Pfizer, Inc. v. Lee

811 F.3d 466, 117 U.S.P.Q. 2d (BNA) 1781, 2016 U.S. App. LEXIS 1088, 2016 WL 276718
CourtCourt of Appeals for the Federal Circuit
DecidedJanuary 22, 2016
Docket2015-1265
StatusPublished
Cited by9 cases

This text of 811 F.3d 466 (Pfizer, Inc. v. Lee) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Pfizer, Inc. v. Lee, 811 F.3d 466, 117 U.S.P.Q. 2d (BNA) 1781, 2016 U.S. App. LEXIS 1088, 2016 WL 276718 (Fed. Cir. 2016).

Opinions

Opinion for the court filed Circuit Judge O’MALLEY. Dissenting opinion filed Circuit Judge NEWMAN.

O’MALLEY, Circuit Judge.

Appellants Pfizer, Inc. and Wyeth Holdings Corporation appeal the district court’s grant of summary judgment in favor of the United States Patent and Trademark Office (“PTO”) on the issue of whether the PTO properly calculated the length of a patent term adjustment (“PTA”) for U.S. Patent No. 8,153,768 (the “'768 patent”).1 For the reasons below, we affirm the judgment of the district court.

Background

A. Statutory Framework for Patent Term Adjustment

A patent has a term of twenty years from the patent application’s effective filing date. 35 U.S.C. § 154(a)(2). Thus, an issued patent’s twenty-year term is measured from the filing date of the parent patent application. An issued patent’s enforceable life thus depends on the length of the PTO’s examination of a patent application. To account for any undue delays in patent examination caused by the PTO, Congress established a system of patent term adjustment to compensate inventors for lost time on their patent term resulting from such delays.

The Patent Term Guarantee Act (“the Act”), 35 U.S.C. § 154(b), provides for the restoration of patent term in three circumstances:

(i) an “A-Delay,” which awards PTA for delays arising from the USPTO’s failure to act by certain examination deadlines;
(ii) a “B-Delay,” which awards PTA for an application pendency exceeding three years; and (iii) a “C-Delay,” which awards PTA.for delays due to interferences, secrecy orders, and appeals. The USPTO calculates PTA by adding the A-, B-, and C-Delays, subtracting any [469]*469overlapping days, and then- subtracting any days attributable to applicant delay.

Pfizer, Inc. v. Lee, No. 1:12-cv-01131-GBL, 119 F.Supp.3d 385, 388, 2014 WL 10212543, at *2, 2014 U.S. Dist. LEXIS 184554, at *4-5 (E.D.Va. Nov. 6, 2014) (“District Court Opinion”) (citing Wyeth v. Kappos, 591 F.3d 1364, 1367 (Fed.Cir. 2010)). It is “A Delay” that is at issue in this appeal. With respect to A Delay, the Act provides for restoration of patent term “if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to provide at least one of the notifications under section 1S2 or a notice of allowance under section 151” within the times specified in the statute. 35 U.S.C. § 154(b)(1)(A) (emphasis added). Section 132 in turn provides that, if a patent examiner finds that a patent application does not comply with the standards of patentability, the examiner will issue an office action with respect to the application, “stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application.” Id. § 132. Thus, the Act provides that A Delay will not accrue when the PTO “provide[s] at least one of the notifications under section 132.” Id.

When a patent is ready to issue, the PTO determines whether any PTA delay has accrued, and informs the applicant regarding the length of any term to be restored to the issued patent. An applicant can appeal the PTO’s determination of PTA by filing an action in the United States District Court for the Eastern District of Virginia. 35 U.S.C. § 154(b)(4). We have jurisdiction over an appeal from a district court’s decision relating to PTA. 28 U.S.C. §§ 1295(a)(1), (a)(4)(C).

B. Factual Background

As Appellants assert, “[t]his appeal presents a pure question of statutory interpretation; no facts are in dispute.” Appellants Br. at 17. On May 2, 2003, Wyeth filed Patent Application No. 10/428,894 (“'894 application”) entitled “Calicheamicin Derivative-Carrier Conjugates,” which generally claimed a pharmacological method utilized in the treatment óf cancer. The '894 application eventually issued as the '768 patent on April 10, 2012. At the time of filing, pursuant to 37 C.F.R. § 1.136(a)(3), Wyeth filed an authorization for the PTO to charge all required fees necessary for it to qualify'automatically for all authorized extensions of time during the pendency of the '894 application. See 37 C.F.R. § 1.136(a)(3). On July 28, 2003, the PTO mailed a Notice to File-Missing Parts of Nonprovisional Application. Wyeth filed the missing parts of its application on December 8, 2003. The statutory deadline for the PTO to issue its first office action expired on July 2, 2004, fourteen (14) months from the date the application was filed. On August 5, 2005, having received no office action, Wyeth sent a letter to the PTO asking when an office action on the merits might be expected.

On August 10, 2005, 404 days after the July 2, 2004 deadline, the PTO mailed , a restriction requirement. A restriction requirement informs the applicant that “two or more independent and-distinct inventions are claimed in one application,” and that the applicant is required to elect one of the inventions if the applicant wishes to continue prosecuting the application. 35 U.S.C. § 121. Generally, a restriction requirement would be considered an office action under Section 132 because it informs the applicant of reasons why its claims are considered to be directed to separate inventions. The deadline for Wyeth to reply to the restriction require[470]*470ment was extended automatically for up to six months based on Wyeth’s previously filed authorization for extension of time. Accordingly, the deadline for Wyeth to respond was February 10, 2006. On February 6, 2006, Wyeth participated in a telephone interview with the Examiner and explained that the restriction requirement had omitted claims 75, 76, and 103-106 from its categorization of the various claims in the application. During the interview, the Examiner acknowledged that the restriction requirement was not complete; he agreed to withdraw it and issue a corrected restriction requirement. Joint Appendix (“J.A.”) A579-80.

The PTO issued a corrected restriction requirement on February 23, 2006, 601 days after the July 2, 2004 deadline. Appellants were given a new deadline to respond to the corrected restriction requirement, which was also extended automatically to six months. On May 22, 2006, Wyeth filed its response.

Later in the course of prosecution, the PTO delayed the mailing of a separate office action with respect to the applicants’ Request for Continued Examination (“RCE”). The PTO’s delay with respect to the RCE amounted to 280 days of additional A Delay. See J.A. A2085-86.

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811 F.3d 466, 117 U.S.P.Q. 2d (BNA) 1781, 2016 U.S. App. LEXIS 1088, 2016 WL 276718, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pfizer-inc-v-lee-cafc-2016.