Novartis Ag v. Focarino ( 2014 )

United States Court of Appeals
for the Federal Circuit
______________________
NOVARTIS AG AND
NOVARTIS VACCINES AND DIAGNOSTICS, INC.,
Plaintiffs-Appellants,
AND
DANA-FARBER CANCER INSTITUTE,
Plaintiff,
v.
MICHELLE K. LEE, Deputy Director,
United States Patent and Trademark Office,
Defendant-Cross Appellant.
______________________
2013-1160, -1179
______________________
Appeals from the United States District Court for the
District of Columbia in Nos. 10-CV-1138, 11-CV-0659, and
11-CV-0821, Judge Ellen S. Huvelle.
______________________
Decided: January 15, 2014
______________________
SCOTT S. CHRISTIE, McCarter & English, LLP, of New-
ark, New Jersey, argued for plaintiffs-appellants. With
him on the brief was MARK H. ANANIA.
2 NOVARTIS AG v. LEE
DANA KAERSVANG, Attorney, Appellate Staff, Civil Di-
vision, United States Department of Justice, of Washing-
ton, DC, argued for defendant-cross appellant. With her
on the brief were STUART F. DELERY, Acting Assistant
Attorney General, and RONALD C. MACHEN, JR., United
States Attorney. Of counsel on the brief were BERNARD J.
KNIGHT, JR., General Counsel, NATHAN K. KELLEY, Depu-
ty Solicitor, and BRIAN T. RACILLA and JOSEPH G.
PICCOLO, Associate Solicitors, United States Patent and
Trademark Office, of Alexandria, Virginia.
DAVID P. FRAZIER and JENNIFER A. JOHNSON, Finne-
gan, Henderson, Farabow, Garrett & Dunner, LLP, of
Washington, DC, for amicus curiae AbbVie Biotherapeu-
tics Inc.
______________________
Before NEWMAN, DYK, and TARANTO, Circuit Judges.
TARANTO, Circuit Judge.
Novartis AG, Novartis Vaccines and Diagnostics, Inc.,
and Novartis Corporation (collectively, Novartis) filed
suits that challenged the determinations by the Patent
and Trademark Office of how much time to add, under 35
U.S.C. § 154(b), to the otherwise-applicable term of vari-
ous Novartis patents. Of the eighteen patents before us,
the district court dismissed Novartis’s claims regarding
fifteen as untimely asserted. For the other three, the
court rejected the PTO’s construction of the statutory
provision that governs patent term adjustment here.
We affirm the district court’s ruling on timeliness as
to the claims at issue, agreeing with its interpretation of
§ 154(b)(3) and (b)(4). As to the standards for patent term
adjustment, however, we conclude that the PTO was
partly correct and partly incorrect in its interpretation of
§ 154(b)(1)(B). The result is that, for three patents,
NOVARTIS AG v. LEE 3
Novartis is entitled to most, but not all, of the patent term
adjustment it seeks.
BACKGROUND
In 1994, Congress changed the method of measuring
the effective term of a patent. Before the change, a pa-
tent’s term generally ran from the date that the patent
issued until the end of a period measured from that
date—typically seventeen years, subject to certain exten-
sions (e.g., those provided by the 1984 Hatch-Waxman
Act, 35 U.S.C. § 156). Under the 1994 law, the term still
begins on the issuance date, but it generally ends twenty
years after the relevant application for that patent was
filed. Pub. L. No. 103-465, § 532, 108 Stat. 4809, 4984
(1994) (revising 35 U.S.C. § 154). As a result, delays in
processing the application at the PTO now reduce a
patent’s term.
In 1999, Congress provided for extensions of patent
terms to compensate for certain application-processing
delays caused by the PTO. See Pub. L. No. 106-113,
§ 1000(a)(9), 113 Stat. 1501, 1536. Specifically, 35 U.S.C.
§ 154(b)(1) makes three “[p]atent term guarantees”—
“(A) Guarantee of prompt patent and trademark office
responses,” “(B) Guarantee of no more than 3-year appli-
cation pendency,” and “(C) Guarantee of adjustments for
delays due to derivation proceedings, secrecy orders, and
appeals.” The statute provides that “the term of the
patent shall be extended 1 day for each day” that the PTO
does not meet certain response deadlines, § 154(b)(1)(A),
for each day after the PTO fails to issue the patent within
three years, subject to exclusions, § 154(b)(1)(B), and for
each day of delay due to an interference, secrecy order, or
successful applicant appeal, § 154(b)(1)(C).
