Glaxosmithkline LLC v. Teva Pharmaceuticals USA, Inc.

Case: 18-1976 Document: 187 Page: 1 Filed: 08/05/2021

United States Court of Appeals
for the Federal Circuit
______________________

GLAXOSMITHKLINE LLC, SMITHKLINE
BEECHAM (CORK) LIMITED,
Plaintiffs-Appellants

v.

TEVA PHARMACEUTICALS USA, INC.,
Defendant-Cross-Appellant
______________________

2018-1976, 2018-2023
______________________

Appeals from the United States District Court for the
District of Delaware in No. 1:14-cv-00878-LPS-CJB, Judge
Leonard P. Stark.
______________________

Decided: August 5, 2021
______________________

JUANITA ROSE BROOKS, Fish & Richardson P.C., San
Diego, CA, argued for plaintiffs-appellants. Also repre-
sented by MICHAEL ARI AMON, CRAIG E. COUNTRYMAN,
JONATHAN ELLIOT SINGER; ELIZABETH M. FLANAGAN,
MICHAEL J. KANE, WILLIAM WOODFORD, Minneapolis, MN;
NITIKA GUPTA FIORELLA, DOUGLAS E. MCCANN, Wilming-
ton, DE.

WILLIAM M. JAY, Goodwin Procter LLP, Washington,
DC, argued for defendant-cross-appellant. Also repre-
sented by JAIME SANTOS; ELAINE BLAIS, J. ANTHONY
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2 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

DOWNS, ROBERT FREDERICKSON, III, CHRISTOPHER T.
HOLDING, ALEXANDRA LU, LANA S. SHIFERMAN, DARYL L.
WIESEN, Boston, MA; IRA J. LEVY, New York, NY.

ANDREW M. ALUL, Taft, Stettinius & Hollister, LLP,
Chicago, IL, for amicus curiae Apotex Inc.

MATTHEW S. HELLMAN, Jenner & Block LLP,
Washington, DC, for amicus curiae Association for
Accessible Medicines. Also represented by NOAH BOKAT-
LINDELL; JEFFREY FRANCER, Association for Accessible
Medicines, Washington, DC.

MICHAEL CARRIER, Rutgers Law School, Camden, NJ,
for amici curiae Margo Bagley, Ann Bartow, Jeremy Bock,
Irene Calboli, Michael Carrier, Bernard Chao, Thomas
Cheng, Andrew Chin, Jorge L. Contreras, Joshua Davis,
Stacey L. Dogan, Stacie B. Dusetzina, Samuel F. Ernst,
Harry First, Michal Gal, William Gallagher, Shubha
Ghosh, Yaniv Heled, Tim Holbrook, Erik Hovenkamp, Ei-
leen M. Kane, Ariel Katz, Aaron S. Kesselheim, John B.
Kirkwood, Mark A. Lemley, Christopher R. Leslie, Yvette
Joy Liebesman, Lee Ann Wheelis Lockridge, Phillip R.
Malone, Duncan Matthews, Stephen M. Maurer, Stephen
McJohn, Michael J. Meurer, Roger Noll, Tyler T. Ochoa,
Jennifer D. Oliva, Barack Orbach, Luigi Palombi, Jordan
Paradise, Srividhya Ragavan, Zia Rahman, Arti K. Rai,
Ana Santos Rutschman, Rachel E. Sachs, William M. Sage,
Christopher L. Sagers, Catherine Sandoval, Joshua David
Sarnoff, Ameet Sarpatwari, Kurt M. Saunders, Steven
Semeraro, David A. Simon, Michael Sinha, Jennifer Stu-
riale, H.H.B. Vedder, Liza Vertinsky, Melissa Feeney Was-
serman. Also represented by MATTHEW JAMES DOWD,
ROBERT JAMES SCHEFFEL, Dowd Scheffel PLLC, Washing-
ton, DC.

HANSJORG SAUER, Biotechnology Innovation Organiza-
tion, Washington, DC, for amicus curiae Biotechnology In-
novation Organization. Also represented by MELISSA A.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 3

BRAND; BRIAN PAUL BARRETT, Eli Lilly and Company, Indi-
anapolis, IN.

KATHRYN ARDIZZONE, Knowledge Ecology Interna-
tional, Washington, DC, for amici curiae Knowledge
Ecology International, James Packard Love.

STEFFEN NATHANAEL JOHNSON, Wilson Sonsini
Goodrich & Rosati, Washington, DC, for amicus curiae
Mylan Pharmaceuticals Inc. Also represented by ADAM
WILLIAM BURROWBRIDGE, JOHN BERNARD KENNEY; WENDY
L. DEVINE, TUNG ON KONG, San Francisco, CA; GEORGE E.
POWELL, III, Palo Alto, CA.

JANE M. LOVE, Gibson, Dunn & Crutcher LLP, New
York, NY, for amicus curiae Novartis Pharmaceuticals Cor-
poration. Also represented by ROBERT TRENCHARD.

MICHAEL N. KENNEDY, Covington & Burling LLP,
Washington, DC, for amicus curiae Pharmaceutical Re-
search and Manufacturers of America. Also represented by
DAVID EVAN KORN, Pharmaceutical Research and Manu-
facturers of America, Washington, DC.

MASON ANDREW KORTZ, Cyberlaw Clinic, Harvard Law
School, Cambridge, MA, for amicus curiae The R Street In-
stitute.

DAN L. BAGATELL, Perkins Coie LLP, Hanover, NH, for
amicus curiae Sandoz, Inc. Also represented by ANDREW
DUFRESNE, Madison, WI.

WILLIAM BARNETT SCHULTZ, Zuckerman Spaeder LLP,
Washington, DC, for amicus curiae Henry A. Waxman. Also
represented by MARGARET DOTZEL, CASSANDRA TROMBLEY-
SHAPIR JONAS.
______________________
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4 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Before MOORE, Chief Judge *, NEWMAN and PROST **,
Circuit Judges.
Opinion for the court filed per curiam.
Dissenting opinion filed by Circuit Judge PROST.
PER CURIAM.
GlaxoSmithKline LLC and SmithKline Beecham
(Cork) Ltd. (collectively, GSK) sued Teva Pharmaceuticals
USA, Inc. in the United States District Court for the Dis-
trict of Delaware for infringement of claims of GSK’s Reis-
sue Patent No. RE40,000. After the jury’s verdict of
infringement and its award of damages, the district court
granted Teva’s renewed motion for judgment as a matter
of law of noninfringement. GlaxoSmithKline LLC v. Teva
Pharm. USA, Inc., 313 F. Supp. 3d 582 (D. Del. 2018) (Dist.
Ct. Op.). GSK appeals the JMOL, and Teva conditionally
cross-appeals the jury’s damages award. We have jurisdic-
tion under 28 U.S.C. § 1295(a)(1).
For the reasons below, we vacate the grant of JMOL,
reinstate the jury’s verdict and damages award, and re-
mand for appropriate further proceedings.
BACKGROUND
GSK markets and sells the medicinal product carve-
dilol, a beta-blocker, under the brand name Coreg®. The
Food and Drug Administration (FDA) has approved carve-
dilol for three indications of use. By 1997, the FDA had
approved carvedilol for treatment of hypertension and con-
gestive heart failure (CHF). Then, in 2003, the FDA ap-
proved carvedilol for a third use: to reduce cardiovascular

* Chief Judge Kimberly A. Moore assumed the posi-
tion of Chief Judge on May 22, 2021.
** Circuit Judge Sharon Prost vacated the position of
Chief Judge on May 21, 2021.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 5

mortality in patients suffering from left ventricular dys-
function following a myocardial infarction, i.e., the
“post-MI LVD” indication.
When GSK began investigating carvedilol’s use for
treating CHF, beta-blockers were contraindicated for that
use. This was because beta-blockers slow the heart rate
and reduce the heart’s ability to pump blood, a potentially
deadly combination for patients with heart failure. Very
few doctors or companies, therefore, saw the potential for
investigating beta-blockers for treating CHF. Despite this
skepticism, GSK spent years investigating, and conducting
trials of, carvedilol for the treatment of heart failure. And
at the time, the only known treatment for improving mor-
tality rates in CHF patients was with angiotensin-convert-
ing enzyme (ACE) inhibitors. Still, even with ACE
inhibitors, patients continued to die from heart failure at
high rates. It was not until the FDA approved GSK’s
Coreg® that using a beta-blocker to treat CHF became the
standard of care for reducing mortality in heart failure pa-
tients.
The carvedilol compound was patented in 1985. See
U.S. Patent No. 4,503,067, expiration date March 5, 2007.
In 1998, U.S. Patent No. 5,760,069 issued, which claimed a
method of administering a combination of carvedilol and
one or more of an ACE inhibitor, a diuretic, and digoxin to
decrease mortality caused by CHF in a patient.
In March 2002, Teva filed an Abbreviated New Drug
Application (ANDA) for FDA approval of its generic carve-
dilol for all three indications. It certified, under Paragraph
III of the Hatch-Waxman Act, 1 that it would not launch its
product until the ’067 patent on the carvedilol compound
expired in March 2007. See 21 U.S.C.

1 Drug Price Competition and Patent Term Restora-
tion Act of 1984, Pub. L. 98–417, 98 Stat. 1585 (1984).
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6 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

§ 355(j)(2)(A)(vii)(III). Teva also certified, under Para-
graph IV, that the ’069 patent was “invalid, unenforceable,
or not infringed.” See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). On
May 24, 2002, Teva sent GSK a Paragraph IV notice stat-
ing that the claims of the ’069 patent are anticipated or
would have been obvious. GSK did not sue Teva upon re-
ceipt of the notice, and on November 25, 2003, GSK applied
for reissue of the ’069 patent under 35 U.S.C. § 251. Teva
received FDA “tentative approval” for its ANDA in 2004,
“for treatment of heart failure and hypertension.”
J.A. 7437. The approval was to become effective when the
’067 patent expired in 2007.
On January 8, 2008, the PTO issued Reissue Patent
No. RE40,000, and GSK notified the FDA on February 6,
2008. See J.A. 6880–82. The ’000 patent, asserted in this
case, claims a method of decreasing mortality caused by
CHF by administering carvedilol with at least one other
therapeutic agent. See, e.g., ’000 patent, col. 1, ll. 17–25.
Claim 1 recites:
1. A method of decreasing mortality caused by con-
gestive heart failure in a patient in need thereof
which comprises[:]
administering a therapeutically acceptable amount
of carvedilol in conjunction with one or more other
therapeutic agents, said agents being selected from
the group consisting of an angiotensin converting
enzyme inhibitor (ACE), a diuretic, and digoxin,
wherein the administering comprises administer-
ing to said patient daily maintenance dosages for a
maintenance period to decrease a risk of mortality
caused by congestive heart failure, and said mainte-
nance period is greater than six months.
(emphasis in original). The ’000 patent is listed in the
FDA’s publication “Approved Drug Products with Thera-
peutic Equivalence Evaluations,” commonly known as the
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 7

Orange Book, as a patent claiming a method of using
Coreg®.
Just before Teva launched its generic carvedilol in
2007, it certified to the FDA that its label “will not include
the indication defined in use code U-233” until the expira-
tion of the ’069 patent. J.A. 6176; see 21 U.S.C.
§ 355(j)(2)(A)(viii) (section viii). Patent use code U-233 cor-
responded to “decreasing mortality caused by congestive
heart failure.” J.A. 7833. Teva’s label dated “8/2007” thus
included only two indications: the post-MI LVD indication
and the hypertension indication. J.A. 5506, 5508. Teva’s
press releases and marketing materials, however, touted
its generic carvedilol as “indicated for treatment of heart
failure and hypertension,” as the “Generic version of
[GSK’s] cardiovascular agent Coreg®,” and as an “AB-rated
generic equivalent of [GSK’s] Coreg® Tablets.” 2 J.A. 6347,
6353.
In 2011, following GSK’s delisting of certain patents
from the Orange Book, including the ’069 patent and U.S.
Patent No. 5,902,821, the FDA instructed Teva to “revise
[its] labeling to include the information associated with pa-
tent ’821 (delisted) and the associated Use Code (U-313).”
J.A. 5557. It told Teva to submit labeling “that is identical
in content to the approved [GSK Coreg®] labeling (includ-
ing the package insert and any patient package insert

2 The FDA assigns an “AB rating” for a drug that is
considered therapeutically equivalent to another drug.
FDA, Orange Book Preface § 1.7 (41st ed. current as of Jan.
21, 2021), https://www.fda.gov/drugs/development-ap-
proval-process-drugs/orange-book-preface. A therapeuti-
cally equivalent drug is one that “can be expected to have
the same clinical effect and safety profile when adminis-
tered to patients under the conditions specified in the label-
ing.” Id. § 1.2 (emphasis added); see also 21 C.F.R.
§ 314.3(b) (same).
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8 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

and/or Medication Guide that may be required).” J.A.
5557. The FDA also requested Teva “provide information
regarding [its] position on [the ’000 patent].” Id.
Teva amended its label to include the indication for
treating patients with chronic heart failure by administer-
ing carvedilol to increase survival and to reduce the risk of
hospitalization. J.A. 5532. In addition, the post-MI LVD
and hypertension indications remained on the label. In re-
sponse to the FDA’s request for information regarding its
position on the ’000 patent, Teva told the FDA it believed
it need not “provide certification to [the ’000 patent]” be-
cause it received final approval of its ANDA before the ’000
patent issued. J.A. 5554.
On July 3, 2014, GSK sued Teva and Glenmark Phar-
maceuticals USA, the two largest suppliers of generic car-
vedilol, in the District of Delaware, alleging that each had
induced infringement of the ’000 patent. The action
against Glenmark was severed and stayed.
During a seven-day jury trial, Teva argued the asserted
claims of the ’000 patent were invalid and not infringed.
Teva argued it could not have induced infringement, at
least prior to 2011, because it had “carved out” the indica-
tion and prescribing information for treatment of conges-
tive heart failure in its 2007 label under section viii. Teva
also argued that it could not be liable for inducement for
any time period because it did not cause others to infringe
the method claimed in the ’000 patent.
The district court instructed the jury to assess whether
Teva induced infringement during two distinct time peri-
ods: the “partial label” period and the “full label” period.
J.A. 171. The partial label period was from January 8,
2008, through April 30, 2011, when Teva’s label had the
post-MI LVD and hypertension indications but not the
chronic heart failure indication. Id. The full label period
was from May 1, 2011, through June 7, 2015, when Teva’s
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 9

label had all three indications, including the chronic heart
failure indication. Id.
The jury found the ’000 patent was not invalid, that
Teva induced infringement of claims 1–3 during the partial
label period, and that Teva induced infringement of claims
1–3 and 6–9 during the full label period. The jury assessed
damages based on a combination of lost profits and a rea-
sonable royalty and found Teva’s infringement willful.
The district court granted Teva’s renewed motion for
JMOL, stating that substantial evidence did not support
the verdict of induced infringement because GSK failed to
prove that Teva’s alleged inducement, as opposed to other
factors, actually caused physicians to directly infringe by
prescribing generic carvedilol for the treatment of mild to
severe CHF. Dist. Ct. Op. at 591. The district court ex-
plained that “[w]ithout proof of causation, which is an es-
sential element of GSK’s action, a finding of inducement
cannot stand.” Id.
The district court also determined no reasonable juror
could have found induced infringement based on the
post-MI LVD indication in Teva’s partial label, which GSK
had argued instructed practice of the claimed method. Id.
at 592 n.9. Although the district court acknowledged there
is some overlap with CHF patients and post-MI LVD pa-
tients, it reasoned “the two indications are distinct and re-
quire different clinical testing and different FDA approvals
to treat.” Id. It further reasoned infringement required
carvedilol be “prescribed to treat the risk of mortality
caused by CHF.” Id. (emphasis in original). The district
court concluded a reasonable juror could not have found
Teva’s post-MI LVD indication “caused or even encouraged
direct infringement” of this claimed use. Id.
GSK appealed, arguing that substantial evidence sup-
ported the jury’s finding of induced infringement and that
its verdict should be reinstated. We agreed. Teva peti-
tioned for en banc rehearing, which we construed as also
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10 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

