Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica Nv, Janssen Research v. Mylan Laboratories Ltd.

N OTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
JANSSEN PHARMACEUTICALS, INC., JANSSEN
PHARMACEUTICA NV, JANSSEN RESEARCH AND
DEVELOPMENT LLC,
Plaintiffs-Appellees
v.
MYLAN LABORATORIES LTD.,
Defendant-Appellant
______________________
2023-2042
______________________
Appeal from the United States District Court for the
District of New Jersey in No. 2:20-cv-13103-EP-LDW,
Judge Evelyn Padin.
______________________
Decided: March 28, 2025
______________________
ARON RUSSELL F ISCHER, Patterson Belknap Webb &
Tyler LLP, New York, NY, argued for plaintiffs-appellees.
Also represented by L ACHLAN S. CAMPBELL -VERDUYN, J.
J AY CHO, A NDREW D. COHEN, COLLIN HONG, B ARBARA
MULLIN, J OYCE N ADIPURAM .
ERIC T HOMAS WERLINGER , Katten Muchin Rosenman
LLP, Washington, DC, argued for defendant-appellant.
Case: 23-2042 Document: 42 Page: 1 Filed: 03/28/2025

-- 1 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
2
Also represented by T IMOTHY H. G RAY ; J ITENDRA MALIK,
Charlotte, NC; D EEPRO MUKERJEE , L ANCE SODERSTROM ,
New York, NY; J ILLIAN SCHURR, Dallas, TX.
______________________
Before D YK and P ROST , Circuit Judges, and G OLDBERG,
Chief District Judge. 1
P ROST , Circuit Judge.
Janssen Pharmaceuticals, Inc., Janssen Pharmaceu-
tica NV, and Janssen Research & Development, LLC (col-
lectively, “Janssen”) sued Mylan Laboratories Ltd.
(“Mylan”) for patent infringement in the United States Dis-
trict Court for the District of New Jersey. After a bench
trial and post-trial briefing, the district court found that
Janssen has demonstrated by a preponderance of the evi-
dence that Mylan will induce health care providers
(“HCPs”) to infringe the asserted claims of U.S. Patent
No. 10,143,693 (“the ’693 patent”), and Mylan has not
demonstrated by clear and convincing evidence that the
’693 patent is invalid. Janssen Pharms., Inc. v. Mylan
Labs. Ltd., No. 20-13103, 2023 WL 3605733 (D.N.J.
May 23, 2023) (“Opinion”). Mylan appeals, and we affirm.
BACKGROUND
The technology here concerns paliperidone palmitate
(“PP”), an antipsychotic used to treat schizophrenia. PP
comes in at least two long-acting injectable forms—one
that lasts for one month (“PP1M”) and another that lasts
for three months (“PP3M”). Janssen manufactures Invega
Trinza ® (“Invega Trinza”), which is a United States Food &
1 Honorable Mitchell S. Goldberg, Chief Judge,
United States District Court for the Eastern District of
Pennsylvania, sitting by designation.
Case: 23-2042 Document: 42 Page: 2 Filed: 03/28/2025

-- 2 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
3
Drug Administration (“FDA”)-approved PP3M for treating
schizophrenia.
The ’693 patent covers the use of Janssen’s Invega
Trinza and “relates to a method for treating patients who
have missed a treatment of 3-month paliperidone palmi-
tate extended-release injectable suspension formulation”
or “PP3M.” ’693 patent col. 1 ll. 15–18. Janssen’s asserted
claims include independent claim 5 and dependent claims
6–7 and 9–14 of the ’693 patent. All dependent claims de-
pend directly or indirectly from claim 5. Claim 5 recites:
A dosing regimen for administering an injectable
paliperidone palmitate depot to a patient in need of
treatment for psychosis, schizophrenia or bipolar
disorder that has been treated with PP3M, wherein
said patient had been last administered a PP3M in-
jection 4 to 9 months ago and the next scheduled
maintenance dose of PP3M should be administered
to said patient, comprising:
(1) administering intramuscularly in the
deltoid muscle of said patient a first reiniti-
ation loading dose of PP1M;
(2) administering intramuscularly in the
deltoid muscle of said patient a second rei-
nitiation loading dose of PP1M on about the
4th day to about the 12th day after admin-
istering of said first reinitiation loading
dose; and
(3) administering intramuscularly in the
deltoid or gluteal muscle of said patient a
reinitiation dose of PP3M on about the 23rd
day to about the 37th day after administer-
ing the second reinitiation loading dose of
PP1M wherein said first and second reiniti-
ation loading doses and the reinitiation
Case: 23-2042 Document: 42 Page: 3 Filed: 03/28/2025

