United States Court of Appeals 

for the Federal Circuit ______________________ 

DAIICHI SANKYO COMPANY, LTD.,

Plaintiff-Appellant

v.

MICHELLE K. LEE, Director, 

United States Patent and Trademark Office,

Defendant-Appellee

______________________ 

2014-1280

______________________ 

Appeal from the United States District Court for the 

District of Columbia in No. 1:10-cv-00215-RWR, Judge 

Richard W. Roberts.

______________________ 

Decided: 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, 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. 
2 DAIICHI SANKYO COMPANY v. LEE

______________________ 

Before MOORE, REYNA, and TARANTO, Circuit Judges.

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 allow1 The letter designation for the two types of delay 

described, A or B, corresponds to the statutory subparagraph governing how the particular delay is handled, 35 

U.S.C. § 154(b)(1)(A) or (b)(1)(B), respectively.

 
DAIICHI SANKYO COMPANY v. LEE 3

ance, 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. 

2 After the 2013 amendments, the current version 

of § 154 requires notification of a patent term adjustment 

at the time of issuance. Leahy-Smith America Invents 

Act Technical Corrections, Pub. L. No. 112-274, § 154, 126 

Stat. 2456, 2457 (2013). The discussion here is about the

previous version of the statute before those amendments. 

 
4 DAIICHI SANKYO COMPANY v. LEE

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. 
DAIICHI SANKYO COMPANY v. LEE 5

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. 

3 As discussed below, the ’135 patent issued after 

August 5, 2009. Daiichi invoked the Optional Interim 

Procedure for the ’135 patent. 

 
6 DAIICHI SANKYO COMPANY v. LEE

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 twomonth 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 
DAIICHI SANKYO COMPANY v. LEE 7

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 

of the March 2, 2010 deadline, it was eligible for the 

Optional Interim Procedure. The district court, thus, 

remanded the ’135 patent to the PTO, which recalculated 

the patent term adjustment from 86 days to 503 days. 

According to Daiichi, this made no practical difference, 

however, since the ’135 patent is terminally disclaimed 

over both the ’014 and ’205 patents. The latter two patents are also terminally disclaimed over each other, so 

that none of the three patents can be enforced past the 

earliest date of expiration of either the ’014 or ’205 patents. 

Daiichi amended its district court complaint to seek 

relief on the ’014 and ’205 patents. It alleged the PTO 

violated the APA and § 154(b) by (1) miscalculating the 
8 DAIICHI SANKYO COMPANY v. LEE

patent terms for the ’014 and ’205 patents and (2) refusing to reconsider its patent term adjustments in light of 

our decision in Wyeth. The parties filed cross-motions for 

summary judgment. 

In its motion for summary judgment, Daiichi presented three arguments relevant to this appeal. First, it 

contended that 35 U.S.C. § 154(b)(4)(A)’s 180-day limitations period for judicial review does not apply to challenges to final patent term adjustment determinations, like 

Daiichi’s challenge. Daiichi argued that § 154(b)(4)(A) 

governs only challenges to determinations made at the 

time of the allowance, i.e., initial determinations. Since B 

Delay takes into account delay in issuing a patent, it 

cannot be determined at the time of allowance. Therefore, 

Daiichi’s challenge to the final patent term adjustments 

for its patents is not subject to the 180-day limitations 

period of § 154(b)(4)(A). According to Daiichi, the regular 

six-year statute of limitations of the APA applies to final 

patent term adjustment determinations made at the time 

of issuance. Id. at 3717–25. 

Second, Daiichi argued that even if the 180-day period 

does apply to final patent term adjustments, that period 

should be equitably tolled because Daiichi relied on the

2004 PTO Notice disclosing how it would calculate A and 

B Delay, and because it acted promptly to seek administrative and judicial review in the wake of the district 

court’s Wyeth decision. Id. at 3730–38. 

Third, Daiichi challenged the PTO’s use of a 180-day 

period for administrative review under the APA. According to Daiichi, 35 U.S.C. § 254 allows the PTO to correct

mistakes in a patent whenever they occur. Thus, the 

importation of the 180-day period for judicial review into 

the context of administrative review of patent term adjustments was overly restrictive, and therefore arbitrary, 

capricious, and not in accordance with the law. Id. at

3725–30.
DAIICHI SANKYO COMPANY v. LEE 9

The district court rejected each of Daiichi’s arguments. As to whether § 154(b)(4)(A) applies to final 

determinations, the district court found that this provision refers to any determination “under paragraph (3),” 

including those made under § 154(b)(3)(A). That section 

requires the Director to prescribe regulations governing 

procedures for the determination of patent term adjustments, without limiting the Director to creating procedures only for initial adjustment determinations. 35 

U.S.C. § 154(b)(3)(A). Thus, the district court found that 

the plain meaning of the statute made clear that 

§ 154(b)(4)(A) covered final determinations. Daiichi 

Sankyo Co., Ltd. v. Rea, 12 F. Supp. 3d 8, 16 (D.D.C. 

