Daiichi Sankyo Company, Limited v. Kappos

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

______________________________
)
DAIICHI SANKYO COMPANY, )
LIMITED, )
)
Plaintiff, )
)
v. ) Civil Action No. 10-215 (RWR)
)
TERESA STANEK REA, )
)
Defendant. )
______________________________)

MEMORANDUM OPINION

Plaintiff Daiichi Sankyo Company, Limited (“Daiichi”) brings

suit under 35 U.S.C. § 154(b)(4)(A) and the Administrative

Procedure Act, 5 U.S.C. § 501 et seq., against the Under

Secretary of Commerce for Intellectual Property and Director of

the United States Patent and Trademark Office (“USPTO”)1 alleging

that the USPTO improperly calculated the patent term adjustments

(“PTA”) for Daiichi’s United States Patent Nos. 7,365,205 (“‘205

patent”), 7,342,014 (“‘014 patent”), and 7,576,135 (“‘135

patent”). Daiichi and the USPTO cross-move for summary judgment.

Because Daiichi did not timely file its challenge to the USPTO’s

PTA determinations, the USPTO’s cross-motion for summary judgment

will be granted and Daiichi’s cross-motion for summary judgment

will be denied.

1
Teresa Stanek Rea is substituted as the defendant under
Federal Rule of Civil Procedure 25(d).
 - 2 -

BACKGROUND

I. LEGAL BACKGROUND

In the United States, patents are granted “for a term

beginning on the date on which the patent issues and ending 20

years from the date on which the application for the patent was

filed in the United States.” 35 U.S.C. § 154(a)(2). “However,

the prosecution of a patent application may take more than three

years. In order to ensure that all patents have terms of at

least seventeen years,” the Patent Act allows the Director of the

USPTO to adjust the term of a patent to account for certain

delays that may occur during patent prosecution (i.e., to make a

PTA determination). Janssen Pharmaceutica, N.V. v. Rea, 928 F.

Supp. 2d 102, 103 (D.D.C. 2013); see also 35 U.S.C. § 154(b).

One category of delay that is excluded from the calculation

of the patent term, known as “A delay,” “extend[s] the term of

the patent one day for each day the PTO does not meet certain

examination deadlines[.]” Wyeth v. Kappos (Wyeth II), 591 F.3d

1364, 1367 (Fed. Cir. 2010) (citing 35 U.S.C. § 154(b)(1)(A)).

This delay is excluded because the Patent Act guarantees “prompt

Patent and Trademark Office responses.” 35 U.S.C.

§ 154(b)(1)(A). “The PTO notifies the patentee of the amount of

A Delay that has been awarded when it issues the Notice of

Allowance. Because the Notice of Allowance is sent well before a

patent is actually granted, the determination of A Delay is known
 - 3 -

as a Pre–Issuance Determination.” Novartis AG v. Kappos, 904 F.

Supp. 2d 58, 61 (D.D.C. 2012).

A second category of excludable delay, known as “B delay,”

“extends the term of the patent one day for each day issuance is

delayed due to the PTO’s failure ‘to issue a patent within 3

years after the actual filing date of the application in the

United States.’” Wyeth II, 591 F.3d at 1367 (quoting 35 U.S.C.

§ 154(b)(1)(B)). This delay is excluded because the Patent Act

guarantees “no more than [a] 3-year application pendency.” 35

U.S.C. § 154(b)(1)(B). “Because B Delay accrues until the actual

date of issuance, the PTO does not determine the proper amount of

B Delay until the patent is granted.” Novartis, 904 F. Supp. 2d

at 61.

“After determining the proper amount of A and B Delay, the

PTO must determine the extent of any overlap between the two

types of delay.” Id. at 62. “To the extent that periods of [A

delay and B delay] overlap, any [PTA] shall not exceed the actual

number of days the issuance of the patent was delayed.” 35

U.S.C. § 154(b)(2)(A). “Because the overlap determination

depends on the amount of B Delay, it is also done at the time the

patent is granted.” Novartis, 904 F. Supp. 2d at 62.

In 2004, the USPTO issued a regulation explaining its

methodology to calculate A/B Overlap. See Revision of Patent

Term Extension and Patent Term Adjustment Provisions, 69 Fed.
 - 4 -

Reg. 21706-01 (Apr. 22, 2004) (“2004 Notice”). On September 30,

2008, in Wyeth v. Dudas (Wyeth I), 580 F. Supp. 2d 138, 141-42

(D.D.C. 2008), the district court found that the USPTO’s A/B

Overlap methodology, as described in the 2004 Notice, was

contrary to the plain language of § 154(b). The USPTO appealed

the decision, and the Federal Circuit affirmed the district

court’s decision in Wyeth II. Wyeth II, 591 F.3d at 1369-70.

