United States Court of Appeals 

for the Federal Circuit ______________________ 

ACTELION PHARMACEUTICALS, LTD.,

Plaintiff-Appellant

v.

JOSEPH MATAL, PERFORMING THE FUNCTIONS 

AND DUTIES OF THE UNDER SECRETARY OF 

COMMERCE FOR INTELLECTUAL PROPERTY 

AND DIRECTOR, U.S. PATENT AND TRADEMARK 

OFFICE,

Defendant-Appellee

______________________ 

2017-1238

______________________ 

Appeal from the United States District Court for the 

Eastern District of Virginia in No. 1:16-cv-00304-LO-TCB, 

Judge Liam O’Grady.

______________________ 

Decided: February 6, 2018

______________________ 

 THOMAS HOXIE, Hoxie & Associates, LLP, Millburn, 

NJ, argued for plaintiff-appellant.

 DANA KAERSVANG, Appellate Staff, Civil Division, 

United States Department of Justice, Washington, DC, 

argued for defendant-appellee. Also represented by CHAD 

A. READLER, DANA J. BOENTE; KIMERE JANE KIMBALL, 

Office of the United States Attorney for the Eastern 
2 ACTELION PHARM., LTD v. MATAL

District of Virginia, Alexandria, VA; NATHAN K. KELLEY, 

BRIAN RACILLA, MOLLY R. SILFEN, Office of the Solicitor, 

United States Patent and Trademark Office, Alexandria, 

VA.

______________________ 

Before LOURIE, O’MALLEY, and WALLACH, Circuit Judges.

LOURIE, Circuit Judge. 

Actelion Pharmaceuticals, Ltd. (“Actelion”) appeals 

from the grant of summary judgment by the United 

States District Court for the Eastern District of Virginia 

in favor of the United States Patent and Trademark 

Office (“PTO”) regarding the length of the patent term 

adjustment (“PTA”) for U.S. Patent 8,658,675 (“the ’675 

patent”), entitled “Pyridin-4-yl Derivatives.” See Actelion 

Pharm., Ltd. v. Lee, 216 F. Supp. 3d 680 (E.D. Va. 2016). 

For the reasons that follow, we affirm. 

BACKGROUND

Congress has established a framework in 35 U.S.C. 

§ 154 (2012) to adjust a patent’s term “[t]o account for any 

undue delays in patent examination caused by the PTO.” 

Pfizer, Inc. v. Lee, 811 F.3d 466, 468 (Fed. Cir. 2016). One 

such delay is designated an “A Delay,” which “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.” Daiichi Sankyo Co. 

v. Lee, 791 F.3d 1373, 1374 (Fed. Cir. 2015). 

The only dispute in the instant case is the A Delay 

calculation, under 35 U.S.C. § 154(b)(1)(A)(i)(II) in particular, for the ’675 patent granted from U.S. Patent Application 13/383,619 (“the ’619 application”), which was filed 

as a national stage application pursuant to 35 U.S.C. 

§ 371. 
ACTELION PHARM., LTD v. MATAL 3

I. Relevant Statutes

On January 14, 2013, Congress enacted the Technical 

Corrections—Leahy-Smith America Invents Act (“Technical Corrections Act” or “TCA”), Pub. L. No. 112-274, 126 

Stat. 2456 (2013). As the name of the Act suggests, the 

TCA made certain technical corrections to various sections of Title 35 following the enactment of the LeahySmith America Invents Act (“AIA”), including amendments to certain provisions of 35 U.S.C. § 154. 

The current version of 35 U.S.C. § 154(b)(1)(A), as 

amended by the TCA, provides in part: 

(A) GUARANTEE OF PROMPT PATENT AND 

TRADEMARK OFFICE RESPONSES.—Subject to the 

limitations under paragraph (2), if the issue of an 

original patent is delayed due to the failure of the 

Patent and Trademark Office to— 

(i) provide at least one of the notifications 

under section 132 or a notice of allowance 

under section 151 not later than 14 

months after— 

. . . 

