Abraxis Bioscience, LLC v. Kappos, Civil Action No. 1:11–cv–00730

Citation10 F.Supp.3d 53,109 U.S.P.Q.2d 1910
Decision Date08 January 2014
Docket NumberCivil Action No. 1:11–cv–00730
PartiesAbraxis Bioscience, LLC, Plaintiff, v. Honorable David Kappos, in his official capacity as Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant.
CourtUnited States District Courts. United States District Court (Columbia)

Alan Cope Johnston, Deanne E. Maynard, Morrison & Foerster, LLP, Washington, DC, for Plaintiff.

Carl Ezekiel Ross, U.S. Attorney's Office, Washington, DC, for Defendant.

MEMORANDUM OPINION

BERYL A. HOWELL, United States District Judge

The plaintiff Abraxis Bioscience, LLC, brought this lawsuit against David Kappos, in his official capacity as Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (“USPTO”), seeking a judgment that the patent term adjustment (“PTA”) for United States Patent No. 7,820,788 (“'788 patent”) be increased by at least 122 days from the 199 days awarded by USPTO, for a total PTA of at least 321 days or, alternatively, 323 days. Pending before the Court are the parties' cross-motions for summary judgment. See Pl.'s Renewed Mot. Summ. J. Re PTA for Patent '788 (“Pl.'s Mot.”), ECF No. 20; Def.'s Cross–Mot. Summ. J. and Opp'n Pl.'s Renewed Mot. Summ. J. Re PTA for Patent '788 (“Def.'s Opp'n”), ECF No. 21.1 For the reasons explained below, the USPTO's Motion for Summary Judgment is granted and the plaintiff's Renewed Motion for Summary Judgment Regarding the Calculation of Part B Delay for the United States Patent No. 7,820,788 is denied.2

I. BACKGROUND
A. Legal Framework

The plaintiff challenges the USPTO's interpretation of a statutory provision at 35 U.S.C. § 154(b)(1)(B)(i), which governs the determination of PTA when the patent applicant files a request for continued examination (“RCE”), as authorized by 35 U.S.C. § 132(b), more than three-years from the filing date of the patent application. Since a fundamental tenet of statutory construction is to examine the challenged text in context, an overview of the legal framework for determining a patent term is necessary. See United States v. Ali, 718 F.3d 929, 937 (D.C.Cir.2013) (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (“It is a fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme.”) (internal quotation marks omitted)).

United States patent law originates from a constitutional grant of authority to the Congress [t]o promote the Progress of Science and useful Arts, by securing for a limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” U.S. Const. art. I, § 8, cl. 8 ; see also Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 5, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966) ( references to “useful Arts” and “Discoveries” creates the right to patent protection). The brevity of this Patent Clause belies the complexity of defining the scope of the “exclusive Right” of inventors to their discoveries. At the outset, inventors do not automatically hold patent rights to their inventions. See 35 U.S.C. § 111. Inventors must submit applications to the USPTO for review and assessment whether a patent should issue. See 35 U.S.C. § 131. Upon issuance, the patent term in the United States was, until 1994, seventeen years, beginning from the date the patent was issued. See Act of March 2, 1861, ch. 88, § 16, 12 Stat. 246, 249 (codified as amended at 35 U.S.C. § 154 ). In order to harmonize the U.S. patent laws with those of America's leading trading partners, Congress amended this regime in 1994 to adjust the term of a patent from seventeen to twenty years, beginning from the date the application was filed.See Uruguay Round Agreements Act (“URAA”), Pub. L. No. 103–465, 102 Stat. 4809 (codified as amended at 35 U.S.C. § 154(a)(2) ); Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1547 (Fed.Cir.1996) (noting that the “purpose of URAA was not to extend patent terms, although it had that effect in some cases).

Despite the addition of three years to the patent term in the URAA, measuring the patent term from the patent application filing date, rather than the date of patent issuance, could consume “some of the effective term of a patent ... by the time it takes to prosecute the application.” Wyeth v. Dudas, 580 F.Supp.2d 138, 139–40 (D.D.C.2008). To mitigate the effect of administrative delays on the patent term, Congress provided in the URAA for patent term extensions of no more than five years due to (1) “interference delay or secrecy orders,” under 35 U.S.C. §§ 135(a) and 181, respectively, or (2) appellate review. URAA § 532, 108 Stat. at 4984. These periods of patent extension were not only subject to a five year cap, but also to other limitations. For example, any period of extension was required to be reduced “by any time attributable to appellate review before the expiration of 3 years from the filing date of the application” and “for the period of time during which the applicant for patent did not act with due diligence.” Id. (originally codified at 35 U.S.C. § 154(b)(3)(B) & (C) (1994) ). USPTO was authorized to determine when the applicant failed to act with due diligence. Id.