This appeal involves § 154(b)(1)(B), which builds on a
goal of application pendency of three years, reflecting the
replacement of a term of seventeen years from issuance by
a term starting at issuance but ending twenty years after
4 NOVARTIS AG v. LEE
application. See S. Rep. No. 105-42, at 42. The provision
states:
(B) Guarantee of no more than 3-year appli-
cation pendency.— Subject to the limitations
under paragraph (2), if the issue of an original pa-
tent is delayed due to the failure of the United
States Patent and Trademark Office to issue a pa-
tent within 3 years after the actual filing date of
the application under section 111(a) in the United
States or, in the case of an international applica-
tion, the date of commencement of the national
stage under section 371 in the international appli-
cation, not including—
(i) any time consumed by continued exam-
ination 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 sec-
tion 181, or any time consumed by appel-
late review by the Patent Trial and Appeal
Board or by a Federal court; or
(iii) any delay in the processing of the ap-
plication by the United States Patent and
Trademark Office requested by the appli-
cant except as permitted by paragraph
(3)(C),
the term of the patent shall be extended 1 day for
each day after the end of that 3-year period until
the patent is issued.
35 U.S.C. § 154(b)(1)(B) (2011).
The PTO regulations call for implementing this provi-
sion in two steps. First, “the term of an original patent
shall be adjusted if the issuance of the patent was delayed
NOVARTIS AG v. LEE 5
due to the failure of the Office to issue a patent within
three years after the date on which the application was
filed . . . , but not including (1) [a]ny time consumed by
continued examination of the application under 35 U.S.C.
132(b) . . . .” 37 C.F.R. § 1.702(b)(1). Second, if an appli-
cant is entitled to an extension, “[t]he period of adjust-
ment . . . is the number of days, if any, in the period
beginning on the day after the date that is three years
after the date on which the application was filed . . . and
ending on the date a patent was issued, but not including
. . . (1) [t]he number of days, if any, in the period begin-
ning on the date on which a request for continued exami-
nation of the application under 35 U.S.C. § 132(b) was
filed and ending on the date the patent was issued . . . .”
37 C.F.R. § 1.703(b)(1).
In 35 U.S.C. § 154(b)(3) & § 154(b)(4), Congress pro-
vided administrative and judicial remedies for applicants
who are dissatisfied with the PTO Director’s determina-
tion of a patent term adjustment. First, under
§ 154(b)(3)(B)(ii), an applicant must have “one opportuni-
ty to request reconsideration of any patent term adjust-
ment determination made by the Director.” Second,
under § 154(b)(4)(A), in the version applicable here (before
recent revisions), “[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.”
Id. The PTO has interpreted the 180-day statute of
limitations to apply to all patent term adjustment deter-
minations, including those made under § 154(b)(1)(B)(i).
Between June 2009 and May 2011, Novartis filed four
lawsuits in the District Court for the District of Columbia
claiming that, for twenty-three of its patents, the Director
had improperly determined the amount of patent term
adjustment. See, e.g., Second Amended Complaint, ¶ 2,
Novartis AG v. Kappos, No. 10-cv-1138 (D.D.C. April 9,
6 NOVARTIS AG v. LEE
2012), ECF 28. (In two of the cases, the Dana-Farber
Cancer Institute was a co-plaintiff, but Dana-Farber has
not appeared on appeal.) On February 16, 2012, the
district court consolidated the cases.
Novartis claimed that the Director’s determinations of
the patent term adjustment rested on two mistaken
interpretations of § 154(b)(1)(B)(i) as it applies to an
applicant’s request for continued examination under 35
U.S.C. § 132(b)—a process, authorized by Congress in
1999, through which an applicant may try to persuade an
examiner to allow an application after an otherwise-final
rejection. First, as previously mentioned, the Director
treated time spent in any continuing examination, no
matter when initiated by the applicant, as not counting
toward the statute’s allotment to the PTO of three years
before adjustment time begins to accrue. Second, the
Director treated as not counting toward the three years
both the time from initiation of continued examination to
allowance and, in addition, the time from allowance to
issuance—even though the latter period is undisputedly
counted toward the three years in a case not involving a
continued examination. Novartis argued that both inter-
pretations were contrary to § 154(b)(1)(B).
