Court Opinion

ID: 4372152
Source: CourtListenerOpinion
Date Created: 2019-02-28 16:00:42.799074+00
Date Added: 2024-06-11T09:24:37.018464
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                 ______________________

    BRIGHAM AND WOMEN'S HOSPITAL, INC.,
         INVESTORS BIO-TECH, L.P.,
           Plaintiffs-Cross-Appellants

                            v.

  PERRIGO COMPANY, L. PERRIGO COMPANY,
             Defendants-Appellants
            ______________________

      2017-1950, 2017-2021, 2017-2555, 2018-1243
               ______________________

    Appeals from the United States District Court for the
District of Massachusetts in No. 1:13-cv-11640-RWZ,
Judge Rya W. Zobel.
                ______________________

               Decided: February 28, 2019
                ______________________

    JAMES M. BOLLINGER, Troutman Sanders LLP, New
York, NY, argued for plaintiffs-cross-appellants. Also rep-
resented by TIMOTHY P. HEATON, PHOENIX S. PAK, GERALD
EAMES PORTER; LINDSAY MITCHELL HENNER, DOUGLAS
SALYERS, Atlanta, GA.

   JEFFREY R. GARGANO, Morgan, Lewis & Bockius LLP,
Chicago, IL, argued for defendants-appellants. Also
2        BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

represented by PETER M. SIAVELIS, Barnes & Thornburg
LLP, Chicago, IL.
                ______________________

    Before LOURIE, O’MALLEY, and STOLL, Circuit Judges.
LOURIE, Circuit Judge.
    Perrigo Company and L. Perrigo Company (collec-
tively, “Perrigo”) appeal from the order of the U.S. District
Court for the District of Massachusetts denying judgment
of invalidity as a matter of law of U.S. Patent 5,229,137
(the “’137 patent”) on the basis of anticipation and obvious-
ness. Brigham & Women’s Hosp., Inc. v. Perrigo Co., 280
F. Supp. 3d 192, 205–06 (D. Mass. 2017) (“Decision”).
Brigham and Women’s Hospital, Inc. and Investors Bio-
Tech, L.P. (collectively, “Brigham”) cross-appeal from the
same order granting judgment of noninfringement as a
matter of law. Id. at 205. Because the district court did
not err in its judgment of noninfringement, we affirm and
do not reach the remaining issues.
                      I. BACKGROUND
    Brigham’s ’137 patent is directed to a method for treat-
ing episodic heartburn by coadministering two known
types of heartburn medications, H2-receptor antagonists
(known as H2-blockers) and antacids. Antacids were
known to provide fast but momentary relief from heart-
burn; in contrast, H2-blockers were known to provide
slower but longer-lasting relief. Critically, the method of
treatment as claimed requires that coadministering an
antacid and H2-blocker achieves a certain clinical result:
“immediate and sustained relief from pain, discomfort
and/or symptoms associated with episodic heartburn.” ’137
patent col. 7 ll. 23–25 (emphasis added). The dispositive
issue on appeal is whether Perrigo’s product meets the “im-
mediate and sustained relief” limitation.
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY              3

                             A.
    Claim 1 of the ’137 patent is the sole independent claim
asserted by Brigham and reads as follows:
    1. A method of providing immediate and sustained
    relief from pain, discomfort and/or symptoms asso-
    ciated with episodic heartburn in a human, said
    method comprising:
    orally administering to a human together or sub-
    stantially together an antacid in an amount effec-
    tive to substantially neutralize gastric acid and a
    histamine H2-receptor antagonist in an amount ef-
    fective to substantially inhibit or block gastric acid
    secretion for providing the human with immediate
    and sustained relief from pain, discomfort and/or
    symptoms associated with episodic heartburn, the
    immediate and sustained relief provided lasting
    longer in duration than when the human is orally
    treated with only the antacid and the immediate
    and sustained relief provided being faster than and
    lasting at least about as long in duration as when
    the human is orally treated with only the hista-
    mine H2-receptor antagonist.
Id. col. 7 ll. 23–42 (emphasis added). The specification de-
fines “immediate and sustained relief,” disclosing:
    It should therefore be appreciated that by the term
    “immediate and sustained relief,” it means herein
    immediate, temporary and sustained relief which
    starts within about 5-10 minutes following inges-
    tion of the active ingredients and continues and re-
    mains constant for at least about 4-6 hours after
    ingestion of the active ingredients; the actual ingre-
    dients being an antacid and a histamine H2-recep-
    tor antagonist.
Id. col. 3 ll. 22–29 (emphasis added).
4       BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