(II) the date of commencement of 

the national stage under section 

371 in an international application;

. . . , 

the term of the patent shall be extended 1 day for 

each day after the end of the period specified in 

clause (i), (ii), (iii), or (iv), as the case may be, until the action described in such clause is taken.

35 U.S.C. § 154(b)(1)(A) (post-TCA) (emphasis added). 

Prior to the amendments under the TCA, 

§ 154(b)(1)(A)(i)(II) read: 
4 ACTELION PHARM., LTD v. MATAL

(II) the date on which an international application fulfilled the requirements of section 371 of this 

title; 

35 U.S.C. § 154(b)(1)(A)(i)(II) (pre-TCA) (emphasis added).

Subsection 1(n) of the TCA provides that “[e]xcept as 

otherwise provided in this Act, the amendments made by 

this Act shall take effect on the date of enactment of this 

Act, and shall apply to proceedings commenced on or after 

such date of enactment.” TCA, Pub. L. No. 112-274, 

§ 1(n), 125 Stat. at 2459.

A patent applicant may file an international patent 

application pursuant to the Patent Cooperation Treaty 

(“PCT” or “Treaty”), which was implemented in 35 U.S.C. 

§ 351 et seq., and enter a national stage in the PTO by 

complying with certain filing requirements. See Exela 

Pharma Scis., LLC v. Lee, 781 F.3d 1349, 1350 (Fed. Cir. 

2015); see also PCT, June 19, 1970, 28 U.S.T. 7645, 1160 

U.N.T.S. 231, as amended on Sept. 28, 1979 and modified 

on Feb. 3, 1984 and Oct. 3, 2001. The commencement of 

the national stage of an international patent application 

filed under the PCT is specified in 35 U.S.C. § 371, which 

provides in part:

(b) Subject to subsection (f) of this section, the national stage shall commence with the expiration of 

the applicable time limit under article 22(1) or (2), 

or under article 39(1)(a) of the treaty.

(c) The applicant shall file in the Patent and 

Trademark Office— 

(1) the national fee provided in section 

41(a);

(2) a copy of the international application, 

. . . , and a translation into the English 
ACTELION PHARM., LTD v. MATAL 5

language . . . , if it was filed in another 

language; 

(3) amendments, if any, to the claims in 

the international application . . . ; 

(4) an oath or declaration of the inventor

. . . ; 

. . . . 

(f) At the express request of the applicant, the national stage of processing may be commenced at 

any time at which the application is in order for 

such purpose and the applicable requirements of 

subsection (c) of this section have been complied 

with. 

35 U.S.C. § 371(b), (c), (f) (emphases added). Section 371 

was unchanged by the TCA. See generally Pub. L. No. 

112-274, 125 Stat. at 2456–59. 

Article 22 of the PCT, which is referenced in § 371(b),

specifies the national stage filing requirements under the 

Treaty, including the requirement to file the national 

stage application “not later than at the expiration of 30 

months from the priority date.” PCT art. 22(1); see 35 

U.S.C. § 371(b).

II. Filing History of the ’675 Patent

Actelion filed International Patent Application 

PCT/IB2009/053089 (“the first PCT application”) on July 

16, 2009 (“the priority date”), and International Patent 

Application PCT/IB2010/053224 (“the second PCT application”) on July 15, 2010, claiming priority from the first 

PCT application. 

On January 12, 2012, four days before January 16, 

2012, i.e., 30 months from the priority date (“the 30-

month date”), Actelion filed the ’619 application as a 

national stage application of the second PCT application, 
6 ACTELION PHARM., LTD v. MATAL

claiming priority from the July 16, 2009 priority date. 

Along with the ’619 application, Actelion filed a preliminary amendment with remarks, including one stating 

that “Applicant earnestly solicits early examination and 

allowance of these claims,” J.A. 162, and submitted a

completed PTO Form 1390, which provides checkboxes for 

the applicant to indicate various information concerning

the national stage application. Notably, in its PTO Form 

1390, Actelion did not check the box numbered 3 (“box 3”)

next to the statement reading: “This is an express request 

to begin national examination procedures (35 U.S.C. 