On February 1, 2010, the USPTO issued an Interim Procedure

setting forth its procedure for recalculating PTAs using the

correct A/B Overlap methodology. See Interim Procedure for

Patentees to Request a Recalculation of the Patent Term

Adjustment, 75 Fed. Reg. 5043-01 (Feb. 1, 2010). The Interim

Procedure established that the USPTO would recalculate the PTA

for any patent that had been issued in the 180 days before the

announcement of the Interim Procedure -- that is, any patent

issued on or after August 5, 2009. Id. at 5044.

The final determination of PTA -- which factors in A Delay,

B Delay, and A/B Overlap -- is done at the time the patent is

granted. Novartis, 904 F. Supp. 2d at 62. If the patent

applicant disagrees with the PTA determination, the applicant may

“request reconsideration of any patent term adjustment

determination made by the Director,” id. § 154(b)(3)(B)(ii),

“within two months of the date the patent issued,” 37 C.F.R.

§ 1.705(d) (2012). “[O]n petition of the interested party,”
 - 5 -

(“Rule 183 petition”) the two-month limitation “may be suspended

or waived by the Director or the Director’s designee” “[i]n an

extraordinary situation, when justice requires.” 37 C.F.R.

§ 1.183 (2013).

II. FACTUAL BACKGROUND

Daiichi is the assignee of the ‘205, ‘014, and ‘135 patents.

2d Am. Compl. ¶ 8. Patent Application Serial No. 10/481,262

issued as the ‘205 patent on April 29, 2008. Id. ¶ 9. The

patent issued with a notice that its term would be extended by

504 days under 35 U.S.C. § 154(b) (i.e., the final PTA

determination is 504 days) subject to the patentee’s terminal

disclaimer over the ‘014 patent.2 Id. ¶¶ 9, 31.

Patent Application Serial No. 10/773,344 issued as the ‘014

patent on March 11, 2008. Id. ¶ 10. The patent issued with a

notice that its term would be extended by 357 days under 35

U.S.C. § 154(b) subject to the patentee’s terminal disclaimer

over the ‘205 patent. Id. ¶¶ 10, 33.

2
A “terminal disclaimer” is a statement in which an
applicant or patent owner “disclaims or dedicates to the public
the entire term or any terminal part of the term of a patent or
patent to be granted.” See Manual of Patent Examining Procedures
§ 1490(II) (citing 37 C.F.R. § 1.321(b)); see also 35 U.S.C.
§ 253(b) (providing that “any patentee or applicant may disclaim
or dedicate to the public the entire term, or any terminal part
of the term, of the patent granted or to be granted”). In other
words, the patent applicant or owner gives up the term of a
granted patent which would extend beyond the expiration date of a
prior patent. As such, the term of the granted patent expires on
the same date that the prior patent expires.
 - 6 -

Patent Application Serial No. 10/540,259 issued as the ‘135

patent on August 18, 2009. Id. ¶ 11. The patent issued with a

notice that its term would be extended by 86 days under 35 U.S.C.

§ 154(b) subject to the patentee’s terminal disclaimer over the

‘014 and ‘205 patents. Id. ¶¶ 11, 35. In other words, Daiichi

disclaimed the part of the ‘135 patent term that extended beyond

the expiration date of the ‘014 and ‘205 patents. Thus, in

effect, the ‘135 patent expires on the same day as the ‘014 and

‘205 patents expire.

On February 2, 2009, Daiichi requested that the Director

reconsider her March 11, 2008 and April 28, 2008 PTA

determinations for the ‘014 and ‘205 patents respectively and

filed Rule 183 petitions seeking a waiver of the two-month limit

for filing a request for reconsideration. Id. ¶ 43. The USPTO

denied Daiichi’s Rule 183 petitions and denied its requests for

reconsideration as untimely. Def.’s Cross-Mot. & Opp’n, Exs. 3-

4.

On February 12, 2010, Daiichi filed suit against the USPTO

alleging that the USPTO improperly calculated the PTA for the

‘135 patent. Daiichi asserted that the correct PTA for the ‘135

patent is 504 days. Compl. ¶ 1. In April 2010, the matter was

“remanded to the USPTO for recalculation and adjustment of

plaintiff’s patent term [for the ‘135 patent] in accordance with

[Wyeth II].” Order, entered 4/20/10. On remand, the USPTO
 - 7 -

recalculated the PTA for the ‘135 patent and issued a Certificate

of Correction stating that “[s]ubject to any disclaimer, the term

of the [‘135] patent is extended or adjusted under 35 U.S.C.

§ 154(b) by 503 days.” Def.’s Cross-Mot. & Opp’n, Ex. 1.