                             B.
    The ’137 patent was filed on May 6, 1992, issued in
1993, and expired on May 6, 2012. Brigham exclusively
licensed the patent in 1996 to Johnson & Johnson Merck
Consumer Pharmaceuticals (“J&J”), also giving J&J the
right to pursue any infringement claims. In December
2004, Perrigo sent Brigham a Paragraph IV notice letter
informing Brigham that it had submitted an Abbreviated
New Drug Application (“ANDA”) to market a combination
H2-blocker/antacid tablet prior to the expiration of the ’137
patent, and Brigham relayed this information to J&J soon
thereafter. J&J declined to assert the ’137 patent against
Perrigo but did sue on a different patent. Perrigo prevailed
and then launched its generic product in 2008. Several
years later, in 2013, Brigham brought the present suit ac-
cusing Perrigo’s generic product of infringing the ’137 pa-
tent’s independent claim 1 and dependent claims 4, 5, 6, 7,
and 12. Perrigo counterclaimed, asserting that the ’137 pa-
tent was invalid as anticipated and obvious.
     At claim construction, the district court construed the
term “immediate and sustained relief” to mean “relief ob-
tained from pain, discomfort and/or symptoms associated
with episodic heartburn which starts within about 5–10
minutes following ingestion of the active ingredients and
continues for at least about 4–6 hours.” J.A. 1380–82; De-
cision, 280 F. Supp. 3d at 200.
     The parties proceeded to trial. A key dispute was
whether Perrigo’s generic product provided immediate re-
lief as defined by the ’137 patent. The main evidence re-
garding this limitation came from clinical data
underpinning J&J’s branded H2-blocker/antacid product,
Pepcid Complete®. Brigham argued that the clinical data
demonstrated that Pepcid Complete® provides immediate
relief, and since Perrigo’s generic product has the same ac-
tive ingredients and dosages as Pepcid Complete®, Per-
rigo’s generic product must also provide immediate relief.
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY           5

    The clinical data came from three studies presented in
the New Drug Application (“NDA”) for Pepcid Complete®.
The first, Study 98, measured 23 qualifying patients’
esophageal and stomach pH levels after administering
Pepcid Complete® and compared changes in these pH val-
ues to controls (an antacid or H2-blocker alone, or a pla-
cebo). Undisputedly, lower (more acidic) esophageal pH
may correspond to episodic heartburn, which results from
reflux of stomach acid into the esophagus that can cause
pain associated with episodic heartburn. In the study,
“[a]n episode of acidic reflux was counted as a drop from pH
5 or more to 4 or below . . . .” J.A. 7044. The study was
designed to show that Pepcid Complete® would raise esoph-
ageal pH faster than an H2-blocker alone and comparably
fast to an antacid alone.
    Although the NDA’s description of Study 98 does not
directly state whether Pepcid Complete® provided sympto-
matic relief from episodic heartburn starting within about
5–10 minutes, as required by claim 1, the NDA does include
a figure of the patients’ mean esophageal pH measured
over one minute intervals before and after administration
of an antacid, Pepcid Complete® (“FACT”), an H2-blocker
(“famotidine”), or a placebo. We reproduce this figure—
Figure 7—below:
6       BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

J.A. 7044.
    At trial, Brigham’s fact and expert witness and the in-
ventor of the ’137 patent, Dr. M. Michael Wolfe, testified
concerning Figure 7. He opined that “the antacid, whether
it was in the combination or by itself, the pH rapidly rose
in the esophagus, and it persisted.” J.A. 7721. With re-
spect to the claimed immediate relief from episodic heart-
burn, Dr. Wolfe further attested that “the increase in pH is
what we’re aiming for. It’s mopping up of the acid that’s
present there. If you mop it up, it’s going to relieve symp-
tom; it’s going to start to relieve symptoms fairly quickly.”
Id.
    In addition to the data from Figure 7, Study 98 also
reported the number and duration of esophageal reflux ep-
isodes that occurred in the hour after administration of the
drugs. On average, patients experienced between 2 and 5
esophageal reflux episodes over the measurement period.
   In addition to the pH study, the NDA included two
symptom relief studies, Studies 110 and 127. Study 110
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY            7

measured “adequate relief for onset of effect within 2 hours,
and for duration of effect the number of episodes of heart-
burn adequately relieved for at least 7 hours.” J.A. 7067.
Adequate relief from heartburn, as determined by a pa-
tient’s own assessment, was first measured fifteen minutes
after administration of one of the drugs listed above. Re-
sults are shown in the table reproduced below:

