Case 1:21-cv-01478-RGA Document 42 Filed 03/11/22 Page 1 of 39 PageID #: 2935
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`SAN ROCCO THERAPEUTICS, LLC,
`
`Plaintiff,
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`v.
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`BLUEBIRD BIO, INC. and THIRD ROCK
`VENTURES, LLC,
`
`Defendants.
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`C.A. No. 21-1478-RGA
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`JURY TRIAL DEMANDED
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`PUBLIC VERSION
`
`SECOND AMENDED AND SUPPLEMENTAL
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff San Rocco Therapeutics, LLC (“SRT”), formerly known as Errant Gene
`
`Therapeutics, LLC, for its Complaint against Defendants Bluebird Bio, Inc. (“Bluebird”) and Third
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`Rock Ventures, LLC (“Third Rock”) (collectively, “Defendants”) hereby alleges, on knowledge
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`as to its own actions, and upon information and belief as to all other matters, as follows:
`
`NATURE OF THE CASE
`
`1.
`
`This is an action for infringement of U.S. Patent Nos. 7,541,179 (“the ’179 Patent”)
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`and 8,058,061 (“the ’061 Patent”) (collectively, the “Patents-in-Suit”) pursuant to the Patent Laws
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`of the United States, 35 U.S.C. § 100, et seq., including §§ 271(a), 271(b), and/or 271(c).
`
`2.
`
`SRT has an exclusive commercial license to the ’179 and ’061 Patents, titled
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`“Vector Encoding Human Globin Gene And Use Thereof In Treatment of Hemoglobinopathies,”
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`which claim recombinant vectors that are used in the treatment of hemoglobinopathies, such as
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`Sickle Cell Disease and Beta Thalassemia.
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`3.
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`SRT is a biopharmaceutical company, established in 1993 by its founder and CEO,
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`Mr. Patrick Girondi, after his son was diagnosed with Beta Thalassemia, a rare inherited blood
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`disorder. Since that time, and for the greater part of nearly three decades, SRT has dedicated itself
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`to developing treatments for life-threatening diseases, with a special focus on rare diseases
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`(commonly referred to as orphan diseases), through the use of gene therapy — a scientific
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`technique that treats genetic disorders by modifying, replacing, and/or inactivating mutated genes
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`responsible for causing the disease.
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`4.
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`As a result of its tireless efforts, SRT has successfully developed recombinant
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`vectors that can be used in gene therapy treatment of rare genetic diseases, such as Sickle Cell
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`Disease and Beta Thalassemia (also referred to as β-thalassemia). Indeed, SRT became the first
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`company to obtain Orphan Drug Designation for Beta Thalassemia in the United States and
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`Europe, and the first to produce a commercial batch (sufficient for 8-10 patients) of gene therapy
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`for Beta Thalassemia.
`
`5.
`
`SRT brings this action to protect its rights and investment in its innovations
`
`embodied in the ’179 and ’061 Patents infringed by Bluebird’s betibeglogene autotemcel (beti-cel)
`
`gene therapy (formerly, marketed as ZYNTEGLO® and LENTIGLOBIN®), which is
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`manufactured using (and containing) the BB305 lentiviral vector (hereinafter “the BB305 Vector”
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`or “Infringing Drug Product”).
`
`6.
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`SRT brings this action against Third Rock for inducing infringement of the ’179
`
`and ’061 Patents by, among other things, actively and knowingly aiding and abetting Bluebird’s
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`infringement of the ’179 and ’061 Patents. With knowledge of SRT’s exclusive (worldwide)
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`license to the ’179 and ’061 Patents, Third Rock actively induced, and possessed the specific intent
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`to cause, urge, encourage, and aid in Bluebird’s direct infringement of the ’179 and ’061 Patents.
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`2
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`
`
`THE PARTIES
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`7.
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`SRT is a Delaware limited liability company with its principal place of business at
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`308 East Emily Street, Tampa, Florida 33603.
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`8.
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`Bluebird is a Delaware corporation with business offices located at 60 Binney
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`Street, Cambridge, Massachusetts 02142, and at 188 East Blaine Street, Suite 300, Seattle,
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`Washington 98102.
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`9.