-- 3 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
4
PP3M dose are selected from the table be-
low based on the amount of the missed dose
Id. at claim 5.
The Invega Trinza dosing instructions on the label
track the asserted claims of the ’693 patent. Specifically,
the label instructs HCPs that if a patient had his or her
last dose between four and nine months ago, “do NOT ad-
minister the next dose . . . [i]nstead, use the re-initiation
regimen shown in Table 2.” J.A. 10037.
Mylan filed three Abbreviated New Drug Applications
(“ANDA”) seeking approval from the FDA to market a ge-
neric version of Janssen’s Invega Trinza product before ex-
piration of the ’693 patent. Mylan’s proposed ANDA labels
are substantially identical to the Invega Trinza label.
Janssen initiated this lawsuit, asserting that Mylan’s
proposed ANDA labels will induce HCPs to infringe the as-
serted claims of the ’693 patent. Mylan responded that the
’693 patent is invalid. After an eight-day bench trial and
considering the parties’ post-trial briefing, the district
court held that: “(1) Janssen has demonstrated by a pre-
ponderance of the evidence that Mylan will inevitably in-
duce HCPs to infringe the [asserted claims of the
’693 patent]; and (2) Mylan has not demonstrated by clear
and convincing evidence that the [’]693 [p]atent is obvious
or otherwise invalid.” Opinion, 2023 WL 3605733, at *2.
Case: 23-2042 Document: 42 Page: 4 Filed: 03/28/2025

-- 4 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
5
Mylan appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(1).
D ISCUSSION
“On appeal from a bench trial, this court reviews the
district court’s conclusions of law de novo and findings of
fact for clear error.” MeadWestVaco Corp. v. Rexam Beauty
& Closures, Inc., 731 F.3d 1258, 1266 (Fed. Cir. 2013).
“[I]nfringement is a question of fact that we review for clear
error.” Vanda Pharms. Inc. v. W.-Ward Pharms., 887 F.3d
1117, 1125 (Fed. Cir. 2018). “Obviousness is a question of
law, which we review de novo, with underlying factual
questions, which we review for clear error following a
bench trial.” Honeywell Int’l, Inc. v. United States, 609
F.3d 1292, 1297 (Fed. Cir. 2010) (emphasis in original).
Mylan raises two main issues on appeal: that the dis-
trict court incorrectly found that (1) Mylan will induce in-
fringement of the asserted claims and (2) the asserted
claims are not invalid for obviousness. We address each
issue in turn.
I
We begin with Mylan’s challenge to the district court’s
finding that Mylan’s proposed ANDA labels will induce in-
fringement of the asserted claims. Mylan offers three main
noninfringement arguments: (1) Mylan cannot induce in-
fringement because its proposed ANDA labels specifically
discourage patients from missing doses in the first place;
(2) Janssen failed to carry its burden of proof to show that
infringement would “inevitably” result because Janssen
did not prove that patients who missed a dose would return
and follow through with the claimed reinitiation regimen;
and (3) because the asserted claims involve two actors—a
doctor and a patient—this gives rise to a divided-infringe-
ment problem, thus defeating Janssen’s showing of direct
infringement. None of these arguments are persuasive.
Case: 23-2042 Document: 42 Page: 5 Filed: 03/28/2025

