Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.

N OTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
CORCEPT THERAPEUTICS, INC.,
Plaintiff-Appellant
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant-Appellee
______________________
2024-1346
______________________
Appeal from the United States District Court for the
District of New Jersey in No. 1:18-cv-03632-RMB-LDW,
Judge Renee Marie Bumb.
______________________
Decided: February 19, 2026
______________________
BRIAN C. CANNON, Quinn Emanuel Urquhart & Sulli-
van, LLP, Redwood Shores, CA, argued for plaintiff-appel-
lant. Also represented by WILLIAM ADAMS , F RANCIS
D OMINIC CERRITO, EVANGELINE SHIH , ERIC C. STOPS ,
D ANIEL C. WIESNER , New York, NY.
J OHN CHRISTOPHER ROZENDAAL , Sterne Kessler Gold-
stein & Fox PLLC, Washington, DC, argued for defendant-
appellee. Also represented by U MA EVERETT , BRADY
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CORCEPT THERAPEUTICS , INC. v. TEVA PHARMS. USA, INC. 2
G LEASON, MICHAEL E. J OFFRE, WILLIAM MILLIKEN, ANNA G.
P HILLIPS .
______________________
Before M OORE, Chief Judge, STOLL , Circuit Judge, and
WANG, District Judge.1
P ER CURIAM .
Corcept Therapeutics, Inc. (Corcept) appeals a decision
from the United States District Court for the District of
New Jersey finding no infringement of U.S. Patent Nos.
10,195,214 and 10,842,800. For the following reasons, we
affirm.
BACKGROUND
Corcept owns the ’214 patent and its continuation, the
’800 patent, both directed to methods of coadministering
mifepristone with a strong CYP3A inhibitor (e.g.,
ketoconazole) to treat Cushing’s syndrome, a disorder that
causes excessive cortisol production. Mifepristone blocks
cortisol’s effects on the body while CYP3A inhibitors block
cortisol production. J.A. 10–11. Coadministration of
mifepristone with strong CYP3A inhibitors, however, can
cause adverse drug-drug interactions. J.A. 11.
In 2012, Corcept’s mifepristone product, Korlym®, was
approved with a product label that warned against
coadministration due to safety concerns. J.A. 14. The 2012
label contained the following warnings:
Use of Strong CYP3A Inhibitors: Concomitant use
can increase mifepristone plasma levels
1 Honorable Nina Y. Wang, District Judge, United
States District Court for the District of Colorado, sitting by
designation.
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CORCEPT THERAPEUTICS , INC v. TEVA PHARMS. USA, INC. 3
significantly. Use only when necessary and limit
mifepristone dose to 300 mg.
J.A. 4212 (Warnings and Precautions section).
CYP3A inhibitors: Caution should be used when
Korlym is used with strong CYP3A inhibitors.
Limit mifepristone dose to 300 mg per day when
used with strong CYP3A inhibitors.
Id. (Drug Interactions section).
Korlym should be used with extreme caution in pa-
tients taking ketoconazole and other strong inhibi-
tors of CYP3A . . . as these could substantially
increase the concentration of mifepristone in the
blood. The benefit of concomitant use of these
agents should be carefully weighed against the po-
tential risks. Mifepristone should be used in com-
bination with strong CYP3A inhibitors only when
necessary, and in such cases the dose should be
limited to 300 mg per day.
J.A. 4217 (Use of Strong CYP3A Inhibitors subsection un-
der Warnings and Precautions section).
Medications that inhibit CYP3A could increase
plasma mifepristone concentrations and dose re-
duction of Korlym may be required. Ketoconazole
and other strong inhibitors of CYP3A . . . may in-
crease exposure to mifepristone significantly. The
clinical impact of this interaction has not been
studied. Therefore, extreme caution should be
used when these drugs are prescribed in combina-
tion with Korlym. The benefit of concomitant use
of these agents should be carefully weighed against
the potential risks. The dose of Korlym should be
limited to 300 mg and used only when necessary.
J.A. 4220–21 (CYP3A Inhibitors subsection under Drug In-
teractions section).
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CORCEPT THERAPEUTICS , INC. v. TEVA PHARMS. USA, INC. 4
In connection with the product’s approval, the FDA
required Corcept to conduct drug-drug interaction studies
to determine the effects of coadministration. J.A. 13–15.
Corcept found a physician can safely coadminister up to
900 mg of mifepristone with a strong CYP3A inhibitor
without undesirably increasing mifepristone blood levels.
J.A. 15–17. The ’214 and ’800 patents are based on this
discovery.
In 2019, Corcept revised Korlym’s label accordingly.
J.A. 15. The 2019 label contained the following language
regarding coadministration:
Use of Strong CYP3A Inhibitors: Concomitant use
can increase mifepristone plasma levels. Use only
when necessary and limit mifepristone dose to
900 mg.
J.A. 4235 (Warnings and Precautions section).