`
`Third Rock is a Delaware limited liability company with business offices located
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`at 29 Newbury Street, 3rd Floor, Boston, Massachusetts 02116, and at 499 Illinois Street, Suite
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`110, San Francisco, California 94158.
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`
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`JURISDICTION AND VENUE
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`10.
`
`This action arises under the patent laws of the United States, 35 U.S.C. § 100, et
`
`seq., including §§ 271(a), 271(b), and/or 271(c).
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`11.
`
`This Court has subject matter jurisdiction over the matters asserted herein pursuant
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`to 28 U.S.C. §§ 1331 and 1338(a).
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`12.
`
`This Court has personal jurisdiction over Bluebird and Third Rock at least because
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`Bluebird and Third Rock are each incorporated in the State of Delaware.
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`13.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391(a), 1391(c), and
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`1400(b) because Bluebird and Third Rock are each incorporated in this District and therefore
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`“reside” in this District.
`
`THE PATENTS-IN-SUIT
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`14.
`
`On June 2, 2009, the United States Patent and Trademark Office (“USPTO”) duly
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`and legally issued the ’179 Patent, entitled “Vector Encoding Human Globin Gene and Use
`
`
`
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`3
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`Thereof in Treatment of Hemoglobinopathies,” to inventors (“Inventors” and each an “Inventor”)
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`Michel Sadelain, Stefano Rivella, Chad May, and Joseph Bertino, and the ’179 Patent was assigned
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`to Memorial Sloan-Kettering Cancer Center (“MSKCC”). A true and correct copy of the ’179
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`Patent is attached as Exhibit A.
`
`15.
`
`The ’179 Patent issued from U.S. Patent Application No. 10/188,221, which claims
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`priority to Provisional Application Nos. 60/301,861 filed on June 29, 2001 and 60/302,852 filed
`
`on July 2, 2001.
`
`16.
`
`On November 15, 2011, the USPTO issued the ’061 Patent, entitled “Vector
`
`Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies,” to
`
`Inventors Michel Sadelain, Stefano Rivella, Chad May, and Joseph Bertino, and the ’061 Patent
`
`was assigned to MSKCC. A true and correct copy of the ’061 Patent is attached as Exhibit B.
`
`17.
`
`The ’061 Patent issued from U.S. Patent Application No. 12/433,412, which is a
`
`division of Application No. 10/188,221 filed on July 1, 2002, now the ’179 Patent. The ’061 Patent
`
`claims priority to Provisional Application Nos. 60/301,861 filed on June 29, 2001 and 60/302,852
`
`filed on July 2, 2001.
`
`SRT has an Exclusive Commercial License
`to the ’179 and ’061 Patents
`
`18.
`
`Pursuant to a settlement agreement executed on November 2, 2020 (the “Settlement
`
`Agreement”), MSKCC granted SRT an
`
`REDACTED
`
` to the
`
`intellectual property listed in a
`
`REDACTED
`
`
`
`R
`
` D.I. 16, [Dfs’ Br.], Ex. C at 2(a) of the Settlement Agreement.
`
`19.
`
`Under the Settlement Agreement, SRT has the right to exclude others from making,
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`having made, using, importing, selling, or offering for sale in the United States any lentiviral
`
`
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`4
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`
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`vector, gene therapy treatment, or drug product that is covered by a valid claim of the Patents-in-
`
`Suit, which are the intellectual property licensed in the
`
`REDACTED
`
`.
`
`20.
`
`Under the Settlement Agreement, SRT has the right to exclude others from
`
`commercializing or engaging in commercialization activities using a lentiviral vector that is within
`
`the scope of a valid claim of the Patents-in-Suit.
`
`21.
`
`The intellectual property licensed in the 2005 Agreement is set forth under
`
`Exhibit A thereto, and includes: U.S. Patent Application No. 10/188,221, filed on July 1, 2002,
`
`“Vector Encoding Human Globin Gene and Use thereof in Treatment of Hemoglobinopathies;”
`
`U.S. Provisional Applications Nos. 60/301,861, filed on June 29, 2001 and 60,302,852 filed on
`
`July 2, 2001; and International Application No. PCT/US2002/020988.
`
`22.
