from the United States District Court for the Eastern
District of Virginia in No. 1:16-cv-00304-LO-TCB, Judge Liam
Hoxie, Hoxie & Associates, LLP, Millburn, NJ, argued for
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 District of Virginia, Alexandria,
VA; Nathan K. Kelley, Brian Racilla, Molly R. Silfen, Office
of the Solicitor, United States Patent and Trademark Office,
Lourie, O'Malley, and Wallach, Circuit Judges.
LOURIE, CIRCUIT JUDGE.
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.
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).
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.
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
Leahy-Smith America Invents Act ("AIA"), including
amendments to certain provisions of 35 U.S.C. § 154.
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).
to the amendments under the TCA, § 154(b)(1)(A)(i)(II)
(II) the date on which an international application
fulfilled the requirements of section 371 of this
35 U.S.C. § 154(b)(1)(A)(i)(II) (pre-TCA) (emphasis
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