requesting panel rehearing. Teva argued our October 2,
2020 decision could be broadly read to impose liability on
ANDA filers that carve out patented uses under section viii
when seeking approval to market generic drug products, in
direct contravention of the Hatch-Waxman Act. Amici cu-
riae raised concerns about lack of clarity of our decision
when the patented uses are carved out of the FDA-
approved label. On February 9, 2021, we granted the peti-
tion for panel rehearing, vacated the October 2, 2020 judg-
ment, and withdrew the October 2, 2020 opinions.
Amici were concerned that our prior decision could be
read to upset the careful balance struck with section viii
carve-outs. The Novartis Brief explained, “Generics could
be held liable for actively inducing infringement if they
marketed a drug with a label describing a patented thera-
peutic use or if they took active steps to encourage doctors
or patients to use the drug in an infringing manner. But
generics could not be held liable for merely marketing and
selling under a ‘skinny’ label omitting all patented indica-
tions, or for merely noting (without mentioning any infring-
ing uses) that FDA had rated a product as therapeutically
equivalent to a brand-name drug.” Novartis Br. at 1–2. We
agree that Novartis accurately stated the law, and we
agreed to rehear this case to make clear how the facts of
this case place it clearly outside the boundaries of the con-
cerns expressed by amici. As this record reflects, in both
time periods, substantial evidence supports that Teva ac-
tively induced by marketing a drug with a label encourag-
ing a patented therapeutic use. They did not “omit[] all
patented indications” or “merely note[] (without mention-
ing any infringing uses) that FDA had rated a product as
therapeutically equivalent to a brand-name drug.” Novar-
tis Br. at 1–2. This is a case in which substantial evidence
supports a jury finding that the patented use was on the
generic label at all relevant times and that, therefore, Teva
failed to carve out all patented indications. This narrow,
case-specific review of substantial evidence does not upset
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 11

the careful balance struck by the Hatch-Waxman Act re-
garding section viii carve-outs.
DISCUSSION
We apply regional circuit law for review of a district
court’s grant of JMOL. Lucent Techs., Inc. v. Gateway, Inc.,
580 F.3d 1301, 1309 (Fed. Cir. 2009). The Third Circuit
reviews those grants de novo. Curley v. Klem, 499 F.3d 199,
205–06 (3d Cir. 2007). Following a jury trial, a district
court should grant JMOL “sparingly” and “only if, viewing
the evidence in the light most favorable to the nonmovant
and giving it the advantage of every fair and reasonable
inference, there is insufficient evidence from which a jury
reasonably could find liability.” Marra v. Phila. Hous.
Auth., 497 F.3d 286, 300 (3d Cir. 2007). “To prevail on a
renewed motion for JMOL following a jury trial, a party
must show that the jury’s findings, presumed or express,
are not supported by substantial evidence or, if they were,
that the legal conclusion(s) implied by the jury’s verdict
cannot in law be supported by those findings.” Power Inte-
grations, Inc. v. Fairchild Semiconductor Int’l, Inc., 843
F.3d 1315, 1326 (Fed. Cir. 2016).
I
INDUCED INFRINGEMENT
“Whoever actively induces infringement of a patent
shall be liable as an infringer.” 35 U.S.C. § 271(b). “In-
fringement is a question of fact, reviewed for substantial
evidence when tried to a jury.” Lucent, 580 F.3d at 1309.
A finding of inducement requires establishing “that the de-
fendant possessed specific intent to encourage another’s in-
fringement.” DSU Med. Corp. v. JMS Co., 471 F.3d 1293,
1306 (Fed. Cir. 2006) (en banc in relevant part) (internal
quotation marks omitted). This requires a plaintiff to show
“that the alleged infringer’s actions induced infringing acts
and that he knew or should have known his actions would
induce actual infringements.” Id. (internal quotation
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12 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

marks omitted). “While proof of intent is necessary, direct
evidence is not required; rather, circumstantial evidence
may suffice.” Id. (internal quotation marks omitted).
When a plaintiff relies on a drug’s label accompanying the
marketing of a drug to prove intent, “[t]he label must en-
courage, recommend, or promote infringement.” Takeda
Pharm. USA, Inc. v. West-Ward Pharm. Corp., 785 F.3d
625, 631 (Fed. Cir. 2015) (citations omitted).
GSK argues that substantial evidence supports the
jury’s verdict of induced infringement. Throughout the
trial and on appeal, GSK argued there are two indications
on the labels that instruct doctors to prescribe carvedilol
for uses that directly infringe the ’000 patent claims: the
post-MI LVD indication and the congestive heart failure in-
dication. Thus, GSK argues both the partial label and the
full label encourage infringement. We first address the
partial label period and then turn to the full label period.
THE PARTIAL LABEL PERIOD
A generic producer may exclude a patented use from its
label, by way of a “section viii carveout” as provided by
21 U.S.C § 355(j)(2)(A)(viii):
(2)(A) An abbreviated application for a new drug
shall contain—
(i) information to show that the conditions
of use prescribed, recommended, or sug-
gested in the labeling proposed for the new
drug have been previously approved for a
drug listed under paragraph (7) (hereinaf-
ter in this subsection referred to as a “listed
drug”);
***
(viii) if with respect to the listed drug re-
ferred to in clause (i) information was filed
under subsection (b) or (c) for a method of
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 13

use patent which does not claim a use for
which the applicant is seeking approval un-
der this subsection, a statement that the
method of use patent does not claim such a
use.
The applicant must also submit its proposed label to
the FDA omitting or carving out all methods of use claimed
in a patent. 21 C.F.R. § 314.94(a)(8)(iv). “FDA acceptance
of the carve-out label allows the generic company to place
its drug on the market (assuming the ANDA meets other
requirements), but only for a subset of approved uses—i.e.,
those not covered by the brand’s patents.” Caraco Pharm.
Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 406 (2012).
GSK argues that, despite Teva’s section viii certifica-
tion purporting to carve out one heart failure indication
and its deletion of the indication from its partial label, sub-
stantial evidence supports the jury’s finding that Teva in-
duced doctors to infringe the method of use claimed in the
’000 patent. GSK argues that substantial evidence sup-
ports the jury’s verdict that Teva’s partial label encouraged
an infringing use (via the post-MI LVD indication) and that
Teva’s marketing materials encouraged prescribing carve-
dilol in a manner that would cause infringement of the ’000
patent. We agree.
A
The parties dispute whether Teva effected a section viii
carve-out of GSK’s patented methods of use, making Teva’s
label a so-called “skinny label.” Since the jury found in-
fringement, we must assume it decided that question in
GSK’s favor. Williamson v. Consol. Rail Corp., 926 F.2d
1344, 1348 (3d Cir. 1991) (“When reviewing the jury’s find-
ing . . . , we give [plaintiff], as verdict winner, the benefit of
all logical inferences that could be drawn from the evidence
presented, resolve all conflicts in the evidence in his favor
and, in general, view the record in the light most favorable
to him.”). And as a quintessential fact question, we must
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14 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

uphold the jury’s verdict on that point so long as substan-
tial evidence supports it. GSK provided substantial evi-
dence that Teva’s partial label instructed the method of use
claimed in the ’000 patent and thus was not a skinny label.
At the outset, GSK’s cardiology expert, Dr.
McCullough, explained that doctors, the alleged direct in-
fringers, receive information about generic drug products
from a variety of sources, including the drug labels. J.A.
10612:1–9. He then walked through each element of claim
1 of the ’000 patent and compared it to Teva’s partial label.
He relied on the post-MI LVD indication in Teva’s partial
label, which stated:
Carvedilol is indicated to reduce cardiovascular
mortality in clinically stable patients who have
survived the acute phase of a myocardial infarction
and have a left ventricular ejection fraction of
≤ 40% (with or without symptomatic heart failure)
(see CLINICAL STUDIES [14.1]).
J.A. 5508 (emphasis and brackets in original). Dr.
McCullough testified this description satisfied the “de-
creasing mortality caused by congestive heart failure in a
patient” limitation. See J.A. 10623:6–17; see also J.A.
10629:19–10630:6, 10630:16–20. He also explained that
post-MI LVD “is intertwined with heart failure.” J.A.
10673:23–10674:1. Teva’s cardiology expert, Dr. Zusman,
agreed that a patient who has a left ventricular ejection
fraction of less than or equal to 40% with symptomatic
heart failure (as recited on Teva’s partial label) would be
diagnosed as suffering from congestive heart failure under
the district court’s construction. J.A. 11226:14–19.
GSK presented evidence that Teva’s partial label also
satisfied the remaining claim limitations. Dr. McCullough
testified that the Dosage and Administration section of the
partial label disclosed administering particular dosages
that satisfied the “administering a therapeutically accepta-
ble amount of carvedilol” and administering “daily
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 15

maintenance dosages” limitations. See J.A. 10624:12–18,
10624:24–10625:3, 10626:9–19, 10626:23–10627:1. The
post-MI LVD indication, the portion of the label Dr.
McCullough testified satisfied the CHF limitation, explic-
itly directs the reader to Clinical Studies § 14.1 of Teva’s
label. J.A. 5508. The Clinical Studies § 14.1 showed that
patients taking carvedilol in the study had background
treatment of ACE inhibitors and diuretics. Dr.
McCullough explained this satisfied the claim limitation of
administering carvedilol in conjunction with one or more
other therapeutic agents selected from the group consisting
of ACE inhibitors, a diuretic, and digoxin. J.A. 10625:4–
19, 10625:24–10626:8; see also J.A. 5523 (CAPRICORN
study in which 47% of patients receiving carvedilol had
symptoms of heart failure, 97% also had background treat-
ment of ACE inhibitors or angiotensin receptor blockers,
and 34% had background treatment of diuretics); Sanofi v.
Watson Labs. Inc., 875 F.3d 636, 645 (Fed. Cir. 2017) (In-
dication section referencing clinical study section “ex-
pressly direct[ed] the reader to that section for elaboration
of the class of patients for whom the drug is indicated to
achieve the stated objective”). Finally, Dr. McCullough tes-
tified that Figure 1 in Clinical Studies § 14.1 showed treat-
ment for longer than six months, which satisfied the
“maintenance period is greater than six months” limita-
tion. J.A. 10627:9–21, 10629:15–18, 10630:21–10631:6,
10631:12–15; see also J.A. 5524 (Fig. 1).
Teva characterizes GSK’s argument as a “cobbl[ing] to-
gether” of disparate portions of the partial label. Teva
Principal and Resp. Br. at 48, 50. The dissent appears to
adopt Teva’s characterization, arguing that a jury would
have to “piece[] together” the partial label to arrive at the
infringing use. Dis. at 18–20; see also id. at 33. All of the
claim limitations were contained in the Indication section
(which amounted to a single sentence), the Clinical Study
section (to which doctors were directly referred by the In-
dication section), and the Dosage and Administration
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16 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

section (which immediately follows the Indication section
and which says how much and how often to give the carve-
dilol). The jury was entitled to credit expert testimony re-
garding the label’s instructions on who should take what
drug, when, why, and how, and to reject the argument that
certain portions of the label were disjointed from others.
Teva relies on our decision in Bayer Schering Pharma
AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012). In Bayer
Schering, the patented method of use required achieving
three simultaneous effects in the body. Id. at 1320. The
defendant’s drug product label contained an indication for
only one of those effects, with no discussion of safety or ef-
ficacy for the other two claimed effects. Id. at 1322. Thus,
we held the label failed to recommend or suggest achieving
the claimed combination of effects. Id. at 1324. Here, how-
ever, as discussed above, Dr. McCullough marched through
Teva’s label explaining how it met the limitations of claim
1. Unlike the absence of information in the label of Bayer
Schering, Dr. McCullough provided testimony that Teva’s
partial label instructed the claimed treatment and use.
Teva never genuinely challenged Dr. McCullough’s tes-
timony regarding the contents of Teva’s partial label. Teva
cites portions of Dr. Zusman’s testimony as purporting to
contradict that the post-MI LVD indication means treating
heart failure. Teva relies on Dr. Zusman’s testimony that
treating patients to help them survive heart attack is not
treating heart failure. Teva Principal and Resp. Br. at 53
(citing J.A. 11183). But Dr. Zusman also agreed the post-
MI LVD patients with symptomatic heart failure would be
diagnosed as suffering from congestive heart failure under
the district court’s construction of that term (which has not
been appealed). J.A. 11226:14–19. It was within the prov-
ince of the jury to weigh the testimony presented by both
sides and make its finding. See Dardovitch v. Haltzman,
190 F.3d 125, 140 (3d Cir. 1999) (“Credibility determina-
tions are the unique province of a fact finder, be it a jury,
or a judge sitting without a jury.”); MobileMedia Ideas LLC
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 17

v. Apple Inc., 780 F.3d 1159, 1168 (Fed. Cir. 2015) (“[W]hen
there is conflicting testimony at trial, and the evidence
overall does not make only one finding on the point reason-
able, the jury is permitted to make credibility determina-
tions and believe the witness it considers more
trustworthy.”).
We also do not agree with Teva’s argument that its par-
tial label’s recitation of treating patients “with or without
symptomatic heart failure” precludes inducement since
this may encourage both infringing and noninfringing
uses. Teva relies on HZNP Medicines LLC v. Actavis La-
boratories UT, Inc., 940 F.3d 680 (Fed. Cir. 2019), and
Grunenthal GmbH v. Alkem Laboratories Ltd., 919 F.3d
1333 (Fed. Cir. 2019). According to Teva, when its generic
carvedilol is used to treat patients without symptomatic
heart failure, there is no infringement, and thus, the label’s
recommended use on both types of patients somehow obvi-
ates infringement. We do not find this argument persua-
sive, and neither of the cases cited by Teva is analogous to
these facts.
In HZNP, the claimed method of use required three
steps: applying a topical medication, waiting for the
treated area to dry, and then applying a second topical
product. 940 F.3d at 702. Actavis’ generic label, however,
only required the first applying step. The district court ex-
amined the label and held, at summary judgment, it did
not induce the claimed use. Id. We agreed given the lack
of evidence that the label encouraged, recommended, or
promoted users to perform two of the three claimed steps.
Id. In contrast, substantial evidence in this case supports
the jury’s determination that Teva’s partial label contained
information encouraging each claimed step and the pream-
ble. Dr. McCullough’s testimony that the partial label met
each claim limitation and represented to doctors that the
treatment decreased mortality caused by CHF supports the
jury’s finding. See J.A. 10623:6–17, 10629:19–10630:6,
10630:16–20.
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18 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

In Grunenthal, the claimed method of use was treating
polyneuropathic pain. 919 F.3d at 1336. The defendants
filed section viii statements carving out treatment of dia-
betic peripheral neuropathy (DPN), a type of polyneuro-
pathic pain. Id. at 1339. The generic labels nonetheless
maintained an indication to broadly treat severe pain re-
quiring around-the-clock treatment. Yet evidence sup-
ported that this severe pain would not necessarily be
polyneuropathic, but could also be mononeuropathic or no-
ciceptive. Id. In that case, the district court made a factual
determination that this label did not instruct the claimed
method. We found no clear error in the district court’s find-
ing of no inducement because the generic labels did not
“implicitly or explicitly encourage or instruct users to take
action that would inevitably lead to . . . treatment of poly-
neuropathic pain.” Id. at 1340. 3 Here, a jury found induce-
ment. The combination of Teva’s partial label, Dr.
McCullough’s element-by-element testimony that the par-
tial label explicitly instructs administering carvedilol for
the claimed use of decreasing mortality caused by CHF,
and Dr. Zusman’s admission that the post-MI LVD indica-
tion falls within the definition of congestive heart failure is
substantial evidence that supports the jury’s finding.
Critically, the district court erred by treating this fact
question—whether the post-MI LVD indication instructs a
physician to prescribe carvedilol for a claimed use—as
though it were a legal one for it to decide de novo. In a
footnote of the district court’s JMOL decision, it decided the
post-MI LVD portion of Teva’s label was insufficient to find
that the label instructed an infringing use. Dist. Ct. Op. at
592 n.9. The district court erred at JMOL by making a fact