Novartis made two additional claims of relevance
here. It claimed that it was entitled to have its patent
term adjustments recalculated to conform to this court’s
decision in Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir.
2010), which held that the Director had taken an incor-
rect view of how § 154(b)(2) applies when there is “over-
lap” between “periods of delay” addressed by the statute.
It is undisputed that Novartis would have received longer
patent terms under the Wyeth standard. Novartis also
claimed that denial of the statutorily authorized term
adjustments constituted a taking of its property in viola-
tion of the Fifth Amendment.
NOVARTIS AG v. LEE 7
The parties filed cross-motions for summary judg-
ment, and on November 15, 2012, the district court dis-
missed Novartis’s claims with respect to nineteen patents
as untimely and granted Novartis relief on its remaining
claims. Novartis AG v. Kappos, 904 F. Supp. 2d 58, 69
(D.D.C. 2012). For the claims dismissed as untimely, the
court held that the applicable limitations rule was the
180-day rule of § 154(b)(4) and that nineteen of Novartis’s
claims—those filed more than 180 days after the PTO
denied reconsideration of its adjustment determination—
were filed too late under that rule. Id. at 65. The court
thus rejected Novartis’s contention that the 180-day
limitations period did not apply to its challenges to final
patent term adjustment determinations. Novartis ap-
peals that ruling with respect to fifteen patents.
Of the four claims that the district court found timely,
one sought a recalculation of a patent term adjustment to
conform to Wyeth; the district court agreed, and neither
party appeals that ruling. Id. at 74. Novartis’s three
other timely claims challenged the Director’s interpreta-
tion of § 154(b)(1)(B). The district court ruled “that the
PTO’s interpretation of § 154(b)(1)(B) is contrary to law.”
Id. at 73. The Director cross-appeals that ruling. The
district court did not reach the merits of Novartis’s Fifth
Amendment contention, which could not alter the untime-
liness conclusion as to eighteen claims or add relief on the
other claims. Id. at 74-75.
Both Novartis and the Director filed timely notices of
appeal from the district court’s final judgment. This court
has jurisdiction under 28 U.S.C. § 1295(a)(4)(C).
DISCUSSION
The dispositive issues presented involve the meaning
of two provisions of 35 U.S.C. § 154(b). Neither party
identifies a material, disputed issue of fact. The correct
interpretation of section 154 is an issue of law, which this
court decides de novo. See Wyeth, 591 F.3d at 1369.
8 NOVARTIS AG v. LEE
A
1
For fifteen patents, Novartis appeals the district
court’s dismissal of its claims as untimely under the pre-
2013 version of 35 U.S.C. § 154(b)(3) & § 154(4)(A) that
applies here. Those provisions state:
(3) Procedures for patent term adjustment
determination. –
(A) The Director shall prescribe regula-
tions establishing procedures for the ap-
plication for and determination of patent
term adjustments under this subsection.
(B) Under the procedures established un-
der subparagraph (A), the Director shall--
(i) make a determination of the
period of any patent term adjust-
ment under this subsection, and
shall transmit a notice of that de-
termination with the written notice
of allowance of the application un-
der section 151; and
(ii) provide the applicant one op-
portunity to request reconsidera-
tion of any patent term
adjustment determination made
by the Director.
...
(4) Appeal of patent term adjustment deter-
mination.—
(A) An applicant dissatisfied with a de-
termination made by the Director under
paragraph (3) shall have remedy by a civil
action against the Director filed in the
NOVARTIS AG v. LEE 9
United States District Court for the Dis-
trict of Columbia within 180 days after the
grant of the patent. Chapter 7 of title 5
shall apply to such action. Any final judg-
ment 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 pa-
tent to reflect such change.
35 U.S.C. § 154(b)(3) & (b)(4) (2011) (emphases added).
It is undisputed in this court that the 180-day clock
does not run while the PTO considers a timely request for
reconsideration under regulations promulgated pursuant
to § (b)(3)(B)(ii)’s guarantee of “one opportunity to request
reconsideration of any patent term adjustment determi-
nation made by the Director.” It is also undisputed that,
for the fifteen patents, Novartis did not file suit within
180 days of denial of reconsideration.
