DCT

1:21-cv-08206

Errant Gene Therap LLC v. Memorial Sloan Ketting Cancer Center

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I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 1:21-cv-08206, S.D.N.Y., 12/15/2021

  • Venue Allegations: Venue is alleged to be proper as Defendants reside and conduct regular business in the district, and a substantial part of the events giving rise to the claims occurred there.

  • Core Dispute: Plaintiff, an exclusive licensee, seeks a judicial declaration that newly developed gene therapy vectors (the "SNS23 Vectors") created by the licensor, Defendant, are covered by the scope of the licensed patents, which would grant Plaintiff exclusive commercial rights to these new vectors.

  • Technical Context: The dispute concerns lentiviral vectors, a sophisticated tool in gene therapy, used for treating genetic blood disorders such as Beta Thalassemia and Sickle Cell Disease.

  • Key Procedural History: The complaint describes a long-standing and contentious relationship rooted in a 2005 exclusive license agreement from Defendant to Plaintiff for the patents-in-suit. This relationship, which involved collaborative development of a prior vector (TNS9), devolved into disputes and state court litigation. The current action was triggered after Defendant developed the new SNS23 Vectors and disputed they were covered by the license, while allegedly attempting to commercialize them with third parties and prosecuting new patent applications on them.

Case Timeline

Date Event
2001-06-29 Earliest Priority Date for '179 and '061 Patents
2005-XX-XX MSK grants EGT an exclusive, royalty-free commercial license
2009-06-02 U.S. Patent 7,541,179 issues
2010-09-01 EGT completes manufacture of clinical batch of TNS9 Vector
2011-06-17 EGT and MSK execute the "2011 Agreement"
2011-11-15 U.S. Patent 8,058,061 issues
2015-XX-XX EGT commences lawsuit against MSK in New York state court
2020-11-03 Date on or after which acts giving rise to DJ action occurred
2021-05-12 MSK inventor presents data on the TNS9 and SNS23 Vectors
2021-12-15 Complaint for Declaratory Judgment filed

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

U.S. Patent No. 7,541,179 - "Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies"

Patent Identification

U.S. Patent No. 7,541,179, "Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies," issued June 2, 2009.

The Invention Explained

  • Problem Addressed: The patent describes the significant limitations of existing treatments for hemoglobinopathies like β-thalassemia, such as the burdens of lifelong blood transfusions or the risks of allogeneic bone marrow transplants (’179 Patent, col. 1:21-34). A central challenge for gene therapy has been the inability to produce "therapeutically useful levels" of a desired protein for sustained periods (’179 Patent, col. 1:36-40).
  • The Patented Solution: The invention is a recombinant lentiviral vector designed to deliver a functional globin gene into a patient's own hematopoietic stem cells. The key to achieving high-level, stable expression is the inclusion of "large portions" of the β-globin locus control region (LCR), a powerful genetic regulatory element. Specifically, the vector incorporates large fragments of three DNase I hypersensitive sites (HS2, HS3, and HS4) from the LCR, which work together to drive robust expression of the therapeutic globin gene once inside the cell (’179 Patent, col. 1:47-57, Fig. 1).
  • Technical Importance: This vector design represented a significant step toward overcoming the low and unstable gene expression that had previously hindered the development of effective gene therapies for these debilitating blood disorders (’179 Patent, col. 1:36-44).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 23 (Compl. ¶118).
  • Independent Claim 1: A recombinant vector comprising:
    • A nucleic acid encoding a functional globin;
    • Operably linked to a 3.2-kb nucleotide fragment which consists essentially of three contiguous nucleotide fragments from a human β-globin locus control region (LCR);
    • The three fragments are specified as a BstXI and SnaBI HS2-spanning fragment, a BamHI and HindIII HS3-spanning fragment, and a BamHI and BanII HS4-spanning fragment; and
    • The vector provides for the expression of the globin in a mammal in vivo.
  • Independent Claim 23: A recombinant vector similar to claim 1, which further specifies:
    • The HS3- and HS4-spanning fragments are adjacent to each other; and
    • The vector further comprises 2 GATA-1 binding sites at the junction between the HS3- and HS4-spanning fragments.

