APPENDIX
`APPENDIX
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`APPENDIX
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`TABLE OF CONTENTS
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`Page
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`APPENDIX A: Opinion of the United States
`Court of Appeals for the Federal Circuit
`(Aug. 26, 2021) .................................................. 1a
`APPENDIX B: Final Judgment of the United
`States District Court for the Central
`District of California (Apr. 8, 2020) ............... 23a
`APPENDIX C: Order of the United States
`District Court for the Central District
`of California (Mar. 24, 2020) .......................... 26a
`APPENDIX D: Jury Verdict Form
`(Dec. 13, 2019) ................................................ 82a
`APPENDIX E: Order of the United States
`Court of Appeals for the Federal Circuit
`Denying Rehearing (Jan. 14, 2022) ............... 85a
`APPENDIX F: Statutory Provisions ...................... 87a
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`1a
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`APPENDIX A
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`
`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.
`
`
`
`
`
`2a
`
`BOSTWICK, ROBBIE MANHAS, JEREMY PETERMAN,
`Washington, DC; GEOFFREY DONOVAN 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 California 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 Kettering Institute for
`Cancer Research (collectively, Juno) were entitled to
`$1,200,322,551.50 in damages. Juno Therapeutics,
`Inc. v. Kite Pharma, Inc., No. 2:17-cv-07639-PSG-KS,
`(C.D. Cal. April 8, 2020), ECF 728. Because we
`conclude 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
`naturally occurring receptors on their surfaces that
`facilitate their attack on target cells (such as cancer
`cells) by recognizing 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
`involves isolating a patient’s T cells; reprogramming
`
`
`
`
`
`3a
`
`those T cells to produce a specific, targeted receptor (a
`CAR) on each T cell’s surface; and infusing the patient
`with the reprogrammed 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 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
`encoding 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
`antigen, is activated to create an initial immune
`response. J.A. 103. The second portion is a
`costimulatory region comprising 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 costimulatory
`region creates a second signal to augment or prolong
`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 costimulatory 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
`
`
`
`
`
`4a
`
`the ’190 patent’s CAR is the binding element, which is
`the portion of the CAR that determines what target
`molecule or antigen the CAR can recognize and bind
`to. ’190 patent at 4:34–45; J.A. 32912–13.
`One type of binding element in the ’190 patent is a
`single-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 variable region and one from the light
`chain of an antibody’s variable region, and linking
`them together with a linker 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
`
`intracellular domain of human CD3 ζ chain,
`
`
`
`
`
`5a
`
`(b) a costimulatory signaling region, and
`(c) a binding element that specifically
`interacts 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
`element” 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 antigen 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 treatment that uses a three-
`part CAR containing an scFv that 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 invalidity 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
`
`
`
`
`
`6a
`
`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 correction 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 verdict,
`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
`revenues
`through
`trial,
`updated YESCARTA®
`awarding prejudgment interest, enhancing damages
`by 50%, and awarding a 27.6% running royalty. J.A.
`56.
`Kite appeals, arguing the district court erred in
`denying 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 record does not contain substantial evidence
`that the patent 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
`
`
`
`
`
`7a
`
`novo, and reversal is appropriate when “the evidence,
`construed
`in the
`light most
`favorable 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
`description 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
`adequate written description.” Centocor Ortho
`Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348
`(Fed. Cir. 2011). What 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.
`
`
`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.
`
`
`
`
`
`8a
`
`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 predictability of the aspect at
`issue.’” 598 F.3d at 1351 (citing Capon, 418 F.3d at
`1359). For genus claims using functional language,
`like the binding function of the scFvs claimed here,
`the written description “must demonstrate that the
`applicant 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 functionally-defined genus.” Ariad, 598
`F.3d at 1349. “The written description requirement [ ]
`ensures that when a patent claims a genus by its
`function or result, the specification recites sufficient
`materials to accomplish that function.” Id. at 1352.
`Generally, a genus can be sufficiently disclosed by
`“either a representative number of species 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 subject
`matter sufficient to distinguish
`it
`from other
`materials.” 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
`description requirement of § 112 ¶ 1 is a question of
`
`
`
`
`
`9a
`
`fact, and “we review a jury’s determinations of facts
`relating to 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
`failing 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 argues that the
`claims cover an enormous number (millions of
`billions) of scFv candidates, only a fraction of which
`satisfy the functional binding limitation for any given
`target, and that the written description does not meet
`the written description
`requirement
`for
`this
`functional binding limitation. It also argues that the
`scFv field is unpredictable since an scFv’s binding
`ability depends on a variety of factors.