-- 5 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
6
A
With respect to the first argument, Mylan argues that,
by discouraging patients from missing doses in the first
place, it has demonstrated a lack of specific intent to en-
courage prescribing the missed-dosage regimen in the
event doses are missed. We disagree and conclude that the
district court did not clearly err in finding that Mylan’s pro-
posed ANDA labels would induce infringement.
To prevail on a theory of induced infringement,
Janssen must prove (1) direct infringement and (2) that
the ANDA applicant has the specific intent to induce in-
fringement. Vanda, 887 F.3d at 1129. “Where ‘the pro-
posed label instructs users to perform the patented method
. . . the proposed label may provide evidence of [the ANDA
applicant’s] affirmative intent to induce infringement.’” Id.
(quoting AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042,
1060 (Fed. Cir. 2010) (alteration in original)). Induced in-
fringement requires showing that the proposed ANDA la-
bels “encourage, recommend, or promote infringement.”
Id.
At issue in this appeal is the second requirement of in-
duced infringement—whether Janssen failed to prove spe-
cific intent to induce infringement of the asserted claims of
the ’693 patent. Mylan’s proposed ANDA labels state: “To
manage missed doses on exceptional occasions, refer to the
Full Prescribing Information. (2.3).” See, e.g., J.A. 10238.
Under the subsection “Missed Dose 4 Months to 9 Months
Since Last Injection,” Mylan’s proposed ANDA labels in-
struct HCPs that, if the patient received a PP3M dose four
to nine months ago, “do NOT administer the next dose of
[PP3M].” J.A. 10243. The labels go on to state: “Instead,
use the re-initiation regimen shown in Table 2,” J.A. 10243,
which directs HCPs to perform the same administrating
steps as the claimed reinitiation regimen. Mylan’s argu-
ment that its proposed ANDA labels discourage missing
doses in the first place is unpersuasive. As the district
Case: 23-2042 Document: 42 Page: 6 Filed: 03/28/2025

-- 6 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
7
court correctly found, the fact that Mylan’s proposed ANDA
labels “discourage missed doses” does not mean that the la-
bels “discourage or make optional the practice of the
[a]sserted [c]laims (or any claimed steps) in the inevitable
situation that doses are missed.” Opinion, 2023 WL
3605733, at *17. Thus, because Mylan’s proposed ANDA
labels explicitly instruct HCPs to reinitiate patients onto
PP3M using the asserted claims’ methodology, the explicit
instructions in Mylan’s proposed ANDA labels establish
specific intent for the purposes of induced infringement.
B
As to the second argument, Mylan argues that Janssen
failed to carry its burden to show that the necessary direct
infringement would occur. We disagree.
The district court found that “missed doses and pa-
tients returning between 4 and 9 months after a missed
dose are inevitable, meaning that infringement of the
claimed reinitiation regimen would be inevitable.” Id. at
*15. The court cited Mylan’s expert’s—Dr. Steven Berger—
testimony admitting that “‘more than 50 percent’ of [In-
vega] Trinza patients have missed a dose, including ‘20 to
30 percent’ returning for an appointment 16 or more weeks
(about 4 months) after the missed dose.” Id. (quoting Dr.
Berger’s testimony). The court found that “based on Ber-
ger’s testimony and other credible testimony, . . . at least
some percentage of PP3M patients would inevitably return
between 4 to 9 months after their last missed dose.” Id. at
*15 n.13. The district court also cited to a study that stated
that the “vast majority of patients [prescribed Invega
Trinza] transitioned from PP1M to PP3M based on the pre-
scribing guidelines” to support its finding. J.A. 12881; see
also Opinion, 2023 WL 3605733, at *16 (citing PTX-220).
Mylan argues that the district court erred by relying
upon Dr. Christian Kohler’s testimony for infringement,
because he was admitted to testify only regarding second-
ary considerations and was explicitly not admitted to
Case: 23-2042 Document: 42 Page: 7 Filed: 03/28/2025

-- 7 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
8
testify about infringement. The district court rejected this
argument: “[T]he [c]ourt notes that its direct infringement
findings do not hinge solely on Kohler’s testimony—there
is other evidence in the record, including Dr. Berger’s tes-
timony, of inevitable infringement.” Opinion, 2023 WL
3605733, at *16 n.14. On this record, we conclude that
there is no clear error in the district court’s finding that
Janssen carried its burden of proof to show infringement.
C
As to the third argument, Mylan argues that under a
divided-infringement theory, Mylan cannot induce in-
fringement because the claimed dosing regimen will be car-
ried out by two actors—the patient and that patient’s
HCPs—such that there will be no direct infringement, and
thus no inducement. We also do not find this argument
persuasive.
The district court rejected Mylan’s divided-infringe-
ment argument on two grounds. First, the district court
concluded that Mylan’s divided-infringement defense was
untimely under the governing local rules. See id. at *11–
12. Second, the district court rejected the divided-infringe-
ment argument on the merits, concluding that a single en-
tity (an HCP) performs the claimed reinitiation dosing
regimen. Id. at *12–15. Mylan challenges both grounds on
appeal.
As to the first ground, we review “a district court’s ap-
plication of its local rules for abuse of discretion.”
Howmedica Osteonics Corp. v. Zimmer, Inc., 822 F.3d 1312,
1320 (Fed. Cir. 2016). “[T]his court gives broad deference
to the trial court’s application of local procedural rules.”
SanDisk Corp. v. Memorex Prods., Inc., 415 F.3d 1278,
1292 (Fed. Cir. 2005). On this record, we conclude that the
district court did not abuse its discretion in rejecting
Mylan’s divided-infringement defense because it was un-
timely. The district court found that “Mylan’s divided in-
fringement theory was not disclosed in its contentions, and
Case: 23-2042 Document: 42 Page: 8 Filed: 03/28/2025