CYP3A inhibitors: Caution should be used when
KORLYM is used with strong CYP3A inhibitors.
Limit mifepristone dose to 900 mg per day when
used with strong CYP3A inhibitors.
Id. (Drug Interactions section).
KORLYM should be used with caution in patients
taking ketoconazole and other strong inhibitors of
CYP3A . . . as these could increase the concentra-
tion of mifepristone in the blood. The benefit of
concomitant use of these agents should be carefully
weighed against the potential risks. KORLYM
should be used in combination with strong CYP3A
inhibitors only when necessary, and in such cases
the dose should be limited to 900 mg per day.
J.A. 4240 (Use of Strong CYP3A Inhibitors subsection un-
der Warnings and Precautions section).
Medications that inhibit CYP3A could increase
plasma mifepristone concentrations and dose
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CORCEPT THERAPEUTICS , INC v. TEVA PHARMS. USA, INC. 5
reduction of KORLYM may be required. Ketocon-
azole and other strong inhibitors of CYP3A . . . may
increase exposure to mifepristone. Caution should
be used when strong CYP3A inhibitors are pre-
scribed in combination with KORLYM. The benefit
of concomitant use of these agents should be care-
fully weighed against the potential risks. The dose
of KORLYM should be limited to 900 mg, and
strong inhibitors of CYP3A should be used only
when necessary.
J.A. 4245 (CYP3A Inhibitors subsection under Drug Inter-
actions section).
The 2019 label also included a new subsection on
dosage and administration of mifepristone with a strong
CYP3A inhibitor.
J.A. 4238 (under Dosage and Administration section). This
new label expressly instructs dosing with up to 900 mg of
mifepristone along with a strong CYP3A inhibitor.
Teva Pharmaceuticals USA, Inc. (Teva) filed an
Abbreviated New Drug Application (ANDA) for a generic
version of Korlym with a proposed product label identical
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CORCEPT THERAPEUTICS , INC. v. TEVA PHARMS. USA, INC. 6
in all material respects to Korlym’s revised 2019 label.
J.A. 20. Corcept sued Teva for infringement of claims 10–
13 of the ’214 patent and claims 1, 6–7, and 9 of the ’800
patent. J.A. 19–20. Claim 10 of the ’214 patent and claims
1 and 6 of the ’800 patent are representative:
10. A method of controlling hyperglycemia secondary
to hypercortisolism in a patient with endogenous
Cushing’s syndrome who is taking an original once-
daily dose of 1200 mg or 900 mg per day of
mifepristone, comprising the steps of:
reducing the original once-daily dose to an adjusted
once-daily dose of 600 mg mifepristone,
administering the adjusted once-daily dose of
600 mg mifepristone and a strong CYP3A inhibitor
to the patient,
wherein said strong CYP3A inhibitor is selected
from the group consisting of ketoconazole, . . . .
1. A method of controlling hyperglycemia secondary to
hypercortisolism in a patient with endogenous
Cushing’s syndrome, said patient taking an original
once-daily dose of 1200 mg per day of mifepristone, the
method comprising the steps of:
reducing the original once-daily dose to an adjusted
once-daily dose of 900 milligrams (mg) per day of
mifepristone, and
administering the adjusted once-daily dose of
900 mg per day of mifepristone and a strong
CYP3A inhibitor to the patient,
wherein said strong CYP3A inhibitor is selected
from the group consisting of ketoconazole, . . . .
6. A method of controlling hyperglycemia secondary to
hypercortisolism in a patient with endogenous
Cushing’s syndrome, said patient taking a strong
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CORCEPT THERAPEUTICS , INC v. TEVA PHARMS. USA, INC. 7
CYP3A inhibitor selected from ketoconazole, . . . , the
method comprising administering to the patient a
once-daily dose of mifepristone of 900 milligrams (mg)
per day.
After a bench trial, the district court found Corcept had
not met its burden to prove either direct infringement or
specific intent to induce infringement. J.A. 3–46. Corcept
appeals. We have jurisdiction pursuant to 28 U.S.C.
§ 1295(a)(1).
D ISCUSSION
On appeal from a bench trial, we review a district
court’s conclusions of law de novo and its fact findings for
clear error. Vanda Pharms. Inc. v. W.-Ward Pharms. Int’l
Ltd., 887 F.3d 1117, 1123 (Fed. Cir. 2018). Infringement,
including induced infringement, is a question of fact. Id.
To establish induced infringement, a plaintiff must prove,
by a preponderance of the evidence, (1) direct infringement
and (2) specific intent to encourage another’s infringement.
Genentech, Inc. v. Sandoz Inc., 55 F.4th 1368, 1376 (Fed.
Cir. 2022) (citing Vanda, 887 F.3d at 1129–30). The district
court’s determination that Corcept failed to prove either el-
ement is a finding of fact that we review for clear error. See
id. at 1375–76.