3 Moreover, in contrast to this case, we recognized in
Grunenthal that the partial label was the only evidence of
inducement and that we could not conclude on those facts
that the district court clearly erred.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 19

finding, namely, “[w]hile there may be some overlap be-
tween populations of patients suffering from CHF – the
treatment of which is within the scope of the ’000 patent’s
claims – and those suffering from post-MI LVD – whose
treatment is outside the scope of the claims – the two indi-
cations are distinct and require different clinical testing
and different FDA approvals to treat.” Id. Whether treat-
ing post-MI LVD patients with symptomatic heart failure
with carvedilol was within the scope of the claims was a
fact question. It was for the jury, not this court or the dis-
trict court, to resolve. “In determining whether the evi-
dence is sufficient to sustain [the jury’s finding of] liability,
the court may not weigh the evidence, determine the cred-
ibility of witnesses, or substitute its version of the facts for
the jury’s version.” Lightning Lube, Inc. v. Witco Corp., 4
F.3d 1153, 1166 (3d Cir. 1993). The district court erred in
reweighing the evidence and finding against GSK following
the jury’s verdict in its favor.
B
To be sure, the record was not devoid of contrary or
equivocal evidence. Teva argues that GSK’s submissions
to the FDA for Orange Book listing associated with the ’000
patent is such evidence. If a new drug application (NDA)
has already been approved when the applicant obtains a
patent, the applicant must notify the FDA of such patent
within 30 days of it issuing. 21 C.F.R. § 314.53(c)(2)(ii).
Under penalty of perjury, GSK submitted information for
the ’000 patent, which issued after carvedilol was FDA-
approved, declaring it claimed a method of use for carve-
dilol. J.A. 6880–87 (Form FDA 3542). GSK was required
in part 4.2a of its declaration to “identify the use with spe-
cific reference to the approved labeling for the drug prod-
uct.” J.A. 6881. It listed: “treatment of mild-to-severe
heart failure of ischemic or cardiomyopathic origin, usually
in addition to diuretics, ACE inhibitor, and digitalis, to in-
crease survival.” Id. GSK did not mention the post-MI
LVD indication in this submission to the FDA. This,
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20 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

however, does not appear to be the information listed in the
Orange Book.
The FDA further required, in part 4.2b of the Form,
that GSK “[s]ubmit the description of the approved indica-
tion or method of use that [it] propose[d] FDA include as
the ‘Use Code’ in the Orange Book.” J.A. 6882. GSK an-
swered: “Decreasing Mortality Caused By Congestive
Heart Failure.” Id. The FDA accepted that representation
and listed the corresponding use code in the Orange Book
as describing what is covered by the ’000 patent.
There are two ways in which GSK’s failure to identify
the post-MI LVD use in its part 4.2a statement could be
relevant to inducement in this case. First, that failure is
relevant to whether the post-MI LVD use infringes. Sec-
ond, at least for the partial label period, that failure is rel-
evant to intent to induce infringement. 4 On both points,
the jury decided against Teva.
As Teva acknowledged, GSK’s submissions to the FDA
are “not absolutely dispositive of infringement.” See Glax-
oSmithKline LLC v. Teva Pharm. USA, Inc., No. 18-1976
(Feb. 23, 2021), Oral Arg. at 55:49–57:07, available at
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=18-
1976_02232021.mp3. As we have observed, “the FDA is not
the arbiter of patent infringement issues.” AstraZeneca LP
v. Apotex, Inc., 633 F.3d 1042, 1061 (Fed. Cir. 2010). In
fact, the FDA has made clear that use codes in the Orange
Book “are not meant to substitute for the [ANDA] appli-
cant’s review of the patent and the approved labeling.”

4 It is hard to imagine how GSK’s failure to identify
that the ’000 patent claims the post-MI LVD use has any
bearing on the full label period, as during the full label pe-
riod, Teva’s listed all three indications without regard for
GSK’s assertions in the Orange Book or its FDA declara-
tion.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 21

Applications for FDA Approval to Market a New Drug, 68
Fed. Reg. 36,676, 36,683 (June 18, 2003) (to be codified at
21 C.F.R. pt. 314). The FDA further concluded that it has
no expertise in patent law and that a court is the appropri-
ate forum for determining the scope of patent rights. Id.;
see also Trial Tr. at 525:12–526:15 (GSK’s regulatory ex-
pert, Prof. Lietzan, discussing the FDA’s statements).
Teva’s FDA expert, Mr. Karst, agreed that a generic may
not rely upon the Orange Book use codes provided by the
brand for patent infringement purposes and that ANDA
applicants have a separate obligation to analyze the scope
of the patents themselves: 5
Q. And FDA has also stated that [use codes listed
in the Orange Book provided by the patentee] are
not meant to substitute for the applicant’s review
of the patent and the approved labeling. Correct?
A. That is what FDA said, correct.
Q. And that is something that you understand in
your line of work; is that correct?
A. Yes, I do.
[. . .]
Q. You believe there’s a separate obligation by
ANDA applicants to analyze the scope of patents
listed in the Orange Book to determine how to pre-
pare their Section viii carve-out label; is that cor-
rect?

5 In fact, an ANDA filer can omit from its label “an
indication or other aspect of labeling protected by patent,”
whether that patent is contained in the Orange Book or
not. See 21 C.F.R. § 314.94(a)(8)(iv).
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22 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

A. It’s correct that FDA said the statement you just
had up there. I guess it’s gone now, where FDA
provides a statement to that effect. That is correct.
Trial Tr. at 1057:13–1058:10. Both FDA experts agreed
that the FDA plays no role in determining patent infringe-
ment. The jury heard this evidence and the evidence dis-
cussed above as to GSK’s claim that the post-MI LVD
indication infringed the ’000 patent. Thus, substantial ev-
idence supports the jury’s finding that the post-MI LVD in-
dication infringed the ’000 patent.
At oral argument on rehearing, Teva suggested that
GSK’s FDA submission for the Orange Book listing for the
’000 patent, which according to Teva is at odds with GSK’s
infringement allegations, creates equitable estoppel. See
Oral Arg. at 53:56–55:28. There are serious consequences
for filing false or incomplete information to the FDA. See
id. at 55:28–56:04 (Teva explaining the consequences in-
cluding rejection of the NDA); see also 18 U.S.C. § 1001 (it
is a criminal act to file a false declaration under penalty of
perjury). Teva argues one such consequence ought to be
equitable estoppel, which should preclude GSK’s assertion
of the ’000 patent against Teva at least as to the post-MI
LVD use. GSK’s representations regarding the Orange
Book listing of the ’000 patent, Teva’s reliance, and fairness
go directly to an equitable estoppel defense, which has not
yet been tried to the district court. The district court
acknowledged that Teva raised this defense, but decided
that it was “reserved to be tried to the Court at a later
date.” J.A. 29.
There are factual disputes regarding the estoppel issue
that the district court has not yet had an opportunity to
decide. For example, GSK argued on appeal that the use
code that was listed in the Orange Book—“decreasing mor-
tality caused by congestive heart failure”—covers all heart
failure patients including post-MI LVD patients and that
Teva’s assertion that the use code covers only the CHF
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 23

indication is wrong. GSK Resp. and Reply Br. at 30. GSK
further argues that “the use code is not tied to any partic-
ular indication, and the FDA tells generics that the use
code ‘is not meant to substitute for the applicant’s review
of the patent and the approved labeling.’” Id. (quoting 68
Fed. Reg. at 36,683). And Dr. McCullough testified that
the post-MI LVD indication satisfied the first claim limita-
tion, i.e., decreasing mortality caused by congestive heart
failure. J.A. 10623:6–10623:23. It is also not clear from
this record whether Teva had access to GSK’s declaration
(which was marked confidential and is not included in the
Orange Book). Teva responds that it modified the label ex-
actly as the FDA instructed it to in accordance with the
GSK-provided use code. See J.A. 6908–10 (FDA mark-up
of Teva label). As acknowledged above, Teva’s own FDA
expert, Mr. Karst, explained that an ANDA filer must per-
form its own analysis for patent infringement purposes.
Trial Tr. at 1057:13–1058:10 (testimony of Mr. Karst). Is-
sues of fact remain as to GSK’s representations and Teva’s
reliance on those representations that have been “reserved
to be tried” by the district court. J.A. 29.
The dissent proposes that this court leapfrog that nor-
mal process and resolve these questions of law, equity, and
fact on appeal without any trial. We decline to do so. The
dissent claims it is not focused on estoppel, but rather on
whether “the law” permits an inference of intent from a la-
bel in light of GSK’s representations to the FDA. See Dis.
at 19. The dissent would hold that GSK’s representations
to the FDA in its declaration bar a finding of intent by the
jury as a matter of law regardless of the remainder of the
record. But intent is itself a question of fact, and this rec-
ord contained substantial evidence from which the jury
could find Teva intended to infringe despite GSK’s repre-
sentation to the FDA. This rule of law the dissent seeks is
exactly the estoppel case made by Teva, which the district
court has yet to try.
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24 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

The issues before us are the issues that were tried to
the jury and decided in the district court. We conclude sub-
stantial evidence supports the finding that Teva’s partial
label was evidence Teva instructed physicians to use its
carvedilol in an infringing way. Dr. McCullough explained
where Teva’s partial label met each claim limitation and
discussed other materials that would lead physicians to the
partial label, culminating with his conclusion that Teva
took action that it “intended would encourage or assist ac-
tions by another, i.e., the physician.” J.A. 10644:15–19.
Dr. McCullough did not testify that Teva’s actions merely
describe infringement; he testified that Teva’s actions en-
couraged infringement.
The dissent’s suggestion that there were only three
pieces of evidence (the partial label plus the two press re-
leases) on which the jury could have relied to find intent is
equally inaccurate. The jury received Teva’s partial label,
extensive expert testimony, Teva’s product catalogs, Teva’s
advertising and promotional activities, Teva’s Monthly
Prescribing References for doctors, and testimony from
Teva’s own company witnesses, all of which the jury could
have relied on to find Teva intended to encourage, recom-
mend, or promote infringement.
As the Supreme Court explained in Grokster:
Evidence of active steps taken to encourage direct
infringement such as advertising an infringing use
or instructing how to engage in an infringing use,
show an affirmative intent that the product be used
to infringe, and a showing that infringement was
encouraged overcomes the law’s reluctance to find
liability when a defendant merely sells a commer-
cial product suitable for some lawful use.
Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545
U.S. 913, 936 (2005) (citation and alterations omitted). In
this case, we must presume the jury found that Teva sold
carvedilol with a label that instructed physicians to use it
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 25

in an infringing manner. Our precedent has consistently
held that, when a product is sold with an infringing label
or an infringing instruction manual, such a label is evi-
dence of intent to induce infringement. See Vanda Pharm.
Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1130–
31 (Fed. Cir. 2018) (no clear error in the district court’s
finding that the label instructions constituted a recommen-
dation to infringe the claimed use); Sanofi v. Watson Labs.
Inc., 875 F.3d 636, 646 (Fed. Cir. 2017) (“The content of the
label in this case permits the inference of specific intent to
encourage the infringing use.”); Eli Lilly and Co. v. Teva
Parenteral Med., Inc., 845 F.3d 1357, 1368 (Fed. Cir. 2017)
(“When the alleged inducement relies on a drug label’s in-
structions, ‘[t]he question is not just whether [those] in-
structions describ[e] the infringing mode, . . . but whether
the instructions teach an infringing use such that we are
willing to infer from those instructions an affirmative in-
tent to infringe the patent. The label must encourage, rec-
ommend, or promote infringement.’”) (citation omitted)
(quoting Takeda, 785 F.3d at 631); AstraZeneca, 633 F.3d
at 1060 (“The pertinent question is whether the proposed
label instructs users to perform the patented method. If so,
the proposed label may provide evidence of . . . affirmative
intent to induce infringement.”); Arthrocare Corp. v. Smith
& Nephew, Inc., 406 F.3d 1365, 1377 (Fed. Cir. 2005) (af-
firming jury’s induced infringement determination when
defendant distributed marketing material and manuals
that instructed how to use the product in an infringing
manner). 6

6 Consistent with all of these cases, when a label in-
structs or teaches an infringing use, it can be considered
evidence of intent to encourage that use. The jury was en-
titled to credit expert testimony regarding the label’s in-
structions on who should take what drug, when, why, and
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26 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

We assume, as we must, that the jury found the post-
MI LVD use infringes the ’000 patent, and that Teva’s label
contained instructions encouraging prescribing carvedilol
in a manner that infringes the ’000 patent. Throughout,
the dissent claims that there was not substantial evidence
upon which the jury could conclude that Teva’s label would
encourage doctors to prescribe Teva’s carvedilol for the la-
beled uses. That is because, according to Teva (and the dis-
sent), there is no evidence that doctors read labels or
prescribe according to those labels. But the jury was pre-
sented expert testimony from Dr. McCullough (GSK’s ex-
pert), from Dr. Zusman (Teva’s expert), and from Teva’s
own documents to the contrary. First, Dr. McCullough tes-
tified that doctors do read labels. See J.A. 10612:7–9 (“Q.
Two, that doctors don’t read labels? Do you agree that that
is the case? A. No, I disagree with that.”). Second, Teva’s
own Monthly Prescribing References, which were “in-
tended solely for use by the medical professional,” ex-
plained that “[t]he clinician must be familiar with the full
product labeling provided by the manufacturer or distribu-
tor of the drug, of every product he or she prescribes, as
well as the relevant medical literature.” J.A. 6196 (Teva’s
2012 Monthly Prescribing Reference); see also J.A.
10611:19–25 (Dr. McCullough); Trial Tr. at 1253:15–23,
1254:23–1255:9 (Dr. Zusman agreeing that Teva’s MPR in-
dicates that the MPR “has been produced to provide an eas-
ily accessible reminder of basic information useful to
review when prescribing medications” and that physicians
should verify any questions against the labelling). In other
words, the literature Teva provided to doctors told them to
read labels and to prescribe according to them. While
Teva’s Monthly Prescribing References were published
during the full label period, they powerfully refute Teva’s
claim that doctors do not and need not read labels in

how, and to reject the dissent’s claim that the label de-
scribes rather than instructs as to an infringing use.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 27

conjunction with their prescribing practices. Teva’s own
Monthly Prescribing References merely confirm the quite
logical proposition that doctors read labels and that the la-
bels are intended to affect prescribing decisions. We cannot
conclude that it would be unreasonable for the jury to think
that, in 2007 or 2011, Teva believed doctors did not and
need not read labels and only then wisened to the idea in
2012. In fact, Teva’s own Director of National Accounts,
Mr. Rekenthaler, testified to his belief that doctors would
prescribe carvedilol according to the package insert (the la-
bel). Trial Tr. at 590:15–17 (“I guess my expectation is, like
any drug, that it would be used as detailed in the package
insert.”); id. at 592:5–8 (“I mean my assumption would be,
unless something specific was brought up, that it would be
used, that the physicians would use it as they should use
it, again which is detailed in our insert.”).
This is record evidence that Teva intended its label to
affect physician’s prescribing practices, and the jury was
entitled, as our caselaw has repeatedly held, to rely upon
that to determine Teva’s intent. But it is not the only evi-
dence.
GSK also presented extensive expert testimony along
with Teva’s marketing efforts, catalogs, press releases, and
testimony from Teva’s own witnesses, showing that Teva
encouraged carvedilol sales for CHF despite its attempted
carve-out. This is evidence supporting the jury’s finding
that Teva induced infringement.
The jury was presented with evidence of Teva’s mar-
keting materials. Teva’s Spring 2008 and Spring 2009
Product Catalogs described Teva’s carvedilol as an
AB rated therapeutic equivalent to Coreg®. J.A. 6221,
6270. Teva and amici agree that an AB rating means the
generic product is therapeutically equivalent to the brand
product under the conditions specified in the generic’s la-
bel. As explained above, substantial evidence supports the
jury’s presumed conclusion that the partial label’s
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28 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

indication for post-MI LVD did not effectively carve out the
use claimed in the ’000 patent. Thus, Teva’s AB rated rep-
resentations under these limited circumstances, when sub-
stantial evidence supports the jury’s presumed
determination regarding the label’s contents, are further
affirmative evidence supporting the jury’s inducement
finding. 7
GSK also presented evidence that, prior to the ’000 pa-
tent’s issuance, Teva issued two relevant press releases:
one in 2004 and another in 2007. In its 2004 press release,
Teva announced that the FDA granted it “tentative ap-
proval” for its carvedilol tablets, with final approval “antic-
ipated upon expiry of patent protection for the brand
product on March 5, 2007.” J.A. 6347. It noted its “Carve-
dilol Tablets are the AB rated generic equivalent of Glax-
oSmithKline’s Coreg® Tablets and are indicated for
treatment of heart failure and hypertension.” Id. (emphasis
added). The dissent suggests that Teva’s “reference to
heart failure” is not evidence that supports the jury’s find-
ing that Teva intended to encourage infringement of GSK’s
claimed method. The entire purpose of this press release
is to announce its approval as a substitute for GSK’s
Coreg® Tablets, and it expressly says that the Teva generic
“tablets are the AB-rated generic equivalent of Glax-
oSmithKline’s Coreg® Tablets and are indicated for treat-
ment of heart failure and hypertension.” J.A. 6347. The
press release’s use of “heart failure” does not parse between
congestive heart failure or post-MI LVD. This is not an