However, because the ‘135 patent is terminally disclaimed by the

‘014 and ‘205 patents, any part of the term of the ‘135 patent

that extends beyond the terms of the earlier ‘014 and ‘205

patents is disclaimed. “Accordingly, although the USPTO has

reinstated the term it denied the ‘135 patent at issuance, the

reinstatement has no practical effect” because the terms of the

‘014 and ‘205 patents expire before the amended term of the ‘135

patent expires. See Pl.’s Mot. for Summ. J., Mem. of P. & A. in

Supp. of Pl.’s Mot. for Summ. J. (“Pl.’s Mem.”) at 4.

On November 9, 2010, Daiichi filed an amended complaint

alleging that the USPTO also incorrectly calculated the PTA for

the ‘014 and ‘205 patents.

The parties now cross-move for summary judgment.

DISCUSSION

“The court shall grant summary judgment if the movant shows

that there is no genuine dispute as to any material fact and the

movant is entitled to judgment as a matter of law.” Fed. R. Civ.

P. 56(a).

In a case involving review of a final agency action under
the APA, . . . [the court has a] limited role of . . .
reviewing the administrative record. The function of the
district court is to determine whether or not as a matter
 - 8 -

of law the evidence in the administrative record
permitted the agency to make the decision it did.
Summary judgment thus serves as the mechanism for
deciding, as a matter of law, whether the agency action
is supported by the administrative record and otherwise
consistent with the APA standard of review.

Nat’l Parks Conservation Ass’n v. Jewell, Civil Action No.

12-1690 (RWR), 2013 WL 4616972, at *2 (D.D.C. Aug. 30, 2013)

(alterations, internal quotation marks, and citations omitted)

(quoting Ctr. for Food Safety v. Salazar, 898 F. Supp. 2d 130,

138 (D.D.C. 2012)).

A patent applicant can challenge the USPTO’s PTA

determination under 35 U.S.C. § 154(b)(4)(A). The Act provided

at the time3 that

[a]n applicant dissatisfied with a determination made by
the Director under paragraph (3) shall have remedy by a
civil action against the Director filed in the United
States District Court for the District of Columbia within
180 days after the grant of the patent. [The APA] shall
apply to such action. Any final judgment resulting in a
change to the period of adjustment of the patent term
shall be served on the Director, and the Director shall
thereafter alter the term of the patent to reflect such
change.

35 U.S.C. § 154(b)(4)(A) (2006). The ‘014 patent issued on

March 11, 2008, and the ‘205 patent issued on April 28, 2008.4

3
As the parties note, see Joint Submission Regarding
Amendments to 35 U.S.C. § 154(b), the relevant statutory language
has been amended. However, the parties agree that the original
version of § 154(b) applies here. Id. at 2.
4
Under § 154(b)(4)(A), the 180-day limitations period for
the ‘014 patent ended on September 7, 2008 and the 180-day
limitations period for the ‘205 patent ended on October 25, 2008.
 - 9 -

However, Daiichi did not bring this suit until February 10,

2010.5 Accordingly, the USPTO argues that because Daiichi did

not file its complaint within 180 days of issuance of the ‘014 or

‘205 patents, Daiichi’s suit is untimely. Daiichi argues that

the 180-day limitations period does not apply to this case but

that, even if it does, the limitations period should be equitably

tolled. The USPTO counters that the statute of limitations is

jurisdictional and not subject to equitable tolling.6

I. WHETHER 35 U.S.C. § 154(b)(4)(A) APPLIES TO FINAL PTA
DETERMINATIONS

Daiichi contends that § 154(b)(4)(A) does not apply to the

final PTA determinations at issue in this case. Instead, Daiichi

asserts that, under the plain language of the statute, the 180-

day limitations period applies only to the USPTO’s determination

of A Delay. Section 154(b)(4)(A) applies to an applicant’s

challenge of a determination made “under paragraph (3).” Section

154(b)(3) provides:

5
Moreover, Daiichi did not seek review of the USPTO’s PTA
determinations of the ‘014 and ‘205 patents in its original
complaint. Instead, it first challenged the USPTO’s
determinations in its first amended complaint, which was filed on
November 9, 2010.
6
The USPTO does not argue that its interpretation of
§ 154(b) is entitled to deference under Chevron, U.S.A., Inc. v.
Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and
courts to have considered this issue have found that the USPTO’s
determination is not entitled to such deference because the USPTO
does not have authority to issue substantiative rules, see
Novartis, 904 F. Supp. 2d at 64; Wyeth I, 580 F. Supp. 2d at 141.
 - 10 -

(A) The Director shall prescribe regulations establishing
procedures for the application for and determination of
patent term adjustments under this subsection.

(B) Under the procedures established under subparagraph
(A), the Director shall –
(i) make a determination of the period of any patent
term adjustment under this subsection, and shall transmit
a notice of that determination with the written notice of
allowance of the application under section 151; and
(ii) provide the applicant one opportunity to
request reconsideration of any patent term adjustment
determination made by the Director.

