At California Central District Court Juno Therapeutics, Inc. et al v. Kite Pharma, Inc. – Multi-party Patent Infringement
Curator and Reporter: Aviva Lev-Ari, PhD, RN
Infringement of Patent: US7446190B2 – which is exclusively licensed to Juno Therapeutics, Inc.
United States
- Inventor
- Michel Sadelain
- Renier Brentjens
- John Maher
- Current Assignee
- Sloan-Kettering Institute for Cancer Research
- Info
- Patent citations (17)
- Non-patent citations (20)
- Cited by (103)
- Legal events
- Similar documents
- Priority and Related Applications
- External links
- USPTO
- USPTO Assignment
- Espacenet
- Global Dossier
- Discuss
SUMMARY OF INVENTION
The present invention provides chimeric TCR’s, nucleic acid polymer encoding the chimeric TCR’s and methods of using the chimeric TCR’s to facilitate T cell response to a specific target. The chimeric TCR’s of the invention combine, in a single chimeric species, the intracellular domain of CD3 ζ-chain (“zeta chain portion”), a signaling region from a costimulatory protein such as CD28 and a binding element that specifically interacts with a selected target. Thus, in accordance with a first aspect of the invention, there is provided a nucleic acid encoding a chimeric T cell receptor, said chimeric T cell receptor comprising a zeta chain, a CD28 signaling region and a binding element that specifically interacts with a selected target. In accordance with a second aspect of the invention, there is provided a chimeric T cell receptor comprising a zeta chain portion, a CD28 signaling region and a binding element.
In accordance with the method of the invention a chimeric TCR is provided which comprises a zeta chain portion, a co-stimulatory signaling element and a binding element which specifically interacts with a cellular marker associated with target cells. T-lymphocytes from the individual to be treated, for example a human individual, are transduced with the chimeric TCR. This transduction may occur ex vivo, after which the transduced cells are reintroduced into the individual. As a result, T cell immune response is stimulated in the individual to the target cells.
SOURCE
https://patents.google.com/patent/US7446190B2/en
- Prior Art Search results: (cells) (nucleic acid) (acid polymer) (cell) (cd28) before:priority:2002-05-28
Assignees Inventors include:
SOURCE
IRELL & MANELLA LLP Morgan Chu (SBN 70446) Alan J. Heinrich (SBN 212782) Elizabeth C. Tuan (SBN 295020) 1800 Avenue of the Stars, Suite 900 Los Angeles, California 90067-4276 Telephone: (310) 277-1010 Facsimile: (310) 203-7199 Attorneys for
Plaintiffs JUNO THERAPEUTICS, INC., MEMORIAL SLOAN KETTERING CANCER CENTER, and SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, and Sloan Kettering Institute for Cancer Research,,
Plaintiffs, v. Kite Pharma, Inc., Defendant. ) ) ) ) ) ) ) ) ) ) ) )
CASE NO.: 2:17-CV-07639
COMPLAINT FOR PATENT INFRINGEMENT
DEMAND FOR JURY TRIAL
Case 2:17-cv-07639 Document 1 Filed 10/18/17 Page 1 of 14 Page ID #:1
Knowing that it infringes the ’190 Patent, Kite challenged the validity of all claims of the ’190 Patent in an inter partes review (“IPR”) in the United States Patent and Trademark Office (“PTO” or “Office”) before the Patent Trial and Appeal Board (“PTAB” or “Board”). The PTAB instituted the IPR and then upheld all claims of the ’190 Patent in a Final Written Decision issued December 16, 2016. The PTAB concluded that Kite did not even show “by a preponderance of the evidence”—the lower standard applicable to validity challenges in an IPR—that any claim of the ’190 Patent was unpatentable.
