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`APPENDIX A
`APPENDIX A
`
`

`

`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.
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`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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`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.
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`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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`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.
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`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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`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.
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`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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`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.
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`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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`JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
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`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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`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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`Case: 20-1758 Document: 75 Page: 14 Filed: 08/26/2021
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`JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
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`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.
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`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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`JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
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`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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`Case: 20-1758 Document: 75 Page: 17 Filed: 08/26/2021
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`JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.