35 U.S.C. § 154(b)(3). Daiichi admits that § 154(b)(3)(A)

“provides the authority for and requires the Director of the

USPTO to establish general procedures for determining PTA.”

Pl.’s Mem. at 13. However, § 154(b)(3)(B) refers to the PTA

determination sent with the notice of allowance. Because only

the A Delay determination is sent at that time, Daiichi argues

that “the unambiguous interpretation of Section 154(b)(3) is that

it relates solely to [A Delay].” Pl.’s Mem. at 12. Thus,

Daiichi argues that the “paragraph (3)” determination referred to

in § 154(b)(4)(A) includes only the Director’s determination of A

Delay, and the general APA statute of limitations applies to an

applicant’s challenge of a final PTA determination.

When interpreting a statute, courts begin by looking at the

statutory text. Caminetti v. United States, 242 U.S. 470, 485

(1917). “[I]f a statute is ‘plain and unambiguous,’ . . . ‘[the

court’s] analysis ends with the text.’” Cook v. Food & Drug

Admin., 733 F.3d 1, 9 (D.C. Cir. 2013) (quoting Chao v. Day, 436
 - 11 -

F.3d 234, 235 (D.C. Cir. 2006)). The plain meaning of a

“paragraph (3)” determination is any determination that could be

made under § 154(b)(3). This includes any PTA determination made

under the regulations the Director promulgated under

§ 154(b)(3)(A), which includes A Delay, B Delay, and A/B Overlap,

as well as the Director’s A Delay determination referred to in

§ 154(b)(3)(B). This interpretation of “paragraph 3” includes

the entirety of the determinations that could be made under

§ 154(b)(3) and does not construe “paragraph (3)” to mean only

“paragraph (3)(B).” Congress knows how to limit a provision to a

certain subparagraph. See Cent. Bank of Denver, N.A. v. First

Interstate Bank of Denver, N.A., 511 U.S. 164, 176-77 (1994)

(comparing statutory provisions and finding that “Congress knew

how to impose aiding and abetting liability when it chose to do

so”). For example, earlier in § 154, Congress referred

specifically to “an adjustment under paragraph (2)(c)” rather

than referring generally to “paragraph (2).” See 35 U.S.C.

§ 154(b)(3)(C) (stating that “[t]he Director shall reinstate all

or part of the cumulative period of time of an adjustment under

paragraph (2)(C)” in certain circumstances). Because in

§ 154(b)(4)(A) Congress used the broader phrase, “paragraph (3),”

the plain meaning of the statute is that the 180-day limitations

period applies to any determination made under § 154(b)(3) --

including the final PTA determination.
 - 12 -

Furthermore, Daiichi’s argument was squarely rejected in

Novartis, 904 F. Supp. 2d 58, and Janssen Pharmaceutica, N.V. v.

Kappos, 844 F. Supp. 2d 707 (E.D. Va. 2012). In Novartis, Judge

Huvelle considered that the title of the subsection -- Procedures

for patent term adjustment determination -- is generic and does

not suggest that the section is limited only to A Delay, and the

fact that it “is the only section of the statute to address the

PTO’s procedures for determining PTA,” and found that the section

“is clearly intended to relate to all PTA determinations,

regardless of when they occur.” Novartis, 904 F. Supp. 2d at 65.

She further reasoned that her interpretation of the statute is

not only “consistent with the plain meaning of the statute,” but

also it “avoids absurd results.” Id. Specifically, she sought

to avoid an interpretation of the statute where “a patentee would

have 180 days in which to challenge the calculation of A Delay

but six years [under the APA, 28 U.S.C. § 2401(a),] in which to

challenge B Delay and A/B Delay Overlap.” Id.

In Janssen, Judge Brinkema found that “[o]n its face,

§ 154(b)(4)(A) applies to all PTA decisions made by the Director

applying the USPTO’s own regulations before issuance of a

patent.” Janssen, 844 F. Supp. 2d at 712. She stated that the

plain intent of the statute is “to strictly limit the forum and

timing for seeking judicial review of these very specific USPTO

decisions.” Id. at 713. Thus, she reasoned that if applicants
 - 13 -

could seek post-issuance review of the USPTO’s PTA determinations

under the APA, “the very limitations on judicial review Congress

included in the patent statute” “would [be] eviscerate[d].” Id.

She further explained that “it would be absurd for Congress to

impose limitations on the specific statutory judicial review

mechanisms (i.e., § 154(b)(4)(A)) when it simultaneously intended

to allow a patentee to seek generic APA review of the very same

question, (i.e., the number of days of PTA to which the . . .

patent is entitled) without any of those same restrictions.” Id.

(emphasis and internal quotation marks omitted). Accordingly,

she held that

in a case in which a patentee is challenging the number
of days of PTA calculated by the USPTO, whether that
calculation occurred before the patent was issued or
afterwards, such a decision is governed by §§ 154(b)(3)
and (b)(4)(A). In other words, any challenge to a PTA
determination is governed by § 154(b)(4)(A).