7 We do not hold that an AB rating in a true section
viii carve-out (one in which a label was produced that had
no infringing indications) would be evidence of inducement.
In this case, Teva’s representation of AB rating would point
physicians to its partial label, which, for the reasons above,
the jury was free to credit as evidence of induced infringe-
ment.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 29

errant reference to “heart failure”; it is Teva in a press re-
lease telling the world that its generic is a substitute for
GSK’s Coreg® tablets to treat congestive heart failure in
the same manner as Coreg® (which is a method that in-
fringed the ’000 patent). The dissent criticizes our analy-
sis, claiming that we have weakened intentional
encouragement because “simply calling a product a ‘generic
version’ or ‘generic equivalent’—is now enough.” Dis. at
34–35. That is not our holding or the facts.
Though the dissent seems to think the press release is
not evidence of encouragement, it seems self-evident that a
jury could conclude that Teva’s intent in issuing a press re-
lease telling the world it could use Teva’s tablets as a sub-
stitute for GSK’s Coreg® tablets to treat congestive heart
failure was to encourage that use. Moreover, Dr.
McCullough testified that he saw the 2004 press release
and that it indicates physicians should prescribe generic
carvedilol for heart failure. J.A. 11656:1–10; J.A. 11657:6–
10 (testifying that Teva’s press release informed doctors
that “it certainly should be” prescribed for the treatment of
heart failure); J.A. 11659:11–19 (Teva’s press release indi-
cates that doctors should be able to prescribe generic car-
vedilol for heart failure). Dr. McCullough also testified
that doctors consider press releases so they “know when
drugs are going generic.” J.A. 11655:9–24.
Teva issued a second press release in 2007 in which it
stated that it had received final approval “to market its Ge-
neric version of GlaxoSmithKline’s cardiovascular agent
Coreg® (Carvedilol) Tablets.” J.A. 6353. Dr. McCullough
testified that the 2007 press release’s use of “cardiovascu-
lar agent” indicated to doctors they could use Teva’s carve-
dilol “for all indications,” including heart failure. J.A.
11660:3–13. Dr. McCullough also testified that he believed
that this press release would encourage doctors to pre-
scribe Teva’s generic carvedilol for the infringing indica-
tions. J.A. 10644:15–19 (“Q. And so this element that Teva
took action and failed to take action, what Teva intended
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30 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

would encourage or assist actions by another party, i.e., the
physician. In your expert opinion, has that requirement
been met? A. Yes.” (emphasis added)) (Dr. McCullough dis-
cussing the impact of the press releases on doctors). On
appeal, we review the jury’s verdict for substantial evi-
dence based upon the record; we cannot hunt outside the
record to find evidence to try to contradict the verdict. The
dissent claims there is no intentional encouragement be-
cause the word cardiovascular is “[a] well-understood ad-
jective” that means “relating to the heart,” and as such
Teva’s press release could simply be read to encourage use
for non-patented heart related conditions. Dis. at 23.
First, the dissent goes outside the record to make up this
definition, something the district court explicitly told the
jury it could not do. See Trial Tr. at 264 (“During the course
of the trial, you must not conduct any independent re-
search about the case . . . . In other words, you should not
consult dictionaries or reference materials.”). Second,
there was actual testimony in the record about how the
word cardiovascular in this press release would be under-
stood by skilled artisans. See J.A. 11660:3–13 (McCullough
testifying that a skilled artisan would understand the word
cardiovascular in this press release to indicate that the ge-
neric could be used for all indications including heart fail-
ure). Third, Teva did not merely say its drug is a
cardiovascular agent, leaving the world to wonder about its
uses. It said its product is a generic equivalent of GSK’s
cardiovascular agent Coreg®. It was reasonable for the jury
to conclude, especially in light of the prior press release
that expressly mentioned heart failure, that Teva was
again encouraging the substitution of its product for all of
Coreg’s® cardiovascular indications, including as claimed
in the ’000 patent.
We have acknowledged that, as a matter of law, affirm-
ative acts taken before a patent issues cannot violate
§ 271(b). Nat’l Presto Indus., Inc. v. W. Bend Co., 76 F.3d
1185, 1196 (Fed. Cir. 1996). Consistent with this rule, the
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 31

jury was instructed GSK needed to prove by a preponder-
ance of the evidence:
that Teva took some affirmative action, or that
Teva continued to take an action that began before
the ’000 patent issued, after the ’000 patent was is-
sued on January 8, 2008, intending to cause the
physicians to directly infringe by administering
Teva’s carvedilol product[.]
J.A. 168. In this case, the jury was presented with evidence
from which it could infer that Teva’s press releases re-
mained on Teva’s website until at least 2015. J.A. 6353
(2007 press release date stamped “4/14/2015”). Teva’s Di-
rector of Marketing testified that Teva added carvedilol
product information to the Teva website as part of its 2007
launch. J.A. 10991:13–22 (Suzanne Collier, Teva’s Direc-
tor of Marketing Communications and Trade Dress). The
2007 press release given to the jury contains a directory
path showing it was stored on the Teva website as follows:
“Home page>Media>Latest News.” And GSK demon-
strated the 2007 Teva press release was available on the
Teva website as late as 2015. The press releases were ex-
tensively and repeatedly presented before the jury, with at
least five witnesses discussing them. See J.A. 10643:2–
10644:14, 11656:4–11657:5, 11659:11–11660:17 (discussed
with Dr. McCullough); J.A. 11238:10–11241:14, Trial Tr. at
1241:15–1243:5 (discussed with Dr. Zusman); J.A.
10533:16–23, 10542:1–25 (discussed with Prof. Lietzan);
Trial Tr. at 445:9–447:10, J.A. 10973:15–10974:23, Trial
Tr. at 974:24–975:4 (discussed with Teva’s Senior Director
of Regulatory Affairs, Jill Pastore); Trial Tr. at 1619:9–18
(discussed with Teva’s damages expert, Dr. Sumanth Ad-
danki). Teva neither provided contrary evidence nor ar-
gued to the jury that the press releases, at least one of
which could be found on the Teva website even at the time
of trial, were not available on Teva’s website throughout
the alleged infringement period. Under these circum-
stances, the jury could infer, from Teva’s placement of
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32 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

information on its website and from its press releases, that
Teva intended its website to be a source of information for
prescribing doctors and that its website promoted the in-
fringing use throughout the period of infringement. 8 Teva
had encouraged in its labels, press releases, product cata-
logs, and marketing materials. Substantial evidence sup-
ports the jury’s verdict that Teva induced infringement.
C
GSK presented evidence that Teva’s partial label did
not successfully carve out the patented use, and thus, Teva
was selling its generic with a label which infringed the
method claim. GSK presented evidence that doctors read
and consider labels, that Teva’s marketing materials
guided doctors to the label and to its website promoting the
patented use, that Teva issued press releases encouraging
doctors to prescribe carvedilol for the patented use, that
Teva’s own employees expected doctors to prescribe carve-
dilol during the partial label period for the patented uses,
and expert testimony that Teva’s actions encouraged doc-
tors to do so. This is substantial evidence from which a
reasonable jury could conclude that Teva intentionally en-
couraged the practice of the claimed method. Accordingly,

8 The jury was even presented evidence that Teva
encouraged doctors to visit its website for information
about its generic drugs when prescribing them. Trial Tr.
at 1245:16–19 (Teva’s expert, Dr. Zusman, acknowledging
that Teva advised doctors to “visit its website” to obtain
product information); Trial Tr. at 1249:12–15 (same); Trial
Tr. at 1251:8–11 (same); Trial Tr. at 1258:12–20 (same).
Though the evidence comes from Teva’s 2012 and 2013
Monthly Prescribing References for doctors (during the full
label period), it was reasonable for the jury to conclude that
Teva intended for doctors to visit its website for prescribing
information about the Teva’s products.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 33

substantial evidence supports the jury’s finding of induced
infringement for the partial label period.
THE FULL LABEL PERIOD
Beginning on May 1, 2011, Teva’s carvedilol label con-
tained all three indications present in the Coreg® label.
That is, in addition to the post-MI LVD and hypertension
indications, Teva’s label contained the “Heart Failure” in-
dication. Specifically, it added the following indication:
1.1 Heart Failure. Carvedilol tablets are indicated
for the treatment of mild-to-severe chronic heart
failure of ischemic or cardiomyopathic origin, usu-
ally in addition to diuretics, ACE inhibitors, and
digitalis, to increase survival and, also, to reduce
the risk of hospitalization [see Drug Interactions
(7.4) and Clinical Studies (14.1)].
J.A. 5532 (brackets in original, italics omitted). Dr.
McCullough testified that the addition of the heart failure
indication also met all the claim limitations of the ’000 pa-
tent. J.A. 10623:24–10625:3, 10625:20–10626:11,
10626:20–10627:8, 10628:15–10629:20, 10630:7–23,
10631:7–21. Substantial evidence supports the jury’s pre-
sumed finding that Teva’s full label contains all of the
claim limitations, which Teva does not dispute.
In addition to the information Teva placed in its press
releases and on its websites, Teva sent marketing materi-
als and catalogs to healthcare providers during the full la-
bel period. For example, Teva’s 2012 Monthly Prescribing
Reference, which explained a “clinician must be familiar
with the full product labeling . . . of every product he or she
prescribes, as well as the relevant medical literature,” con-
tained a listing for carvedilol with the heart failure indica-
tion. J.A. 6196, 6200. Dr. McCullough testified that the
2012 MPR was intended for prescribing doctors and that
he and doctors across the country receive the MPR “on a
regular basis.” J.A. 10607:9–10608:1, 10609:19–22. He
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34 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

also testified that the 2012 MPR was telling doctors to “ver-
ify any questions against the labeling or contact the com-
pany marketing the drug,” that the label “provides the base
information that flows to doctors,” and that Teva is “clearly
telling doctors they should read the labels.” J.A. 10610:3–
21.
Teva’s 2013 MPR contained the same information,
same instructions to doctors, and same carvedilol listing
with the heart failure indication. J.A. 6205, 6208. Dr. Zus-
man agreed that one could interpret the 2013 MPR as be-
ing a part of the educational materials Teva provided to
doctors and that Teva wanted the MPR to be a part of a
treating doctor’s toolbox. Trial Tr. at 1250:18–23, 1252:5–
1253:9. He also agreed that the 2013 MPR was instructing
doctors to verify the information in the MPR by referring
to the product labeling or contacting the company market-
ing the drug, here Teva. Trial Tr. at 1254:24–1255:9,
1256:1–10. He also acknowledged that the 2013 MPR in-
structed doctors to visit Teva’s website for more infor-
mation. Trial Tr. at 1258:8–20.
Substantial evidence supports the finding that Teva
encouraged physicians to use its carvedilol for an infring-
ing purpose during the full label period. The jury was en-
titled to credit the full label itself containing the infringing
use, Dr. McCullough’s testimony that the full label con-
tained each claim limitation, and Teva’s marketing mate-
rials as demonstrating Teva specifically intended to
encourage, recommend, or promote the use of carvedilol in
an infringing manner. The dissent confronts none of this
evidence. To be clear, the dissent would overturn a jury
verdict, finding Teva’s full label encouraged doctors to pre-
scribe an infringing manner, as not supported by substan-
tial evidence where the label undisputedly encourages an
infringing uses (CHF) and when Teva tells doctors to read
its label for prescribing information. To do so would be a
major change in our precedent.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 35

CAUSATION
To establish inducement, a patent owner must show
that the accused inducer’s actions actually induced the in-
fringing acts of another and knew or should have known
that its actions would induce actual infringement. DSU
Med., 471 F.3d at 1304. The jury was instructed “GSK
must prove that Teva’s alleged inducement, as opposed to
other factors, actually caused physicians to directly in-
fringe the ’000 patent.” J.A. 173. Teva could only be found
liable for induced infringement if GSK showed “Teva suc-
cessfully communicated with and induced a third-party di-
rect infringer and that the communication was the cause of
the direct infringement by the third-party infringer.” Id.
The jury was also instructed “GSK must prove that Teva’s
actions led physicians to directly infringe a claim of the ’000
patent, but GSK may do so with circumstantial – as op-
posed to direct – evidence.” Id.
Teva argues that it did not cause doctors to actually
prescribe generic carvedilol. Teva argues that, at all rele-
vant times, doctors were prescribing carvedilol for CHF
based on information they had received for GSK’s Coreg®.
Teva points to guidelines from the American College of
Cardiology (ACC), the American Heart Association (AHA),
medical textbooks, and treatises to argue doctors already
knew to treat CHF using carvedilol long before Teva
launched its generic. Teva argues that this information,
not its actions, made physicians aware of all the benefits of
carvedilol for heart failure patients. The district court ac-
cepted Teva’s argument as sufficient to overcome the jury’s
verdict in GSK’s favor. Dist. Ct. Op. at 594. We do not
agree.
The jury had before it Teva’s partial label, full label,
various marketing materials, and press releases. It heard
from the expert witnesses that doctors read labels and that
Teva’s labels satisfied all of the claim limitations. See J.A.
10612:7–9 (testimony of Dr. McCullough: “Q. Two, that
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36 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

doctors don’t read labels? Do you agree that that is the
case? A. No, I disagree with that.”). It also heard that doc-
tors received marketing materials from Teva, that these
materials directed doctors to prescribe according to the la-
bels, and that these materials told doctors to visit Teva’s
website for more information regarding its products. Teva
tried to convince the jury that doctors do not read labels
even after its own marketing material, which was sent di-
rectly to doctors, explicitly instructed them to read the la-
bels.
Despite all of this evidence, Teva asks us to supplant
the role of the jury and reweigh evidence in its favor. But
it was for the jury to decide—not us, the district court, or
the dissent—whether Teva’s efforts actually induced in-
fringement. It was fair for the jury to infer that when Teva
distributed and marketed a product with labels encourag-
ing an infringing use, it actually induced doctors to in-
fringe. 9 “Indeed, we have affirmed induced infringement
verdicts based on circumstantial evidence of inducement
(e.g., advertisements, user manuals) directed to a class of
direct infringers (e.g., customers, end users) without re-
quiring hard proof that any individual third-party direct
infringer was actually persuaded to infringe by that mate-
rial.” Power Integrations, 843 F.3d at 1335; see also Arthro-
care, 406 F.3d at 1377 (“There was also strong
circumstantial evidence that Smith & Nephew’s probes
were used in an infringing manner, and that Smith &

9 The dissent acknowledges that an example of when
a jury might reasonably infer causation is when a product’s
user manual encourages an infringing use. Dis. at 32–33
(collecting cases). But the dissent would hold, nonetheless,
that a jury cannot infer causation from the full label, which
undisputedly contains all of the claim limitations, despite
the evidence showing the full label instructs doctors to in-
fringe, just as a user manual.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 37