`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
`demonstrates that the inventors possessed the full
`scope of the claimed invention. We hold that
`
`
`
`
`
`10a
`
`substantial evidence does not support the jury’s
`finding of adequate written description 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 explains, “[t]he target . . . can be any
`target of clinical interest to which it would be desirable
`to induce a T cell response.” ’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
`species within, or defining characteristics for, that
`expansive genus.
`
`1
`The ’190 patent’s written description contains scant
`details 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 derived 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 designations 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 embodiments
`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
`
`
`
`
`
`11a
`
`targets. In claims 3 and 9 there is no limit as to the
`particular target. To satisfy the written description
`requirement, the patent needed to demonstrate to a
`skilled artisan that the inventors possessed and
`disclosed in their filing the particular species of scFvs
`that would bind to a representative number of targets.
`Kite demonstrated by clear and convincing evidence
`that this patent does not satisfy the written
`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 establish that a skilled
`artisan would understand how to identify the species
`of scFvs capable of binding to the limitless number of
`targets as the claims require.
`Juno primarily relies on the testimony of its
`immunological 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
`
`
`
`
`
`12a
`
`acid sequence of the claimed scFvs to satisfy the
`written description 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
`Interferences
`to require
`“recitation in the specification of the nucleotide
`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 understand that the inventors possessed the
`entire scope of the claimed invention. Ariad, 598 F.3d
`at 1353–54 (“[T]he purpose 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 contribution to the field of
`art as described in the patent specification.” (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 about which scFvs bind to which target. It is
`not fatal that the amino acid sequences of these two
`scFvs were not disclosed as long as the patent
`provided other means of identifying 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
`demonstrate the inventors possessed the entire class
`of possible scFvs that bind to various selected targets.
`
`
`
`
`
`13a
`
`Relying upon witness testimony, Juno argues that
`because 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 testifying 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
`possessed 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 provides 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
`definition, 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 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
`
`
`
`
`
`14a
`
`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 chimeric genes must
`be fully presented, although the nucleotide 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
`inventors here used only two scFvs as of the ’190
`patent’s priority 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
`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 possessed the claimed invention. See
`
`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 targets, 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.
`
`
`
`
`
`15a
`
`Ariad, 598 F.3d at 1350. Juno argues that the ’190
`patent satisfies the written description 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 consisting 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 connected with a linker. J.A.
`33936–38. These general assertions 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, regardless 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 solutions to it . . . cover[ing]
`any compound later actually invented and determined
`to fall within the claim’s functional boundaries,”
`Ariad, 598 F.3d at 1353, which fails to satisfy the
`written description requirement.
`
`
`
`
`
`16a
`
`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
`deprived 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 inadequate 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 in these two cases, the ’190 patent does
`
`
`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 compounds 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 artisan “could make modifications to increase potency
`and selectivity.” Id. at 652–53. The ’190 patent, in contrast, does
`not disclose any amino acid sequences or structures to
`
`
`
`
`
`
`17a
`
`not provide meaningful 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 description of the ’190 patent discloses only
`two scFv examples and provides no details regarding
`the characteristics, sequences, or structures that
`would allow a person of ordinary 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 deficiency. Thus,
`substantial evidence does not support the jury’s
`finding that the ’190 patent conveys, to a skilled
`artisan, 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
`description 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.
`
`distinguish 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 few CD19-
`specific scFvs were known as of the priority date. See § II.B
`below.
`
`
`
`
`
`18a
`
`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 that
`the ’190 patent discloses species representative of the
`claimed genus.
`Juno does not dispute Kite’s characterizations
`regarding 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
`finding that the ’190 patent disclosed sufficient
`information to show the inventors possessed the
`claimed genus of functional 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 target-specific
`scFv to bind.
` Instead,
`it provides only an
`alphanumeric 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.
`
`
`
`
`
`19a
`
`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. 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
`backbone.” J.A. 33943–44 (emphasis added). But that
`testimony presupposes an scFv already known to be
`functional; one that was known to bind to CD19. Such
`circular reasoning 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
`
`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 human scFv sequences
`
`
`
`
`
`
`20a
`
`the written description requirement is satisfied as of
`the filing date of the patent application. A
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