Id.

II. EQUITABLE TOLLING

Daiichi argues that the 180-day limitations period is not

jurisdictional and should be equitably tolled in this case. The

USPTO opposes.

A. Whether § 154(b)(4)(A) is jurisdictional

“The Supreme Court has distinguished between prescriptions

that may be ‘properly typed jurisdictional,’ and those better

classified as ‘claim-processing rules[.]’” Menominee Indian

Tribe of Wis. v. United States, 614 F.3d 519, 523 (D.C. Cir.
 - 14 -

2010) (quoting Scarborough v. Principi, 541 U.S. 401, 413-14

(2004)). A jurisdictional rule “governs a court’s adjudicatory

capacity, that is, its subject-matter or personal jurisdiction.”

Henderson ex rel. Henderson v. Shinseki, 131 S. Ct. 1197, 1202

(2011). Claim-processing rules are those “that seek to promote

the orderly progress of litigation by requiring that the parties

take certain procedural steps at certain specified times.” Id.

at 1203. Unlike a jurisdictional rule, “a nonjurisdictional

federal statute of limitations is normally subject to a

‘rebuttable presumption’ in favor ‘of equitable tolling.’”

Holland v. Florida, 130 S. Ct. 2549, 2560 (2010) (quoting Irwin

v. Dep’t of Veterans Affairs, 498 U.S. 89, 95-96 (1990)).

Under the “‘readily administrable bright line’” rule the

Supreme Court established in Arbaugh v. Y&H Corp., 546 U.S. 500

(2006), to decide whether a rule is jurisdictional, courts “look

to see if there is any ‘clear’ indication that Congress wanted

the rule to be ‘jurisdictional.’” Henderson, 131 S. Ct. at 1203

(quoting Arbaugh, 546 U.S. at 515-16). “Congress, of course,

need not use magic words in order to speak clearly on this point.

‘[C]ontext, including [the Supreme] Court’s interpretation of

similar provisions in many years past, is relevant.’” Id.

(quoting Reed Elsevier, Inc. v. Muchnick, 559 U.S. 154, 168

(2010)).
 - 15 -

For example, courts have found that 28 U.S.C. § 2253(a),

(b), and (c)(1), 28 U.S.C. § 2501(a), and 28 U.S.C. § 2401(a)

contain unambiguous jurisdictional language. See Gonzalez v.

Thaler, 132 S. Ct. 641, 649 (2012) (28 U.S.C. § 2253(a), (b), and

(c)(1)); John R. Sand & Gravel Co. v. United States, 552 U.S.

130, 132-34 (2008) (28 U.S.C. § 2501(a)); Spannaus v. U.S. Dep’t

of Justice, 824 F.2d 52, 55 (D.C. Cir. 1987) (28 U.S.C.

§ 2401(a)). Section 2501(a) states: “Every claim of which the

United States Court of Federal Claims has jurisdiction shall be

barred unless the petition thereon is filed within six years

after such claim first accrues.” 28 U.S.C. § 2501(a) (emphasis

added). Section 2401(a) provides that “every civil action

commenced against the United States shall be barred unless the

complaint is filed within six years after the right of action

first accrues.” 28 U.S.C. § 2401(a) (emphasis added).

Section 2253(a) states: “In a habeas corpus proceeding or a

proceeding under section 2255 before a district judge, the final

order shall be subject to review, on appeal, by the court of

appeals for the circuit in which the proceeding is held.” 28

U.S.C. § 2253(a) (emphasis added). Section 2253(b) limits that

grant to the appeals court, stating that

[t]here shall be no right of appeal from a final order in
a proceeding to test the validity of a warrant to remove
to another district or place for commitment or trial a
person charged with a criminal offense against the United
States, or to test the validity of such person’s
detention pending removal proceedings.
 - 16 -

28 U.S.C. § 2253(b) (emphasis added). Section 2253(c)(1)

provides that “[u]nless a circuit justice or judge issues a

certificate of appealability, an appeal may not be taken to the

court of appeals from” a final order in habeas corpus proceeding

or proceeding under 28 U.S.C. § 2255. 28 U.S.C. § 2253(c)(1)

(emphasis added).

Although “[f]iling deadlines . . . are quintessential

claim-processing rules,” Henderson, 131 S. Ct. at 1203, the USPTO

argues that, like the jurisdictional statutes listed above,

§ 154(b)(4)(A) bars any suit that is filed after a certain

limitations periods and thus, should be considered

jurisdictional. See 35 U.S.C. § 154(b)(4)(A) (2006) (stating

that a patent applicant has a “remedy by a civil action” that is

filed “within 180 days after the grant of the patent”). However,

the USPTO has not demonstrated that § 154(b)(4)(A) includes

unambiguous jurisdictional terms such as “jurisdiction,” that it

states that suits not filed timely are “barred,” or that it

explicitly establishes procedures that must be met before the

applicant can file suit. Compare 28 U.S.C. § 2501(a), 28 U.S.C.

