MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH, Plaintiff-Appellant
ANDREI IANCU, UNDER SECRETARY OFCOMMERCE FOR INTELLECTUAL PROPERTYAND DIRECTOR OF THE UNITED STATESPATENT AND TRADEMARK OFFICE, Defendant-Appellee
from the United States District Court for the Eastern
District of Virginia in No. 1:17-cv-01153-TSE-JFA, Judge T.
S. Ellis, III.
Jamal Davis, Fish & Richardson PC, Washington, DC, argued
for plaintiff-appellant. Also represented by Craig E.
Countryman, Jared Alexander Smith, San Diego, CA.
Trent McCotter, Office of the United States Attorney,
Alexandria, VA, argued for defendant-appellee. Also
represented by G. Zachary Terwilliger; Thomas W. Krause,
Kakoli Caprihan, Brian Racilla, Office of the Solicitor,
United States Patent and Trademark Office, Alexandria, VA.
Newman, Lourie, and Dyk, Circuit Judges.
Lourie, Circuit Judge.
Mayo Foundation for Medical Education and Research
("Mayo") appeals from a decision of the United
States District Court for the Eastern District of Virginia,
Mayo Found. v. Iancu, 309 F.Supp.3d 425 (E.D. Va.
2018) ("Decision"), which affirmed the
United States Patent and Trademark Office's (the
"PTO's") calculation of patent term adjustment
("PTA") for U.S. Patent 8, 981, 063 (the
"'063 patent") under 35 U.S.C. § 154.
Because we conclude that the PTO's interpretation of
"any time consumed by continued examination of the
application requested by the applicant under section
132(b)" in 35 U.S.C. § 154(b)(1)(B)(i),
see 37 C.F.R. § 1.703(b)(1), was correct, we
1994, Congress implemented the trade agreements reached
during the Uruguay Round of multilateral trade negotiations
by enacting the Uruguay Round Agreements Act (the
"URAA"). Pub. L. No. 103-465, 108 Stat. 4809
(1994). Pursuant to the URAA, Congress changed the patent
term length from seventeen years from the date of issuance of
the patent to twenty years from the effective filing date of
the application. See id. § 532 (codified as
amended at 35 U.S.C. § 154) (defining the effective
filing date as the filing date of the instant application or
that of the application from which it can claim priority
under §§ 120, 121 or 365). Congress envisioned in
the URAA that this change could disadvantage patent owners
whose applications underwent lengthy prosecution, and it
provided for PTA compensating for delays attributable to
interference proceedings under 35 U.S.C. § 135(a) and
certain appeals to the Board or federal courts under 35
U.S.C. §§ 134, 141, 145. See URAA, §
effort to streamline patent prosecution, Congress expanded
PTA in 1999. American Inventors Protection Act of 1999, Pub.
L. No. 106-113, App. I, tit. IV, 113 Stat. 1501,
1501A-552-1501A-591 (1999) (codified as amended, in relevant
portion, at 35 U.S.C. § 154(b)) (the "AIPA").
The statute compensates applicants for three broad classes of
delay: § 154(b)(1)(A) ("A Delay") provides PTA
when the PTO does not meet certain deadlines in the
processing of patent applications; § 154(b)(1)(B)
("B Delay") generally entitles the applicant to PTA
for each day the application is pending beyond three years;
and § 154(b)(1)(C) ("C Delay") provides PTA
for each day the application is pending in an interference
proceeding, a secrecy order, or a successful appeal to the
Patent Trial and Appeal Board (the "Board") or a
federal court. Each of these entitlements is subject to the
"[l]imitations" set forth in § 154(b)(2),
which, inter alia, reduce PTA "by a period
equal to the period of time during which the applicant failed
to engage in reasonable efforts to conclude
prosecution." Id. § 154(b)(2)(C); see
Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1353-54
(Fed. Cir. 2019).
appeal concerns the calculation of B Delay. While §
154(b)(1)(B) generally "guarantee[s] . . . no more than
3-year application pendency," that 3-year period is
subject to several exclusions:
(i) any time consumed by continued examination of the
application requested by the applicant under section 132(b);
(ii) any time consumed by a proceeding under section 135(a),
any time consumed by the imposition of an order under section
181, or any time consumed by appellate review by the Patent
Trial and Appeal Board or by a Federal court; or
(iii) any delay in the processing of the application by the
United States Patent and Trademark Office requested by the
applicant except as permitted by paragraph (3)(C) . . . .
Id. § 154(b)(1)(B)(i)-(iii). The time consumed
during one of the proceedings referred to in §
154(b)(1)(B)(ii)-interfer-ences, secrecy orders, and appeals,
respectively-is excluded because it is already counted as C
Delay. See § 154(b)(2)(A) ("[PTA] shall
not exceed the actual number of days the issuance of the
patent was delayed.").
several occasions since 2000, the PTO has promulgated
regulations setting forth its interpretation of "time
consumed by continued examination of the application
requested by the applicant under section 132(b)."
