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Daiichi Sankyo Co., Ltd. v. Lee

United States Court of Appeals, Federal Circuit

July 2, 2015

DAIICHI SANKYO COMPANY, LTD., Plaintiff-Appellant
v.
MICHELLE K. LEE, Director, United States Patent and Trademark Office, Defendant-Appellee

Appeal from the United States District Court for the District of Columbia in No. 1:10-cv-00215-RWR, Judge Richard W. Roberts.

DARYL JOSEFFER, King & Spalding LLP, Washington, DC, argued for plaintiff-appellant. Also represented by ADAM CONRAD, Charlotte, NC; KENNETH H. SONNENFELD, MARGARET B. BRIVANLOU, MICHAEL P. DOUGHERTY, New York, NY.

BRIAN THOMAS RACILLA, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for defendant-appellee. Also represented by NATHAN K. KELLEY, FARHEENA YASMEEN RASHEED; JOHN G. INTERRANTE, U.S. Attorney's Office, Washington, DC.

Before MOORE, REYNA, and TARANTO, Circuit Judges.

OPINION

Page 1374

Reyna, Circuit Judge.

Daiichi Sankyo Company, Ltd. (" Daiichi" ) brought suit in the District Court for the District of Columbia challenging patent term adjustments made by the United States Patent and Trademark Office (" PTO" ) for two Daiichi patents. The district court granted summary judgment in favor of the government. Daiichi appeals from the entry of final judgment in the government's favor. For the reasons given below, we affirm.

I. Background

A. The Patent Term Statute, 35 U.S.C. § 154

Section 154 of the Patent Act restores a patent's term for two types of delay during patent prosecution that are attributable to the PTO. The first type of delay, " A Delay," arises when the PTO fails to meet statutory dead-lines for events that occur during prosecution, such as providing notice to the applicant of the rejection of a claim or taking action on an applicant's reply to such a rejection. 35 U.S.C. § 154(b)(1)(A). The second type of delay, " B Delay," arises when, through the fault of the PTO, the agency fails to issue a patent within three years after the actual filing date of the patent's application. Id. § 154(b)(1)(B).[1]

Two patent term adjustment determinations are made prior to the issuance of a patent. First, when the PTO determines that a patent is in condition for allowance, the agency will make an initial determination and will " transmit a notice of that determination with the written notice of allowance of the application" to the applicant. 35 U.S.C. § 154(b)(3)(B)(i) (2012).[2]

Page 1375

At the time of issuance, and upon a timely request for reconsideration that satisfies the regulatory requirements, the PTO will make a final determination, which it then prints on the face of the patent. See 37 C.F.R. § 1.705(d) (2012).

B. Review of Patent Term Adjustments

A patentee who is dissatisfied with the number of days restored to the term of the patent has a statutory right to both administrative and judicial review. Regarding administrative review, the statute requires the Director of the PTO to provide a patentee one opportunity to request reconsideration of any patent term adjustment determination made by the agency. 35 U.S.C. § 154(b)(3)(B)(ii). The statute instructs the Director to prescribe regulations that create the procedures for challenging the determination at the agency. See id. § 154(b)(3)(A), (b)(3)(B). The PTO promulgated 37 C.F.R. § 1.705, which imposes a deadline for requesting that the agency reconsider the patent term adjustment determination, stating that " any request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued." 37 C.F.R. § 1.705(d) (2012).

Additionally, a patentee can seek judicial review of the agency's patent term adjustment determination. Under the statute in force when Daiichi filed this action, a patentee who was dissatisfied with the determination could bring an action against the Director of the PTO in the District Court for the District of Columbia within 180 days after the issuance of the patent. 35 U.S.C. § 154(b)(4)(A) (2006) (amended 2011).

C. The Wyeth Decision

Prior to 2010, the PTO's practice was to restore, upon issuance, patent term equaling the greater of the number of days of A and B Delays occurring during prosecution. Wyeth v. Kappos, 591 F.3d 1364, 1368 (Fed. Cir. 2010). The PTO explained this method for calculating patent term adjustments in the Federal Register in 2004. Id. at 1367-68 (quoting 69 Fed.Reg. 21706 (Apr. 22, 2004) (" 2004 PTO Notice" )).

In 2007, a patent-holder brought a suit that challenged the PTO's practice of adjusting the patent term by the greater of the A and B Delay. Wyeth v. Dudas, 580 F.Supp.2d 138 (D.D.C. 2008). The District Court for the District of Columbia rejected the PTO's practice on the basis that it effectively counts B Delay before it occurs. Id. at 142. We affirmed the district court's rejection of the PTO's practice in Wyeth v. Kappos. 591 F.3d at 1372. The effect of Wyeth was to require the PTO to extend a patent's term for every day of A or B Delay where those delays did not occur on the same day, and to extend the term by one day for each day the A and B Delays did occur on the same day.

On February 1, 2010, after we decided Wyeth, the PTO adopted an " Interim Procedure" for requesting patent term adjustments. The Interim Procedure set out the procedure by which a patentee could request reconsideration within two months of the patent issuance date. 75 Fed.Reg. 5043 (Feb. 1, 2010). The Interim Procedure also adopted an " optional" procedure (" Optional Interim Procedure" ) for patents that issued before March 2, 2010. Under the Optional Interim Procedure, patentees could file a petition for reconsideration up to 180 days after the issuance date, provided the sole basis for the request was that the patent term adjustment was made under the PTO's pre- Wyeth adjustment calculation method. Id. at 5043-44. The net result of the specified date and filing window was to make the Optional Interim Procedure available for patents that issued from August 5, 2009 (the earliest date of

Page 1376

availability of the Optional Interim Procedure) to March 1, 2010. Petitions filed outside this 180-day window would be " den[ied] as untimely." Id. at 5044. This appeal involves Daiichi's challenge to the PTO's denial of Daiichi's requests for ...


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