Nephew induced users to employ the probes in that way.”).
Given Teva distributed other materials in addition to its
labels, we do not have to decide in this case whether the
labels alone are enough to establish causation. The dissent
criticizes the presence of circumstantial evidence, but as
the jury was correctly instructed, “[i]t is your job to decide
how much weight to give the direct and circumstantial ev-
idence. The law makes no distinction between the weight
that you should give to either one, nor does it say that one
is any better evidence than the other.” J.A. 147 (Jury In-
struction 1.4). The jury had sufficient circumstantial evi-
dence, in the form of labels, marketing materials, catalogs,
press releases, and expert testimony, for it to conclude that
Teva succeeded in influencing doctors to prescribe carve-
dilol for the infringing use. We thus vacate the district
court’s grant of JMOL of no induced infringement and re-
instate the jury verdict, which was supported by substan-
tial evidence.
II
DAMAGES
The Patent Act provides: “the court shall award [the
patent owner] damages adequate to compensate for the in-
fringement, but in no event less than a reasonable royalty
for the use of the invention by the infringer.” 35 U.S.C.
§ 284. To recover lost profit damages, “the patent owner
must show ‘causation in fact,’ establishing that ‘but for’ the
infringement, he would have made additional profits.”
Grain Processing Corp. v. Am. Maize-Prod. Co., 185 F.3d
1341, 1349 (Fed. Cir. 1999).
GSK’s damages expert testified that 17.1% of Teva’s ge-
neric carvedilol sales during the period of infringement
were for the method claimed in the ’000 patent. Teva does
not dispute this calculation. The jury assessed damages of
$234,110,000 based on lost profits, plus a reasonable roy-
alty payment of $1,400,000. The verdict amount is about
half of that presented by GSK’s damages expert. Teva
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38 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

argues that, if the jury had been properly instructed, it
would have assessed no damages or at most only a reason-
able royalty.
Teva argues the jury should have been instructed that
GSK must prove that, for every infringing sale Teva made,
the direct infringer would have purchased Coreg® rather
than another generic producer’s carvedilol. The district
court declined to present that instruction, explaining:
The undisputed evidence is that [Teva’s] generic
carvedilol is interchangeable with the generic car-
vedilol of the non-party manufacturers; therefore,
the generic carvedilol of these non-party manufac-
turers is an infringing alternative – and not a
non-infringing alternative. These non-parties’
products, thus, would not exist in the but-for world,
which must be constructed to include “likely out-
comes with infringement factored out of the
economic picture.” Grain Processing Corp. v.
Am. Maize-Prods. Co., 185 F.3d 1341, 1350 (Fed.
Cir. 1999) (emphasis added).
J.A. 222 (Memorandum Order (June 9, 2017) (emphasis in
original)). The district court recognized that “[i]t is undis-
puted that, at all times relevant to the lost profits analysis,
there were generic carvedilol tablets available from at least
eight different generic manufacturers,” J.A. 222 n.3, and
stated that “[i]t doesn’t matter whether the sales by other
generic suppliers would be non-infringing, because the ul-
timate use of those products by doctors would be infring-
ing and thus not a permissible consideration.” J.A. 223
(emphasis in original).
Teva argues that it was incorrect to instruct the jury
that “[t]he use of the acceptable substitutes also must not
infringe the patent because they did not include all the fea-
tures required by the patent. For example, the use of ge-
neric carvedilol supplied by companies other than Teva
was not an acceptable non-infringing substitute.” J.A. 195
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 39

(Jury Instruction 6.3.3). Teva argues that this instruction
ignores the reality of the marketplace because other carve-
dilol producers who had not been sued for infringement
would have made the sales Teva made, in part because
pharmacies would automatically substitute generic carve-
dilol for Coreg® prescriptions. Teva’s argument is in con-
flict with long-standing precedent that the presence of
noninfringing alternatives precludes an award of lost prof-
its, but the presence of other infringers does not.
The district court correctly instructed the jury that the
availability of carvedilol from other generic producers is
not a “non-infringing substitute.” GSK’s expert’s analysis
accounted for Teva’s sales for the infringing use, amount-
ing to 17.1% of Teva’s total carvedilol sales. Had another
generic producer made those sales, those uses too would
have been infringing. The other generic carvedilol produc-
ers were, therefore, not noninfringing alternatives. See
Grain Processing, 185 F.3d at 1350 (“The ‘but for’ inquiry
therefore requires a reconstruction of the market, as it
would have developed absent the infringing product, to de-
termine what the patentee would have made.”) (internal
quotations and alterations omitted); Micro Motion, Inc. v.
Kane Steel Co., Inc., 894 F.2d 1318, 1322 (Fed. Cir. 1990)
(“There is precedent for finding causation despite an alter-
native source of supply if that source is an infringer.”). Ac-
cordingly, the damages verdict, which is not otherwise
challenged, is sustained.
CONCLUSION
Because substantial evidence supports the jury’s ver-
dict of induced infringement, we vacate the district court’s
grant of JMOL. Because the district court did not err in its
jury instructions on damages, we affirm on the cross-ap-
peal. We remand for appropriate further proceedings.
VACATED-IN-PART, AFFIRMED-IN-PART, AND
REMANDED
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40 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

COSTS
Costs are awarded to GSK.
Case: 18-1976 Document: 187 Page: 41 Filed: 08/05/2021

United States Court of Appeals
for the Federal Circuit
______________________

GLAXOSMITHKLINE LLC, SMITHKLINE
BEECHAM (CORK) LIMITED,
Plaintiffs-Appellants

v.

TEVA PHARMACEUTICALS USA, INC.,
Defendant-Cross-Appellant
______________________

2018-1976, 2018-2023
______________________

Appeals from the United States District Court for the
District of Delaware in No. 1:14-cv-00878-LPS-CJB, Judge
Leonard P. Stark.
______________________

PROST, Circuit Judge, dissenting.
GSK’s patent on carvedilol expired in 2007. At the
time, however, it still had a patent on one of carvedilol’s
three FDA-approved uses. Because the FDA cannot au-
thorize a generic version of a drug that would infringe a
patent, this one remaining patented use could have pre-
vented a less-expensive, generic carvedilol from coming to
market altogether—even though the drug itself and other
uses of it were unpatented. Congress saw this problem
coming. It wanted to make sure that one patented use
wouldn’t prevent public access to a generic version of a
drug that also has unpatented uses. See Caraco Pharm.
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2 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Labs. Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 415 (2012).
So it created rules for just this situation.
These rules, embodied in the so-called skinny-label pro-
visions of the Hatch-Waxman Act, are straightforward. If
a brand drug company (here, GSK) has a patent on one of
a drug’s uses, it tells the FDA which use is patented. In
fact, it tells the FDA exactly what language from its label
is covered by its patents. The FDA will then permit a ge-
neric version of that drug to come to market if the manu-
facturer “carves out” such use from its drug label by
omitting the language that the brand drug company iden-
tified. That’s what happened here. GSK’s sworn FDA fil-
ings identified just one use as patented. So Teva carved
out that use and came to market with its “skinny” label. It
played by the rules, exactly as Congress intended. It sold
its generic for years without controversy.
And then, in the seventh year, GSK finally sued. It al-
leged that, even though Teva’s skinny label carved out the
very use—indeed, the only use—that GSK said was pa-
tented, the label showed that Teva intended to encourage
an infringing use. GSK also supported its inducement case
by pointing to two cursory, pre-patent press releases that
announced Teva’s drug’s approval (or “tentative” approval)
and called it the generic equivalent of GSK’s brand drug
Coreg. The evidence of inducement—i.e., that Teva had
culpable intent to encourage infringement and that its
skinny label or press releases caused doctors’ prescribing
practices—was thin to nonexistent. But a jury found Teva
liable all the same. This sometimes happens. And when it
does, there is a remedy: a court will reverse a jury’s verdict
if there is insufficient evidence to support it. The experi-
enced trial judge sensibly did just that.
The majority, now on its second try, again reinstates
the verdict nonetheless. Its first try prompted widespread
criticism concerning the troubling implications for skinny
labels. This effort is no better. With reasoning sometimes
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 3

labored, sometimes opaque, the majority strains to prop up
a jury verdict that is unsupportable. For example, based
on language that remained on the skinny label after Teva’s
carve-out, the majority finds it reasonable to infer that
Teva intentionally encouraged infringement. It finds this
reasonable even though Teva, by carving out everything
that GSK said would infringe, was trying to avoid having
its label encourage infringement. The majority then in-
dulges the inference that doctors, as a class, relied on
Teva’s skinny label to infringe, even though every expert
cardiologist at trial said he didn’t even read the label to
make prescribing decisions. And, most troubling, the ma-
jority is willing to see culpable intent behind a generic’s de-
scribing its product as the “equivalent” of a brand drug—in
a system that requires generic drugs to be equivalent, and
in which everyone understands that generic drugs are
equivalent.
I write in this case because far from being a disagree-
ment among reasonable minds about the individual facts,
this case signals that our law on this issue has gone awry.
I am particularly concerned with three aspects of the ma-
jority’s analysis. First, even setting aside the majority’s
willingness to glean intentional encouragement from a la-
bel specifically designed to avoid encouragement, the ma-
jority further weakens the intentional-encouragement
prong of inducement by effectively eliminating the demar-
cation between describing an infringing use and encourag-
ing that use in a label. Second, the majority defies basic
tort law by eviscerating the causation prong of inducement.
The upshot of these two moves is that a plaintiff now has
to show very little for a jury to speculate as to the rest.
Third, the majority creates confusion for generics, leaving
them in the dark about what might expose them to liabil-
ity. These missteps throw a wrench into Congress’s design
for enabling quick public access to generic versions of un-
patented drugs with unpatented uses.
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4 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

I. BACKGROUND
A. Hatch-Waxman: Congress’s Compromise
With the Hatch-Waxman Act, Congress contemplated
this case. Indeed, Congressman Waxman himself agrees. 1
When Congress passed the Act, it enacted a complex stat-
utory framework to balance generic and brand interests.
See Drug Price Competition and Patent Term Restoration
Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585. 2 One effect
was to bolster patent terms for brand companies. Eli Lilly
& Co. v. Medtronic Inc., 496 U.S. 661, 669 (1990). Another
was to “speed the introduction of low-cost generic drugs to
the market,” Caraco, 566 U.S. at 405, in part by permitting
immediate market entry for drugs with at least one unpat-
ented FDA-approved use. 3

1 See Brief of Amicus Curiae Former Congressman
Henry A. Waxman in Support of Petition for Rehearing En
Banc 3–8, ECF No. 170 (“Waxman Br.”).
2 See generally Brief of Amici Curiae Fifty-Seven
Law, Economics, Business, Health, and Medicine Profes-
sors in Support of Cross-Appellant’s Petition for Rehearing
En Banc, ECF No. 171 (“57 Law Professors Br.”); Waxman
Br.; Brief of Amicus Curiae Association for Accessible Med-
icines in Support of Defendant-Cross-Appellant in Support
of Affirmance 1–9, ECF No. 69; Brief for the Association for
Accessible Medicines as Amicus Curiae in Support of Re-
hearing En Banc 5–7, ECF No. 164.
3 See also Warner-Lambert Co. v. Apotex Corp.,
316 F.3d 1348, 1358 (Fed. Cir. 2003); H.R. Rep. No. 98–
857, pt. 1, at 14–15 (1984) (“The purpose . . . is to make
available more low cost generic drugs by establishing a ge-
neric drug approval procedure . . . .”); id. at 22 (explaining
that a “listed drug may be approved for two indications. If
the [generic] applicant is seeking approval only for Indica-
tion No. 1, and not Indication No. 2 because it is protected
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 5

Under Congress’s design, the FDA regulates the man-
ufacture, sale, and labeling of prescription drugs. See Car-
aco, 566 U.S. at 404–05. The process begins when a brand
manufacturer submits a new drug application (“NDA”).
The NDA must include a proposed label describing the spe-
cific uses—called indications—for the drug. Id. at 404; see
21 U.S.C. § 355(b)(1); 21 C.F.R. § 314.50(a)(1), (e)(2)(ii).
See generally 21 C.F.R. pt. 201.
Once the FDA has approved a brand drug, another
company may seek permission to market a generic version
by filing an abbreviated new drug application (“ANDA”).
Because the Act is designed to minimize the barriers to en-
try for generic drugs, the generic doesn’t have to rehash the
brand’s safety-and-efficacy trials. It must, however, show
that what it manufactures is bioequivalent to the brand
drug. 21 U.S.C. § 355(j)(2)(A)(iv), (j)(4)(F); 21 C.F.R.
§ 314.94(a)(7)(i). 4 And the generic’s proposed labeling
must essentially copy the brand drug’s label. See 21 U.S.C.
§ 355(j)(2)(A)(i), (v), (j)(4)(G); Caraco, 566 U.S. at 406.
Thus, by congressional design, generic approval is a com-
parison of equivalence between the generic and a specific
brand drug.

by a use patent, then the applicant must make the appro-
priate certification and a statement explaining that it is not
seeking approval for Indication No. 2”).
4 “Bioequivalence is the absence of a significant dif-
ference in the rate and extent to which the active ingredi-
ent or active moiety in pharmaceutical equivalents or
pharmaceutical alternatives becomes available at the site
of drug action when administered at the same molar dose
under similar conditions in an appropriately designed [bi-
oequivalence] study.” 21 C.F.R. § 314.3(b). That is, two
drugs are “bioequivalent” if they would be expected for all
practical purposes to be the same.
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6 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Often a generic wants to launch while patents remain
on a drug or its uses. Anticipating this, Congress provided
two pathways for generics to show that a proposed label
will not infringe.
The first pathway is to file a certification explaining
why the generic label will not infringe any patent that a
brand has identified to the FDA as covering the drug. The
commonly used “paragraph IV” certification states that a
generic label will not infringe because the patent “is invalid
or will not be infringed by the manufacture, use, or sale of
the [generic] drug.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Para-
graph IV often prompts litigation. If a generic, armed with
a good-faith paragraph IV argument, files an ANDA with a
brand’s full label, the Hatch-Waxman Act allows the brand
to sue and entitles it to an automatic 30-month stay of final
FDA approval of the generic drug while the underlying pa-
tent issues are worked out in court. See 35 U.S.C.
§ 271(e)(2)(A); 21 U.S.C. § 355(j)(5)(B)(iii); Eli Lilly,
496 U.S. at 670–71, 676. This first pathway, then, has par-
ties sort things out up front if infringement or validity are
in legitimate dispute.
The second pathway—and the one relevant here—is
available if at least one brand-labeled use is unpatented. If
that’s so, the generic can just “carve out” the patented uses
from its label. See 21 U.S.C. § 355(j)(2)(A)(viii) (“section
viii”); 21 C.F.R. § 314.94(a)(8)(iv); Caraco, 566 U.S.
at 404–07; Takeda, 785 F.3d at 630 (“Congress intended
that a single drug could have more than one indication and
yet that an ANDA applicant could seek approval for less
than all of those indications.” (cleaned up)). The result, an
exception to “the usual rule that a generic drug must bear
the same label” as the brand, Caraco, 566 U.S. at 406, is
commonly called a “skinny” or “partial” or “carve-out” label.
Because the skinny-label pathway’s availability de-
pends on at least one brand-labeled use being unpatented,
the FDA needs to know whether any labeled uses are
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 7

unpatented—and which. More pragmatically, because the
FDA “cannot authorize a generic drug that would infringe
a patent,” Caraco, 566 U.S. at 405, it needs assurance that
a generic’s skinny label has carved out the patented brand-
labeled uses, leaving behind only unpatented ones. But be-
cause the FDA is not an arbiter of patent issues, 5 how can
it know whether the skinny-label pathway is available and
whether it can approve a given label?
The solution that worked—before today, at least—was
for the FDA and generics to rely on what brands say their
patents cover. See Caraco, 566 U.S. at 407 (“[W]hether sec-
tion viii is available to a generic manufacturer depends on
how the brand describes its patent.”); see also 21 U.S.C.
§ 355(b), (c) (requiring submission of patent information
with NDA). In particular, a brand submits under penalty
of perjury a declaration identifying “each pending method
of use or related indication and related patent claim” and
“the specific section of the proposed labeling for the drug
product that corresponds to the method of use claimed by
the patent submitted.” 21 C.F.R. § 314.53(c)(2)(O) (2008). 6
This declaration also contains a brand-crafted, 240-charac-
ter “use code.” 7 68 Fed. Reg. at 36,683, 36,686, 36,697; see

5 Indeed, it routinely disclaims expertise on that
front. See, e.g., 68 Fed. Reg. 36,676, 36,683 (2003) (“[W]e
have long observed that we lack expertise in patent mat-
ters.”); Caraco, 566 U.S. at 406–07.
6 Subsequent amendments to the FDA’s regulations
now require even more detail, underscoring the critical
public-notice function of patent declarations. See, e.g.,
21 C.F.R. § 314.53(c)(2)(O) (2020).
7 The majority quotes a portion of the Federal Regis-
ter saying that use codes “are not meant to substitute for
the [ANDA] applicant’s review of the patent and the ap-
proved labeling” and relies on testimony concerning the
same. Maj. 20–21 (alteration in original) (quoting 68 Fed.
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8 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

also 21 C.F.R. § 314.53(c). This “use code” appears in the
Orange Book, 8 a reference in which brands list the patents
on their drugs and the covered uses to provide notice to ge-
nerics and the FDA. The FDA relies on what the brand
says: “In determining whether an ANDA applicant can
‘carve out’ the method of use, . . . we will rely on the de-
scription of the approved use provided by the NDA holder
or patent owner in the patent declaration and listed in the
Orange Book.” 68 Fed. Reg. at 36,682; see also Caraco,
566 U.S. at 406 (in assessing a proposed skinny label, the
FDA looks to what the brand says, takes it “as a given,” and
approves the label only if there is no perceived overlap).

