Case: 20-1758 Document: 75 Page: 1 Filed: 08/26/2021
United States Court of Appeals
for the Federal Circuit
______________________
JUNO THERAPEUTICS, INC., SLOAN KETTERING
INSTITUTE FOR CANCER RESEARCH,
Plaintiffs-Appellees
v.
KITE PHARMA, INC.,
Defendant-Appellant
______________________
2020-1758
______________________
Appeal from the United States District Court for the
Central District of California in No. 2:17-cv-07639-PSG-
KS, Judge Philip S. Gutierrez.
______________________
Decided: August 26, 2021
______________________
MORGAN CHU, Irell & Manella LLP, Los Angeles, CA,
argued for plaintiffs-appellees. Also represented by ALAN
J. HEINRICH, ELIZABETH C. TUAN; GREGORY A. CASTANIAS,
JENNIFER L. SWIZE, Jones Day, Washington, DC; LISA LYNN
FURBY, Chicago, IL; ANDREA WEISS JEFFRIES, Los Angeles,
CA; MATTHEW J. RUBENSTEIN, Minneapolis, MN.
E. JOSHUA ROSENKRANZ, Orrick, Herrington & Sutcliffe
LLP, New York, NY, argued for defendant-appellant. Also
represented by MELANIE L. BOSTWICK, ROBBIE MANHAS,
JEREMY PETERMAN, Washington, DC; GEOFFREY DONOVAN
Case: 20-1758 Document: 75 Page: 2 Filed: 08/26/2021
2 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
BIEGLER, Fish & Richardson, San Diego, CA; TED G. DANE,
PETER GRATZINGER, ADAM R. LAWTON, GARTH VINCENT,
JEFFREY I. WEINBERGER, Munger, Tolles & Olson LLP, Los
Angeles, CA.
______________________
Before MOORE, Chief Judge, PROST and O’MALLEY, Circuit
Judges.
MOORE, Chief Judge.
Kite Pharma, Inc. appeals a final judgment of the
United States District Court for the Central District of Cal-
ifornia that (1) claims 3, 5, 9, and 11 of U.S. Patent No.
7,446,190 are not invalid for lack of written description or
enablement, (2) the ’190 patent’s certificate of correction is
not invalid, and (3) Juno Therapeutics, Inc., and Sloan Ket-
tering Institute for Cancer Research (collectively, Juno)
were entitled to $1,200,322,551.50 in damages. Juno Ther-
apeutics, Inc. v. Kite Pharma, Inc., No. 2:17-cv-07639-PSG-
KS, (C.D. Cal. April 8, 2020), ECF 728. Because we con-
clude that the jury verdict regarding written description is
not supported by substantial evidence, we reverse.
BACKGROUND
T cells are white blood cells that contribute to the
body’s immune response. J.A. 32906–07. They have natu-
rally occurring receptors on their surfaces that facilitate
their attack on target cells (such as cancer cells) by recog-
nizing and binding an antigen, i.e., a structure on a target
cell’s surface. J.A. 32907–08.
Chimeric antigen receptor (CAR) T-cell therapy in-
volves isolating a patient’s T cells; reprogramming those
T cells to produce a specific, targeted receptor (a CAR) on
each T cell’s surface; and infusing the patient with the re-
programmed cells. J.A. 32913; ’190 patent at 2:31–36,
7:24–33. The reprogramming involves introducing genetic
material containing a nucleotide sequence encoding for a
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 3
CAR into the T cell so that the cell produces the CAR on its
surface. J.A. 32913; ’190 patent at 1:30–34, 2:27–36. This
CAR allows the T cell to recognize the specific antigen for
which it was programmed. J.A. 32913; ’190 patent at 2:27–
36.
The ’190 patent relates to a nucleic acid polymer encod-
ing a three-part CAR for a T cell. It claims priority to a
provisional application filed May 28, 2002, a time period
that one of the inventors labeled as “the birth of the CAR-
T field.” J.A. 32976. The first portion of the three-part
CAR is called the intracellular domain of the human CD3 ζ
(zeta) chain. See, e.g., ’190 patent at 2:14–16, 4:12–17. It
is a signaling domain that, when the T cell binds to an an-
tigen, is activated to create an initial immune response.