Kite recently received marketing approval from the Food and Drug Administration (“FDA”) for its Yescarta™ product (axicabtagene ciloleucel) (“axicel” or “Yescarta,” also known as “KTE-C19”) on October 18, 2017. Plaintiffs accordingly bring suit against Kite for infringement based on Kite’s making, using, offering to sell, and selling of its chimeric antigen receptor products that comprise the claimed nucleic acid polymers of the ’190 Patent. 35 U.S.C. § 271(a). Plaintiffs hereby allege for their Complaint against Defendant Kite, on personal knowledge as to their own actions and on information and belief as to the actions of others,
26. Indeed, the DNA sequence of Kite’s retroviral vector demonstrates that Kite’s anti-CD19 chimeric TCR falls within the scope of the ’190 Patent claims. In a document Kite filed with the Recombinant DNA Advisory Committee (“RAC”), a federal committee that reviews clinical trial protocols that are either directly funded by the National Institutes of Health (“NIH”) or conducted at institutions that receive NIH funding, Kite provided the DNA sequence of KTE-C19’s anti-CD19 chimeric TCR vector. Exhibit 10 (KTE-C19 DNA Sequence). The RAC filing described the retroviral vector used as
encoding a chimeric antigen receptor directed against the B cell antigen, CD19 . . . The retroviral vector utilizes the MSGV1 (murine stem cell virus-based splice-gag vector 1) retroviral vector backbone and consists of 7026 bps including the 5’ long terminal repeat (LTR) from the murine stem cell virus (promoter), packaging signal including the splicing donor (SD) and splicing acceptor sites, FMC63- based (anti-CD19 FMC63-28) CAR protein containing a signal peptide (human GM-CSF receptor), FMC63 light chain variable region (FMC63 VL), linker peptide, FMC63 heavy chain variable region (FMC63 VH), CD28 (hinge, transmembrane and cytoplasmic region), and TCR-zeta (cytoplasmic region), followed by the murine stem cell virus 3’LTR. This particular vector was provided by Dr. Steven A. Rosenberg from the Surgery Branch/NCI and is the same vector used in an ongoing RAC-approved clinical trial of which Dr. Stephen A. Rosenberg is the Principal Investigator (OBA/RAC submission 0809-940). . . . [T]he complete nucleotide sequence as determined by the standard nucleotide sequencing protocol is shown in Appendix 2 of this application.
27. During the IPR Kite initiated against the ’190 Patent, Sloan Kettering’s expert, Prof. Thomas Brocker, the Director of the Institute for Immunology at the Ludwig-Maximilians University in Munich, Germany, compared the chimeric TCR used by Kite’s scientific collaborators to the claims of the ’190 Patent, demonstrating that Kite’s collaborators’ chimeric TCR construct, and thus, Kite’s own KTE-C19 product, falls within the scope of at least claims 1-3 and 5 of the ’190 Patent. Exhibit 12 (Brocker Declaration), ¶ 224. The NCI chimeric TCR analyzed by Prof. Brocker contains the same nucleotide sequence as KTE-C19’s chimeric TCR. See Exhibit 11 (RAC Filing).
28. On October 18, 2017, Kite received approval for the FDA to market and sell Yescarta (axicabtagene ciloleucel) in the United States.
COUNT 1:
INFRINGEMENT OF THE ’190 PATENT UNDER 35 U.S.C. § 271(a)
29. Plaintiffs re-allege and incorporate by reference the allegations contained in paragraphs 1-28 above.
30. to 40. are Plaintiffs’ description of Defendant Infringement on claims of the Patent
MAIN SOURCE for Filings by Plaintiffs
http://litigationtools.maxval-ip.com/UnifiedPatentViewDocument/home/index?caseid=128416
Plaintiffs:
- Juno Therapeutics, Inc.,
- Memorial Sloan Kettering Cancer Center,
- Sloan Kettering Institute for Cancer Research
Defendant and Counterclaimant
- Kite Pharma, Inc.
Effective April 17, 2018, Magistrate Judge Rozella A. Oliver will be located at the Edward R. Roybal Federal Building and U.S. Courthouse, COURTROOM 590 on the 5th floor, located at 255 East Temple Street, Los Angeles, California 90012. All Court appearances shall be made in Courtroom 590 of the Roybal Federal Building,
100
Oct 9, 2018
MINUTE IN CHAMBERS CLAIM CONSTRUCTION ORDER by Judge S. James Otero: The Court finds that a POSITA encountering the 190 Patent prior to the CoC would have understood SEQ ID NO:6 to begin with nucleotide 336 of the CD28 protein. The Court construes the disputed claim terms as follows: 1. The amino acid sequence encoded by SEQ ID NO:6 before the Certificate of Correction means Amino Acids 113-220 of CD28 (starting with lysine (K)) and after the Certificate of Correction means Amino Acids 114-220 of CD28 (starting with isoleucine (I)). 2. nucleic acid polymer encoding… a binding element that specifically interacts with a selected target is given its plain and ordinary meaning. (shb) (Entered: 10/10/2018)
Main Doc
Juno Therapeutics, Inc. et al v. Kite Pharma, Inc. (2:17-cv-07639), California Central District Court
Juno Therapeutics, Inc. et al v. Kite Pharma, Inc.