`
`The 2005 Agreement further provides that the patent rights shall mean all of the
`
`following intellectual property: (a) the United States and foreign patents and patent applications
`
`listed in Exhibit A; (b) the United States and foreign patents issued from the applications listed in
`
`Exhibit A and from divisionals and continuations of these applications; (c) claims of U.S. and
`
`foreign continuation-in-part applications, and of the resulting patents, which are directed to the
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`subject matter specifically described in the U.S. and foreign patent applications listed in Exhibit
`
`A; and (d) any reissues or re-examinations of patents described in (a), (b), or (c), above.
`
`23.
`
`The ’179 Patent issued from U.S. Patent Application No. 10/188,221, which is
`
`listed in Exhibit A to the 2005 Agreement. The ’061 Patent is a Division of U.S. Application No.
`
`10/188,221 filed on July 1, 2002, now the ’179 Patent. The ’179 and ’061 Patents claim priority
`
`to U.S. Provisional Application Nos. 60/301,861 and 60/302,852, which are listed in Exhibit A to
`
`the 2005 Agreement.
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`
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`5
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`24.
`
` The Settlement Agreement unambiguously states: “MSK[CC] shall [g]ive [SRT]
`
`REDACTED
`
` to the intellectual property licensed in the
`
`R
`
`R
`
` which includes the ’179 and ’061 Patents. D.I. 16, Ex. C, ¶ 2(a).
`
`25. MSKCC agrees that SRT has
`
`
`
`REDACTEDREDACTED
`
` to the
`
`intellectual property listed in the
`
`REDACTED
`
`(i.e., the ’179 and ’061 Patents) pursuant to the
`
`Settlement Agreement. See Errant Gene Therapeutics, LLC v. Memorial Sloan-Kettering Cancer
`
`Center and Sloan Kettering Institute of Cancer Research, Case No. 21-cv-08206-VSB (S.D.N.Y.),
`
`D.I. 27 [“MSKCC Br.”] at 3 (stating “The 2020 Settlement Agreement granted SRT a new
`
`REDACTED
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`to the intellectual property licensed in the
`
`R
`
`
`
`R
`
` (emphasis in original)).
`
`26. MSKCC does not dispute that it granted SRT an exclusive commercial license to
`
`any lentiviral vector that is covered by any claim of the Patents-in-Suit. See id.
`
`27. MSKCC does not dispute the scope of SRT’s license, as explicitly and
`
`unambiguously, set forth in the Settlement Agreement, which states that “[SRT] . . . [has]
`
`R
`
`
`
`REDACTED
`
` to the intellectual property licensed in the
`
`R
`
`
`
`R
`
` See id. at 3. MSKCC agrees that the ’179 and ’061 Patents are included as the
`
`intellectual property licensed in the
`
`. Id. at 3.
`
`28. MSKCC does not dispute the construction of the Settlement Agreement that is set
`
`forth in the first 2(a) section, which clearly and unambiguously, states that “MSK shall: Give
`
`[SRT] an
`
`REDACTED
`
`REDACTED
`
`.” See id., at 3.
`
`to the intellectual property licensed in the
`
`29. MSKCC admits that it gave SRT an
`
`REDACTED
`
`to the intellectual property
`
`licensed in the
`
`REDACTED
`
` See MSKCC Br. at 3 (admitting that under the Settlement
`
`
`
`
`
`6
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`
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`Agreement, MSKCC granted to SRT “an
`
`REDACTED
`
`to the
`
`intellectual property licensed in the
`
`REDACTED
`
`.”).
`
`30.
`
`Accordingly, MSKCC and SRT do not dispute the construction of the first 2(a)
`
`section of the Settlement Agreement that grants SRT an
`
`REDACTED
`
`to the ’179
`
`and ’061 Patents.
`
`31.
`
`The doctrine of equitable estoppel, as a matter of law, prevents MSKCC from
`
`claiming that SRT does not have an
`
`REDACTED
`
`to the intellectual
`
`property licensed in the
`
`REDACTED
`
` (i.e., the ’179 and ’061 Patents).
`
`32.