J.A. 103. The second portion is a costimulatory region com-
prising a specific amino acid sequence (SEQ ID NO:6) that
is part of a naturally occurring T-cell protein called CD28.
’190 patent at 2:16–17, 3:44–54. When activated, the cost-
imulatory region creates a second signal to augment or pro-
long the immune response by, for example, directing the
T cells to multiply. J.A. 103; J.A. 32912. The CD3-zeta
portion and the costimulatory region combine to make a
signaling element, or backbone, of the CAR. J.A. 32906;
J.A. 32912–13. This combination of the CD3-zeta and cost-
imulatory regions allows the T cells to not only kill target
cells but also to divide into more T cells. J.A. 32913–14.
The third and final portion of the ’190 patent’s CAR is the
binding element, which is the portion of the CAR that de-
termines what target molecule or antigen the CAR can rec-
ognize and bind to. ’190 patent at 4:34–45; J.A. 32912–13.
One type of binding element in the ’190 patent is a sin-
gle-chain antibody, i.e., a single-chain antibody variable
fragment (scFv). ’190 patent at 4:52–57; see also
J.A. 32910. An scFv is made by taking two pieces of an
antibody, one from the heavy chain of an antibody’s varia-
ble region and one from the light chain of an antibody’s var-
iable region, and linking them together with a linker
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4 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
sequence. J.A. 32908–09; see also J.A. 2643–44; J.A. 103;
’190 patent at 4:52–5:5. Each variable region has a unique
amino acid sequence that can dictate whether and how an
antibody, and thus an scFv, binds to a target. J.A. 2643;
J.A. 103. The ’190 patent discloses two scFvs. One of those
scFvs is derived from the SJ25C1 antibody and binds
CD19, a protein that appears on the surface of diffuse large
B-cell lymphoma cells. ’190 patent at 11:12–22; see also
J.A. 58. The other disclosed scFv is derived from the J591
antibody and binds PSMA, a protein that appears on the
surface of prostate cancer cells. ’190 patent at 7:43–51,
8:5–10; see also J.A. 32967; J.A. 33945. The ’190 patent
does not disclose the amino acid sequence of either scFv.
Independent claim 1 of the ’190 patent recites:
1. A nucleic acid polymer encoding a chimeric T cell
receptor, said chimeric T cell receptor comprising
(a) a zeta chain portion comprising the in-
tracellular domain of human CD3 ζ chain,
(b) a costimulatory signaling region, and
(c) a binding element that specifically inter-
acts with a selected target, wherein the
costimulatory signaling region comprises
the amino acid sequence encoded by SEQ
ID NO:6.
Dependent claims 3 and 9 limit the claimed “binding ele-
ment” to “a single chain antibody,” i.e., an scFv. Claims 5
and 11, which depend from claims 3 and 9, respectively,
further specify that the claimed scFv binds to CD19.
Kite’s YESCARTA® is a “therapy in which a patient’s T
cells are engineered to express a [CAR] to target the anti-
gen CD19, a protein expressed on the cell surface of B-cell
lymphomas and leukemias, and redirect the T cells to kill
cancer cells.” J.A. 58; J.A. 384; Kite Br. 17. It is a treat-
ment that uses a three-part CAR containing an scFv that
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 5
binds the CD19 antigen, a CD3-zeta chain portion, and a
costimulatory signaling region. J.A. 58; see also Kite Br.
11; J.A. 383–96 (Complaint).
Juno sued Kite, alleging infringement of various claims
of the ’190 patent through the use, sale, offer for sale, or
importation of YESCARTA®. Kite filed counterclaims
seeking declaratory judgments of noninfringement and in-
validity of the ’190 patent. After a two-week jury trial, the
jury reached a verdict in Juno’s favor, finding (1) Kite
failed to prove the ’190 patent’s certificate of correction was
invalid, (2) Kite failed to prove any of the asserted claims
were invalid for lack of written description or enablement,
(3) Juno proved Kite’s infringement was willful, and
(4) Juno proved Kite owed damages amounting to a $585
million upfront payment and a 27.6% running royalty.