[§] 371(f)). . . .” J.A. 151. 

It is undisputed that the requirements under 35 

U.S.C. § 371(c) were met on January 12, 2012. See Appellant’s Br. 4; Appellee’s Br. 7; J.A. 163. It is also undisputed that the 30-month date, January 16, 2012, fell on a 

federal holiday, namely, Martin Luther King, Jr. Day. On 

April 26, 2013, the PTO issued a restriction requirement, 

which constituted “at least one of the notifications under 

section 132,” 35 U.S.C. § 154(b)(1)(A)(i), undisputedly 

ending the accrual of A Delay, which started from “14 

months after,” id., the date specified in

§ 154(b)(1)(A)(i)(II), the identity of which is at issue in 

this appeal. 

On February 5, 2014, the PTO issued an Issue Notification of the ’675 patent, providing a grant of 41 PTA 

days, encompassing the period from March 16, 2013 to 

April 26, 2013. The ’675 patent thereafter was issued on 

February 25, 2014, bearing a notice of 41 PTA days. In 

July 2014, Actelion filed PTO Form 132, entitled “Request 

for Recalculation of Patent Term Adjustment in View of 

AIA Technical Corrections Act,” requesting recalculation 

of the PTA for the ’675 patent. J.A. 178. In September

2014, the PTO did recalculate the PTA for the ’675 patent, 

but reduced it to 40 days, encompassing the period from 

March 17, 2013 to April 26, 2013. 
ACTELION PHARM., LTD v. MATAL 7

In November 2014, Actelion filed a petition for reconsideration under 37 C.F.R. § 1.705, contending that the 

’675 patent is entitled to 45 PTA days, or alternatively, at 

least 41 PTA days. Actelion argued that the accrual of A 

Delay for the ’675 patent should have been calculated 

based on the ’619 application’s filing date, January 12, 

2012, or at least based on the 30-month date, January 16, 

2012. In September 2015, the PTO denied Actelion’s 

petition. Actelion filed a second petition for reconsideration in November 2015, for which the PTO did not issue a 

decision in view of the pendency of this suit. 

On March 18, 2016, Actelion filed suit against the 

PTO in the Eastern District of Virginia pursuant to 

§ 154(b)(4). Actelion and the PTO filed, respectively, a 

motion and a cross-motion for summary judgment in the 

district court, and the court granted summary judgment 

in favor of the PTO.1 Actelion, 216 F. Supp. 3d at 688. 

The district court agreed with the PTO that under either 

pre- or post-TCA law, the PTA for the ’675 patent should 

be the same because the conditions under 35 U.S.C. 

§ 371(b) and (f) were not met on the day the ’619 application was filed. Id. at 686. The district court further 

agreed with the PTO that it properly determined that the 

national stage did not commence on the 30-month date 

that fell on a federal holiday. Id. at 687–88. 

Actelion timely appealed. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(C) (2012). 

 

1 Although the district court phrased its discussion 

in terms of “standing,” Actelion, 216 F. Supp. 3d at 684–

85, the district court’s analysis and conclusion actually 

decided the merits of the PTO’s determination of the PTA 

for Actelion’s ’675 patent. Because we affirm the district 

court’s merits determination, a remand to correct this 

error in “label” is unnecessary. See Morrison v. Nat’l 

Austl. Bank Ltd., 561 U.S. 247, 254 (2010). 
8 ACTELION PHARM., LTD v. MATAL

DISCUSSION

We review the district court’s grant of summary 

judgment de novo, “applying the same standard as the 

district court.” Pfizer, 811 F.3d at 470 (internal quotation 

marks and citation omitted). “[W]e review questions of 

pure statutory interpretation without deference to the 

district court.” Mohsenzadeh v. Lee, 790 F.3d 1377, 1381 

(Fed. Cir. 2015) (citation omitted). As Actelion challenges

the PTO’s PTA determination that is “governed by those

standards employed by the Administrative Procedure 

Act,” Pfizer, 811 F.3d at 470–71 (citing 35 U.S.C. 