§ 2401(a), 28 U.S.C. § 2253(a), 28 U.S.C. § 2253(b), and 28

U.S.C. § 2253(c)(1), with 35 U.S.C. § 154(b)(4)(A) (“An applicant

dissatisfied with a determination made by the Director under

paragraph (3) shall have remedy by a civil action against the

Director filed in the United States District Court for the
 - 17 -

District of Columbia within 180 days after the grant of the

patent.”). Thus, the USPTO has not shown that § 154(b)(4)(A)

“speak[s] in jurisdictional terms or refer[s] in any way to the

jurisdiction of the district courts.” Zipes v. Trans World

Airlines, Inc., 455 U.S. 385, 394 (1982). Because courts should

be hesitant to find that a rule is jurisdictional, see Gonzalez,

132 S. Ct. at 648, and the USPTO has not shown that

§ 154(b)(4)(A) contains jurisdictional language, the court holds

that the provision is not jurisdictional. Cf. Novartis, 904 F.

Supp. 2d at 67 (finding that “it is perhaps more prudent to

conclude that § 154(b)(4)(A) should be viewed as a

‘claim-processing rule’” “[i]n light of . . . recent

admonishments to construe the meaning of ‘jurisdictional’

narrowly”). Because § 154(b)(4)(A) is not jurisdictional, there

is a rebuttable presumption that it is subject to equitable

tolling.7

B. Whether § 154(b)(4)(A) should be equitably tolled

“[E]quitable tolling -- as a method for adjusting the rights

of two ‘innocent parties’ -- merely ensures that the plaintiff is

not, by dint of circumstances beyond his control, deprived of a

‘reasonable time’ in which to file suit.” Chung v. U.S. Dep’t of

Justice, 333 F.3d 273, 279 (D.C. Cir. 2003) (quoting Cada v.

Baxter Healthcare Corp., 920 F.2d 446, 452 (7th Cir. 1990)).

7
The USPTO does not attempt to rebut this presumption.
 - 18 -

“Generally, a litigant seeking equitable tolling bears the burden

of establishing two elements: (1) that he has been pursuing his

rights diligently, and (2) that some extraordinary circumstance

stood in his way.” Pace v. DiGuglielmo, 544 U.S. 408, 418

(2005). Courts must decide whether to equitably toll a statute

of limitations period on a “‘case-by-case basis.’” Holland, 130

S. Ct. at 2563 (quoting Baggett v. Bullitt, 377 U.S. 360, 375

(1964)). However, courts “extend[] equitable relief only

sparingly.” Irwin, 498 U.S. at 96.

Daiichi argues that the statute of limitations should be

equitably tolled because extraordinary circumstances prevented it

from timely pursuing its rights. Specifically, Daiichi asserts

that it reasonably relied on the correctness of the USPTO’s

methodology for calculating A/B Overlap described in the 2004

Notice, and thus, did not challenge the USPTO’s PTA determination

for the ‘014 and ‘205 patents. Pl.’s Mem. at 28-29.

Accordingly, Daiichi contends that the 180-day limitations period

should be equitably tolled until the district court decided Wyeth

I in September 2008.8

8
Daiichi’s argument assumes that, under general tolling
principles, the 180-day limit would have been tolled while its
petitions for reconsideration and Rule 183 petitions were pending
before the Director. Because Daiichi has not shown that the
limitations period should be equitably tolled in this case,
whether the limitations period was tolled by Daiichi filing
petitions for reconsideration and Rule 183 petitions is not
addressed.
 - 19 -

To toll a statute of limitations, a

[p]laintiff must either show that defendant has concealed
its acts with the result that plaintiff was unaware of
their existence or it must show that its injury was
“inherently unknowable” at the accrual date. . . . In
[the second] situation the statute will not begin to run
until plaintiff learns or reasonably should have learned
of his cause of action.

Japanese War Notes Claimants Ass’n of Phil., Inc. v. United

States, 373 F.2d 356, 359 (Ct. Cl. 1967) (footnote omitted)

(quoting Urie v. Thompson, 337 U.S. 163, 169 (1949)). In

particular, equitable tolling may be appropriate where failure to

meet a statute of limitations “is the result of justifiable

reliance on the advice of [a] government officer.” See Jarrell

v. U.S. Postal Serv., 753 F.2d 1088, 1092 (D.C. Cir. 1985); see

also Bull S.A. v. Comer, 55 F.3d 678, 681 (D.C. Cir. 1995). In

determining whether equitable tolling is justified in such a

case, courts distinguish between a government officer’s or

agency’s advice on the limitations period and the officer’s or

agency’s understanding of the party’s substantive legal rights.