The parties then filed post-trial briefs. Kite moved for
judgment as a matter of law (JMOL), arguing (a) the claims
were not supported by a sufficient written description,
(b) the claims were not enabled, (c) Juno’s certificate of cor-
rection was invalid, (d) Kite acted in good faith such that it
could not be found to be a willful infringer, and (e) Juno’s
damages expert should have been excluded. J.A. 57, 60.
Juno, for its part, moved for entry of judgment on the ver-
dict, prejudgment interest, enhanced damages, and for the
court to set an ongoing royalty rate. J.A. 38. The district
court denied Kite’s motions for JMOL. J.A. 86. The district
court granted-in-part Juno’s motion, updating the jury’s
award to $778,343,501 to reflect updated YESCARTA® rev-
enues through trial, awarding prejudgment interest, en-
hancing damages by 50%, and awarding a 27.6% running
royalty. J.A. 56.
Kite appeals, arguing the district court erred in deny-
ing JMOL on each of the above issues that Kite raised in
its post-trial briefing. We have jurisdiction under
28 U.S.C. § 1295(a)(1). Because we determine that the rec-
ord does not contain substantial evidence that the patent
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6 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
contains written description support for the asserted
claims, we hold the claims invalid and need not reach Kite’s
alternative arguments.
DISCUSSION
We review denial of a motion for JMOL under regional
circuit law. See Trs. of Boston Univ. v. Everlight Elecs. Co.,
896 F.3d 1357, 1361 (Fed. Cir. 2018). The Ninth Circuit
reviews a denial of JMOL de novo, and reversal is appro-
priate when “the evidence, construed in the light most fa-
vorable to the nonmoving party, permits only one
reasonable conclusion, and that conclusion is contrary to
that of the jury.” White v. Ford Motor Co., 312 F.3d 998,
1010 (9th Cir. 2002).
I
A patent’s specification “shall contain a written de-
scription of the invention.” 35 U.S.C. § 112 ¶ 1. 1 “[T]he
hallmark of written description is disclosure.” Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (en banc). A specification adequately describes
an invention when it “reasonably conveys to those skilled
in the art that the inventor had possession of the claimed
subject matter as of the filing date.” Id. at 1351. “A ‘mere
wish or plan’ for obtaining the claimed invention is not ad-
equate written description.” Centocor Ortho Biotech, Inc.
v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011). What
1 Paragraph 1 of 35 U.S.C. § 112 was replaced with
newly designated § 112(a) by section 4(c) of the Leahy-
Smith America Invents Act (“AIA”), Pub. L. No. 112-29,
sec. 4, 125 Stat. 284, 296–97 (2011). Section 4(e) of the AIA
makes those changes applicable “to any patent application
that is filed on or after” September 16, 2012. Id. Because
the applications resulting in the patent at issue in this case
was filed before that date, we refer to the pre-AIA version
of § 112.
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 7
is required to meet the written description requirement
“varies with the nature and scope of the invention at issue,
and with the scientific and technologic knowledge already
in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed.
Cir. 2005); see also Ariad, 598 F.3d at 1351.
As we explained in Ariad, “[f]or generic claims, we have
set forth a number of factors for evaluating the adequacy
of the disclosure, including ‘the existing knowledge in the
particular field, the extent and content of the prior art, the
maturity of the science or technology, [and] the predictabil-
ity of the aspect at issue.’” 598 F.3d at 1351 (citing Capon,
418 F.3d at 1359). For genus claims using functional lan-
guage, like the binding function of the scFvs claimed here,
the written description “must demonstrate that the appli-
cant has made a generic invention that achieves the
claimed result and do so by showing that the applicant has
invented species sufficient to support a claim to the func-
tionally-defined genus.” Ariad, 598 F.3d at 1349. “The
written description requirement [ ] ensures that when a pa-
tent claims a genus by its function or result, the specifica-
tion recites sufficient materials to accomplish that
function.” Id. at 1352. Generally, a genus can be suffi-
ciently disclosed by “either a representative number of spe-
cies falling within the scope of the genus or structural
features common to the members of the genus so that one
of skill in the art can ‘visualize or recognize’ the members
of the genus.” Id. at 1350. “A written description of an
invention involving a chemical genus, like a description of
a chemical species, ‘requires a precise definition, such as by
structure, formula, [or] chemical name,’ of the claimed sub-
ject matter sufficient to distinguish it from other materi-
als.” Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d
1559, 1568 (Fed. Cir. 1997) (quoting Fiers v. Revel, 984 F.2d
1164, 1171 (Fed. Cir. 1993)).