J.A. 7068.
    Study 127 was similar to Study 110. It also measured
“adequate relief” beginning fifteen minutes after admin-
istration. Table 8, reproduced below, displays the results:

J.A. 6999.
     At trial, Dr. Wolfe testified that the parameter meas-
ured in Studies 110 and 127—adequate relief at 15
minutes—would “correlate to immediate relief” within 5–
10 minutes, but he admitted that the two parameters were
different. J.A. 7847–48.
8        BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

    The jury returned a verdict finding that the asserted
claims of the ’137 patent were not invalid, that Perrigo’s
generic product infringed each asserted claim, and that
Perrigo’s infringement was willful. The jury awarded
Brigham damages of about $10 million. The district court
entered judgment consistent with the verdict on December
19, 2016, but without specifying damages or resolving
Brigham’s claim for enhanced damages. J.A. 8739.
                             C.
    Several days after the judgment, on December 23,
2016, both parties jointly requested the district court to ex-
tend various deadlines for filing post-trial motions. The
joint request suggested a deadline for Perrigo’s motions for
judgment as a matter of law (“JMOL”) of January 24, 2017.
The court granted the extensions in full.
    Perrigo then moved for JMOL of noninfringement and
invalidity on the date of the revised deadline. Brigham also
then moved for enhanced damages. Additionally, in
Brigham’s opposition to Perrigo’s JMOL motions, Brigham
contended that Perrigo’s motions were untimely under
Rule 50(b). Soon afterwards, in February 2017, Perrigo no-
ticed an appeal from the district court’s December 19 judg-
ment.
    Several months later, the district court resolved the
parties’ pending motions. Brigham & Women’s Hosp., Inc.
v. Perrigo Co., 251 F. Supp. 3d 285 (D. Mass. 2017) (“April
Decision”). The court ruled that its December 19, 2016,
judgment was final except for an accounting and therefore
triggered the 28-day mandatory deadline set forth in Rule
50(b) for renewed motions for JMOL. Id. at 289–90. The
28-day deadline fell on January 17, 2017, a week earlier
than the agreed-upon day on which Perrigo renewed its
JMOL motions. While the court recognized that it had
blessed the January 24 deadline, the court concluded that
it had lacked authority under the Federal Rules to do so.
Id. at 290–91 (citing Fed. R. Civ. P. 6(b)(2)). The court thus
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY            9

denied Perrigo’s motions for JMOL and its notice of appeal
as untimely. Id. at 292. Finally, the district court denied
Brigham’s motion for enhanced damages because it found
that Perrigo’s conduct was not egregious. Id. at 293–94.
     Perrigo again moved for JMOL and noticed a second
appeal on May 19 and May 11, 2017, respectively, this time
from the district court’s April decision. Brigham then
moved to dismiss for lack of jurisdiction, arguing that Per-
rigo failed to timely file its JMOL motions and notice of ap-
peal. In a single-judge order, we denied the motion.
Brigham & Women’s Hosp., Inc. v. Perrigo Co., No. 2017-
1950, -2021, slip op. at 4 (Fed. Cir. June 21, 2017), ECF No.
33 (“Jurisdiction Decision I”). We concluded that the dis-
trict court’s December 19 judgment was not final because
it did not resolve Brigham’s claim for enhanced damages.
Id. at 3. Although we observed that Perrigo could have ap-
pealed from the December 19 judgment under 28 U.S.C.
§ 1292(c), we held that Perrigo was not obliged to do so be-
cause such an appeal from a non-final judgment “is permis-
sive, not mandatory.” Id. (quoting DNIC Brokerage Co. v.
Morrison & Dempsey Comm’cns Inc., No. 90-1389, 1991 WL
335745, at *1 (Fed. Cir. Apr. 25, 1991)). We held that
“[w]hat matters is that [Perrigo] filed a timely appeal once
all the issues were resolved by the April 24, 2017 decision.”
Id. We thus consolidated both of Perrigo’s appeals and de-
activated them pending the district court’s consideration of
certain unresolved motions. Id. at 4.
    Brigham moved for panel reconsideration. A three-
judge panel reaffirmed our original decision. Brigham &
Women’s Hosp., Inc. v. Perrigo Co., No. 2017-1950, -2021,
slip op. at 8–9 (Fed. Cir. Aug. 2, 2017), ECF No. 38 (“Juris-
diction Decision II”).
                             D.
    The district court then considered the pending motions
and granted JMOL of noninfringement because it con-
cluded that Brigham failed to present sufficient evidence of
10       BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