On the one hand, a statute of limitations may be equitably

tolled where a party reasonably relies on a government officer’s

incorrect advice regarding the limitations period. For example,

in Bull, the Commissioner of Patents and Trademarks gave Bull

S.A. an incorrect renewal deadline for Bull’s trademark in a

signed and sealed Certificate of Renewal. Bull, 55 F.3d at 679.

Bull applied to renew its trademark on the incorrect deadline in
 - 20 -

the Certificate of Renewal, but was informed that it had missed

the correct, statutory renewal deadline, and that it was unable

to renew its trademark. Id. The D.C. Circuit found that the

statutory renewal deadline should be equitably tolled because

Bull justifiably relied on the Commissioner’s incorrect renewal

deadline. Id. at 682 (“The facts of this case support Bull’s

claim of justifiable reliance: Bull received an official

government document, published under the signature and Seal of

the Commissioner, that certified a renewal lasting until May 15,

1992. Once in receipt of this document, and, as detailed below,

absent any circumstances that would alert Bull to the error, Bull

was entitled to rely on its validity.” (emphasis omitted)).

On the other hand, a statute of limitations may not be

equitably tolled where a party relies on the government officer’s

or agency’s interpretation of the party’s legal rights. See,

e.g., Venture Coal Sales Co. v. United States, 370 F.3d 1102

(Fed. Cir. 2004); Catawba Indian Tribe of S.C. v. United States,

982 F.2d 1564 (Fed. Cir. 1993).9 In Venture Coal Sales, the

9
In Catawba Indian Tribe, the Federal Circuit considered
whether the Catawba Indian Tribe’s claims were barred by a six-
year statute of limitations. Catawba Indian Tribe, 982 F.2d at
1569. In that case, the Tribe argued that a representative of
the Bureau of Indian Affairs had assured the Tribe that the
Catawba Indian Tribe Division of Assets Act, 25 U.S.C. §§ 931-938
(1988), would not affect the Tribe’s rights to its ancestral
lands. Catawba Indian Tribe, 982 F.2d at 1567. Later, the
Supreme Court construed the Act in such a way as to cause the
Tribe to lose a portion of its land. See id. at 1571-72. The
Tribe argued that the statute of limitations for claims regarding
 - 21 -

plaintiffs paid a Coal Sales Tax on all of the coal they

produced. Id. at 1103. In 1997, the district court in the

Eastern District of Virginia held the Coal Sales Tax

unconstitutional because it violated the Export Clause of the

United States Constitution, U.S. Const. art. I, § 9, cl. 5. Id.

(citing Ranger Fuel Corp. v. United States, 33 F. Supp. 2d 466

(E.D. Va. 1998)). The plaintiffs argued that “the statute of

limitations should be tolled because it did not know nor could it

have known in the exercise of reasonable diligence that its

claims [for a refund] had accrued.” Id. at 1107. The plaintiffs

asserted that their claims were “inherently unknowable” until the

tax was held unconstitutional in 1997. Id. The Federal Circuit

found that the plaintiffs knew that they had paid the Coal Sales

Tax and knew of the Export Clause, and concluded that the

plaintiffs “had all the facts necessary to initiate a claim

against the United States.” Id. The Federal Circuit rejected

the plaintiffs’ argument that equitable tolling was justified

because the plaintiffs “did not know the legal theory on which

the Tribe’s lands did not begin to run until the Supreme Court’s
decision. Id. The Federal Circuit recognized that equitable
tolling may be justified in “the case when the facts necessary to
know of the harm were intentionally withheld from the plaintiff
by the defendant.” Id. at 1572. However, it inferred that
equitable tolling is not permissible where “all the relevant
facts were known” but the plaintiff, such as the Tribe,
misunderstood “the meaning of the law.” See id. Thus, the court
concluded that the statute of limitations should not be equitably
tolled. See id.
 - 22 -

[their] refund claim might succeed.” Id. The court explained

that “‘ignorance of rights which should be known is not enough’”

to toll a statute of limitations. Id. (alteration omitted)

(quoting Japanese War Notes Claimants Ass’n, 373 F.2d at 359).

Daiichi insists that Bull should be applied in this case.

However, unlike Bull, Daiichi does not argue that the USPTO

misled it about the § 154(b)(4)(A) 180-day deadline or that

Daiichi was otherwise unaware of the statute of limitations.

Daiichi asserts that this is a “distinction without a

difference,” Reply Mem. of P. & A. in Supp. of Pl.’s Mot. for

Summ. J. & Mem. of P. & A. in Opp’n to Def.’s Cross-Mot. for

Summ. J. (“Pl.’s Reply & Opp’n”) at 18, but provides no support

for its assertion that Bull applies to this case despite this

distinguishing factor.