§ 154(b)(4)(A)), “we must affirm the PTO’s [PTA] determination unless it is ‘arbitrary, capricious, an abuse of 

discretion, or otherwise not in accordance with law,’” id.

at 471 (quoting 5 U.S.C. § 706) (citation omitted); see also 

Gilead Scis., Inc. v. Lee, 778 F.3d 1341, 1346 (Fed. Cir. 

2015). 

On appeal, Actelion makes three arguments in support of its request for additional PTA.2 First, Actelion 

argues that the ’675 patent’s A Delay calculation should 

be based on the ’619 application’s filing date, January 12, 

2012. Actelion contends this is so because, under the preTCA version of § 154(b)(1)(A)(i)(II) that Actelion argues 

should apply here, Actelion “fulfilled the requirements of 

section 371” by fulfilling all applicant-side requirements 

of § 371, namely, those set forth in § 371(c), as of that 

 

2 Actelion contends that we should reach an argument the district court did not consider: that the PTO’s 

denial of additional PTA time constituted an unconstitutional taking. Given our conclusion that the district court 

did not err in affirming the PTO’s PTA calculation, this 

issue is moot. See Oral Argument at 4:28–51, Actelion 

Pharm., Ltd. v. Matal, No. 17-1238 (Fed. Cir. Dec. 8, 

2017), http://oralarguments.cafc.uscourts.gov/default.

aspx?fl=2017-1238.mp3. 
ACTELION PHARM., LTD v. MATAL 9

date. Second, Actelion argues that regardless whether 

the pre- or post-TCA version of § 154(b)(1)(A)(i)(II) is 

applicable, it has made an “express request” under 

§ 371(f) despite its failure to check box 3 because it stated 

in its preliminary amendment that it “earnestly solicits 

early examination.” Finally, and alternatively, Actelion 

argues that the ’675 patent’s A Delay should be based 

strictly on the 30-month date without regard to the fact 

that the 30-month date fell on a federal holiday, because 

§ 371(b) requires that the national stage “shall commence” on the expiration date specified in PCT Article 22, 

i.e., “30 months from the priority date.”

A Delay calculation must be based on the date on 

which the entirety of § 371 has been complied with, 

including § 371(c) as well as § 371(b) and § 371(f). We 

conclude that, to commence the national stage early, 

Actelion was required to make an express request pursuant to § 371(f) regardless whether the pre- or post-TCA 

version of § 154(b)(1)(A)(i)(II) applies to the ’675 patent. 

In addition, the district court did not err in affirming the 

PTO’s finding that Actelion failed to make an express 

request for early examination on the ’619 application such 

that national entry could have commenced before January 

16, 2012. Nor did it err in affirming the PTO’s A Delay 

calculation on the ’675 patent, as per the relevant PCT 

articles and regulations, national stage commencement 

cannot occur on a federal holiday. 

I. Compliance with the Entirety of § 371 Is Necessary 

Under § 154(b)(1)(A)(i)(II)

Actelion first argues that the ’675 patent’s A Delay 

calculation should be based on the ’619 application’s filing 

date, January 12, 2012. Actelion contends that the preTCA version of § 154(b)(1)(A)(i)(II) should apply because 

the ’619 application was filed before the effective date of 

the TCA. It asserts that under the pre-TCA version of 

§ 154(b)(1)(A)(i)(II), it has “fulfilled the requirements of 
10 ACTELION PHARM., LTD v. MATAL

section 371” because it has fulfilled all the applicant’s

requirements of § 371(c).

The PTO responds that the pre-TCA “requirements of 

section 371” include the requirements under § 371(b) and 

(f), and that, under the PCT, the national stage of an 

international application cannot commence prior to the 

expiration of the exclusive 30-month international processing period unless early examination is expressly 

requested by the applicant pursuant to § 371(f). The PTO 

argues that, although post-TCA law applies to the PTA 

for the ’675 patent, whether pre- or post-TCA law applies 

does not matter because of Actelion’s failure to make an 

express § 371(f) request under either pre- or post-TCA 

law. 

