DCT

2:17-cv-07639

Juno Therap Inc v. Kite Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-07639, C.D. Cal., 10/18/2017
  • Venue Allegations: Venue is alleged to be proper based on Defendant having a principal place of business in Santa Monica, California, and committing acts of infringement within the district.
  • Core Dispute: Plaintiffs allege that Defendant’s Yescarta® cancer immunotherapy infringes a patent related to the fundamental design of nucleic acids that encode chimeric antigen receptors (CARs).
  • Technical Context: The technology involves CAR-T cell therapy, a field of oncology where a patient’s own T cells are genetically engineered to recognize and destroy cancer cells, representing a major advance in cancer treatment.
  • Key Procedural History: The complaint notes that Defendant Kite previously challenged the validity of all claims of the patent-in-suit in an inter partes review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB). In a Final Written Decision, the PTAB found that Kite had failed to prove any claim of the patent was unpatentable. The patent is exclusively licensed to Plaintiff Juno from Plaintiff Sloan Kettering.

Case Timeline

Date Event
2002-05-28 Earliest Priority Date ('190 Patent)
2008-11-04 Issue Date (U.S. Patent No. 7,446,190)
2015-08-13 Defendant Kite files IPR petition against the '190 Patent
2016-12-16 PTAB issues Final Written Decision upholding all claims of the '190 Patent
2017-10-18 FDA approves Defendant's Yescarta® product
2017-10-18 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,446,190, “Nucleic Acids Encoding Chimeric T Cell Receptors,” issued November 4, 2008

  • The Invention Explained:
    • Problem Addressed: The patent’s background section describes a central challenge in developing effective T-cell-based cancer immunotherapies. For T-cells to become fully activated and proliferate to mount a sustained attack, they require two distinct signals: a primary activation signal (“signal 1”) and a separate “co-stimulatory” signal (“signal 2”) (’190 Patent, col. 1:15-28, col. 2:52-61). Early attempts to engineer T-cell receptors could provide signal 1, but the absence of a coordinated signal 2 often resulted in a weak response or T-cell inactivation, a state known as anergy (’190 Patent, col. 2:56-61).
    • The Patented Solution: The invention is a nucleic acid polymer that encodes a single, multi-part chimeric T-cell receptor (TCR) designed to deliver both required signals simultaneously upon binding to a target cancer cell (’190 Patent, Abstract). This engineered receptor combines three critical components into one molecule: (1) an external binding element (such as a single-chain antibody fragment) that recognizes a specific antigen on a tumor cell; (2) an intracellular signaling domain from the CD3 zeta (ζ) chain to provide signal 1; and (3) an intracellular signaling region from a costimulatory protein, specifically CD28, to provide signal 2 (’190 Patent, col. 2:10-26). By uniting these functions, the invention enables a T-cell to be robustly activated by a tumor cell, even if that tumor cell does not naturally provide a co-stimulatory signal.
    • Technical Importance: This design, which integrates an antigen-dependent co-stimulatory signal directly into the chimeric receptor, was a key conceptual advance for creating T-cell therapies capable of potent and sustained expansion and anti-tumor activity in a clinical setting (Compl. ¶14).
  • Key Claims at a Glance:
    • The complaint asserts independent claim 1 and dependent claims 2-3, 5, 7-9, and 11 (Compl. ¶30).
    • Independent Claim 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,
      • (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.
    • The complaint states that Plaintiffs will provide their full list of asserted claims at a later date (Compl. ¶35).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendant Kite's Yescarta® (axicabtagene ciloleucel) therapy (Compl. ¶18).
  • Functionality and Market Context: Yescarta® is described as a cancer therapy in which a patient’s own T cells are genetically engineered to express a CAR that targets the CD19 antigen, a protein found on the surface of certain B-cell lymphomas and leukemias (Compl. ¶18). The complaint alleges that the nucleic acid construct used to create the Yescarta® product is "substantively identical" to one publicly described by Kite's scientific collaborators (Compl. ¶20). This construct is alleged to encode a CAR comprising an anti-CD19 single-chain antibody fragment (scFv), a portion of the human CD28 molecule, and the intracellular component of the human TCR-ζ molecule (Compl. ¶20). The complaint was filed on the same day that Kite announced it had received marketing approval for Yescarta® from the U.S. Food and Drug Administration (Compl. ¶19). The complaint provides a schematic diagram of the accused KTE-C19 construct, illustrating its components as an "scFv (FMC63)," a "Hinge/Transmembrane" region, "Signal 2: CD28," and "Signal 1: CD3ζ" (Compl. ¶24, p. 8).