Alternatively, Daiichi argues that Wyeth I was a change in

law that justifies equitable tolling. See Pl.’s Reply & Opp’n at

15-17 (arguing that “[t]olling is appropriate here due to . . .

[the] shift in law occasioned by Wyeth”). However, Daiichi has

not shown that it was unable to pursue its rights until “such

time as a federal court . . . ruled on and upheld the very claims

[it] seek[s] to pursue.” Novartis, 904 F. Supp. 2d at 68. As in

Venture Coal, Daiichi possessed all the facts necessary to

challenge the USPTO’s PTA determinations before Wyeth I was

decided. Daiichi does not dispute that it knew of the PTA
 - 23 -

determinations for the ‘014 and ‘205 patents, the USPTO’s

methodology for calculating PTAs described in its 2004 Notice,

and 35 U.S.C. § 154(b). Thus, Daiichi “was free to raise the

issues that Wyeth . . . raised in [its] lawsuit[] within the 180

days after [its] patents were granted.” Novartis, 904 F. Supp.

2d at 68. Accordingly, Daiichi has not shown that extraordinary

circumstances exist that warrant equitable tolling.10

Even if Daiichi could demonstrate that extraordinary

circumstances justify equitable tolling, it has not shown that it

diligently pursued its rights to challenge the USPTO’s PTA

determinations. Daiichi asserts that it would have been futile

to challenge the PTAs for the ‘014 and ‘205 patents before the

district court decided Wyeth I but that it “diligently acted to

preserve its rights” by filing Rule 183 Petitions and motions for

reconsideration of the PTA determinations for the ‘014 and ‘205

patents less than 180 days after the Wyeth I decision and

amending its complaint to challenge the PTA determinations for

the ‘014 and ‘205 patents promptly after the USPTO denied its

Rule 183 Petitions and motions for reconsideration. Pl.’s Mem.

10
Daiichi also argues that equitable tolling of the statute
of limitations for its challenges of the ‘014 and ‘205 PTA
determinations is necessary to correct the patent term for the
‘135 patent. Pl.’s Mem. at 31; Pl.’s Reply & Opp’n at 19-20.
However, Daiichi does not provide any support for its argument
that such a related effect justifies equitably tolling the
statute of limitations. Furthermore, this argument does not
explain why Daiichi did not timely challenge the ‘014 and ‘205
PTA determinations.
 - 24 -

at 29-30. In Communications Vending Corp. of Arizona, Inc. v.

FCC, 365 F.3d 1064, 1075 (D.C. Cir. 2004), the D.C. Circuit

rejected a similar argument. In that case, the court found that

the plaintiff’s argument that it would have been futile to pursue

its claim in light of the agency’s interpretation of the

governing law did not excuse the party from timely filing its

claim. The court explained:

The only sure way to determine whether a suit can be
maintained is to try it. The application of the statute
of limitations cannot be made to depend upon the
constantly shifting state of the law, and a suitor cannot
toll or suspend the running of the statute by relying
upon the uncertainties of controlling law. It is
incumbent upon him to test his right and remedy in the
available forums. These suits were not commenced until
through the labor of others the way was made clear.

Id. (quoting Fiesel v. Bd. of Educ., 675 F.2d 522, 524–25 (2d

Cir. 1982)). Confronted in Novartis with the same argument as

Daiichi raises in this case, Judge Huvelle relied on

Communications Vending to conclude:

It is of no moment that the PTO had consistently applied
its pre-Wyeth interpretation of A/B Delay Overlap; the
question is not what the PTO would have done in response
to a request for reconsideration, but rather what a
federal court would have done in reviewing the PTO’s
interpretation. That was both unasked and unanswered
until Wyeth raised exactly this issue in its lawsuit,
just as [the patent applicant] was free to do at any
point within 180 days of its patents being granted.

Novartis, 904 F. Supp. 2d at 68. Thus, Daiichi has not shown

that it was justified in not pursuing its rights until after

Wyeth I was decided. Instead, Daiichi sat on its rights for
 - 25 -

almost a year after the ‘014 and ‘205 patents issued, and has not

demonstrated that equitable considerations exist for not

diligently pursuing its rights to challenge the PTA

determinations.

CONCLUSION

Section 154(b)(4)(A) applies to final PTA determinations.

Although § 154(b)(4)(A) is subject to equitable tolling, Daiichi

has not shown that extraordinary circumstances prevented it from

timely challenging the PTA determinations for the ‘014 and ‘205

patents or that it has been diligently pursuing its rights.

Therefore, the USPTO’s motion for summary judgment will be

granted and Daiichi’s motion for summary judgment will be denied.

A separate Order accompanies this Memorandum Opinion.

SIGNED this 3rd day of December, 2013.

/s/
RICHARD W. ROBERTS
Chief Judge