Id. § 154(b)(1)(B)(i) ("RCE time").
Section 132(b) was also enacted as part of the AIPA,
id. § 4403, 113 Stat. at 1501A-560, and it
requires the PTO to "prescribe regulations to provide
for . . . continued examination . . . at the request of the
applicant," commonly referred to as an "RCE."
As set forth by the PTO in 37 C.F.R. § 1.114, filing an
RCE "with-draw[s] the finality of any Office
action" and allows prosecution to proceed.
Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014),
we held that the PTO's previous interpretation of RCE
time-as extending from the filing date of the RCE to
issuance, see 37 C.F.R. § 1.703(b)(1)
(2013)-was incorrect because, absent resumption of
examination after the date of mailing of the Notice of
Allowance, which is an exceptional circumstance,
"allowance-to-issuance time" is "plainly
attributable to the PTO," regardless "whether there
is a continued examination in a prosecution."
Novartis, 740 F.3d at 602. Thereafter, the PTO
promulgated and finalized a new regulation, interpreting RCE
time as "[t]he number of days . . . in the period
beginning on [the RCE filing date] and ending on the date of
mailing of the notice of allowance . . . ." 37 C.F.R.
§ 1.703(b)(1) (2019).
'063 patent claims certain antibodies purportedly useful
for treating "disease conditions characterized by
im-munosuppression: e.g., cancer, AIDS or AIDS-related
com-plex[es], other virally or environmentally-induced
conditions, and certain congenital immune deficiencies."
Id. col. 14 ll. 20-23. The '063 patent issued
from Application 12/421, 310 (the "'310
application"), filed on April 9, 2009, with an effective
filing date of November 30, 1999. The PTO issued a final
rejection of the pending claims on October 14, 2010, as
anticipated by U.S. Patent 7, 635, 757 (the "'757
patent"), and, for some of the claims, as lacking
written description. J.A. 419-25. The PTO also noted in its
rejection that Mayo had suggested an interference with the
'757 patent in its previous response, and it invited Mayo
to make the requisite priority showing under 37 C.F.R. §
41.202(d)(1) (2010). On September 14, 2011, Mayo filed an RCE
along with remarks arguing that Mayo had priority of
invention over the '757 patent and suggesting an
filed a supplemental amendment shortly afterward cancelling
certain claims that the examiner had indicated, in an
apparently off-the-record discussion, would not correspond to
the count in the impending interference. Some of these claims
had previously been withdrawn in response to a restriction
requirement, and the examiner advised Mayo that, for the
purposes of eventual PTA calculation, claims not relevant to
the impending interference should be removed. Mayo
accordingly cancelled those claims and pursued them in a
separate continuation application, which later issued as U.S.
Patent 8, 460, 927 (the "'927 patent").
February 9, 2012, an interference was declared between all
the remaining claims of the '310 application and all the
claims of the '757 patent. The interference proceeded for
two years. On February 19, 2014, the Board awarded priority
to Mayo's '310 application claims and cancelled all
the claims of the '757 patent. See Chen v.
Freeman, Int. No. 105, 872, 2014 WL 664019 (P.T.A.B.
Feb. 19, 2014); J.A. 764-787. The interference decision
became final on April 23, 2014, when the sixty-day period for
appeal expired. See 35 U.S.C. § 142; 37 C.F.R.
termination of the interference, the Board returned the
'310 application to the examiner. The examiner conducted
a further prior art search, and on June 30, 2014, issued an
Office Action rejecting the claims of the '310
application on the ground of non-statutory obviousness-type
double patenting in view of the '927 patent, which
contained the claims that had been cancelled in the '310
application. Mayo filed a reply on October 24, 2014, arguing
on the merits that the claims of the '310 application
were patentably distinct. The examiner then withdrew the
rejection and mailed a Notice of Allowance on November 3,
2014. The '310 application issued as the '063 patent
on March 17, 2015.
provides the following timeline to summarize the prosecution
Br. 7. The first bracketed time period is 148 days; the
second, 805 days; and the third, 194 days. The parties agree
that the first period is RCE time and the second period is
not. This appeal concerns the third period.
issuance of the '063 patent, the PTO calculated a PTA of
621 days, with no B Delay. Mayo filed a request for
redetermination, claiming that it was due 685 days, because
"[t]he examiner's sua sponte reopening of
prosecution after termination of the interference was not
[RCE time under 35 U.S.C. § 154(b)(1)(B)(i)]." J.A.
877-79. Mayo calculated the RCE time ...