Novartis contends, however, that the 180-day period
is inapplicable. Subparagraph (b)(4)(A) by its terms
applies only to “a determination made by the Director
under paragraph (3)” of subsection (b). Novartis asserts
that a determination of the final patent term adjustment,
announced upon issuance of the patent, is not made under
“paragraph (3),” which, it says, addresses only the provi-
sional adjustment announced upon allowance of claims
(when the PTO process is not complete, so that the final
adjustment cannot yet be calculated). Therefore, Novartis
argues that the 180-day period is not applicable to its
challenges to the final patent term adjustment determi-
nations because, it says, the Director did not make those
determinations under paragraph (b)(3). Novartis’s con-
tention thus turns on its interpretation of paragraph
(b)(3). That interpretation is, ultimately, unreasonable.
The applicable version of paragraph (b)(3)—the whole
of which subparagraph (b)(4)(A) refers to—addresses all
10 NOVARTIS AG v. LEE
patent term adjustment determinations, not just some.
Subparagraph (b)(3)(A) broadly declares that “[t]he Direc-
tor shall prescribe regulations establishing procedures for
the application for and determination of patent term
adjustments under [(b)].” That breadth of application is
reinforced by the breadth of at least clause (b)(3)(B)(ii)
and subparagraph (b)(3)(D), both of which plainly cover
the final adjustment announced at issuance, not just a
provisional adjustment announced at allowance.
Novartis seeks to overcome the evident breadth of
paragraph (b)(3) based on the language of clause
(b)(3)(B)(i). That provision, in the version applicable here,
states: “Under the procedures established under subpara-
graph (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 determina-
tion with the written notice of allowance of the application
under section 151.” Id. § 154(b)(3) (emphasis added).
Novartis infers from that language that all adjustment
determinations covered by paragraph (b)(3) must be ones
capable of being transmitted at the time of allowance,
thus limiting paragraph (b)(3)—and therefore paragraph
(b)(4)—to provisional determinations, excluding final
determinations.
Although the statutory phrasing provides a starting
point for Novartis’s argument, the inference Novartis
draws is not a reasonable one given the rest of paragraph
(b)(3). The only reasonable construction is that the
(b)(3)(B)(i) command regarding transmittal with a notice
of allowance is itself implicitly limited to determinations
that can be transmitted at that time. Adopting that
focused implicit limitation best fulfills the judicial obliga-
tion “to make sense rather than nonsense out of” the
statute as a whole. West Virginia Univ. Hosps., Inc. v.
Casey, 499 U.S. 83, 101 (1991) (noting obligation to do so
for relevant “corpus juris”). This reading is far preferable
to Novartis’s alternative, which would use one provision
NOVARTIS AG v. LEE 11
to contradict the broad language of several other provi-
sions and produce the senseless result that the detailed
judicial-review provision of paragraph (b)(4)—with its
180-day rule and its confinement of venue to one district
court—would apply to review only of provisional, but not
final, adjustment determinations. In the end, the statuto-
ry language on which Novartis relies is a flaw in drafting
that cannot reasonably support the construction Novartis
advances. 1
2
Having rejected Novartis’s construction of paragraph
(b)(4), we readily affirm the district court’s holding that
Novartis’s claims as to fifteen patents were untimely
asserted. Neither of Novartis’s two remaining arguments
on timeliness has merit.
First, Novartis has not demonstrated that the 180-day
rule of paragraph (b)(4) should be equitably tolled on the
ground that Novartis could properly wait to challenge the
PTO’s adjustment determinations until some other pa-
tentee undertook and completed the task of establishing
the legal standard this court adopted in Wyeth. That is an
insufficient ground for equitable tolling, which applies
only if the litigant proves “‘(1) that he has been pursuing
his rights diligently, and (2) that some extraordinary
circumstance stood in his way’ and prevented timely
filing.” Holland v. Florida, 560 U.S. 631, ___, 130 S. Ct.
2549, 2562 (2010). At a minimum, nothing stood in the
1 Congress recognized the flaw and altered the lan-
guage in the Technical Corrections to the Leahy-Smith
America Invents Act, Pub. L. No. 112-274, § 1, 126 Stat.
2456 (2013). Clause (b)(3)(B)(i) now requires transmittal
of an adjustment determination “no later than the date of
issuance of the patent.” 35 U.S.C. § 154(b)(3)(B)(i) (2013).
