Daiichi Sankyo Co. v. Lee

791 F.3d 1373

115 U.S.P.Q.2d 1653

DAIICHI SANKYO COMPANY, LTD., Plaintiff–Appellant

v.Michelle K. LEE, Director, United States Patent and Trademark Office, Defendant–Appellee.

No. 2014–1280.

United States Court of Appeals, Federal Circuit.

July 2, 2015.

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, N.Y.

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

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 deadlines 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

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 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 reconsideration of the patent term adjustments for two of its patents.

D. Daiichi's Patents

Daiichi is a pharmaceutical company that owns three patents that it claims have been affected by the PTO's pre-Wyeth interpretation. These three patents, U.S. Patent Nos. 7,342,014 (“'014 patent”), 7,365,205 (“'205 patent”), and 7,567,135 (“'135 patent”), cover compounds that are useful for treating tissue death due to lack of oxygen, blood clots, and other ailments. The '014 and '205 patents issued before August 5, 2009 and, thus, did not qualify for the Optional Interim Procedure.³ According to Daiichi, in the PTO's patent term adjustment calculations for each of Daiichi's patents in this case, the agency chose to restore days for either the A or B Delay, but not both. Daiichi claims that the term of each of its patents was shortened by at least 321 days under the pre-Wyeth calculation method.

E. Procedural History

Shortly after the district court's decision in Wyeth , but before the implementation of the Interim Procedure, Daiichi filed a petition requesting reconsideration of the patent term adjustments for the '014 and '205 patents under 37 C.F.R. § 1.705(d).

Because Daiichi's petitions were filed outside the two-month window set in 37 C.F.R. § 1.705(d), Daiichi concurrently filed a petition to waive the two-month window under 37 C.F.R. § 1.183. Section 1.183 allows the Director, on petition, to waive regulatory requirements in “extraordinary situations” when justice so requires. Daiichi argued that the district court's Wyeth decision constituted an extraordinary situation that justified waiving the normal two-month window for filing a request for reconsideration of the patent term adjustments under 37 C.F.R. § 1.705(d).

In late March and early April 2010, the PTO dismissed both of Daiichi's waiver petitions and denied both requests for reconsideration of the patent term adjustments because neither was timely filed within the required two-month window. Neither rejection mentioned the Interim Procedure.

Daiichi filed requests for reconsideration of the dismissals of its waiver petitions and its requests for reconsideration of the patent term adjustments for both the '014 and '205 patents. The PTO rejected both requests on the same grounds. The PTO explained that the Optional Interim Procedure allowed a patent owner to request recalculation of the patent term adjustment within 180 days after the grant of the patent. Further, the PTO had determined “not to accept any requests for PTA [patent term adjustment] recalculation initially filed more than 180 days after patent grant” because the judicial-review provision of 35 U.S.C. § 154(b)(4) evidenced “congressional intent that PTA issues be resolved” soon after issuance. J.A. 3121, 3382. (emphasis underlined in original).

The PTO explained that it did not believe Congress intended to create a scheme “under which the time period to seek initial USPTO review of a PTA determination extends beyond the” 180–day “time period provided for a dissatisfied patentee to seek judicial review” of the PTO's adjustment determination under § 154(b)(4). Id. at 3121–22, 3382. Accordingly, the PTO believed that the 180–day period of § 154(b)(4) “represent[ed] the outer limit” of its authority to conduct an administrative review of patent term adjustment determinations. Id. at 3122, 3383.

On February 12, 2010, Daiichi simultaneously filed the instant lawsuit seeking judicial review of the adjustments for all three patents under the Administrative Procedure Act (“APA”) and § 154(b)(4)(A) and petitioned the PTO for recalculation of the patent term adjustment for the '135 patent. The PTO dismissed the petition for recalculation of the adjustment for the ' 135 patent based on Daiichi's challenge to that adjustment in the district court.

Because the '135 patent was granted within 180 days...