| California Central District Court | |
| Judge: | S James Otero |
| Referred: | Jacqueline Chooljian |
| Case #: | 2:17-cv-07639 |
| Nature of Suit | 830 Property Rights – Patent |
| Cause | 35:271 Patent Infringement |
| Case Filed: | Oct 18, 2017 |
| Docket last updated: 03/08/2019 11:59 PM PST |
| Thursday, March 07, 2019 | ||
| 150 | ORDER GRANTING DEFENDANT KITE PHARMA, INC.S EX PARTE APPLICATION FOR AN EXTENSION OF TIME FOR THE MAGISTRATE JUDGE TO HEAR MOTIONS TO COMPEL PRODUCTION OF DOCUMENTS AND WITNESSES144 by Judge S. James Otero: 1. Time is extended until April 17, 2019, for the Magistrate Judge to hear (a) any motions to compel Plaintiffs to produce documents that Kite has already identified as deficient in Plaintiffs production and Plaintiffs have not yet produced, and (b) a motion to compel Bristol-Myers Squibb Company to produce documents in response to Kites subpoena; and 2. Time is extended until May 10, 2019, for the Magistrate Judge to hear a motion to compel deposition testimony regarding the documents described in paragraph 1 above. (lc) Modified on 3/7/2019 (lc) |
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| Wednesday, March 06, 2019 | ||
| 149 | TRANSCRIPT ORDER as to Defendant Kite Pharma, Inc. for Court Smart (CS). Court will contact Adam R. Lawton at adam.lawton@mto.com with further instructions regarding this order. Transcript preparation will not begin until payment has been satisfied with the transcription company. (Lawton, Adam) |
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| Tuesday, March 05, 2019 | ||
| 147 | REPLY in support of EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses 144 filed by Defendant Kite Pharma, Inc..(Lawton, Adam) |
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| 146 | OPPOSITION Ex Parte Application re: EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses 144Opposition filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research.(Wells, Crawford) |
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| Monday, March 04, 2019 | ||
| 148 | MINUTES OF CONTINUED PRE-MOTION TELEPHONIC DISCOVERY CONFERENCE settling139 Motion re: Informal Discovery Dispute held before Magistrate Judge Karen L. Stevenson. Should Judge Otero grant Kite’s Ex Parte Application, Kite may file a motion to compel. In the interim, at the request of counsel for non-party BMS, who does not receive the CM/ECF notifications in this case, the Court ORDERS Defendant Kite, to provide copies to BMS counsel of the following: (1) Minutes of Pre-Motion Telephonic Discovery Conference held on February 26, 2019, (Dkt. No. 138) (see document for further details). Court Recorder: XTR 03-04-19. (hr) |
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| 145 | DECLARATION of Adam R. Lawton (Corrected) in support of EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses 144 filed by Defendant Kite Pharma, Inc.. (Lawton, Adam) |
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| 144 | EX PARTE APPLICATION for Order for Extension of Time for the Magistrate Judge to Hear Motions to Compel Production of Documents and Witnesses filed by Defendant Kite Pharma, Inc.. (Lawton, Adam) |
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| Thursday, February 28, 2019 | ||
| 143 | ORDER GRANTING-IN-PART DEFENDANT KITE PHARMA, INC.’S APPLICATION FOR LEAVE TO FILE A 10-PAGE REPLY BRIEF IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT OF NONINFRINGEMENT140 by Judge S. James Otero. It is hereby ordered that Defendant Kite Pharma, Inc. may file a reply brief of no more than 10 pages in support of its motion for summary judgment of noninfringement. Plaintiffs are permitted to file a sur-reply, not to exceed 7 pages, addressing the admissibility of the expert declarations submitted in support of its opposition to Defendant’s motion for summary judgment of noninfringement. The sur-reply shall be filed no later than 5 days from Defendant’s reply. IT IS SO ORDERED. (lom) |
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Juno Therapeutics, Inc. v. Kite Pharma, Inc. (2:17-cv-07639)
District Court, C.D. California
Recorded here ONLY if PDF is Downloadable
Oct 18, 2017