12 NOVARTIS AG v. LEE
way of Novartis’s timely pressing the very claim Wyeth
pressed. This court has held that a litigant cannot secure
equitable tolling based on the argument “not that it
lacked sufficient facts on which it could sue, but rather it
did not know the legal theory on which its refund claim
might succeed.” Venture Coal Sales Co. v. United States,
370 F.3d 1102, 1107 (Fed. Cir. 2004); see Commc’ns Vend-
ing Corp. of Arizona Inc. v. FCC, 365 F.3d 1064, 1075
(D.C. Cir. 2004). A fortiori equitable tolling is unavailable
where, as here, there is no reason even to doubt that the
litigant knew the legal theory, but just waited until
another person secured a favorable ruling on the theory in
another case.
Second, there is no merit to Novartis’s suggestion that
its property was taken, in violation of the Fifth Amend-
ment, when the paragraph (b)(4) timeliness rule, as
construed and applied, eliminated its ability to secure the
extra time on its patents that was authorized by the
statute if timely sought. 2 It is sufficient for us to say that
the Fifth Amendment does not “compensate the owner for
the consequences of his own neglect” in preserving its
rights. United States v. Locke, 471 U.S. 84, 107 (1985).
For the patents as to which it did not timely file suit
under § 154(b)(4), it was only Novartis’s failure to comply
with reasonable filing deadlines that prevented it from
securing any patent term adjustment authorized by
Wyeth. Novartis thus cannot challenge the application of
the timing rule as an uncompensated taking.
2 Novartis does not and cannot suggest that, for
purposes of the Takings Clause, it has a property right in
a patent term beyond what the statute entitled it to
obtain. Its argument is that application of the timeliness
rule took part of the patent term authorized by the stat-
ute.
NOVARTIS AG v. LEE 13
B
Novartis timely challenged the Director’s term ad-
justment for three patents at issue in this court—U.S.
Patent Nos. 7,807,155, 7,968,518, and 7,973,031. The
challenge concerns 35 U.S.C. § 154(b)(1)(B)(i) as it applies
to continued examinations requested by Novartis. Novar-
tis challenges two PTO interpretations of that provision.
We agree with the PTO on one but not the other.
Novartis argues that, once three calendar years from
the application-filing date have come and gone, time spent
in the PTO after that date must be added to the patent
term even if it is time spent on a continued examination
requested after that date. In contrast, the PTO argues
that “any time consumed by continued examination,” id.
§ 154(b)(1)(B)(i), no matter when initiated, does not count
toward depleting the allotment of three years the PTO
has before any adjustment time begins to accrue. In the
PTO’s view, no adjustment time is available for any time
in continued examination, even if the continued examina-
tion was initiated more than three calendar years after
the application’s filing. On this point, we agree with the
PTO.
The PTO’s view is the approach that best accords with
the language of the statutory provision. The provision
indicates that the “3 years” (the goal for issuance) does
“not includ[e]” time identified in three enumerated cate-
gories. In isolation, that language might be read, as two
district courts have read it, to mean that the processes
identified in the exclusions have no effect on the three-
year time period unless they interrupt that period, i.e.,
unless they were initiated before it ends. But that view
runs counter to the textual fact that there is no time-of-
initiation restriction on the processes identified in the
exclusions, including continued examinations. See id.
§ 154(b)(1)(B)(i), (ii), (iii).
14 NOVARTIS AG v. LEE
The better reading of the language is that the patent
term adjustment time should be calculated by determin-
ing the length of the time between application and patent
issuance, then subtracting any continued examination
time (and other time identified in (i), (ii), and (iii) of
(b)(1)(B)) and determining the extent to which the result
exceeds three years. Such a reading ensures that appli-
cants recover for any “delay[s] due to the failure of the
[PTO],” without allowing the applicant to recover for “any
time consumed by continued examination,” as the statute
requires. Id. § 154(b)(1)(B)(i). Novartis has not given any
persuasive reason that this reading of the statute is
incorrect.