direct infringement. Decision, 280 F. Supp. 3d at 199. Spe-
cifically, the court determined that the clinical evidence did
not demonstrate that Pepcid Complete® provided immedi-
ate relief from episodic heartburn. Id. at 202.
    The district court first assessed Study 98 and Dr.
Wolfe’s related testimony concerning Figure 7, including
his contention that Figure 7 showed immediate relief
through its rapid rise in esophageal pH after administering
Pepcid Complete®. However, the court observed that Study
98 defined an episode of acid reflux as requiring esophageal
pH to go to 4 or below, but the average pH values in Figure
7 never did so. Id. at 202. And, as the study did not other-
wise purport to correlate pH recordings to heartburn sever-
ity or other symptoms, the court concluded that Figure 7
did not prove that patients in the study were provided with
immediate relief. Id.
    The district court next considered the symptom relief
studies. Because these studies indisputably measured a
parameter different from the claimed immediate relief—
“adequate relief” at 15 minutes, not the start of relief
within 5–10 minutes—the court determined that the symp-
tom relief studies also did not support the infringement
verdict. Id.
    Given Brigham’s proffered evidence of infringement,
the district court concluded that “no reasonable jury could
have found direct infringement and Perrigo is entitled to
judgment as a matter of law” of noninfringement with re-
spect to claim 1. Id. It similarly followed that Brigham
could not prove direct infringement of the dependent
claims. Id. Consequently, the court vacated the jury’s
award of damages. Id. at 205. The court denied Perrigo’s
motions for JMOL of invalidity. Id. at 204–05.
   Perrigo appealed from the district court’s denial of
JMOL of invalidity and its denial of Perrigo’s evidentiary
motion. Brigham cross-appealed from the court’s grant of
JMOL of noninfringement, its denial of enhanced damages,
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY             11

attorney fees, and pre-judgment interest, and its conclu-
sion with respect to a disputed invention date.
                       II. DISCUSSION
                       A. Jurisdiction
    Notwithstanding that this court has twice decided that
we have jurisdiction over Perrigo’s appeal, Brigham main-
tains that “[t]here is a serious question regarding this
Court’s jurisdiction to hear Perrigo’s appeal.” Cross-Appel-
lant Br. 1–2. Brigham points to no error, however, in our
decision, and simply requests that we “assure [ourselves]
that [we have] jurisdiction to hear the appeals as pre-
sented.” Id. at 2. Presumably, Brigham refers to the time-
liness issue. But our prior decisions are law of the case,
and we do not disturb them.
    Under the law of the case doctrine, “when a court de-
cides upon a rule of law, that decision should continue to
govern the same issues in subsequent stages in the same
case.” Christianson v. Colt Indus. Operating Corp., 486
U.S. 800, 816 (1988) (quoting Arizona v. California, 460
U.S. 605, 618 (1983)). The underlying principle of the doc-
trine is self-consistency. See Charles Alan Wright et al.,
18B Federal Practice & Procedure Jurisdiction § 4478 (2d
ed. 2002). “Without something like it, an adverse judicial
decision would become little more than an invitation to
take a mulligan, encouraging lawyers and litigants alike to
believe that if at first you don’t succeed, just try again.”
Entek GRB, LLC v. Stull Ranches, LLC, 840 F.3d 1239,
1240 (10th Cir. 2016) (Gorsuch, J.). As the doctrine is di-
rected at the integrity of the judicial process, we may ad-
dress the law of the case sua sponte. See United States v.
Wallace, 573 F.3d 82, 90 n.6 (1st Cir. 2009).
    In two decisions, the latter by a three-judge panel, we
decided that Perrigo’s appeal in this case was timely but
deactivated it to allow the district court to resolve Perrigo’s
pending JMOL motions. Jurisdiction Decision I, slip op. at
12      BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

