Daiichi Sankyo Company v. Lee ( 2015 )

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. § 154Section 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 De-
lay,” 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 rejec-
tion. 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 allow-
1 The letter designation for the two types of delay
described, A or B, corresponds to the statutory subpara-
graph 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. Regard-
ing administrative review, the statute requires the Direc-
tor 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 determina-
tion, 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 chal-
lenged 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 pa-
tent’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 reconsid-
eration 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 Pro-
cedure”) 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 Proce-
dure) 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 two-
month window set in 37 C.F.R. § 1.705(d), Daiichi concur-
rently filed a petition to waive the two-month window
under 37 C.F.R. § 1.183. Section 1.183 allows the Direc-
tor, 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 dis-
missed both of Daiichi’s waiver petitions and denied both
requests for reconsideration of the patent term adjust-
ments because neither was timely filed within the re-
quired two-month window. Neither rejection mentioned
the Interim Procedure.
Daiichi filed requests for reconsideration of the dis-
missals of its waiver petitions and its requests for recon-
sideration 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 adjust-
ments 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 pa-
tents 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 pa-
tents.
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) refus-
ing 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 present-
ed three arguments relevant to this appeal. First, it
contended that 35 U.S.C. § 154(b)(4)(A)’s 180-day limita-
tions period for judicial review does not apply to challeng-
es 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 adminis-
trative 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. Accord-
ing 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 ad-
justments 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 argu-
ments. As to whether § 154(b)(4)(A) applies to final
determinations, the district court found that this provi-
sion 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 adjust-
ments, without limiting the Director to creating proce-
dures 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 prerequi-
site 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 pa-
tents 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 de-
terminations (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, arbi-
trary, 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 recalcu-
lating 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 adjust-
ment 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, Con-
gress 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 rele-
vant time in 2010, the law offered Daiichi two separate
avenues for challenging the patent term adjustments
calculation. First, Daiichi could have requested reconsid-
eration 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 two-
month 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 arbitrari-
ly 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 . . . determina-
tion of patent term adjustments,” 35 U.S.C. § 154(b)(3), in
adopting the 180-day period as part of the Interim Proce-
dure.
Similarly, the PTO acted within its discretion in deny-
ing 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 ef-
fect 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 treat-
ment 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 Proce-
dure’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. Submis-
sion 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 gov-
ernment, 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 extraordi-
nary circumstances. Our decision in Wyeth did not obli-
gate 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 dead-
line 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 conces-
sion 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 argu-
ments in Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir.
2014), as Daiichi concedes. Accordingly, we do not ad-
dress them further here.
CONCLUSION
The PTO’s denial of Daiichi’s requests for reconsidera-
tion 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.