and are thus not a part of the statute's eligibility requirements. Rather, according to Hoechst, the paragraph (6) limitations are caps on the length of a term extension for a patent which has already been determined to be eligible for an extension pursuant to Sections 156(a) and (g)(1)(B). It further argues that Congress's failure to place a cap on the length of term extensions for the Trental patent and the small number of other drug patents which received FDA approval shortly before the Act's passage, was simply an oversight.

In response to these same arguments, the district court said that although the Commissioner's and Hoechst's interpretations were both plausible, neither was ultimately convincing. It consequently sought clarification in the Act's legislative history. Hoechst, 724 F.Supp. at 401-02, 13 USPQ2d at 1546-47.

Specifically, the court noted the purpose of the Act: to compensate drug patent owners who lost part of their patent term due to the protracted FDA approval...