IV. Analysis of Infringement Allegations

'190 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A nucleic acid polymer encoding a chimeric T cell receptor... The Yescarta® therapy allegedly uses retroviral vectors that are nucleic acid polymers encoding a chimeric TCR. ¶36 col. 2:10-14
...a zeta chain portion comprising the intracellular domain of human CD3 ζ chain, The Yescarta® CAR is alleged to contain an "intracellular human CD3ζ signaling region." ¶36 col. 4:11-18
...a costimulatory signaling region, The Yescarta® CAR allegedly includes a "costimulatory region derived from CD28." ¶36 col. 2:16-18
...a binding element that specifically interacts with a selected target, The Yescarta® CAR allegedly includes an "anti-CD19 binding domain" that targets the CD19 protein on cancer cells. ¶36 col. 4:34-46
...wherein the costimulatory signaling region comprises the amino acid sequence encoded by SEQ ID NO:6. The CD28-derived region in the Yescarta® CAR is explicitly alleged to comprise the amino acid sequence encoded by SEQ ID NO:6 of the '190 Patent. ¶¶26, 36 col. 4:26-28
  • Identified Points of Contention:
    • Technical Questions: The complaint's infringement theory relies on public disclosures from Kite and its collaborators, including scientific publications and a filing with the Recombinant DNA Advisory Committee (RAC), to describe the structure of the Yescarta® CAR (Compl. ¶¶ 20, 26). This raises the evidentiary question of whether the final, commercialized Yescarta® product is identical to the constructs described in these documents. The court may need to resolve what evidence is required to prove the precise amino acid sequence of the CAR in the product as sold.

V. Key Claim Terms for Construction

  • The Term: "costimulatory signaling region"
  • Context and Importance: This term is at the core of the patent's claimed advance over the prior art. The scope of this term, especially as limited in Claim 1 by the reference to SEQ ID NO:6, will be central to the infringement analysis. Practitioners may focus on this term because the dispute could turn on whether it carries a purely structural meaning (the presence of a specific amino acid sequence) or also implies a functional requirement (the achievement of a certain level or type of co-stimulation).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification lists other costimulatory molecules beyond CD28, such as 4-1BB, DAP-10, and ICOS, as being within the scope of the invention generally, which could suggest the term itself is meant to be interpreted broadly across the patent (’190 Patent, col. 4:49-51).
    • Evidence for a Narrower Interpretation: Claim 1 explicitly narrows the term by requiring that the region "comprises the amino acid sequence encoded by SEQ ID NO:6," which is derived from CD28 (’190 Patent, cl. 1). A party could argue that the term "signaling region" itself implies that the component must be functional in a particular way, potentially seeking to limit the claim to constructs that exhibit specific, measurable co-stimulatory activity as described in the patent's examples (’190 Patent, col. 2:56-65).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced infringement under 35 U.S.C. § 271(b) and contributory infringement under § 271(c) (Compl. ¶¶ 31-32). The inducement allegation is based on Kite allegedly encouraging and assisting others, such as medical institutions and end-users, to use Yescarta® in an infringing manner (Compl. ¶31). The contributory infringement allegation is based on the assertion that the Yescarta® product components are especially made for infringement and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶32). The complaint also pleads infringement under § 271(f) for supplying components from the U.S. for combination abroad (Compl. ¶¶ 33-34).
  • Willful Infringement: The complaint alleges that Kite’s infringement has been willful and deliberate (Compl. ¶40). The basis for this allegation is Kite's alleged actual knowledge of the '190 Patent, evidenced by its own filing of an inter partes review petition against the patent on August 13, 2015 (Compl. ¶¶ 37, 40). The complaint notes that Kite continued its infringing activities even after the PTAB issued a Final Written Decision confirming the patentability of all claims (Compl. ¶¶ 16, 40).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of evidentiary proof: will Plaintiffs be able to demonstrate through discovery that the commercial Yescarta® product, as manufactured and sold, is encoded by a nucleic acid that contains the exact combination of elements recited in Claim 1, particularly the specific CD28-derived amino acid sequence of SEQ ID NO:6?
  • A key question for damages will be "willfulness": given that Kite challenged the '190 Patent in an IPR and received a final decision confirming its patentability prior to launching Yescarta®, did its subsequent commercialization constitute objective recklessness, or can Kite present a good-faith, albeit unsuccessful, basis for believing the patent was invalid or not infringed?
  • The case may also turn on a nuanced question of claim construction: does the term "costimulatory signaling region," as used in the claims, require only the presence of the specified amino acid structure, or does it also import a functional requirement that the accused product must be shown to meet?