2013). 

On the issue of equitable tolling, the district court 

found that Daiichi could have brought a lawsuit making 

the same arguments that Wyeth did within the 180-day 

period, yet failed to do so. As such, Daiichi had not shown 

the existence of extraordinary circumstances, a prerequisite for equitable tolling. Id. at 20. 

The district court also rejected Daiichi’s argument 

that it was entitled to relief under the APA because the 

PTO’s refusal to suspend the 180-day filing period of the 

Optional Interim Procedure as to the ’014 and ’205 patents was arbitrary, capricious, and not in accordance 

with law. The district court granted summary judgment 

to the government and entered final judgment in its favor.

On appeal, Daiichi challenges the district court’s determinations (1) that the PTO’s denial of administrative 

relief on Daiichi’s requests for reconsideration of the 

patent term adjustments was not contrary to law, arbitrary, capricious, or an abuse of discretion under the APA; 

(2) that the 180-day limitations period applies to final 

patent term adjustment determinations; and (3) that 35 

U.S.C. § 154(b)(4)(A) is not subject to equitable tolling. 

For the reasons stated below, we affirm. 
10 DAIICHI SANKYO COMPANY v. LEE

II. DISCUSSION

We review the grant of summary judgment under the 

law of the regional circuit, here the D.C. Circuit. Epos 

Techs. Ltd. v. Pegasus Techs. Ltd., 766 F.3d 1338, 1341 

(Fed. Cir. 2013). The D.C. Circuit reviews the grant of 

summary judgment de novo. Coal. for Common Sense in 

Gov’t Procurement v. United States, 707 F.3d 311, 315 

(D.C. Cir. 2013). Summary judgment is appropriate 

when, after drawing all justifiable inferences in the 

nonmoving party’s favor, Anderson v. Liberty Lobby, Inc., 

477 U.S. 242, 255 (1986), there are no genuine issues of 

material fact and the movant is entitled to judgment as a 

matter of law, Fed. R. Civ. P. 56(a).

III. DAIICHI’S CHALLENGE UNDER THE APA

A. DENIAL OF RECONSIDERATION

Daiichi argues that the PTO’s denials of its requests 

for reconsideration of the patent term adjustments were 

an abuse of the agency’s discretion. Daiichi argues that 

the PTO’s view that § 154(b)(4) prevents it from recalculating patent term adjustments more than 180 days after 

a patent is granted is erroneous. Daiichi contends this 

error is evidenced by the language of the final decisions 

denying its requests for reconsideration, where the PTO 

reasoned that the 180-day period represented the “outer 

limit” of PTO authority to conclude patent term adjustment determinations. Oral Arg. at 8:15–8:27, available at

http://oralarguments.cafc.uscourts.gov/

default.aspx?fl=2014-1280.mp3. 

Daiichi provides two reasons to support its position

that the PTO is incorrect that 180 days is the outer limit 

of its authority. First, the statute does not suggest that 

Congress intended that the period for judicial review 

should also apply to administrative review. Second, 

Daiichi asserts that Congress provided the PTO with 

authority to correct its own mistakes, “[w]henever a 
DAIICHI SANKYO COMPANY v. LEE 11

mistake in a patent, incurred through the fault of the 

Patent and Trademark Office, is clearly disclosed by the 

records of the Office.” Appellant’s Br. 20 (quoting 35 

U.S.C. § 254) (emphasis omitted). In other words, Congress has not limited the time for the PTO to correct 

mistakes in patent term adjustment determinations. 

Daiichi contends the only rationale advanced in the 

denials was that 180 days was the outer limit of the 

PTO’s authority. Therefore, Daiichi claims, the agency 

relied entirely on an erroneous view of the law, rendering 

the decisions “arbitrary and capricious, and an abuse of 

discretion, as a matter of law.” Id. at 22.

The government argues in response that, at the relevant time in 2010, the law offered Daiichi two separate 

avenues for challenging the patent term adjustments

calculation. First, Daiichi could have requested reconsideration of the patent term adjustments within two 

months of the patent’s issuance under 37 C.F.R. 