Whether a patent complies with the written descrip-
tion requirement of § 112 ¶ 1 is a question of fact, and “we
review a jury’s determinations of facts relating to
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8 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
compliance with the written description requirement for
substantial evidence.” Ariad, 598 F.3d at 1355 (quoting
PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1243
(Fed. Cir. 2002)).
II
Kite argues that the asserted claims are invalid for fail-
ing to satisfy the written description requirement because
the ’190 patent discloses neither representative species nor
common structural features of the claimed scFv genus to
identify which scFvs would function as claimed. Kite ar-
gues that the claims cover an enormous number (millions
of billions) of scFv candidates, only a fraction of which sat-
isfy the functional binding limitation for any given target,
and that the written description does not meet the written
description requirement for this functional binding limita-
tion. It also argues that the scFv field is unpredictable
since an scFv’s binding ability depends on a variety of fac-
tors.
Juno responds that scFvs were well-known (as was how
to make them), that multiple scFvs for specific targets were
well-known, that the ’190 patent describes two working
scFv embodiments that are representative of all scFvs, and
that scFvs had been incorporated in CARs well before the
’190 patent’s priority date. It also argues that scFvs are
interchangeable and have common structural features.
We agree with Kite that no reasonable jury could find
the ’190 patent’s written description sufficiently demon-
strates that the inventors possessed the full scope of the
claimed invention. We hold that substantial evidence does
not support the jury’s finding of adequate written descrip-
tion for any of the asserted claims.
A
The broadest asserted claims of the ’190 patent, claims
3 and 9, recite that the scFv binding element “specifically
interacts with a selected target.” As the ’190 patent
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 9
explains, “[t]he target . . . can be any target of clinical in-
terest to which it would be desirable to induce a T cell re-
sponse.” ’190 patent at 4:36–39 (emphasis added). In other
words, claims 3 and 9 broadly cover, as part of the claimed
nucleic acid polymer encoding for the three-part CAR, any
scFv for binding any target. But the ’190 patent’s written
description fails to provide a representative sample of spe-
cies within, or defining characteristics for, that expansive
genus.
1
The ’190 patent’s written description contains scant de-
tails about which scFvs can bind which target antigens.
The ’190 patent discloses two example scFvs for binding
two different targets: one derived from J591, which targets
a PSMA antigen on prostate cancer cells, and another de-
rived from SJ25C1, which targets CD19. J.A. 32922–23;
J.A. 32967; J.A. 33945. The ’190 patent contains no details
about these scFv species beyond the alphanumeric desig-
nations J591 and SJ25C1 for a skilled artisan to determine
how or whether they are representative of the entire
claimed genus. Juno argues these two working embodi-
ments are representative of all scFvs in the context of a
CAR. The evidence does not support Juno’s argument. The
claims are directed to scFvs that bind to selected targets.
In claims 3 and 9 there is no limit as to the particular tar-
get. To satisfy the written description requirement, the pa-
tent needed to demonstrate to a skilled artisan that the
inventors possessed and disclosed in their filing the partic-
ular species of scFvs that would bind to a representative
number of targets. Kite demonstrated by clear and con-
vincing evidence that this patent does not satisfy the writ-
ten description requirement for the claims at issue and this
record does not contain substantial evidence upon which a
jury could have concluded otherwise. The disclosure of one
scFv that binds to CD19 and one scFv that binds to a PSMA
antigen on prostate cancer cells in the manner provided in
this patent does not provide information sufficient to
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10 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
establish that a skilled artisan would understand how to
identify the species of scFvs capable of binding to the lim-
itless number of targets as the claims require.
Juno primarily relies on the testimony of its immuno-
logical expert, Dr. Brocker, but that testimony is far too
general. Dr. Brocker testified that the two exemplary
scFvs are representative “because [scFvs] all do the same
thing. They bind to the antigen.” J.A. 33945. Nothing
about that testimony explains which scFvs will bind to
which target or cures the ’190 patent’s deficient disclosure
on this score. Without more in the disclosure, such as the
characteristics of the exemplary scFvs that allow them to
bind to particular targets or nucleotide sequences, the mere
fact that scFvs in general bind does not demonstrate that
the inventors were in possession of the claimed invention.