3; Jurisdiction Decision II, slip op. at 8–9. In accordance
with those decisions, the district court resolved those mo-
tions, resulting in the judgment now before us. Brigham
now invites us to disregard the law of the case and our prior
decisions, without articulating any reasons why we should
do so.
     We decline. We depart from the law of the case only in
“extraordinary circumstances such as where the initial de-
cision was ‘clearly erroneous and would work a manifest
injustice.’” Christianson, 486 U.S. at 817 (quoting Arizona,
460 U.S. at 618 n.8). No such circumstances are evident
here. The prior panel concluded that the district court’s
December 19 judgment was not a final judgment because
it did not resolve the issue of enhanced damages, and that
Perrigo’s appeal from that judgment was therefore inter-
locutory. Jurisdiction Decision II, slip op. at 4–5. While an
aggrieved party may appeal under 28 U.S.C. § 1292(c)(2)
from a district court’s judgment that does not fully resolve
damages, Robert Bosch, LLC v. Pylon Mfg. Corp., 719 F.3d
1305, 1309 (Fed. Cir. 2013) (en banc), the panel held that
an appeal from such a judgment was permissive, not man-
datory. Jurisdiction Decision II, slip op. at 8 (citing DNIC,
1991 WL 335745, at *1); see Jurisdiction Decision I, slip op.
at 3. In DNIC, we encountered a situation similar to the
one here—an untimely appeal from a judgment not speci-
fying damages, but a timely appeal from a later judgment
that did specify damages. 1991 WL 335745, at *1. There,
we permitted the appeal as to issues from both the earlier
and later judgments. Id. at *2. We see no clear error or
manifest injustice in the prior panel’s consistent holding
here.
    As Brigham has alleged no extraordinary circum-
stances warranting departure from the law of the case, we
conclude that we have jurisdiction over these appeals un-
der 28 U.S.C. § 1295(a)(1). We therefore proceed to the
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY          13

merits. We decide only the question regarding infringe-
ment. 1
                     B. Infringement
     We review the district court’s grant of JMOL of nonin-
fringement under First Circuit law. “In assessing the suf-
ficiency of the evidence, we consider whether, viewing the
evidence in the light most favorable to the verdict, a ra-
tional jury could find in favor of the party who prevailed.”
Soto-Lebron v. Fed. Express Corp., 538 F.3d 45, 56 (1st Cir.
2008). JMOL is warranted when the prevailing party’s
case contained no legally sufficient evidentiary basis for a
reasonable jury to find for that party. Id.; Fed. R. Civ. P.
50(a)(1). We review the court’s grant of JMOL de novo.
Soto-Lebron, 538 F.3d at 56.
    At trial, Brigham alleged only literal infringement.
Literal infringement is a question of fact and requires
every limitation in the claim to be found in the accused

   1     Under Cardinal Chemical Co. v. Morton Int’l, Inc.,
508 U.S. 83 (1993), a judgment of noninfringement does not
moot a counterclaim of invalidity. However, “we retain the
discretion to limit the grounds upon which appeals are de-
cided.” Meds. Co. v. Mylan, Inc., 853 F.3d 1296, 1302 n.1
(Fed. Cir. 2017) (affirming judgment of noninfringement
and not reaching issues of validity). Given the facts here,
we decline to reach the issues of validity. Perrigo agrees
that affirming noninfringement would make it unneces-
sary to review the patent’s validity. Reply Br. 3. And while
we recognize the “strong public interest” in resolving ques-
tions of patent validity, Cardinal Chem., 508 U.S. at 100,
that interest here is minimal because the ’137 patent has
expired and cannot be asserted against others, there are no
pending suits involving the patent, and there are no related
patents in examination at the U.S. Patent and Trademark
Office.
14       BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

product. Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811
F.3d 1334, 1339, 1341 (Fed. Cir. 2016). “If even one limita-
tion is missing or not met as claimed, there is no literal
infringement.” Mas-Hamilton Grp. v. LaGard, Inc., 156
F.3d 1206, 1211 (Fed. Cir. 1998). The patentee has the bur-
den of proving literal infringement by a preponderance of
the evidence. Enercon GmbH v. Int’l Trade Comm’n, 151
F.3d 1376, 1384 (Fed. Cir. 1998).
    Brigham argues that the district court erred in over-
turning the jury verdict and granting JMOL of nonin-
fringement.     According to Brigham, the court
misinterpreted Figure 7 and improperly dismissed the
other studies. Based on the totality of the evidence pre-
sented, Brigham asserts that a reasonable jury could have
found infringement.
    Perrigo responds that the district court properly
granted JMOL of noninfringement because none of the ev-
idence presented to the jury demonstrated immediate and
sustained relief as claimed in the ’137 patent.
    We agree with Perrigo that the district court’s JMOL
of noninfringement was proper. The parties’ dispute cen-
ters on whether the evidence at trial was sufficient to show
that Pepcid Complete®, and by implication Perrigo’s ge-
neric product, provides “immediate . . . relief from pain,
discomfort and/or symptoms associated with episodic
heartburn.” ’137 patent col. 7 ll. 23–25. The district court’s
construction of this term is undisputed: immediate relief
means “relief obtained from pain, discomfort and/or symp-
toms associated with episodic heartburn which starts
within about 5–10 minutes following ingestion of the active
ingredients.” J.A. 1380–82; Decision, 280 F. Supp. 3d at
200. As we discuss, Brigham’s evidence was insufficient to
show immediate relief as claimed, and no reasonable jury
could have found otherwise.
    Brigham’s infringement case relied primarily on the
clinical studies 98, 110, and 127 reported in the NDA for
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY           15

Pepcid Complete®. Like the district court, we begin with
Figure 7 of Study 98, reproduced earlier. Figure 7 depicts
mean esophageal pH before and after Pepcid Complete® or
a control drug is administered to a set of patients. The sole
heartburn symptom related to esophageal pH measured in
the study was acidic reflux, and “[a]n episode of acidic re-
flux was counted as a drop from pH 5 or more to 4 or below.”
J.A. 7044. None of the curves at any point in Figure 7 de-
pict a mean pH below 4. Nor does the study disclose indi-
vidual esophageal pH data.
     Because Study 98 defined an episode of acidic reflux as
requiring a drop in pH to below 4, but the pH curves in
Figure 7 never drop below 4, the district court concluded
that Figure 7 could not prove that the patients in Study 98
taking Pepcid Complete® were provided with immediate re-
lief from episodic heartburn within 5–10 minutes. Deci-
sion, 280 F. Supp. 3d at 202. We agree. While Figure 7
does show a rapid rise in esophageal pH after administer-
ing Pepcid Complete®, that rise is untethered to any symp-
tomatic relief. It cannot support the jury verdict that
Pepcid Complete® provides immediate relief from episodic
heartburn within 5–10 minutes. At most, the study sug-
gests that Pepcid Complete® might provide immediate and
sustained relief; such speculative data, however, cannot
sustain Brigham’s burden of proof.
    Brigham argues that Study 98’s definition of an epi-
sode of acidic reflux only applies to a prior table showing
the number and duration of esophageal reflux episodes, not
to Figure 7. Implicit in Brigham’s argument is the notion
that the investigators defined an episode of acidic reflux in
different ways within the same study. Brigham cites no
evidence in support of that reading. Moreover, the general
definition of an episode of acidic reflux offered in Study 98
does not refer to any particular data or figure, and the
study contains no alternative definition. Thus, no reason-
able jury could have interpreted the study according to
Brigham’s newly presented reading.
16       BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