This construction is supported by the statutory pur-
pose and other aspects of the statutory structure. The
evident policy behind the three enumerated exclusions is
that certain delays are not attributable to the PTO—
delays not “due to the failure of” the PTO to move the
process along, § 154(b)(1)(B)—and so should not count
against the three years before adjustments begin. That
focus on PTO responsibility or its absence does not distin-
guish continued examinations according to when they
were initiated. Moreover, Novartis’s view, were it adopt-
ed for continued examinations, would seem to cover the
parallel exclusion for “any time consumed by appellate
review” in clause (b)(1)(B)(ii). The resulting extensions
even for unsuccessful appeals, if initiated more than three
years after the application’s filing, is in strong apparent
tension with clause (b)(1)(C)(iii), which provides for exten-
sions only for appeals that succeed. These considerations
bolster our conclusion that the correct interpretation of
the statute is the PTO’s view that time spent in a contin-
ued examination does not deplete the PTO’s allotment of
three years for application processing before a resulting
patent has its term extended, no matter when the contin-
ued examination begins.
NOVARTIS AG v. LEE 15
While we thus disagree with Novartis on its first
§ 154(b)(1)(B) issue, we agree with Novartis on its second
§ 154(b)(1)(B) issue. Novartis argues that the “time
consumed by continued examination” should be limited to
the time before allowance, as long as no later examination
actually occurs. In contrast, the PTO contends that any
time up until the patent issues, even after allowance,
should be excluded from the adjustment awarded to the
patentee. We reject the PTO’s view that the time after
allowance, until issuance, is “time consumed by continued
examination” and so is excluded from adjustments given
to the patentee. Such time from allowance to issuance
undisputedly would count toward the PTO’s three-year
allotment in a case not involving a continued examina-
tion. There is no basis for distinguishing a continued-
examination case.
As already noted, the PTO has explained that
§ 154(b)(1)(B) is best understood as making distinctions
based on whether certain delays are attributable to the
PTO. On that basis the PTO has properly insisted that
continued examinations are not to be distinguished ac-
cording to when they are initiated. By the same token,
allowance-to-issuance time is not to be distinguished
according to whether there is a continued examination in
a prosecution. Either way such time is plainly attributa-
ble to the PTO.
The language of “examination” used in § 154(b)(1)(B)
reflects that underlying principle. An “examination”
presumptively ends at allowance, when prosecution is
closed and there is no further examination on the merits
in the absence of a special reopening. The Notices of
Allowance for the ’155, ’518, and ’631 patents here read:
“THE APPLICATION . . . HAS BEEN EXAMINED AND
IS ALLOWED FOR ISSUANCE AS A PATENT.
PROSECUTION ON THE MERITS IS CLOSED.” J.A.
291 (the ’155 patent); J.A. 367 (the ’518 patent); J.A. 488
(the ’631 patent). And the Manual of Patent Examining
16 NOVARTIS AG v. LEE
Procedure, in §§ 1305, 1309, indicates that, when a notice
of allowance is mailed, the application moves from the
examiner to the office of publication. The common-sense
understanding of “time consumed by continued examina-
tion,” 35 U.S.C. § 154(b)(1)(B)(i), is time up to allowance,
but not later, unless examination on the merits resumes.
The PTO identifies several circumstances in which af-
firmative action is taken to resume examination after
allowance, perhaps based on new information submitted
by applicants in fulfillment of their continuing duty to
disclose information material to patentability, 37 C.F.R.
§ 1.56. See, e.g., BlackLight Power, Inc. v. Rogan, 295
F.3d 1269, 1273-74 (Fed. Cir. 2002) (even after payment
of the issue fee, but before issuance, PTO officials can
take “extraordinary action to withdraw a patent from
issue” and “return the . . . application to examination”); 37
C.F.R. § 1.313(a) (applicant may request resumption of
examination). But such circumstances are exceptional,
and an appropriate adjustment can be made when they
occur. For none of the three applications at issue does the
PTO identify any “continued examination of the applica-
tion” that occurred after the notice of allowance was
mailed. The possible existence of these exceptional cases
does not support a general rule excluding time between
allowance and issuance. In the present case, time after
allowance was not time caused by the continued examina-
tion. Because the PTO applied the contrary view in
calculating the patent term adjustment for the ’155, ’518,
and ’631 patents, those calculations must be corrected.
CONCLUSION
For the foregoing reasons, we affirm the dismissal of
Novartis’s claims with respect to fifteen patents as un-
timely, partly reverse the judgment as to patent term
adjustment for the ’155, ’518, and ’631 patents, and re-
mand for redetermination of the proper adjustments in
accordance with this opinion.
NOVARTIS AG v. LEE 17
No costs.
AFFIRMED IN PART, REVERSED IN PART, AND
REMANDED