§ 1.705(d). Second, Daiichi could have filed suit in the 

federal district court within 180 days of issuance under 

§ 154(b)(4)(A). Having failed to take advantage of either 

option, Daiichi should not be permitted to do so now. The 

government notes that the PTO noted that Daiichi cannot 

rely on the Wyeth decision to establish extraordinary 

circumstances warranting a waiver of the regular twomonth administrative filing period because Daiichi could 

have made a timely challenge, as Wyeth did. Appellee’s 

Br. 23. 

Regarding the agency’s adoption of the 180-day period 

for administrative review, the government argues that 

this selection was logical because it lengthened the period 

for administrative review to match the period for seeking 

judicial review. Id. at 25. Additionally, the government 

points to the abbreviated period of judicial review as 

evidence of Congress’ intent that questions regarding 

patent term adjustments be “decided quickly and soon 

after the issuance of the patent.” Id. at 26. Hence, any 
12 DAIICHI SANKYO COMPANY v. LEE

extension of the period for administrative review beyond 

180 days would be contrary to the statute. Finally, the 

government contends that to consider any recalculation 

request regardless of how long after issuance it was 

filed—as Daiichi claims is appropriate under 35 U.S.C. 

§ 254—would run contrary to the PTO’s authority to 

adopt regulations governing the procedures for requesting 

reconsideration of patent term adjustments. Id. at 28 

(citing 35 U.S.C. § 154(b)(3)).

Pursuant to the APA, an agency decision will be set 

aside if it is arbitrary, capricious, an abuse of discretion, 

or not in accordance with the law. 5 U.S.C. § 706. The 

scope of review under this standard is narrow, and the 

reviewing court may not “substitute its judgment for that 

of the agency.” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. 

State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983). An 

agency abuses its discretion when its decision is based on 

an erroneous interpretation of the law. See Burandt v. 

Dudas, 528 F.3d 1329, 1332 (Fed. Cir. 2008) (citation and 

quotation omitted). “Otherwise, an agency acts arbitrarily or capriciously only if the decision was not based on the 

relevant factors or it fails to ‘examine the relevant data 

and articulate a satisfactory explanation for its action 

including a rational connection between the facts found 

and the choice made.’” Japanese Found. for Cancer 

Research v. Lee, 773 F.3d 1300, 1304 (Fed. Cir. 2014) 

(quoting Motor Vehicle Mfrs., 463 U.S at 43)).

Here, we agree with the government that the PTO has 

not erroneously interpreted the law. Rather, the agency 

acted within its discretion under the statute to “prescribe 

regulations establishing procedures for the . . . determination of patent term adjustments,” 35 U.S.C. § 154(b)(3), in 

adopting the 180-day period as part of the Interim Procedure. 

Similarly, the PTO acted within its discretion in denying Daiichi’s requests for reconsideration of the patent 
DAIICHI SANKYO COMPANY v. LEE 13

term adjustment determinations. Both decisions provide

ample reasoning for considering only requests filed within 

180 days of the patent grant. The PTO points to the 180-

day statutory judicial review period and notes that it is 

shorter than the normal six-year statute of limitations for 

administrative challenges under the APA. The PTO 

explains that this brief period for judicial review indicates 

Congress’ intent that it resolve patent term adjustment

issues more expeditiously than allowed under the full

administrative challenge period. The PTO also reasoned 

that it was unlikely that Congress intended for the period 

for administrative review to extend beyond the period in 

which that administrative review could be challenged in 

the district court. See J.A. 3121–22, 3382.

The PTO’s decisions are consistent with the law in effect at the time of the decisions, including all of § 154’s 

provisions. The PTO’s conclusion that its authority to 

conduct administrative reviews extends no further than 

the period for judicial review is also consistent with the 

statute, which expressly authorizes the PTO to make 

regulations governing the procedures of patent term 

adjustment reconsiderations. 35 U.S.C. § 154(b)(3)(A). As 

such, we find that the PTO did not abuse its discretion by 

determining not to accept petitions for administrative 

review filed more than 180 days after the patent grant.

B. DISPARATE TREATMENT OF PATENTS

Daiichi also contends that the PTO’s disparate treatment of patents issued on August 5, 2009 (the earliest day 

on which a patent could issue and still qualify for the 

optional procedure) and the previous day was arbitrary 

and capricious. According to Daiichi, the issuance of 

Wyeth is no less of an extraordinary circumstance for 

patents issued before August 5, 2009 than it is for patents 

issued on or after that day. Daiichi contends the PTO has 

treated similarly situated patentees differently because

one has a remedy and the other does not. 
14 DAIICHI SANKYO COMPANY v. LEE

The government argues that Daiichi is not similarly 

situated with patentees whose patents issued during the 

period for which the Optional Interim Procedure was 

available. Rather, Daiichi was similarly situated with all 

patentees whose patents issued before the Interim Procedure’s cutoff date. The government asserts that since the 

PTO did not consider the petitions of any patentees like 

Daiichi who failed to show extraordinary circumstances, 

Daiichi’s disparate treatment argument fails. 