We agree with the PTO that, under either the pre- or 

post-TCA version of § 154(b)(1)(A)(i)(II), the A Delay 

calculation must be based on the date on which the entirety of § 371 is complied with, including § 371(b) and (f). 

As such, we conclude that under either pre- or post-TCA 

law, Actelion was required to comply with the “express 

request” provision of § 371(f) if it wished to commence the 

national stage before the expiration date provided in 

§ 371(b).

Actelion argues, relying on the pre-TCA statute, that 

the A Delay calculation should be based on the date that 

§ 371(c) was complied with, regardless of § 371(b) and (f). 

According to Actelion, on January 12, 2012, Actelion

“fulfilled” its “requirements” by filing all the necessary 

documents under § 371(c), which is the only subsection of 

§ 371 imposing requirements on an applicant. Actelion 

further contends that the “requirements” in § 371 refer

specifically to applicant’s requirements, or § 371(c) requirements, as referenced in § 371(d). Therefore, Actelion

argues, the accrual of the ’675 patent’s A Delay should 

have been based on this “fulfill[ment]” of § 371(c)’s applicant “requirements” under pre-TCA law. Actelion does 
ACTELION PHARM., LTD v. MATAL 11

not make any corresponding post-TCA statutory arguments. 

Actelion’s argument for discerning a distinction between the pre- and post-TCA § 154(b)(1)(A)(i)(II) hinges 

on the alleged distinction between the “commencement of 

the national stage under” (pre-TCA) and the “fulfilled the 

requirements of” (post-TCA) language as applied to the

filing history of the ’675 patent. However, this argument 

fails for the simple reason that both pre- and post-TCA 

provisions are followed by reference to “section 371” 

without reference to any particular subsection of § 371. 

Congress knew how to specify requirements of particular 

subsections where it so desired, but did not do so in either 

the pre- or post-TCA § 154(b)(1)(A)(i)(II). 35 U.S.C. 

§ 371(d) (referring to the “requirements” in specific “subsection[s]”); id. § 371(f) (referring to “the applicable requirements of subsection (c)”); see also Sebelius v. Cloer, 

569 U.S. 369, 378 (2013) (“We have long held that where 

Congress includes particular language in one section of a 

statute but omits it in another section of the same Act, it 

is generally presumed that Congress acts intentionally 

and purposely in the disparate inclusion or exclusion.” 

(citation and internal quotation marks omitted)). 

Aside from urging us to read the PTA statute to compensate an applicant for a time period not attributable to 

the applicant’s inaction, Actelion does not provide a 

convincing reason why the clear language of “the requirements of section 371” should be limited to the applicant’s requirements of § 371(c) under pre-TCA law. 

Similarly, although not challenged by Actelion on appeal,

the post-TCA statute also unambiguously refers to the 

entirety of “section 371.” We therefore decline to read

either the pre- or post-TCA § 154(b)(1)(A)(i)(II) in a manner that would disregard compliance with § 371(b) and (f), 

contrary to the clear language of the statute. See Simmons v. Himmelreich, 136 S. Ct. 1843, 1848 (2016) (“Ab-
12 ACTELION PHARM., LTD v. MATAL

sent persuasive indications to the contrary, we presume 

Congress says what it means and means what it says.”). 

II. Actelion Failed to Make an Express Request for Early 

Examination

Having concluded that under either the pre- or postTCA statute, Actelion was required to make an express 

request pursuant to § 371(f) if it wished to commence the 

national stage on January 12, 2012, we next turn to the 

question whether Actelion actually made such a request. 

Actelion argues that even if its statutory argument 

fails, under either pre- or post-TCA law, it made a § 371(f) 

express request in its remark that it “earnestly solicits 

early examination and allowance of these claims.” Appellant’s Br. 28 (citing J.A. 162). Actelion contends that the

use of the PTO forms is only optional, as stated in the 

PTO’s own guidance materials, and that PTO Form 1390 

is only one of many ways to make an express § 371(f) 

request. 

The PTO responds that Actelion failed to make an 

“express request” for early examination under § 371(f) 

because it did not check box 3, failed to make any mention 

of § 371(f) in the remarks portion of the preliminary 

amendment, and, at any rate, the “earnestly solicits early 

examination” remark was mere boilerplate language it 

has used in a number of its non-PCT based applications.