Reg. at 36,683); see also id. at 21–23. It bears emphasizing
that this statement refers specifically to the 240-character
use code (given its length limitations and particular notice
role), as distinct from other parts of the declaration (e.g.,
part 4.2a) identifying the label language corresponding to
the claimed method. The full context of the passage makes
this clear:

Use codes are intended to alert ANDA applicants
to the existence of a patent that claims an approved
use. They are not meant to substitute for the ap-
plicant’s review of the patent and the approved la-
beling. We understand that in some cases
240 characters may not fully describe the use as
claimed in the patent. The declaration, which in-
cludes the complete description of the method-of-
use claim and the corresponding language in the
labeling of the approved drug, will be publicly
available after NDA approval.

68 Fed. Reg. at 36,683.
8 U.S. Food & Drug Admin., Approved Drug Products
with Therapeutic Equivalence Evaluations (40th ed. 2020).
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 9

The point is clarity. Hatch-Waxman is designed to re-
solve patent disputes as early as possible. 9 And to know
whether there is a dispute, the FDA and generic manufac-
turers rely on a brand’s representations of which labeled
indications are patented. See, e.g., 68 Fed. Reg. at 36,682.
B. Carvedilol
Carvedilol, the drug here, is well studied and well un-
derstood. By 2007, the compound itself was no longer pa-
tented, nor were most uses of it.
Carvedilol is a beta blocker, a class of drugs used since
the 1960s to treat heart conditions. Carvedilol in particu-
lar was developed in the 1980s and was covered by U.S.
Patent No. 4,503,067, which issued in 1985 and claimed
the compound itself.
By the early 1990s, research from various groups re-
vealed that beta blockers could be useful for treating a con-
dition called congestive heart failure (“CHF”), which
prevents the heart from being able to deliver enough oxy-
genated blood to the body. By 1995, GSK had already re-
ceived approval for an NDA under the brand name Coreg
for hypertension. A supplement to that NDA added the
CHF indication to the label in 1997. After the approval of
the CHF labeling, GSK received U.S. Patent No. 5,760,069,
relating to a particular manner of using carvedilol with
other drugs to treat CHF. GSK listed the ’069 and

9 See Brief of Amici Curiae Novartis Pharmaceuti-
cals Corporation and Sandoz Inc. in Support of Rehearing
En Banc 7, ECF No. 168 (“Novartis & Sandoz Br.”) (“Both
branded and generic pharmaceutical companies require
stable, predictable legal environments to operate effec-
tively. Patent litigation inherently entails some uncer-
tainty, but the governing legal framework should be as
predictable as possible and consistent with Congress’s in-
tent.”).
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10 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

’067 patents in the Orange Book. Eventually, and well be-
fore any generic launched, carvedilol became the standard
of care for CHF. This standard was incorporated into the
official guidelines of the American College of Cardiology
and American Heart Association (as well as numerous
medical textbooks and journals) and taught to medical stu-
dents around the country.
As the 2007 expiration of GSK’s carvedilol compound
patent approached, interest grew among generics. Upon
this expiration, generics would be able to market carvedilol
in one of two ways: either with an all-indications label (by
challenging GSK’s method patent under a paragraph IV
certification) or by simply omitting any patented uses from
the label (with a section viii statement). Teva first chose
the former, reasoning—correctly, as it turned out—that
GSK’s ’069 method patent was invalid. And so in mid-2002
Teva filed its ANDA with a proposed full label directed to
hypertension and CHF, certifying that it would wait for
GSK’s compound patent to expire but that GSK’s
’069 method patent was invalid. J.A. 3003–19, 5463. GSK
did not sue or seek to block Teva’s approval. Instead it
sought reissue of its ’069 patent, admitting invalidity of the
original and adding narrowing limitations to overcome va-
lidity challenges.
In 2003, GSK got approval to add another indication to
its label: post-MI LVD. 10 This entailed a discrete new set
of label text, with new underlying clinical studies and new
instructions. Teva likewise updated the label accompany-
ing its pending ANDA to include all three indications. In
2004, the FDA determined that Teva had shown its product

10 This condition concerns patients who have recently
suffered a heart attack (a “myocardial infarction,” or “MI”)
and whose hearts have trouble pumping blood (“left ven-
tricular dysfunction,” or “LVD”).
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 11

to be bioequivalent to GSK’s and granted it tentative ap-
proval pending resolution of any exclusivity issues.
But by 2007—the year GSK’s compound patent was set
to expire—it was apparent that other generic manufactur-
ers had opted for skinny labels instead. So Teva did too,
informing the FDA that it now intended to carve out from
GSK’s label the uses GSK said were patented.
Again, GSK’s label contained three sets of instructions
for three distinct indications: CHF, post-MI LVD, and hy-
pertension:

J.A. 7992. And according to GSK’s sworn declaration to the
FDA (which appropriately tracked the label’s language),
only one of these three was patented—CHF:

J.A. 6895. Faithful to GSK’s declaration, the FDA for-
warded Teva a redlined label for use that omitted every-
thing GSK had said the ’069 method patent covered:
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12 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

J.A. 6913. It instructed Teva to use that label, which Teva
did—with the same carve-out as the other seven generic
manufacturers that launched at that time.
After the generics launched, GSK’s ’069 method patent
reissued as U.S. Patent No. RE40,000, the patent relevant
here. GSK added several narrowing limitations to the
’000 patent to save it from invalidity. With the reissue pro-
cess now completed, GSK delisted its ’069 method patent
from the Orange Book and listed the ’000 patent in its
stead—again submitting a sworn declaration identifying
only the CHF indication as covered. J.A. 6880–87. Con-
sistent with this representation, GSK did not sue the ge-
nerics, whose skinny labels included everything but CHF.
Years later in 2011, the FDA directed Teva to revise its
label to include the CHF indication. Teva complied. The
skinny-label period thus ended and the full-label period be-
gan. Teva did not issue a press release or otherwise notify
doctors of the change to its label. Indeed, Teva did not
change anything about how it marketed its generic
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 13

carvedilol; it continued to sell its product in the same man-
ner since approved. And, to little surprise, nothing
changed in the market: Teva and GSK maintained their
respective market shares, and no doctor’s prescribing hab-
its changed.
C. This Litigation
GSK did not sue in 2004 when Teva made its full-label
paragraph IV certification. Nor in 2007 when Teva
launched its skinny-label generic. Nor in 2008 when GSK’s
’000 patent emerged from reissue. Nor even in 2011 when
Teva transitioned to the full label. It sued instead in 2014,
just before the ’000 patent expired.
The lawsuit ultimately led to a seven-day jury trial in
2018. The jury was asked to determine whether Teva in-
duced infringement of the ’000 patent based on the skinny-
label period and the full-label period separately. It found
that Teva induced infringement of the ’000 patent based on
both labels. It also found that GSK was entitled to
$234.1 million in lost profits and $1.4 million in reasona-
ble-royalty damages.
After the verdict, Teva filed a renewed motion for
JMOL, arguing that GSK had not presented legally suffi-
cient evidence to support a finding of inducement. The dis-
trict court agreed and granted Teva’s motion. See
GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 313 F.
Supp. 3d 582 (D. Del. 2018). GSK appealed, and Teva
cross-appealed as to damages.
The case was argued to us in September 2019. In Oc-
tober 2020, the majority issued a first opinion reversing the
district court’s JMOL. That opinion prompted widespread
consternation and confusion, as described in Teva’s peti-
tion for rehearing and the eight amicus briefs in support.
Among these amici: both generics and brands, fifty-seven
law professors, and Congressman Waxman. See Novartis
& Sandoz Br.; 57 Law Professors Br.; Waxman Br.
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14 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Following these submissions, the majority vacated its
first opinion and ordered another round of oral argument.
Order, ECF No. 181. The majority now issues a second
opinion reaching the same result as before, but with new
reasoning. In particular, it now declares that this is not a
“true” skinny-label case. E.g., Maj. 10–11, 28 n.7. But this
remains a skinny-label case, the record remains the record,
and inducement liability remains unsupportable.
II. DISCUSSION
Although the JMOL standard is well settled, two points
bear emphasizing. First, while we give the verdict winner
the benefit of “every favorable and reasonable inference,”
Dun & Bradstreet Software Servs., Inc. v. Grace Consult-
ing, Inc., 307 F.3d 197, 205 (3d Cir. 2002), the operative
word here is “reasonable.” Indeed, “only all reasonable” in-
ferences need be drawn in GSK’s favor, not “all possible in-
ferences.” See Villiarimo v. Aloha Island Air, Inc., 281 F.3d
1054, 1065 n.10 (9th Cir. 2002). Second, if too many infer-
ences must be strung together to support the verdict, the
verdict is likely unsupportable. See Roebuck v. Drexel
Univ., 852 F.2d 715, 736 (3d Cir. 1988) (“Although we be-
lieve that each of the inferences that we have discussed [is]
individually logically sound, we recognize that at some
point too many inferences become[s] mere specula-
tion . . . .”); cf. United States v. Weber, 923 F.2d 1338, 1345
(9th Cir. 1990) (“Each of these inferences standing alone
may be reasonable. But with each succeeding inference,
the last reached is less and less likely to be true.”).
As to induced infringement under 35 U.S.C. § 271(b),
GSK bore the burden at trial to prove two things relevant
here. First, GSK had to prove that, more likely than not,
Teva engaged in “culpable conduct, directed to encouraging
another’s infringement.” DSU Med. Corp. v. JMS Co.,
471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc in relevant
part); see Metro-Goldwyn-Mayer Studios Inc. v. Grokster,
545 U.S. 913, 937 (2005) (“The inducement rule . . .
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 15

premises liability on purposeful, culpable expression and
conduct . . . .”). In other words, not only must Teva have
“possessed specific intent to encourage another’s infringe-
ment,” DSU, 471 F.3d at 1306, it must have taken “affirm-
ative steps to bring about [that] desired result,” Global-
Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 760 (2011).
Second, GSK had to prove that, more likely than not,
Teva’s affirmative steps actually caused the infringement
it wanted to bring about. DSU, 471 F.3d at 1304 (plaintiff
must show that “the alleged infringer’s actions induced in-
fringing acts”); see Grokster, 545 U.S. at 936–37 (when de-
fendant takes “affirmative steps” to “foster infringement,
[it] is liable for the resulting acts of infringement by third
parties” (emphasis added)); Sanofi v. Watson Labs. Inc.,
875 F.3d 636, 644 (Fed. Cir. 2017) (noting the “purposeful-
causation connotation” of the Supreme Court’s characteri-
zation of inducement).
The discussion that follows has three parts. Part A ad-
dresses the lack of inducement during the skinny-label pe-
riod, as well as the flaws in the majority’s analysis. Part B
does the same for the full-label period. Part C addresses
more broadly why the majority’s analysis has troubling im-
plications for skinny labels and inducement law generally.
A. The Skinny-Label Period
For the skinny-label period—that is, from Teva’s
skinny-label launch in 2007 to its full-label amendment in
2011—the majority relies on three key pieces of evidence to
conclude that substantial evidence supports the verdict:
the skinny label itself (in particular, the post-MI LVD in-
dication on that label) and two press releases distributed
before the ’000 patent issued—one from 2007, another from
2004. I discuss each in turn, followed by the majority’s sup-
posedly substantial other evidence of intent. From them,
alone or combined, no reasonable jury could have found
(1) culpable intent to encourage infringement or (2) causa-
tion, much less both.
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16 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

1. The Skinny Label Itself
Before discussing what the skinny label said, recall
what it didn’t say—and why. The label omitted the CHF
indication (and only the CHF indication) because GSK’s
sworn FDA filings asserted patent coverage of the CHF in-
dication (and only the CHF indication). Analogizing to a
typical patent case, it’s as though Teva had drafted a po-
tentially infringing user manual and then, abiding by the
patentee’s clear guidance, deleted all the pages that might
be viewed as encouraging infringement of a patented
method. Ironically, everything about this process signals
that, far from intending to encourage infringement, Teva
very much intended not to encourage infringement with its
skinny label.
Of course, this will likely be true of most generics that
get approved via the Hatch-Waxman section viii skinny-la-
bel pathway. Indeed, inferring intentional encouragement
to infringe a method—from a label that has intentionally
omitted everything that the brand said covers that
method—is a lot to ask of a reasonable factfinder. Only
once has this court upheld an inducement finding involving
a putative skinny label, and that case had a crucial, addi-
tional fact: the generic knew it had an infringement prob-
lem. AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060
(Fed. Cir. 2010); see Grunenthal GmbH v. Alkem Labs.
Ltd., 919 F.3d 1333, 1340 (Fed. Cir. 2019) (“[AstraZeneca]
held that specific intent could be inferred because the de-
fendant proceeded with a plan to distribute the generic
drug knowing that its label posed infringement prob-
lems.”). By contrast, GSK put on no similar evidence here.
Indeed, the facts surrounding Teva’s skinny label are sim-
ple and undisputed.
The majority nonetheless manufactures a factual dis-
pute, all on its own. It surmises that: maybe, just maybe,
GSK’s declarations were confidential, hidden from Teva’s
view—the implication being that Teva couldn’t have relied
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 17

on them. 11 Maj. 23. Of course, GSK itself has never made
this argument, despite having every incentive to do so
(given how Teva featured the declarations and their signif-
icance to the jury, the district court, and this court). It’s
easy to guess why: the FDA confirms that the declarations
are available to the public. 68 Fed. Reg. at 36,683.
At any rate, the majority’s confidentiality conjecture is
a red herring. Even if it were true that Teva never laid
eyes on GSK’s exact documents, it wouldn’t matter. As no
one disputes, Teva asked to carve out GSK’s patented uses,
and the FDA in return used GSK’s representations to pro-
vide Teva with a carved-out label. The FDA itself took no
non-infringement position; GSK did. And so by accepting
the FDA-provided skinny label, which hewed to GSK’s pa-
tent declarations, Teva relied on GSK’s representations of
patent scope. 12 See, e.g., Cross-Appellant’s Br. 12–13,
51–52; J.A. 12475 (Teva’s JMOL motion).

