Actelion Pharmaceuticals, Ltd v. Matal , 881 F.3d 1339 ( 2018 )

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 partic-
ular, for the ’675 patent granted from U.S. Patent Appli-
cation 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 (“Tech-
nical 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 sec-
tions of Title 35 following the enactment of the Leahy-
Smith America Invents Act (“AIA”), including amend-
ments 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 applica-
tion;
...,
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, un-
til 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 interna-
tional application fulfilled the re-
quirements 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 na-
tional 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 na-
tional 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 appli-
cation”) 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 prelimi-
nary 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 Appel-
lant’s Br. 4; Appellee’s Br. 7; J.A. 163. It is also undisput-
ed 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 Notifi-
cation 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 recon-
sideration 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 reconsidera-
tion 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 applica-
tion 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 pur-
suant 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] determi-
nation 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 sup-
port 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 pre-
TCA 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 argu-
ment the district court did not consider: that the PTO’s
denial of additional PTA time constituted an unconstitu-
tional 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 com-
mence” 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 pursu-
ant 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 pre-
TCA 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 pro-
cessing 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 en-
tirety 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) re-
quirements, 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 appli-
cant “requirements” under pre-TCA law. Actelion does
ACTELION PHARM., LTD v. MATAL 11
not make any corresponding post-TCA statutory argu-
ments.
Actelion’s argument for discerning a distinction be-
tween 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 “sub-
section[s]”); id. § 371(f) (referring to “the applicable re-
quirements 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 com-
pensate 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 re-
quirements of section 371” should be limited to the appli-
cant’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 man-
ner that would disregard compliance with § 371(b) and (f),
contrary to the clear language of the statute. See Sim-
mons 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 post-
TCA 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.” Appel-
lant’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 re-
quest” pursuant to § 371(f). However, neither the fact
that using the PTO forms may be optional nor the availa-
bility 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 re-
quest.
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 deter-
mined 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 commence-
ment 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. There-
fore, 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 appli-
cant’s benefit. As such, Actelion emphasizes its alleged
lack of fault during the time periods in question. Howev-
er, 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 (empha-
sis added). We find no error in the PTO’s determination
that the national stage for the ’675 patent did not com-
mence 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