Both the bases for extensions of patent terms and the limitations on those extensions were further refined in 1999 with passage of American Inventors Protection Act of 1999 (“AIPA”). AIPA included, as Subtitle D of Title IV, the Patent Term Guarantee Act of 1999,” which provided for the patent term adjustment that is at issue here. See AIPA, Pub. L. No. 106–113, §§ 4401–02, 113 Stat. 1501, 1501A–557 (1999) (codified, as amended, at 35 U.S.C. § 154(b) ). While the five year cap on any PTA imposed by the URAA was eliminated, other limitations were retained in slightly different form. The key provisions of AIPA and implementing regulations implicated by the plaintiff's challenge to the USPTO's PTA calculation are summarized below.

1. Patent Term Adjustments Under AIPA

The AIPA amendments, inter alia, authorized “guarantee[d] adjustments to the patent term in three circumstances set out in section 154(b)(1) ; imposed “limitations” on those adjustments in section 154(b)(2) ; and outlined the “procedures for patent term adjustment determination[s] in section 154(b)(3). 35 U.S.C. § 154(b)(1),(2) & (3). The interplay among these guarantees, limitations and determination procedures provide significant interpretative fodder for the parties in this litigation.

a. PTA “Guarantees” in Section 154(b)(1)

The statute frames the three circumstances extending the patent term as “guarantees” designed to guard against diminution of a patent term due to enumerated administrative delays during consideration of the patent application. First, to [g]uarantee [ ] prompt patent and trademark office responses,” a patent term is extended one day for each day that the USPTO fails to meet certain examination deadlines. 35 U.S.C. § 154(b)(1)(A) (Part A). For instance, most notably for purposes of the instant case, the patent term is extended under Part A for each day the issuance of the patent is delayed “due to the failure of the [USPTO] to ... issue a patent within 4 months after the date on which the issue fee was paid ... and all outstanding requirements were satisfied.” Id. at § 154(b)(1)(A)(iv). This provision provides the USPTO with a 4–month “grace” period to issue a patent after issue fee payment before days begin to be counted as Part A delay.

Second, to [g]uarantee [ ] no more than 3–year application pendency,” the patent term is extended one day for each day after the 3–year period after the application filing date “due to the failure of the [USPTO] to issue a patent within 3 years after the actual filing date of the application.” 35 U.S.C. § 154(b)(1)(B) (Part B). The extension of the patent term authorized under Part B does “not includ[e] five enumerated time periods (set out in three clauses). These five time periods are described, in clauses (i) and (ii), as “any time consumed by” the applicant's RCE under section 132(b), and proceedings under sections 135(a), 181, or appellate review, id. at § 154(b)(1)(B)(ii) and (ii) ; and, in clause (iii), as “any delay in” application processing requested by the applicant, “except as permitted by paragraph (3)(C),” id. at § 154(b)(1)(B)(iii).3

The USPTO's interpretation of both subparagraph (B) and its clause (i) are the focus of the instant dispute. Section 154(b)(1)(B) provides in pertinent part:

(B) Guarantee of no more than 3–year application pendency. —Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the [USPTO] to issue a patent within 3 years after the actual filing date of the application ... in the United States ..., not including—
(i) any time consumed by continued examination of the application requested by the applicant under section 132(b) ;
(ii) any time consumed by a proceeding under section 135(a), any time consumed by the imposition of an order under section 181, or any time consumed by appellate review by the Patent Trial and Appeal Board4 or by a Federal court; or
(iii) any delay in the processing of the application by the [USPTO] requested by the applicant except as permitted by paragraph (3)(C), the term of the patent shall be extended 1 day for each day after the end of that 3–year period until the patent is issued.

Id.

The Federal Circuit in Wyeth v. Kappos , 591 F.3d 1364 (Fed.Cir.2010), addressed the calculation of Part B delay within the framework of section 154(b), noting that each period of delay in Parts A, B and C “has its own discrete time span whose boundaries are defined in section 154(b)(1),” with “a start and an end.” Id. at 1369–70. [A] violation of the “B guarantee ... begins when the PTO fails ‘to issue a patent within 3 years after...

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  • Abraxis Bioscience, LLC v. Kappos, Civil Action No. 1:11–cv–00730
    • United States
    • United States District Courts. United States District Court (Columbia)
    • January 8, 2014
    ...10 F.Supp.3d 53Abraxis Bioscience, LLC, Plaintiff,v.Honorable David Kappos, in his official capacity as Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant.Civil Action No. 1:11–cv–00730United States District Court, ......

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