U.S. Patent No. 8,058,061 - "Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies"

Patent Identification

U.S. Patent No. 8,058,061, "Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies," issued November 15, 2011.

The Invention Explained

  • Problem Addressed: As a divisional of the '179 Patent, the '061 Patent addresses the same technical problems related to achieving therapeutically effective gene expression for treating hemoglobinopathies (’061 Patent, col. 1:24-45).
  • The Patented Solution: The '061 Patent claims the application of the same vector technology described in the '179 Patent. However, instead of claiming the vector itself, the '061 Patent claims the cells that have been modified with the vector and the methods of making those modified cells. The core technology—a lentiviral vector with a functional globin gene and large portions of the LCR (HS2, HS3, HS4)—remains the same (’061 Patent, col. 2:35-39).
  • Technical Importance: By claiming the transduced cells and the methods of making them, the patent provides a different and complementary layer of protection for the overall gene therapy treatment process.

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 11 (Compl. ¶¶128-129).
  • Independent Claim 1: An isolated mammalian hematopoietic progenitor cell (or stem cell) that comprises the recombinant lentiviral vector described in the '179 Patent (i.e., a nucleic acid encoding a functional globin linked to the specified 3.2-kb LCR fragment).
  • Independent Claim 11: A method for making a mammalian hematopoietic progenitor cell or stem cell composition, the method comprising the steps of:
    • Preparing the recombinant lentiviral vector with the specified LCR fragments;
    • Obtaining hematopoietic progenitor cells or stem cells from a mammal; and
    • Transducing those cells with the prepared vector.

III. The Accused Instrumentality

Product Identification

The "SNS23 Vectors," specifically SNS23.B87.A1 and SNS23.2.B87.A1, which were developed by Defendant (Compl. ¶6).

Functionality and Market Context

The complaint characterizes the SNS23 Vectors as a "later version" and a "real straight arrow" from the TNS9 Vector, a prior vector that Defendant allegedly admits is covered by the patents-in-suit (Compl. ¶¶66, 80, 83). The SNS23 Vectors are described as gene therapy vectors for treating hemoglobinopathies (Compl. ¶¶6, 66). According to allegations, Defendant's own subsequent patent application ('436 Application) describes the SNS23 Vectors as comprising the core elements of the licensed patents, including a human globin gene linked to an LCR containing HS2, HS3, and HS4 regions (Compl. ¶¶176-177). The dispute over rights to these vectors is commercially significant, with Plaintiff alleging that Defendant has transferred commercial rights to a third party and is prosecuting new patents to exclude Plaintiff from a market potentially worth over a billion dollars (Compl. ¶¶94, 168, 206).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Ex. E and Ex. F) that were not provided in the submitted document. Therefore, the infringement allegations are summarized below in prose. No probative visual evidence provided in complaint.

  • '179 Patent Allegations (Vectors): Plaintiff EGT seeks a declaration that the SNS23 Vectors fall within the scope of claims 1 and 23 of the '179 Patent (Compl. ¶118). The complaint alleges that the SNS23 Vectors are recombinant lentiviral vectors that contain the claimed elements: a functional globin gene operably linked to a large LCR fragment comprising HS2, HS3, and HS4 regions, which provides for globin expression in a mammal (Compl. ¶¶119-120). To support this, the complaint points to Defendant's own pending '436 Patent Application, which allegedly describes the SNS23 Vectors as containing these specific LCR components (Compl. ¶¶176-177).