    Brigham also emphasizes that Figure 7 involved pa-
tients who generally experienced heartburn. This may be
true but it is irrelevant to whether Figure 7 demonstrated
immediate relief from heartburn symptoms within 5–10
minutes. The fact that the patients in Study 98 experi-
enced heartburn at some time does not support a finding
that the rise in esophageal pH shown in Figure 7 demon-
strated the claimed immediate relief.
     We next consider Studies 110 and 127, which did report
symptomatic relief from heartburn. However, the district
court concluded that these studies could not support the
infringement verdict because they each measured “ade-
quate relief” beginning at 15 minutes, not immediate relief
starting within 5–10 minutes as claimed. Decision, 280 F.
Supp. 3d at 202. There is no dispute that adequate relief
first measured at 15 minutes after administration is a pa-
rameter different from relief starting 5–10 minutes after
administration. Dr. Wolfe testified as such. J.A. 7846
(“[I]t’s onset versus – this is adequate relief. Different pa-
rameters.”). As Studies 110 and 127 did not measure the
result that Brigham claimed in the ’137 patent, we agree
with the district court that they do not support the jury
verdict.
    On appeal, Brigham argues that the evidence of ade-
quate relief at 15 minutes necessarily showed onset of re-
lief within 5–10 minutes. But at most, Dr. Wolfe’s
testimony only indicated that the measured parameter
would “correlate to” the claimed result. J.A. 7847 (“‘15
minutes would be in the five or ten, around that time.’ So
that would correlate to immediate relief.”). Data merely
correlating to the claimed limitation does not suffice to
prove literal infringement. As Dr. Wolfe testified regard-
ing the data on adequate relief at 30 minutes, “[w]e have
no idea” how many patients in Studies 110 and 127 were
provided relief starting within 5–10 minutes because that
result was not measured or even estimated in either study.
J.A. 7791. “Although a jury is entitled to draw reasonable
BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY           17

inferences from circumstantial evidence, reasonable infer-
ences themselves must be more than speculation and con-
jecture.” Phillip M. Adams & Assocs., LLC v. Dell Comput.
Corp., 519 F. App’x 998, 1004 n.10 (Fed. Cir. 2013) (quoting
Sunward Corp. v. Dun & Bradstreet, Inc., 811 F.2d 511,
521 (10th Cir. 1987)); see Welch v. Ciampa, 542 F.3d 927,
935 (1st Cir. 2008) (“Although we give the nonmoving party
the benefit of all reasonable inferences, a party cannot rest
on ‘conclusory allegations, improbable inferences, [or] un-
supported speculation’ to defeat a motion for summary
judgment.” (alteration in original) (quoting McCarthy v.
Northwest Airlines, Inc., 56 F.3d 313, 315 (1st Cir. 1995))).
Because only speculation supports Brigham’s contention
that data showing adequate relief at 15 minutes implies
that relief started within 5–10 minutes, it cannot sustain
the jury verdict.
    Brigham also points to other evidence purportedly
showing that Pepcid Complete® provided the claimed im-
mediate relief—that antacids were conventionally known
to act quickly, and that the NDA stated that Pepcid Com-
plete® worked as quickly as an antacid. However, none of
this evidence indicates that Pepcid Complete® provides im-
mediate relief within 5–10 minutes as claimed. It therefore
cannot support the infringement verdict.
    Last, we consider the bare assertion by Dr. Wolfe, the
inventor of the ’137 patent, that he ingested Perrigo’s prod-
uct after litigation began, and that it provided immediate
relief as claimed. J.A. 7760 (“Q. And you have no direct
evidence that Perrigo’s generic product provides immediate
relief within five to ten minutes, correct? A. Well, yeah. I
took it myself, and it does.”); J.A. 7758. Considering the
absence of any clinical data demonstrating the claimed im-
mediate relief, we conclude that this uncorroborated, con-
clusory, and interested testimony is insufficient to carry
Brigham’s burden of proof and to sustain the jury verdict.
See Medtronic Inc. v. Boston Sci. Corp., 558 F. App’x 998,
1000 (Fed. Cir. 2014) (“The district court correctly noted
18      BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY

that conclusory statements are insufficient to support a
verdict finding infringement under the doctrine of equiva-
lents . . . .”); cf. McKeown v. Bayshore Concrete Prods.
Corp., 34 F. App’x 741, 743 (Fed. Cir. 2002) (“[U]nsup-
ported, conclusory statements on the ultimate issue of in-
fringement are wholly insufficient to raise a genuine
evidentiary dispute for trial.”).
    Having considered the totality of the evidence, we
agree with the district court that Brigham failed as a mat-
ter of law to prove that Perrigo’s product meets the claimed
limitation of providing immediate relief from episodic
heartburn within 5–10 minutes. Because each asserted
claim contains this limitation, the court did not err in con-
cluding that the infringement verdict and damages award
could not stand.
                       CONCLUSION
     We have considered Brigham’s remaining arguments
but find them unpersuasive. For the foregoing reasons, we
affirm the judgment of the district court.
                       AFFIRMED