This is not to say, however, that a patentee must in all
circumstances disclose the nucleotide or amino acid se-
quence of the claimed scFvs to satisfy the written descrip-
tion requirement when such sequences are already known
in the prior art. See Capon, 418 F.3d at 1360–61 (holding
it was error for the Board of Patent Appeals and Interfer-
ences to require “recitation in the specification of the nu-
cleotide sequence of claimed DNA, when that sequence is
already known in the field”). But the written description
must lead a person of ordinary skill in the art to under-
stand that the inventors possessed the entire scope of the
claimed invention. Ariad, 598 F.3d at 1353–54 (“[T]he pur-
pose of the written description requirement is to ensure
that the scope of the right to exclude, as set forth in the
claims, does not overreach the scope of the inventor’s con-
tribution to the field of art as described in the patent spec-
ification.” (internal quotation marks omitted)).
Dr. Sadelain, one of the ’190 patent’s inventors, testified
that, at the time he filed his patent application, he had
used only the SJ25C1-derived scFv and J591-derived scFv.
J.A. 32965–67. Yet the ’190 patent claims any scFv on its
CAR that binds to any target, without disclosing details
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 11
about which scFvs bind to which target. It is not fatal that
the amino acid sequences of these two scFvs were not dis-
closed as long as the patent provided other means of iden-
tifying which scFvs would bind to which targets, such as
common structural characteristics or shared traits. But
this patent provides nothing to indicate that the inventors
possessed the full scope of the genus that they chose to
claim. Thus, the ’190 patent’s disclosure does not demon-
strate the inventors possessed the entire class of possible
scFvs that bind to various selected targets.
Relying upon witness testimony, Juno argues that be-
cause scFvs, in general, were known, the two scFvs in the
’190 patent are representative. See, e.g., J.A. 32909
(Dr. Sadelain testifying that scFvs were not new in the
field, and that they “had been around since the [1980s]”);
J.A. 33209 (Kite’s founder, Dr. Belldegrun, agreeing that
“scientists knew about the scFvs that could be used with
CARs going back to the 1980s”); J.A. 33932 (Juno’s expert,
Dr. Brocker, testifying that scFvs “were in the field for
more than a decade, nearly 15 years” at the time of
Dr. Sadelain’s invention); J.A. 33939–40 (Dr. Brocker tes-
tifying that people knew how to make scFvs and “several of
them had been described”). To satisfy written description,
however, the inventors needed to convey that they pos-
sessed the claimed invention, which encompasses all scFvs,
known and unknown, as part of the claimed CAR that bind
to a selected target. Even accepting that scFvs were known
and that they were known to bind, the specification pro-
vides no means of distinguishing which scFvs will bind to
which targets. See Eli Lilly, 119 F.3d at 1568 (“A written
description of an invention involving a chemical genus, like
a description of a chemical species, ‘requires a precise defi-
nition, such as by structure, formula, [or] chemical name,’
of the claimed subject matter sufficient to distinguish it
from other materials.” (quoting Fiers, 984 F.2d at 1171)).
Accordingly, testimony that scFvs were generally known in
the field is insufficient to satisfy the written description
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12 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
requirement for the ’190 patent’s claims requiring scFvs
that bind to a selected target.
Juno relies heavily on our decision in Capon, arguing
that we already determined that “scFvs were well-known
CAR components that did not need to be detailed in CAR
patents’ specifications to satisfy Section 112.” Juno Br. 27.