  • '061 Patent Allegations (Cells and Methods): EGT seeks a declaration that cells transduced with the SNS23 Vectors would be covered by claim 1 of the '061 Patent, and that the methods for creating such cells would be covered by claim 11 (Compl. ¶¶128-129). The logic follows directly from the allegations regarding the '179 Patent: if the SNS23 Vectors themselves are covered, then the cells containing them and the methods of making them would also be covered by the corresponding claims of the '061 Patent (Compl. ¶¶136-137).

  • Identified Points of Contention:

    • Scope Questions: The core of the dispute appears to be whether the specific modifications made in the SNS23 Vectors remove them from the scope of the licensed claims. Defendant's new patent applications suggest it may argue that the SNS23 Vectors are a distinct, non-covered invention (Compl. ¶¶88, 190). This raises the question of whether the addition of new elements (e.g., an "insulator") or the specific truncation of claimed elements (e.g., an HS4 region of "less than about 800 bp") in the SNS23 Vectors is a material change that avoids the "consists essentially of" language in the '179 Patent's claims (Compl. ¶¶175, 179).
    • Technical Questions: A central question for the court will be what evidence demonstrates that the SNS23 Vectors possess the same basic and novel properties as the invention claimed in the licensed patents. Defendant's filing of new patent applications on the SNS23 Vectors suggests it will argue that the modifications confer new, materially different properties (e.g., enhanced safety or a different expression profile) that render them a separate invention outside the scope of the license agreement (Compl. ¶¶154, 172-174).

V. Key Claim Terms for Construction

  • The Term: "consists essentially of" (from '179 Patent, claim 1)

  • Context and Importance: This transitional phrase is narrower than "comprising" and is central to the dispute. It limits the claim to the specified LCR fragments and any other components that do not materially affect the "basic and novel properties" of the claimed vector. The entire case may turn on whether the modifications in the SNS23 Vectors—such as a truncated HS4 region and an added insulator—are considered to materially alter those properties.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Plaintiff may argue that the "basic and novel" property is simply achieving high-level, stable globin expression using large LCR fragments. The specification supports this by stating the vector can include "some lesser site which provides the same functionality" as the disclosed sequences, suggesting tolerance for some modification ('179 Patent, col. 2:65-66).
    • Evidence for a Narrower Interpretation: Defendant may argue that the "basic and novel" properties are tied to the specific 3.2-kb, three-fragment structure recited in the claim. The prosecution of new patent applications for the SNS23 Vectors suggests an argument that the new vectors have materially different properties (e.g., improved safety, efficiency, or manufacturing characteristics) that place them outside the scope of what "consists essentially of" the originally claimed fragments.

VI. Other Allegations

  • Unfair Competition: The complaint includes a cause of action for unfair competition under New York common law (Compl. ¶¶139-229). The claim is based on allegations that Defendant, after granting Plaintiff an exclusive license, has misappropriated the licensed technology and EGT's own confidential know-how to create the SNS23 Vectors (Compl. ¶¶146, 218). It is further alleged that Defendant is attempting to commercialize these vectors with third parties and prosecuting new patent applications to "improperly extend patent protection," with the alleged intent of destroying the value of Plaintiff's license and excluding it from the market (Compl. ¶¶154, 174).

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

This declaratory judgment action centers on a contract and licensing dispute that will be resolved through patent claim construction. The key questions for the court are:

  • A core issue will be one of contractual and claim scope: Does the term "consists essentially of," as used in the licensed patents, permit modifications like those in the SNS23 Vectors (e.g., a truncated HS4 region and an added insulator)? The answer will determine whether the new vectors are an improvement covered by the exclusive license to Plaintiff or a new, unencumbered invention belonging to Defendant.

  • A key evidentiary question will be one of technical materiality: Do the engineering changes in the SNS23 Vectors confer new "basic and novel properties" sufficient to place them outside the scope of the licensed claims, or are they incremental improvements that perform the same function in substantially the same way? Defendant's pursuit of separate patent protection for the SNS23 Vectors suggests it will argue the former, framing them as a distinct and superior invention.