-- 8 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
9
appeared improperly for the first time in Mylan’s rebuttal
expert report.” Opinion, 2023 WL 3605733, at *12. Mylan
also did not seek to amend its contentions to add the di-
vided-infringement defense. Thus, in view of this record
and our deferential review standard, we are not able to con-
clude that the district court abused its discretion. Because
we affirm the district court’s untimeliness ruling, we need
not and do not address the merits of Mylan’s divided-in-
fringement argument.
II
We next address Mylan’s challenge to the district
court’s determination of nonobviousness. Mylan chal-
lenges the district court’s findings for two main reasons:
(1) the claimed PP3M reinitiation regimen is obvious in
view of the prior-art PP1M regimen; and (2) the prior art
taught the specific four-to-nine-month reinitiation window
claimed in the asserted claims. As discussed below, be-
cause we reject Mylan’s first argument, we need not and do
not address Mylan’s second argument.
As to Mylan’s first argument, the district court found
that nothing in the prior art motivated a skilled artisan to
use PP1M after a patient has been advanced to PP3M. See,
e.g., id. at *27 (“There was nothing obvious, in other words,
about using a non-PP3M formulation to reinitiate a patient
that had been advanced to PP3M.”); id. at *28 (similar); id.
at *27 (observing that the ’693 patent “was the first [long-
acting injectable antipsychotic] that recommended using
two different long-acting injectable formulations to manage
a missed dose” (emphasis added)). Mylan argues that a
skilled artisan would have been motivated to ramp back up
to PP3M with PP1M because a skilled artisan would have
known that PP1M was “faster acting.” Yet, the district
court found that there was not “any credible evidence that
taught that PP1M reaches therapeutic levels any faster
than PP3M,” and provided several reasons why Mylan’s ar-
gument was not persuasive. Id. at *28. One of those
Case: 23-2042 Document: 42 Page: 9 Filed: 03/28/2025

-- 9 of 10 --

JANSSEN PHARMACEUTICALS, INC. v.
MYLAN LABORATORIES LTD.
10
reasons was that Mylan’s own expert’s “flawed modeling
suggests identical PP1M and PP3M absorption,” “even
though his comparison was skewed to favor faster absorp-
tion of PP1M.” Id.
The district court also found that although the prior art
showed starting a patient on PP1M to get them up to PP3M
in the first place (i.e., not for reinitiation to PP3M), that
prior art taught stabilizing on PP1M for at least four
months before advancing to PP3M—as opposed to the as-
serted claim’s “reinitiation dose of PP3M on about the 23rd
day to about the 37th day after administering the second
reinitiation loading dose of PP1M,” ’693 patent claim 5.
The court found “[t]hus, if a patient who missed a dose of
PP3M were given PP1M, there would have been no reason
or motivation to advance them to PP3M without first sta-
bilizing them on PP1M for at least 17 weeks, since that was
the only way PP3M was reportedly used in the prior art.”
Opinion, 2023 WL 3605733, at *29.
On this record, we see no clear error in the district
court’s findings supporting its conclusion that Mylan failed
to prove that the ’693 patent is invalid for obviousness.
CONCLUSION
We have considered Mylan’s remaining arguments and
find them unpersuasive. For the foregoing reasons, we af-
firm the district court’s determination on induced infringe-
ment and nonobviousness.
AFFIRMED
Case: 23-2042 Document: 42 Page: 10 Filed: 03/28/2025

-- 10 of 10 --