COMPLAINT Receipt No: 0973-20685642 – Fee: $400, filed by Plaintiffs Juno Therapeutics, Inc., Sloan Kettering Institute for Cancer Research, Memorial Sloan Kettering Cancer Center. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Exhibit 9, # 10 Exhibit 10, # 11 Exhibit 11, # 12 Exhibit 12, # 13 Exhibit 13, # 14 Exhibit 14) (Attorney Morgan Chu added to party Juno Therapeutics, Inc.(pty:pla), Attorney Morgan Chu added to party Memorial Sloan Kettering Cancer Center(pty:pla), Attorney Morgan Chu added to party Sloan Kettering Institute for Cancer Research(pty:pla))(Chu, Morgan) (Entered: 10/18/2017)
Main Doc
3
Oct 18, 2017
Request for Clerk to Issue Summons on Complaint (Attorney Civil Case Opening),, 1 filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Chu, Morgan) (Entered: 10/18/2017)
SKIPPED
46
Jan 29, 2018
JOINT REPORT Rule 26(f) Discovery Plan ; estimated length of trial 5-12 days, filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research.. (Attachments: # 1 Appendix 2)(Chu, Morgan) (Entered: 01/29/2018)
66
Mar 29, 2018
AMENDED ANSWER and AMENDED COUNTERCLAIM to Complaint (Attorney Civil Case Opening),, 1 filed by Defendant and Counterclaimant Kite Pharma, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Appendix (redline version of amended pleading))(Lawton, Adam) (Entered: 03/29/2018)
74
May 11, 2018
STIPULATION for Protective Order filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Attachments: # 1 Proposed Order)(Tuan, Elizabeth) (Entered: 05/11/2018)
75
May 14, 2018
ORDER GRANTING PROTECTIVE ORDER by Magistrate Judge Rozella A. Oliver re Stipulation for Protective Order 74 (dml) (Entered: 05/14/2018)
Protective Order
85
Aug 13, 2018
DECLARATION of Alan J. Heinrich re Brief (non-motion non-appeal), 84 ISO Juno’s Claim Construction Brief filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research, Counter Defendants Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Attachments: # 1 Exhibit Exhibit 1, # 2 Exhibit Exhibit 2, # 3 Exhibit Exhibit 3, # 4 Exhibit Exhibit 4, # 5 Exhibit Exhibit 5, # 6 Exhibit Exhibit 6, # 7 Exhibit Exhibit 7, # 8 Exhibit Exhibit 8, # 9 Exhibit Exhibit 9, # 10 Exhibit Exhibit 10, # 11 Exhibit Exhibit 11)(Heinrich, Alan) (Entered: 08/13/2018)
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Declaration
SKIPPED115
Dec 3, 2018
SEALED DECLARATION IN SUPPORT OF APPLICATION to file document (Reply in Support of Motion to Dismiss and Exhibits J-M) under seal 114 filed by Defendant Kite Pharma, Inc.. (Attachments: # 1 Unredacted Document Reply in Support of Motion to Dismiss, # 2 Unredacted Document Exhibit J, # 3 Unredacted Document Exhibit K, # 4 Unredacted Document Exhibit L, # 5 Unredacted Document Exhibit M)(Lawton, Adam) (Entered: 12/03/2018)
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SKIPPED117
Jan 4, 2019
STIPULATION to AMEND Protective Order 75 filed by Defendant Kite Pharma, Inc.. (Attachments: # 1 Amended Protective Order, # 2 Proposed Order)(Lawton, Adam) (Entered: 01/04/2019)
118
Jan 7, 2019
ORDER GRANTING AMENDED PROTECTIVE ORDER by Magistrate Judge Rozella A. Oliver, re Stipulation to Amend Protective Order 117 (dml) (Entered: 01/07/2019)
119
Jan 7, 2019
AMENDED PROTECTIVE ORDER by Magistrate Judge Rozella A. Oliver, re Order Granting 118 (dml) (Entered: 01/07/2019)
SKIPPED122
Jan 24, 2019
Joint STIPULATION to Extend Discovery Cut-Off Date to March 29, 2019 filed by Plaintiffs Juno Therapeutics, Inc., Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute for Cancer Research. (Attachments: # 1 Proposed Order)(Heinrich, Alan) (Entered: 01/24/2019)
Main Doc
SOURCE
https://www.courtlistener.com/docket/6175992/juno-therapeutics-inc-v-kite-pharma-inc/
Other related sources
35 U.S.C. 271 – Infringement of patent
Other related articles published in this Online Open Access Scientific Journal, include the following:
Economic Potential of a Drug Invention (Prof. Zelig Eshhar, Weitzman Institute, registered the patent) versus a Cancer Drug in Clinical Trials: CAR-T as a Case in Point, developed by Kite Pharma, under Arie Belldegrun, CEO, acquired by Gilead for $11.9 billion, 8/2017.
Curator: Aviva Lev-Ari, PhD, RN
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