Actelion’s argument is unsound. Using the PTO form

may be optional, and, as Actelion contends, there may be 

other ways to communicate to the PTO an “express request” pursuant to § 371(f). However, neither the fact 

that using the PTO forms may be optional nor the availability of other § 371(f)-compliant means of making an

express request excuses an applicant’s failure to make its 

intention clear. See Amgen Inc. v. F. Hoffmann-La Roche 

Ltd, 580 F.3d 1340, 1354 (Fed. Cir. 2009) (declining to 

treat the applications at issue as divisional applications 
ACTELION PHARM., LTD v. MATAL 13

when the applicant indicated that the applications were 

continuation applications in a PTO form). Even viewed 

most favorably to Actelion, the casual “solicits early 

examination” language with no reference to § 371(f), the 

PCT, or the national stage, when combined with the 

unchecked box 3 of its completed PTO Form 1390, was, if 

not an express election not to commence the national 

stage early, at least an inconsistent or ambivalent request. 

We therefore find no error in the PTO’s determination 

that Actelion’s submission of PTO Form 1390 with box 3 

unchecked, and its precatory solicitation remark having 

no operative consequence, did not amount to an express 

request pursuant to § 371(f).

III. The PTO Correctly Calculated the A Delay for the 

’675 Patent

We finally consider whether the PTO properly determined the PTA for the ’675 patent. First, we find no error 

in the PTO’s determination that the A Delay start date 

calculation for the ’675 patent was not based on January 

12, 2012, the ’619 application’s filing date, because 

Actelion did not make an express request to commence 

the national stage on that date under § 371(f).

Actelion alternatively argues that the ’675 patent’s A 

Delay should be based strictly on the 30-month date, 

January 16, 2012, and should not take into consideration 

the fact that the 30-month date fell on a federal holiday, 

because § 371(b) requires that the national stage “shall

commence” on the expiration date specified in PCT Article

22, i.e., “30 months from the priority date.” 

The PTO responds that according to the governing 

PCT articles and regulations, national stage commencement cannot occur on a federal holiday. Appellee’s Br. 32 

(citing PCT Rule 80.5).
14 ACTELION PHARM., LTD v. MATAL

We find no error in the PTO’s determination that the 

national stage for the ’675 patent commenced on January 

17, 2012, the next workday after the 30-month date that

fell on a federal holiday. Actelion, again, primarily relies 

on the fact that it has met all of its filing requirements

before the 30-month date. According to Actelion, the PCT 

Rule 80.5 holiday exception, similar to the federal court 

rules that govern timeliness of a party’s filing, benefits 

the filer such as Actelion by giving it an option to file on 

the next workday if a filing date falls on a holiday. Therefore, Actelion argues, if it had not taken advantage of the 

holiday exception, it should not be “harm[ed]” by it. 

Appellant’s Br. 35. We find this argument unpersuasive. 

Actelion’s “no holiday exception” argument, similar to 

its pre-TCA statutory argument, is premised on the 

assumption that any time period of inaction that is not 

attributable to the applicant should inure to the applicant’s benefit. As such, Actelion emphasizes its alleged 

lack of fault during the time periods in question. However, by the same logic, inaction on a holiday is also not 

attributable to the PTO. Although the PTA statutes do

serve a remedial purpose of restoring patent term lost 

during prosecution of an application, they only restore

“undue delays in patent examination caused by the PTO” 

as provided by Congress. Pfizer, 811 F.3d at 468 (emphasis added). We find no error in the PTO’s determination

that the national stage for the ’675 patent did not commence until the next workday after the 30-month date 

that fell on a federal holiday.

We therefore conclude that the PTO did not err in its

40-day determination of the PTA for the ’675 patent 

under § 154(b)(1)(A)(i)(II). 

CONCLUSION

For the foregoing reasons, the decision of the district 

court is affirmed.
ACTELION PHARM., LTD v. MATAL 15

AFFIRMED