Our Capon decision neither made the determination Juno
alleges nor determined that the inventors there satisfied
the written description requirement. Instead, we vacated
the Board’s decision for imposing too high a standard to
satisfy the written description requirement, and remanded
for the Board to consider the evidence and determine
whether the specification adequately supported the claims
at issue. Capon, 418 F.3d at 1358–61; see also id. at 1358
(“The Board’s rule that the nucleotide sequences of the chi-
meric genes must be fully presented, although the nucleo-
tide sequences of the component DNA are known, is an
inappropriate generalization.”). Also, more was known in
the prior art in Capon than here, particularly when the in-
ventors here used only two scFvs as of the ’190 patent’s pri-
ority date out of the vast number of possibilities. See id. at
1355, 1358; J.A. 32965–67. Capon does not support Juno’s
arguments regarding its exceedingly broad functional
claim limitations. 2
2 We agree with Juno that a patent specification
need not redescribe known prior art concepts. Juno Br. 28
(citing Immunex Corp. v. Sandoz Inc., 964 F.3d 1049, 1064
(Fed. Cir. 2020)). The problem with the ’190 patent is that,
although there were some scFvs known to bind some tar-
gets, the claims cover a vast number of possible scFvs and
an undetermined number of targets about which much was
not known in the prior art.
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 13
2
In addition to lacking representative species, the ’190
patent does not disclose structural features common to the
members of the genus to support that the inventors pos-
sessed the claimed invention. See Ariad, 598 F.3d at 1350.
Juno argues that the ’190 patent satisfies the written de-
scription requirement because scFvs are interchangeable,
with a similar, common structure. It relies on
Dr. Brocker’s testimony that scFvs have “known structural
commonalities, similarities.” J.A. 33926. He explained
that scFvs have the same general, common structure con-
sisting of a variable region derived from the light chain of
an antibody and a variable region derived from the heavy
chain of an antibody, where these two portions are con-
nected with a linker. J.A. 33936–38. These general asser-
tions of structural commonalities, in the context of the
technology in this case, are insufficient.
It is undisputed that scFvs generally have a common
structure, as described by Dr. Brocker. But, as Dr. Brocker
acknowledged, an scFv with the same general common
structure but with a different amino acid sequence would
recognize a different antigen. J.A. 33938. Dr. Brocker also
testified that all scFvs have a common structure, regard-
less of whether they bind. J.A. 33959. The ’190 patent not
only fails to disclose structural features common to scFvs
capable of binding specific targets, it also fails to disclose a
way to distinguish those scFvs capable of binding from
scFvs incapable of binding those targets. The ’190 patent
provides no amino acid sequences or other distinguishing
characteristics of the scFvs that bind. Simply put, the ’190
patent claims a “problem to be solved while claiming all so-
lutions to it . . . cover[ing] any compound later actually in-
vented and determined to fall within the claim’s functional
boundaries,” Ariad, 598 F.3d at 1353, which fails to satisfy
the written description requirement.
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14 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
We have previously held similar claims invalid based
on lack of written description. In Idenix, we held invalid
claims that required nucleosides effective against hepatitis
C virus, and the patent merely provided “lists or examples
of supposedly effective nucleosides, but [did] not explain
what makes them effective, or why.” Idenix Pharms. LLC
v. Gilead Scis. Inc., 941 F.3d 1149, 1164 (Fed. Cir. 2019).
Without this explanation, “a [person of ordinary skill] is de-
prived of any meaningful guidance into what compounds
beyond the examples and formulas, if any, would provide
the same result.” Id. Similarly, in AbbVie, we concluded
that substantial evidence supported the jury’s verdict of in-
adequate written description when the patents described
one species of structurally similar antibodies derived from
only one lead antibody but the asserted claims covered
“every fully human IL-12 [targeted] antibody that would
achieve a desired result” without an indication about an
established correlation between the structure and the
claimed function. AbbVie Deutschland GmbH v. Janssen
Biotech, Inc., 759 F.3d 1285, 1301–02 (Fed. Cir. 2014). 3 As
3 Juno also relies on Erfindergemeinschaft UroPep
GbR v. Eli Lilly & Co., 276 F. Supp. 3d 629 (E.D. Tex.
2017), aff’d, 739 F. App’x 643 (Fed. Cir. 2018). In that case,
there were hundreds of known PDE5 inhibitors, the type of
compound at issue, and the patent identified the com-
pounds by chemical name and structural drawings. Id. at
645–46. The compounds also shared a common physical
structure to fit the active site of the PDE5 enzyme to inhibit
its activity, and the evidence supported that a skilled arti-
san “could make modifications to increase potency and se-
lectivity.” Id. at 652–53. The ’190 patent, in contrast, does
not disclose any amino acid sequences or structures to dis-
tinguish scFvs that bind to selected targets from those that
do not, and the modifications of the sequence can change
the binding ability. Juno also does not dispute that very
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 15
in these two cases, the ’190 patent does not provide mean-
ingful guidance about which scFv will bind which target.