We conclude that Daiichi has not shown that the PTO 

treated any requests for reconsideration of patent term 

adjustments filed for patents issuing before August 5, 

2009 differently than Daiichi’s petitions. All other similar 

requests were denied by the agency, showing that the 

PTO acted consistently with respect to similarly situated 

patentees. Accordingly, the PTO did not act arbitrarily or 

capriciously based on its treatment of reconsideration 

requests submitted by similarly situated patentees. 

Through post-argument submission, Daiichi points 

the court to Merck Sharp & Dohme Corp. v. Lee, No. 10-

1110, 2014 WL 5775749 (D.D.C. Nov. 6, 2014). In Merck, 

the government conceded before the district court that the 

facts of the case justified equitably tolling the 180-day 

judicial review period for a patent issued prior to the

availability of the Optional Interim Procedure. Submission of Supplemental Authority, Daiichi Sankyo Co. v. 

Lee, No. 14-1280 (Fed. Cir. Jan. 16, 2015). Thereafter, the 

district court tolled the statute and remanded to the PTO 

to adjust the term of the patent. Daiichi argues that, 

under Merck, the government acts arbitrarily whenever it 

opposes a patentee that seeks recalculation under the 

agency’s new calculation method for patents issued prior 

to the Optional Interim Procedure’s earliest qualifying 

date. We disagree. In Merck, the government contested 

equitable tolling on legal grounds, when it should have 

done so on factual grounds. The Supreme Court has held 

that the government will “not be bound by the mistaken 
DAIICHI SANKYO COMPANY v. LEE 15

representations of an agent unless it were clear that the 

representations were within the scope of the agent’s 

authority.” Office of Pers. Mgmt. v. Richmond, 496 U.S. 

414, 419–20 (1990) (collecting cases supporting holding) 

(citations omitted). There is no indication that the government, in Merck, intended its concession to have any 

effect beyond that particular case. Further, there is no 

indication that counsel was acting with authority to bind 

the government so as to prevent it from ever disputing 

that a patent issuing before the earliest qualifying date 

for the Optional Interim Procedure is not entitled to a 

recalculation under the new calculation method.

We must also consider whether the agency’s choice to 

grant extensions of the administrative review period for 

some patents to match the judicial review period for all 

patents was arbitrary and capricious. As discussed above, 

the statute provides for the Director’s ability to prescribe 

the timeframe for a petition at the PTO. Daiichi was 

treated identically to all other patentees whose patents 

had issued more than 180-days prior to the deadline for 

filing a petition and who were unable to show extraordinary circumstances. Our decision in Wyeth did not obligate the PTO to create the Optional Interim Procedure. 

Indeed, all patentees who could take advantage of the 

Optional Interim Procedure could still challenge their 

patent term adjustment in the district court under the 

statute. The PTO simply provided an alternative, and 

more cost-effective, mechanism at the agency for attaining

the same result. Choosing an administrative filing deadline that mirrors the judicial filing deadline, especially 

when it lengthens that deadline for some patentees, is 

neither arbitrary nor capricious. 

In sum, we do not find that the PTO’s consistent 

treatment of all patents issuing prior to the availability of 

the Optional Interim Procedure, the government’s concession in Merck, or its selection and use of the 180-day 
16 DAIICHI SANKYO COMPANY v. LEE

administrative review period amount to arbitrary and 

capricious action by the government. 

IV. DAIICHI’S ADDITIONAL ARGUMENTS

Daiichi presents two additional arguments that it 

acknowledges are for preservation purposes only: (1) 

Daiichi argues 35 U.S.C. § 154(b)(4)(A)’s 180-day judicial 

review period applies only to challenges of patent term 

adjustment determinations that consider A Delays; and 

(2) the 180-day limitation period is subject to equitable 

tolling. We considered, and rejected, both of these arguments in Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 

2014), as Daiichi concedes. Accordingly, we do not address them further here.

CONCLUSION

The PTO’s denial of Daiichi’s requests for reconsideration was not based on an erroneous view of the law or 

otherwise arbitrary or capricious. Daiichi is not entitled 

to relief on the basis that the statute only covers A Delay. 

And Daiichi is not entitled to equitable tolling of the 

judicial review period. Therefore, the decision of the 

district court is

AFFIRMED

COSTS

Each party shall bear its own costs.