In finding that Corcept failed to prove direct infringe-
ment, the district court relied on outside-the-label evidence
in a manner that is expressly authorized by this Court’s
precedents. See J.A. 24–38. For past infringement, the
court found a lack of record evidence showing any physi-
cians had ever practiced the claimed methods. J.A. 25–30.
For future infringement, the court found it was highly un-
likely physicians will practice the claimed methods because
(1) physicians avoid coadministration due to dosing chal-
lenges and safety concerns; (2) the recently approved osilo-
drostat drug that blocks cortisol production is a safer and
more effective non-infringing alternative; and (3) a physi-
cian can follow Teva’s proposed label and not infringe the
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CORCEPT THERAPEUTICS , INC. v. TEVA PHARMS. USA, INC. 8
claims. J.A. 30–38. Because we discern no clear error in
that approach, we affirm the district court’s decision on
this basis.
In Genentech, this Court affirmed a district court’s rul-
ing that a proposed ANDA label that “encourages, recom-
mends, or promotes an infringing use without any
additional evidence showing such an infringing use will in
fact occur, is insufficient for a finding of direct infringe-
ment.” 55 F.4th at 1375. Although the label in Genentech
contained instructions recommending an infringing use, id.
at 1378–79, this Court affirmed the district court’s finding
of no direct infringement based on outside-the-label evi-
dence of physician practice, id. at 1379–81. That evidence
included physicians’ testimony that they had never prac-
ticed the claimed methods in the past, and that if they en-
countered a future situation where the claimed methods
might be clinically indicated, “they would choose a nonin-
fringing response . . . instead.” Id. at 1380. This Court con-
cluded that the district court “did not clearly err by
considering physician evidence, weighing it against the
language in Sandoz’s proposed label, and finding that
Genentech failed to prove direct infringement.” Id.
The district court in this case followed the approach set
out in Genentech. First, the district court found that Cor-
cept had provided no evidence that any physician had ever
practiced the claimed methods. J.A. 28–30. The district
court emphasized that evidence of prior practice is not re-
quired but may serve as a useful “starting point” to the
analysis. J.A. 28. Next, the district court found that future
direct infringement was “highly unlikely” based on evi-
dence that (1) physicians avoid the claimed methods due to
the safety concerns and dosing problems associated with
coadministration; (2) a noninfringing alternative, osilodro-
stat, is available and preferred as a treatment for hyper-
cortisolism; and (3) a physician could follow the proposed
label and not infringe the claims. J.A. 31–36. Based on
this evidence, the district court “reject[ed] Corcept’s
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CORCEPT THERAPEUTICS , INC v. TEVA PHARMS. USA, INC. 9
conclusion that infringement will occur,” and found that
Corcept failed to prove direct infringement. J.A. 38.
Although the direct infringement inquiry in an ANDA
case is hypothetical, a patent owner still must prove that
“if a particular drug were put on the market, it would in-
fringe the relevant patent.” Vanda, 887 F.3d at 1129–30
(quotation omitted); see also Limelight Networks, Inc. v.
Akamai Techs., Inc., 572 U.S. 915, 921–22 (2014) (holding
that direct infringement is required in an induced infringe-
ment case, because a method patent “is not infringed un-
less all the steps are carried out”). This panel is bound by
Genentech, which permits district courts to consider out-
side-the-label evidence to determine whether direct in-
fringement will actually occur, even where the proposed
label recommends an infringing use. See 55 F.4th at 1379–
81.
As in Genentech, the district court looked to evidence of
how physicians weigh the potential risks of the patented
method in practice. For instance, the district court specif-
ically credited physician testimony that “the benefits of co-
administering mifepristone and ketoconazole never
outweigh the risks, especially since the introduction of osil-
odrostat.” J.A. 34 (emphasis added). The district court
also found that Corcept had “no real response” to evidence
that the leading authorities on Cushing’s syndrome do not
recommend coadministration of mifepristone with other
drugs. J.A. 32–33. We perceive no clear error in the dis-
trict court’s finding—based on “all the relevant evidence”—
that Corcept failed to prove that if Teva’s proposed product
were marketed, direct infringement would result. Vanda,
887 F.3d at 1129–30 (quotation omitted).
Because we see no clear error in the district court’s fact
findings regarding direct infringement, we need not and do
not reach the additional finding of specific intent to induce
infringement. We do note that this suit could have been
avoided had Teva filed a “section viii carveout” under
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CORCEPT THERAPEUTICS , INC. v. TEVA PHARMS. USA, INC. 10
21 U.S.C § 355(j)(2)(A)(viii). GlaxoSmithKline LLC v. Teva
Pharms. USA, Inc., 7 F.4th 1320, 1327 (Fed. Cir. 2021);
21 C.F.R. § 314.94(a)(8)(iv).
CONCLUSION
For the foregoing reasons, we affirm.
AFFIRMED
COSTS
No costs.
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