Claims 3 and 9 broadly claim all scFvs, as part of the
claimed CAR, that bind to any target. But the written de-
scription of the ’190 patent discloses only two scFv exam-
ples and provides no details regarding the characteristics,
sequences, or structures that would allow a person of ordi-
nary skill in the art to determine which scFvs will bind to
which target. That scFvs in general were well-known or
have the same general structure does not cure that defi-
ciency. Thus, substantial evidence does not support the
jury’s finding that the ’190 patent conveys, to a skilled ar-
tisan, that the inventors possessed the broad genus of
scFvs as recited in claims 3 and 9.
B
Claims 5 and 11, which are limited to scFvs that bind
CD19 (a specific target), likewise find no written descrip-
tion support in the ‘190 patent. And again, Juno’s general
testimony about general scFv structure does not provide
substantial evidence regarding the claims containing the
functional limitation that covers all scFvs that bind to
CD19.
Kite argues that there were “four or five” CD19-specific
scFvs “arguably known in the art” at the priority date of
the ’190 patent. Kite Br. 35. Kite argues that the universe
of possible sequences for scFvs is in the range of “millions
of billions.” Id. at 26. Given the vast number of possible
scFvs, the lack of detail in the ’190 patent regarding the
scFv sequences, and the few scFvs known in the art to bind
CD19, Kite argues substantial evidence does not support
few CD19-specific scFvs were known as of the priority date.
See § II.B below.
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16 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
that the ’190 patent discloses species representative of the
claimed genus.
Juno does not dispute Kite’s characterizations regard-
ing either the number of known CD19 scFvs at the priority
date of the ’190 patent or the universe of possible scFvs.
Instead, it cites Dr. Brocker’s general testimony that “there
were several known” CD19 scFvs and publications “which
have demonstrated that it’s possible to make these single-
chain Fvs that can bind to CD19.” J.A. 33942. Juno also
acknowledges that the ’190 patent discloses only one CD19-
specific scFv (the SJ25C1-derived scFv), but argues that a
second CD19-specific scFv, the one used in YESCARTA®,
was known by 1997. Juno Br. 24.
Substantial evidence does not support the jury’s find-
ing that the ’190 patent disclosed sufficient information to
show the inventors possessed the claimed genus of func-
tional CD19-specific scFvs as part of their claimed CAR.
The ’190 patent provides no details about any CD19-
specific scFv, such as an exemplary amino acid sequence, a
shape, or general characteristics that would allow this tar-
get-specific scFv to bind. Instead, it provides only an al-
phanumeric designation, SJ25C1, as the source for the
CD19-specific scFv. Without more guidance, in a vast field
of possible CD19-specific scFvs with so few of them known,
no reasonable jury could find the inventors satisfied the
written description requirement.
Juno’s reliance on a combination of expert and inventor
testimony does not provide the required support.
Dr. Brocker’s testimony that “there were several [CD19
scFvs] known” at the priority date and that it was “possible
to make these single-chain Fvs that can bind CD19,”
J.A. 33942, at most demonstrates a small number of CD19-
specific scFvs were known and others were possible, albeit
undiscovered. Indeed, Dr. Sadelain admitted that the
SJ25C1-derived scFv was the only CD19-specific scFv he
used at the time he filed his patent application. J.A. 32965.