11 The suggestion appears to be based on the word
“confidential” at the bottom of the declarations’ pages in
our appendix. See Maj. 23. The majority’s reliance on this
branding seems misplaced. Among documents similarly
branded “confidential”: (1) the American College of Cardi-
ology/American Heart Association Guidelines, published in
the Journal of American College of Cardiology, J.A. 3245;
and (2) Teva’s 2012 Monthly Prescribing Reference,
J.A. 6192, a circulation that the majority says doctors re-
ceived “on a regular basis,” Maj. 33 (quoting
J.A. 10607–08).
12 To that end, the declarations also belie GSK’s in-
sistence that the 240-character use code was “not tied to
any particular indication.” See Appellant’s Reply Br. 30.
GSK submitted a patent declaration identifying only one
indication. E.g., J.A. 6895. From that declaration came
the use code. GSK’s use-code argument is therefore wrong
as a matter of law here. And regardless, GSK’s problem
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18 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Everything that follows must be assessed against the
carve-out backdrop. With that in mind, I turn to what re-
mained of the label after it was carved out. For a drug label
to induce, it must “encourage, recommend, or promote in-
fringement.” Takeda, 785 F.3d at 631. “Merely describing
an infringing use” in a label “will not suffice.” HZNP Meds.
LLC v. Actavis Labs. UT, Inc., 940 F.3d 680, 702 (Fed. Cir.
2019); Takeda, 785 F.3d at 631.
The majority supports the verdict with GSK’s expert
testimony concerning the post-MI LVD indication. Again,
this indication remained on the label because GSK’s sworn
declarations never said it was patented. Dr. McCullough
did walk through claim 1 of the ’000 patent and compare
each limitation to somewhere on the skinny label.
Maj. 14–16 (citing testimony at J.A. 10623–31). But he
never testified that the skinny label encouraged, recom-
mended, or promoted practicing the claimed method. 13

remains part 4.2a of the declarations, which required GSK
to “[s]ubmit indication or method of use information as
identified specifically in the approved labeling.” E.g.,
J.A. 6895 (emphasis added).
13 The majority suggests otherwise, via a misleading
cite to a snippet of testimony. See Maj. 24 (citing
J.A. 10644). While Dr. McCullough did testify that Teva
“took action” intended to encourage, none of the evidence
he was referencing included the skinny label itself. His
earlier skinny-label testimony concerned underlying direct
infringement. E.g., J.A. 10631. But after moving to the
intent element of inducement, where the majority finds this
testimony, the label did not come up again—neither di-
rectly nor indirectly. J.A. 10634–44. This may explain why
GSK never cited this testimony to show that the skinny la-
bel encouraged. Had GSK done so, Teva would have had
an opportunity to contest the characterization the majority
now adopts.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 19

Rather, in response to a series of questions about whether
certain portions of the label “met” the claim limitations, he
testified that some limitations were met (or “mentioned”)
in the Indications and Usage section, others in the Dosage
and Administration section, and still others in the Clinical
Studies section. J.A. 10623–31. At most, a reasonable jury
could have found that the skinny label described the in-
fringing use (if pieced together just right), in the context of
post-MI LVD patients. Describing is not enough.
This failure of proof alone should end the intentional-
encouragement inquiry as to the skinny label here. But
when we also consider the backdrop as to how the skinny
label arose—i.e., that Teva took out the only indication
GSK said was patented—the lack of inducement based on
this label is beyond dispute. See Vita-Mix Corp. v. Basic
Holding, Inc., 581 F.3d 1317, 1329 n.2 (Fed. Cir. 2009)
(“[The question] is whether [defendant’s] instructions
teach an infringing use . . . such that we are willing to infer
from those instructions an affirmative intent to infringe
the patent.” (emphasis added)); see also Grokster, 545 U.S.
at 937 (“The classic instance of inducement is by advertise-
ment . . . that broadcasts a message designed to stimulate
others to commit violations.” (emphasis added)). The law
simply does not permit an inference of culpable, intentional
encouragement from the label on this record. 14

14 Despite the majority’s characterization, this is not
a contention that estoppel arose from GSK’s FDA filings.
Maj. 23. Rather, the issue concerns what intent could be
reasonably gleaned from the skinny label, given the way
that label came about and the absence of other evidence of
intent. Intent is a required element of inducement—and,
as the majority itself acknowledges, GSK’s failure to list
the post-MI LVD indication in its FDA filings “is relevant
to intent to induce infringement.” Id. at 20. Estoppel is a
separate issue based on a different legal standard that the
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20 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

All of that is just the intentional-encouragement prong
though; GSK also had to show causation. At a minimum,
it had to prove that doctors would have read the skinny la-
bel, then pieced together the disparate portions just like
Dr. McCullough did at trial, then viewed that pieced-to-
gether description as an encouragement to prescribe carve-
dilol for CHF according to the specific limitations of the
claimed method, and then relied on that pieced-together
message to make that prescribing decision.
Dr. McCullough certainly didn’t connect these dots. In-
deed, he would have been a poor choice for that task. A
question arose at trial as to whether he had even read the
label before making his prescribing decisions. To survive a
pre-verdict JMOL motion on causation, GSK’s counsel
promised the trial judge that if given another chance,
Dr. McCullough would “absolutely” testify that he did so.
J.A. 10959; see also J.A. 10959 (counsel insisting that “ob-
viously, he always reads the label”). But when given the
chance, he testified that no, he didn’t read the label before
making his prescribing decisions. J.A. 11662–63. Not that
Dr. McCullough was alone in this regard; the other two ex-
pert cardiologists at trial testified that they didn’t do so ei-
ther. J.A. 11151 (Dr. Zusman); J.A. 11296–97
(Dr. Rosendorff).
Nothing else connected these dots. In fact, evidence
from both sides showed that doctors relied primarily on

district court may resolve in the first instance. The major-
ity’s charge that I seek to “leapfrog” and resolve estoppel
here on appeal is therefore disturbingly off-base. Id. at 23.
I am instead addressing what a reasonable jury could find
Teva’s intent to be. I do not understand the majority to be
suggesting that the potential availability of a different type
of relief (i.e., estoppel) forecloses the court from considering
the main issue in this appeal (i.e., inducement) if resolution
of the two issues might involve some of the same facts.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 21

medical guidelines, experience, education, and journals
when making their prescribing decisions. E.g., J.A. 10668,
10676–77 (Dr. McCullough), 11151–52, 11164–68 (Dr. Zus-
man), 11296–97 (Dr. Rosendorff). Evidence from both sides
also showed that pharmacies substituted generics for the
brand version automatically, as all fifty states allow or
even require. See, e.g., J.A. 10678–79 (Dr. McCullough),
10750–51 (Dr. Reisetter), 11038 (Mr. Karst), 11076–77
(Ms. Kinsey). The majority, however, disregards this un-
controverted, direct evidence of causation in favor of letting
unsupported inferences bridge GSK’s evidentiary gap. It
starts with the label’s contents and that they were perhaps
“read”—then ends up at causation. Maj. 35–36. I disagree
with the majority that this inferential leap is “fair,” id.
at 36, particularly here, where direct evidence across the
board points to medical texts and expertise as being the
main influence. In my view, “fair” would be ensuring that
causation means something. See infra Part II.C.2.
Before turning to the press releases, one last, critical
point bears mentioning. The majority confines its reliance
on the skinny label to the post-MI LVD indication. In par-
ticular, its skinny-label inducement path starts with “en-
couragement” from the post-MI LVD indication, and ends
in direct infringement when a doctor prescribes carvedilol
for any post-MI LVD patient who also happens to have
CHF (assuming that the rest of the claim limitations are
met when so prescribing). See Maj. 13–16, 18–19. Notably,
however, as both sides acknowledge, the damages award in
this case was not confined to just the appropriate subset of
infringing prescriptions to post-MI LVD patients who also
had CHF—it encompassed CHF patients more broadly.
Cross-Appellant’s Br. 54; see Appellant’s Reply Br. 31–32.
GSK’s damages testimony was not predicated on, nor did it
quantify, the subset of uses that would infringe under the
majority’s skinny-label-based inducement theory.
Recognizing the problem, GSK leans on the press re-
leases to save the full damages award; it says they
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22 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

“encouraged the infringing use for all . . . symptomatic
heart failure patients.” Appellant’s Reply Br. 31. But, as I
explain below, that’s far too much weight for these press
releases to bear. Accordingly, even if the majority’s uphold-
ing the verdict on the basis of the skinny label were appro-
priate, we would have to remand this case for a proper
damages calculation. But Teva’s argument on this im-
portant issue goes unacknowledged in the majority’s opin-
ion.
2. The 2007 Press Release
Beyond the skinny label itself, the majority also sup-
ports the verdict with a 2007 Teva press release that an-
nounced final FDA approval for Teva to market its
“[g]eneric version of [GSK’s] cardiovascular agent Coreg®
(Carvedilol) Tablets.” Maj. 29 (citing J.A. 6353). From this
press release—which was distributed before the ’000 pa-
tent issued but apparently appeared on Teva’s website dur-
ing the patent’s term—the majority permits inferences of
intentional encouragement and causation. Neither is rea-
sonable.
As to intentional encouragement, the majority inter-
prets Teva’s 2007 press release as saying that its product
is a “generic equivalent of GSK’s cardiovascular agent
Coreg®,” id. at 30—and, from this, permits the inference
that Teva intended to encourage substitution of its product
for all of Coreg’s indications, including CHF, id. at 29–30.
In other words, the majority holds that a generic can be
deemed liable for inducement for saying that its product is
a “generic version” or “generic equivalent” of a brand drug.
This is a drastic holding. And it makes little sense. Essen-
tially all ANDA generics are the “generic version” or “ge-
neric equivalent” of a brand drug; the law requires them to
be. To come to market, such a generic must demonstrate
that its product is bioequivalent to a brand drug. 21 U.S.C.
§ 355(j)(2)(A)(iv), (j)(4)(F); 21 C.F.R. § 314.94(a)(7)(i); see
also 21 C.F.R. § 314.92(a) (noting that, with limited
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 23

exceptions not relevant here, ANDAs are suitable only for
“[d]rug products that are the same as a listed drug,” and
that “the same as” includes drugs with label modifications
made for patent carve-outs). See generally supra Part I.A.
The system is inherently comparative. I therefore find it
highly unlikely that Congress intended to make generics
liable for simply stating what the law requires.
The majority also sees culpable intent in Teva’s de-
scribing its product as a “cardiovascular” agent. See
Maj. 29–30. A well-understood adjective, “cardiovascular”
means relating to the heart. Carvedilol is a heart-related
drug; it’s used to treat CHF, post-MI LVD, and hyperten-
sion—all heart-related conditions. I cannot see how using
the word “cardiovascular” to describe a heart-related drug
could reasonably be viewed as evidencing culpable intent
to encourage practicing the specific claimed CHF method
in particular here—or how this adjective does anything be-
yond what “generic version” or “generic equivalent” do in
terms of intent.
And still there remains causation. The majority never
explains how a reasonable jury could have found that this
press release (as it later appeared on Teva’s website) af-
fected doctors’ prescribing practices so as to cause their in-
fringement. Indeed, outside of testimony that doctors “get”
press releases, J.A. 11655, and that it’s “possible” doctors
read them, J.A. 11239, GSK supplied no evidence that any
doctor read this one before the litigation—much less ac-
cessed it from Teva’s website, and was then so moved by it
that it caused him or her to prescribe carvedilol in an in-
fringing manner, trumping every medical text along the
way.
We simply have a press release that describes a generic
version of a cardiovascular brand drug as a “generic ver-
sion” of a “cardiovascular” brand drug. From that alone,
the majority permits inferences of culpable intent to
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24 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

encourage and causation. I fail to see how those inferences
are reasonable.
3. The 2004 Press Release
The majority’s final key piece of evidence is the 2004
press release, which announced Teva’s “tentative [FDA]
approval” to market its product, described as “the AB-rated
generic equivalent of [GSK’s] Coreg® . . . indicated for
treatment of heart failure and hypertension.” J.A. 6347.
Before turning to whether these statements could show
intentional encouragement to infringe, some undisputed
facts must be acknowledged. First, this press release was
distributed several years before the ’000 patent issued, at
a time when Teva was pursuing a different pathway to reg-
ulatory approval. At that time, Teva’s product was indi-
cated for treatment of CHF. But Teva ultimately pursued
the section viii pathway. Second, the press release an-
nounced the product’s “tentative approval,” which has a
specific, legal meaning—namely, that a patent or regula-
tory exclusivity stands in the way of final approval.
21 U.S.C. § 355(j)(5)(B)(iv)(II)(dd)(A); 21 C.F.R. § 314.3(b);
see J.A. 10533. In other words, this “approval” had condi-
tions.
With that in mind, the question remains: what is there
in this press release to suggest intent to encourage in-
fringement of the (future-issued) ’000 patent? Like the
2007 press release, the majority sees culpable intent in
Teva’s describing its product as the “AB-rated generic
equivalent” of Coreg. Maj. 28. But, for the reasons de-
scribed above, this cannot plausibly support liability within
Congress’s framework in this area. And although the press
release does reference “heart failure,” given the circum-
stances here—i.e., that the press release was distributed
years before the patent issued (under materially different
regulatory circumstances) and announced “tentative” ap-
proval—inferring culpable intent from this press release
exceeds the bounds of reasonableness.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 25

And again: causation. To prove it, GSK first had to
show that Teva made this years-old press release available
on its website during the patent’s term. This should have
been a crucial showing—after all, this press release is one
of the three key pieces of evidence the majority relies on.
Once again, though, direct evidence is missing. And once
again, the majority is untroubled. It simply calls up some
inferences to bridge the gap. In particular, the majority
suggests the inference that, because the 2007 press release
was on Teva’s website, and because Teva had a website
with some information about carvedilol, the 2004 press re-
lease must have been there too. Maj. 30–31. GSK, for its
part, never argued any of these inferences to the jury. And
while the majority faults Teva for not showing that the
2004 press release was not there, id. at 31, this is GSK’s
case and its burden—and besides, it’s hard to blame Teva
for not rebutting a fact that GSK never even tried estab-
lishing.
But, for argument’s sake, let’s assume the jury could
have reasonably found that GSK carried its burden on this
point. A further question remains: what is there to suggest
that any doctor saw it—years later on the website—then
relied on that as the basis for his or her infringing prescrib-
ing decisions? The answer: nothing. At least, that’s the
answer the majority gives. See id. at 35–37. Nothing in
the record suggested that doctors were in the habit of
searching a generic’s website for old press releases to help
them make life-or-death prescribing decisions. The most
we have is that Dr. McCullough saw the 2004 press release
(timing unspecified) and that it said what it said. The rest
is left to sheer possibility.
And indeed, it’s possible that things panned out this
way. Maybe a doctor did search Teva’s website for old
press releases, found this one (assuming it was there), and
then relied on that press release to make his or her pre-
scribing decision (at least three years after the date of this
press release), trumping every medical text along the way.
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26 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Maybe every relevant doctor did. Many things are possible.
But “‘[m]ere speculation’ is not substantial evidence.” OSI
Pharms., LLC v. Apotex Inc., 939 F.3d 1375, 1382 (Fed. Cir.
2019) (quoting Intell. Ventures I LLC v. Motorola Mobility
LLC, 870 F.3d 1320, 1331 (Fed. Cir. 2017)).
In sum, the 2004 press release’s description of Teva’s
product as the “AB-rated generic equivalent” of Coreg,
along with its reference to “heart failure,” would be a slen-
der enough reed upon which to rest culpable intent, given
that this communique was distributed years before the pa-
tent issued (under materially different regulatory circum-
stances) and announced an approval that was only
“tentative.” But it’s the causation that truly vexes me. It’s
the notion that, instead of the various medical texts (and
experience, and education), all along it was really the 2004
press release, found years later on the website, that caused
doctors’ CHF prescribing decisions. In the face of uncon-
troverted evidence of the former, some evidence of the lat-
ter should be necessary. But there’s none.
4. The Supposedly Substantial Other Evidence of Intent
The majority calls it “inaccurate” to observe that it re-
lies on only three key pieces of evidence as to culpable in-
tent during the skinny-label period. Maj. 24. It says
there’s additional evidence too. 15 But while the majority
discusses the three pieces above in some detail, it only ges-
tures to the rest without much meaningful discussion.
Such references can hardly be enough to sustain a verdict,
and they return us to the uncertainty concerns plaguing
the first, vacated version of the majority’s opinion. At

15 Much of this evidence comes in the form of trial tes-
timony that was not included in the record on appeal—
which means it’s testimony that GSK didn’t rely on, and to
which Teva therefore had no occasion to respond. Anything
the majority cites as “Trial Tr.” references such testimony.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 27

bottom, however, this other evidence just relates back to
the three key pieces.
There was “extensive expert testimony,” the majority
first insists without elaboration. Maj. 24. As best I can
tell, the majority is referring to Dr. McCullough and
Dr. Zusman, see id. at 26—Dr. McCullough saying that doc-
tors read labels, and Dr. Zusman agreeing that Teva’s cir-
culations suggested reading labels if doctors have
questions. So, we’re back to the skinny label—the first of
the three key pieces of evidence. And if the skinny label
doesn’t show intent, then neither does suggesting that doc-
tors should read it. 16
Teva’s “Monthly Prescribing References” get some at-
tention elsewhere. See id. at 26–27. But, like the “exten-
sive” expert testimony discussed above, that’s just for the
proposition that Teva intended doctors to read its labels.
Again, back to the skinny label.
The majority adds to the list Teva’s “product catalogs”
and “advertising and promotional activities.” Id. at 24. I
presume it means Teva’s catalogs discussed shortly after-
ward. But the only thing for which that evidence was relied
on was to show that Teva described its drug as the “AB
rated” equivalent to Coreg. See id. at 27 (discussing 2008
and 2009 catalogs at J.A. 6221 and J.A. 6270). Statements
of equivalence were discussed with respect to the two press
releases—the other two key pieces of evidence. So it’s un-
clear what this adds to the intent calculus. And as before,
if this is evidence of intent, we should be disturbed.