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 17
And Juno’s reliance on only one more CD19-specific scFv,
the one used in YESCARTA®, further demonstrates that
the number of known CD19-specific scFvs at the time was
small. Juno again relies on Dr. Brocker, who testified that
he was not “aware of any functional CD19 scFv that has
not been shown to work with Dr. Sadelain’s CAR back-
bone.” J.A. 33943–44 (emphasis added). But that testi-
mony presupposes an scFv already known to be functional;
one that was known to bind to CD19. Such circular reason-
ing does not support that the inventors possessed the full
scope of possible CD19-specific scFvs, particularly when
the genus of possibilities is expansive with only four or five
CD19 scFv species known at the time. Finally, Juno relies
on Dr. Sadelain’s testimony that, since he filed his patent
application, he has “placed multiple scFvs” on the CAR
backbone, “probably up to 30 [CD19-specific scFvs] by
now.” J.A. 32923. 4 But we assess whether the written de-
scription requirement is satisfied as of the filing date of the
patent application. Ariad, 598 F.3d at 1351. Dr. Sadelain’s
testimony about post-priority date developments, there-
fore, is irrelevant to the inquiry before us. See id. at 1355
(post-priority date evidence “legally irrelevant to the ques-
tion of whether” the disclosure conveyed possession at the
time of filing).
Juno’s further arguments that it would not matter to a
person of ordinary skill (1) that scFvs may be highly di-
verse in the abstract, (2) that “millions of billions” of scFvs
would need to be made and tested to ascertain their bind-
ing properties, or (3) that a skilled artisan could not predict
4 Fifteen years after the ’190 patent’s priority date,
individuals from Juno published an article, J.A. 37426–34,
in which they discussed having screened over a billion hu-
man scFv sequences to arrive at only 60 that “displayed el-
evated binding to CD19-expressing cells,” J.A. 37427–28.
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18 JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
before testing whether an scFv would bind, Juno Br. 28–
29, are contrary to our precedent. In Ariad, we explained
that “the level of detail required to satisfy the written de-
scription requirement varies depending on the nature and
scope of the claims and on the complexity and predictabil-
ity of the relevant technology.” 598 F.3d at 1351. Some
factors to consider when evaluating the adequacy of the
disclosure include “the existing knowledge in the particu-
lar field, the extent and content of the prior art, the ma-
turity of the science or technology, [and] the predictability
of the aspect at issue.” Id. (alteration in original) (citing
Capon, 418 F.3d at 1359). Contrary to Juno’s argument,
the diversity of the functional scFv genus, the unpredicta-
bility of an scFv’s binding ability, and that the prior art
had, at most, five CD19-specific scFvs as of the priority
date are all relevant to the written description inquiry.
We likewise reject Juno’s argument that our decision
in Ariad is “irrelevant” because the claims at issue here do
not involve method claims reciting a “newly-identified cel-
lular function or mechanism of action.” Juno Br. 25. Juno
relies on its expert’s testimony that Dr. Sadelain invented
the backbone, not scFvs. J.A. 33932; see also J.A. 33934
(Dr. Brocker testifying that scFvs were “not part of this in-
vention. The real invention was the backbone.”). But the
’190 patent’s claims are not limited to just the claimed
backbone; they also include the functional scFv for binding
the target. As we explained in Boston Scientific Corp. v.
Johnson & Johnson, “[t]he test for written description is
the same whether the claim is to a novel compound or a
novel combination of known elements. The test is the same
whether the claim element is essential or auxiliary to the
invention.” 647 F.3d 1353, 1365 (Fed. Cir. 2011). The ’190
patent inventors, therefore, needed to provide a sufficient
disclosure that “reasonably conveys to those skilled in the
art that the inventor[s] had possession of the claimed sub-
ject matter as of the filing date,” Ariad, 598 F.3d at 1351,
including for the claimed functional binding element.
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JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. 19
While it is true that scFvs in general were known, and
even known to bind, the record demonstrates that, for even
the narrowest claims at issue, the realm of possible CD19-
specific scFvs was vast and the number of known CD19-
specific scFvs was small (five at most). The ’190 patent,
however, provides no details about which scFvs bind to
CD19 in a way that distinguishes them from scFvs that do
not bind to CD19. Without this guidance, under our con-
trolling Ariad decision, no reasonable jury could find the
’190 patent satisfies the written description requirement.
CONCLUSION
Substantial evidence does not support the jury’s verdict
in Juno’s favor on the issue of written description. For the
claimed functional scFv genus, the ’190 patent does not dis-
close representative species or common structural features
to allow a person of ordinary skill in the art to distinguish
between scFvs that achieve the claimed function and those
that do not. Accordingly, we reverse.
REVERSED
COSTS
Costs to Kite.