16 Of course, because causation is an element, what
matters in the end is whether doctors did in fact not only
read but also rely on this label. See supra pp. 20–21. Recall
too that every relevant witness testified that he hadn’t read
this label before prescribing.
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28 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Finally, the majority notes “testimony from Teva’s own
company witnesses.” Id. at 24. Maybe this means Teva’s
marketing director (who the majority says “added carve-
dilol product information to the Teva website” in 2007) and
regulatory-affairs director (who the majority says “dis-
cussed” the press releases with the jury). See id. at 31.
Whatever the case, this discussion just concerns the press
releases—well-trodden ground. Or maybe instead the ma-
jority means Mr. Rekenthaler, who it quotes as having “ex-
pected” or “assum[ed]” that doctors would use drugs as
labeled. Id. at 27. But this just brings us back to the
skinny label.
The bottom line is that, to the extent that this evidence
is relevant, its relevance depends on finding culpability
from the three key pieces of evidence—i.e., the skinny label
or the two press releases, particularly their statements of
equivalence.
B. The Full-Label Period
As with the skinny-label period, JMOL of no induce-
ment was necessary for the full-label period. The reason is
simple: nothing about doctors’ prescribing practices
changed when Teva amended its label to the full version.
Both GSK and its experts confirmed as much. Appellant’s
Br. 21 (“Doctors continued to administer Teva’s accused
product for infringing use during [the full-label] period
(without change from the partial label period) . . . .” (em-
phasis added)); J.A. 12204–05 (GSK’s counsel conceding
that any market impact as a result of the amendment was
“minimal”); J.A. 10699 (Dr. McCullough agreeing that, in
his practice, there was “no difference in [his] prescribing
habits from when Teva had its skinny label to after Teva
amended to have its full label”); J.A. 10754 (different GSK
expert testifying that his survey of 200 doctors indicated no
change in prescription patterns from pre- to post-amend-
ment).
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 29

The majority, for its part, identifies nothing about doc-
tors’ prescribing practices that changed after Teva
amended its label. Maj. 33–37. If nothing about this
changed, then nothing Teva did during the full-label period
could have caused anything beyond whatever caused direct
infringement during the skinny-label period. And because
the record lacks evidence that Teva caused direct infringe-
ment during the skinny-label period, Teva cannot have
caused direct infringement during the full-label period—
and therefore cannot have induced.
C. Why the Majority’s Flawed Analysis Matters
In reinstating the jury’s unsupportable verdict, the ma-
jority commits several errors—some legal, some practical,
and all spelling trouble for skinny labels specifically and
inducement law generally. Below are three main concerns
with the majority’s approach.
1. The Majority Weakens the Intentional-
Encouragement Requirement as to Labels
Direct infringement is strict liability; induced infringe-
ment is not. And when it comes to inducement’s inten-
tional-encouragement requirement, the law draws a line
between encouraging, recommending, or promoting an in-
fringing use and merely describing that use. E.g., Takeda,
785 F.3d at 631. This line is important because while the
former provides evidence of intent, the latter does not. See
id. (collecting cases); HZNP, 940 F.3d at 702 (“Merely de-
scribing an infringing use . . . will not suffice . . . .”). The
majority blurs this line beyond recognition. 17

17 GSK would have us ignore this line entirely. Ap-
pellant’s Reply Br. 28 (“It is doubtful whether such a dis-
tinction actually exists . . . .”); see id. at 16 (“Teva’s partial
label encouraged doctors to infringe GSK’s patent because
it described every limitation of the claimed method.”).
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30 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

Take the skinny label here. GSK’s expert
Dr. McCullough, despite having never read the label him-
self before making prescribing decisions, walked through it
and found piecemeal language that he could say “met” or
“mentioned” each claim limitation in isolation. Supra
pp. 18–19. That was the extent of it. There was no testi-
mony or other evidence that this label language encour-
aged practicing the patented method, or that it even came
with a wink or nudge. At most, then, a reasonable jury
could have found that the skinny label described the in-
fringing use.
The majority somehow ends up at encouragement but
fails to justify how it got there. In particular, it never
meaningfully engages with the legal distinction between
encouraging, recommending, or promoting an infringing
use and describing it. Nor does it explain how a reasonable
jury could have found the former from the latter on this
record. If a jury can simply infer culpable intent to encour-
age from a mere description, the legal distinction is mean-
ingless. Description would always suffice to infer
inducement.
That’s a problem. “[S]howing that infringement was
encouraged” is necessary to “overcome[] the law’s reluc-
tance to find liability when a defendant merely sells” a
product with legitimate non-infringing uses, like carve-
dilol. Grokster, 545 U.S. at 936; see id. at 937 (acknowledg-
ing “the need to keep from trenching on regular commerce
or discouraging the development of technologies with law-
ful and unlawful potential”). “This requirement of induc-
ing acts is particularly important in the Hatch-Waxman
Act context because the statute was designed to enable the
sale of drugs for non-patented uses even though this would
result in some off-label infringing uses.” Takeda, 785 F.3d
at 631 (citing Caraco, 566 U.S. at 414–15).
On that note, I emphasize that this criticism is all
about how the majority treats what was left of the skinny
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 31

label after the carve-out. That Teva first carved out exactly
what GSK said would infringe should settle the question of
what intent could be reasonably inferred from the label it-
self on these facts. It’s also a circumstance that distin-
guishes every case the majority relies on to support its
holding.
2. The Majority Eviscerates the
Causation Requirement
Patent infringement is a tort. E.g., Wordtech Sys., Inc.
v. Integrated Networks Sols., Inc., 609 F.3d 1308, 1313
(Fed. Cir. 2010); see Carbice Corp. of Am. v. Am. Pats. Dev.
Corp., 283 U.S. 27, 33 (1931). Accordingly, liability at-
taches only to one who causes the injury—here, practice of
the patented method. Legal cause, not simply but-for
cause, is required. Restatement (Second) of Torts § 9
cmt. a.
Traditional tort principles inform how a plaintiff
proves, or fails to prove, causation:
As on other issues in civil cases, the plaintiff is re-
quired to produce evidence that the conduct of the
defendant has been a substantial factor in bringing
about the harm he has suffered, and to sustain his
burden of proof by a preponderance of the evi-
dence. . . . A mere possibility of such causation is
not enough; and when the matter remains one of
pure speculation and conjecture, or the probabilities
are at best evenly balanced, it becomes the duty of
the court to direct a verdict for the defendant.
Id. § 433B cmt. a (emphasis added); see also id. § 876 cmt. d
(noting that if “encouragement or assistance is a substan-
tial factor in causing [a] resulting tort, the one giving it is
himself a tortfeasor”). Therefore, to prove causation, GSK
had to show that Teva’s conduct (apart from simply being
on the market) was a substantial factor in causing doctors
to prescribe its carvedilol in an infringing way. A mere
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32 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

possibility wouldn’t do; rather, a reasonable jury must have
been able to find that it was more likely than not. Here it
could not.
To start, the majority identifies no direct evidence of
causation by Teva. And it casts aside the direct evidence
from both sides pointing to the same things—things other
than Teva—as the cause. Supra pp. 20–21, 23–26. In-
stead, it says that it was “fair” for the jury to “infer” causa-
tion from the existence of the skinny label itself and the
two press releases. Maj. 36. This conclusion relies on a
passing observation in one case saying: “[W]e have af-
firmed induced infringement verdicts based on circumstan-
tial evidence of inducement (e.g., advertisements, user
manuals) directed to a class of direct infringers (e.g., cus-
tomers, end users) without requiring hard proof that any
individual third-party direct infringer was actually per-
suaded to infringe by that material.” Id. (quoting Power
Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
843 F.3d 1315, 1335 (Fed. Cir. 2016)). But this observation
is not a license to substitute speculation for proof. The ev-
idence-to-conclusion link must always make sense.
In some inducement cases, a jury might reasonably in-
fer causation based solely on circumstantial evidence. One
example might be where a product’s user manual encour-
ages an infringing use, and where the user had no famili-
arity with the product other than the manual. A reasonable
jury might infer that the manual caused the user, other-
wise unfamiliar with the product’s intricacies, to use the
product that way, and we have upheld inducement verdicts
on this basis. E.g., Golden Blount, Inc. v. Robert H. Peter-
son Co., 438 F.3d 1354, 1362–63 (Fed. Cir. 2006) (causation
evidence included an instruction sheet teaching infringe-
ment and packaged with each product); ArthroCare Corp.
v. Smith & Nephew, Inc., 406 F.3d 1365, 1377 (Fed. Cir.
2005) (causation evidence included “sales literature accom-
panying one of the accused devices” and other instruction
manuals recommending an infringing use); Moleculon
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 33

Rsch. Corp. v. CBS, Inc., 793 F.2d 1261, 1272 (Fed. Cir.
1986) (causation evidence included “dissemination of an in-
struction sheet teaching” the infringing method). Although
purely circumstantial, the inferential hops are few and
short. In those cases, what else but the user manual might
have caused the user to use the product in an infringing
way? Cf. Golden Blount, 438 F.3d at 1363 (“[N]othing in
the record suggests that either [defendant] or any end-user
ignored the instructions . . . .”).
In other inducement cases, inferential leaps are too
many and too great, and evidence of a different cause too
strong, for the circumstantial evidence that is offered to
carry the day. Take this case. To accept that Teva’s skinny
label was a substantial factor in causing doctors to infringe,
one would have to infer doctors read it to make prescribing
decisions (even though all three testifying expert cardiolo-
gists said they didn’t); infer those doctors pieced together
the portions of the label to uncover a description of the in-
fringing use (maybe); infer those doctors interpreted that
description as an encouragement (no evidence); and then
infer those doctors relied on that description to make their
prescribing decisions (no evidence). Supra pp. 20–21. As
to the press releases, one would have to infer Teva made
them available during the relevant time period (maybe);
infer doctors read them during that time (no evidence); and
then infer doctors relied on some inducing message therein
to make prescribing decisions affecting their patients’
health (no evidence). 18 Supra pp. 23–26.
Unlike the prototypical user-manual case, in which we
might permit the inference that a user relied on the man-
ual without requiring testimony to that effect, the

18 This is to say nothing of the causal implications of
pharmacies’ ubiquitous automatic-substitution practices—
where, for example, a doctor might write “Coreg,” but a ge-
neric is dispensed nonetheless. See J.A. 10750–51.
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34 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

inference might not hold up as well in this context—with
highly educated users and well-studied products. And
whatever strength the inference has in a context such as
this, it crumbles when, as here, we have users who testi-
fied, and they either (1) failed to say they relied or (2) af-
firmatively said they didn’t rely on the allegedly inducing
materials.
Moreover, unlike the prototypical user-manual case,
it’s not as though the record here was wanting for another
cause. Both sides’ expert cardiologists said under oath and
without contradiction that medical texts, education, and
experience caused their prescribing decisions. Supra
pp. 20–21. Under these circumstances, would accepting
the Teva-caused version of events amount to anything
more than speculation, given the chain of inferences re-
quired—not all of them reasonably grounded in the record
evidence?
The most troubling part of all this is that the majority
never explains how a reasonable jury could have come out
this way on this record. Given the size of the infringing
doctor class here, it should have been easy to present testi-
mony of causation if that theory had a basis in fact. Cf.
TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2212 (2021)
(pointing to evidence that could have been sought and cit-
ing Interstate Circuit, Inc. v. United States, 306 U.S. 208,
226 (1939), for the proposition that “[t]he production of
weak evidence when strong is available can lead only to the
conclusion that the strong would have been adverse”). But
not a single doctor testified as to causation by Teva, and in
fact, the most on-point testimony shows the absence of cau-
sation.
As a doctrinal matter, the majority’s opinion suggests
that there is no independent causation element for induce-
ment; intentional encouragement might always suffice to
infer causation too. Add that to the majority’s weakening
of intentional encouragement (where describing an
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 35

infringing use piecemeal—or simply calling a product a “ge-
neric version” or “generic equivalent”—is now enough), and
finding inducement becomes possible based largely on
speculation. The law requires more from a plaintiff.
3. The Majority Creates Confusion
About Skinny Labels
The majority’s opinion will create confusion for every-
one. Under its analysis, the difference is indiscernible be-
tween this case and one in which the generic is safe.
Indeed, it’s unclear what Teva even did wrong—or, put an-
other way, what another generic in its shoes should do dif-
ferently.
Initially, the majority suggests that this is not a
skinny-label case. Nothing to see here, the majority reas-
sures concerned amici: the Act remains intact. See
Maj. 10–11. But it’s hard to see how. As a matter of law,
this is a skinny-label case about the skinny-label provi-
sions. The Act’s text makes that much clear: section viii by
its own terms references the brand-submitted patent “in-
formation” (i.e., patent declaration). 21 U.S.C.
§ 355(j)(2)(A)(viii); see 21 C.F.R. § 314.53(c)(2)(O) (patent
“information” includes portions of label covered by method
patent). This patent information dictates whether a ge-
neric label is a section viii label. If a generic omits the uses
the brand has said are patented, the label is skinny. The
FDA understands that. See supra Part I.A (discussing
brand-dependent regulatory framework). So does the Su-
preme Court. Caraco, 566 U.S. at 404–07. So should we.
What’s more, the background facts here will seemingly
persist in most skinny-label cases. Under the Act,
“[g]eneric copies” are essentially “the same as the original
drug.” See H.R. Rep. No. 98–857, pt. 1, at 14–15; accord
21 U.S.C. § 355(j)(2)(iv); 21 C.F.R. § 314.92(a)(1). Thus, bi-
oequivalence; comparison to a brand drug; duplication of a
brand’s label (at least in part); reliance on a brand’s clini-
cal-trial data; references to a drug’s therapeutic class;
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36 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

cursory press releases announcing a generic’s regulatory
approval; doctors’ assumptions about what going generic
means; pharmacies’ generic substitution; a generic’s
knowledge that some sales may occur from off-label, in-
fringing uses—all of that will generally be there whether
there is inducement or not. See, e.g., AstraZeneca Pharms.
LP v. Apotex Corp., 669 F.3d 1370, 1380 (Fed. Cir. 2012)
(discussing “market realities” of substitution that do not
implicate infringement). Those facts cannot sort induce-
ment from non-inducement.
So where did Teva go wrong in this case? Should it not
have followed the brand’s sworn representations as to what
was patented? The majority offers no principled division
between this and what it suggests would be a true skinny
label. For decades, everyone has assumed they could rely
on what brands said about what their patents covered. The
FDA’s skinny-label approval pathway and regulations are
expressly predicated on that. As far as adherence to Con-
gress’s framework, this was about as faithful as it gets.
Or is the takeaway, instead, that Congress meant to
expose ANDA generics to liability for simply describing
themselves as the “generic version” or “generic equivalent”
of a brand drug? Given that the Hatch-Waxman Act’s
framework requires ANDA generics to be the same as a
brand drug, and that doctors understand what being a ge-
neric means, this seems a dubious proposition.
One of amici’s key criticisms of the first version of the
majority’s opinion was that it was unclear what among the
muddled mass of evidence actually formed the basis of lia-
bility. So too here. It’s unclear whether the skinny label
was enough—or whether the press releases were, or some
of the other ancillary evidence in the record, “all of which”
the majority suggests the jury “could have relied on.”
Maj. 24.
The lack of clarity extends to the majority’s character-
ization of its holding as “case-specific.” See id. at 10–11.
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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 37

For example, the majority’s new opinion relies on the post-
MI LVD indication remaining on the skinny label as a po-
tentially “case-specific” circumstance. See id. Not only is
this reliance problematic (for the reasons described above),
it’s a mirage. If the majority were truly relying on this cir-
cumstance to distinguish this case, it would accept Teva’s
argument that the damages should be confined to the ap-
propriate subset of infringing prescriptions to post-MI LVD
patients who also had CHF. See supra pp. 21–22. But,
given that this argument goes unacknowledged in the ma-
jority’s opinion, the implication is that the press releases
alone—with their references to “generic version” or “ge-
neric equivalent”—suffice to support the entire verdict, en-
compassing CHF patients more broadly. And if that’s so,
then it’s unclear why the majority’s analysis of the skinny
label itself is relevant. Under the majority’s holding, a
brand can just rely on statements of equivalence to capture
even that portion of the market that was specifically carved
out.
The only clear thing now is that no generic can know
until hit with the bill whether it’s staying within the con-
fines of the law. Being unable to predictably rely on use
codes and patent declarations “throws a wrench” into Con-
gress’s skinny-label design. See Caraco, 566 U.S. at 419.
III. CONCLUSION
Before today, there was an equilibrium to the skinny-
label system—one that allowed companies to make in-
formed, responsible decisions in this area. If a generic
wanted to avoid patented uses, it had the simple expedient
of omitting from its label the uses the brand identified.
And if a brand wanted to block a skinny label containing a
use it thought was patented, it had the simple expedient of
including that use in its FDA patent declaration. That
equilibrium is no more.
So, what’s next? We are now on the majority’s second
opinion in this case. The first was vacated in light of Teva’s
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38 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.

petition for rehearing and the eight amicus briefs in sup-
port. This new opinion does little to assuage, and even ex-
acerbates, concerns raised by the original.
I respectfully dissent.