`
`There is no dispute between MSKCC and SRT about the scope of SRT’s license as
`
`being an “
`
`REDACTED
`
`” to any lentiviral vector, transduced cells
`
`containing lentiviral vectors, and methods of making transduced cells that are covered by the
`
`claims of the ’179 Patent and/or ’061 Patent. However, MSKCC and SRT may disagree about the
`
`interpretation of claims of the ’179 and ’061 Patents as properly construed. See, e.g., Errant Gene
`
`Therapeutics, LLC v. Memorial Sloan-Kettering Cancer Center and Sloan Kettering Institute of
`
`Cancer Research, Case No. 21-cv-08206-VSB (S.D.N.Y.), D.I. 31 [“SRT’s Amended
`
`Complaint”] at ¶¶ 7-10, 80-85, 113-116, 125, and 137.
`
`33.
`
`On November 2, 2020, MSKCC transferred to SRT an undivided interest (i.e., an
`
`) in the ’179 and ’061 Patents.
`
`34.
`
`Under the Settlement Agreement, MSKCC did not retain any rights to make, sell,
`
`license, use or market products within the scope of the claims of the ’179 and ’061 Patents.
`
`35.
`
`Under the Settlement Agreement, MSKCC did not retain any rights to enforce or
`
`commence an infringement action on the Patents-in-Suit.
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`7
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`36.
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`Under the Settlement Agreement, MSKCC is only permitted to conduct internal
`
`research using one specific lentiviral vector, and that vector is a non-clinical grade,
`
`R
`
`
`
`vector (the “
`
`R
`
`”). See D.I. 16, Ex. C at 2.
`
`37.
`
`Under the Settlement Agreement, SRT and MSKCC terminated the 2011
`
`Agreement, thereby extinguishing any prior rights and restrictions MKSCC had to enforce or
`
`commence a civil action for patent infringement.
`
`38.
`
`Under the Settlement Agreement, SRT and MSKCC terminated the 2011
`
`Agreement, thereby extinguishing any rights MSKCC had to make, sell, license, use or market
`
`products within the scope of the claims of the ’179 and ’061 Patents.
`
`39.
`
`As of November 3, 2020, SRT has an exclusive (worldwide) commercial license to
`
`any process, service, or any product, or part thereof made, used or sold that is covered by any claim
`
`of the ’179 Patent and/or the ’061 Patent for any field of use.
`
`40.
`
`As of November 3, 2020, SRT has an exclusive (worldwide) commercial license to
`
`any process, service, or any product, or part thereof made, used, or sold that is manufactured by
`
`using a process covered by any claim of the ’179 and/or the ’061 Patent for any field of use.
`
`41.
`
`As of November 3, 2020, as an exclusive licensee, SRT is able to commence an
`
`action for infringement when the patent owner refuses to vindicate SRT’s rights.
`
`42.
`
`As of November 3, 2020, SRT has the primary responsibility for enforcing the
`
`patent rights to the ’179 and ’061 Patents because SRT is the exclusive (worldwide) commercial
`
`licensee having all substantial rights in the Patents-in-Suit.
`
`43.
`
`As the exclusive (worldwide) commercial licensee, SRT has standing to bring this
`
`action in its own name, without joining MSKCC, because “all substantial rights” in the Patents-
`
`
`
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`8
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`
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`in-Suit were transferred to SRT pursuant to its
`
`REDACTED
`
` to the
`
`Patents-in-Suit granted under the Settlement Agreement.
`
`44.
`
`As the exclusive (worldwide) commercial licensee, SRT has the constitutional right
`
`under the Patents-in-Suit to exclude Bluebird from engaging in its infringing activity and conduct
`
`which has injured SRT.
`
`FACTS AND CLAIMS THAT LEAD TO
`THE SETTLEMENT AGREEMENT WITH MSKCC
`
`45.
`
`SRT has diligently worked and expended substantial sums of money for the
`
`development of lentiviral vectors in collaboration with Inventors Drs. Michel Sadelain and Stefano
`
`Rivella.
`
`46.
`
`In 2000, SRT began financially supporting the research of Inventors Drs. Sadelain
`
`and Rivella, both of whom were researchers at MSKCC, and had published a paper on their
`
`experiments with gene therapy for treating Beta Thalassemia in mice.
`
`47.
`
`SRT’s tireless efforts, and work with Inventors Drs. Sadelain, Rivello and others,
`
`resulted in the development of the TNS9 Vector for the treatment of Beta Thalassemia.
`
`48.
`
`SRT committed every available resource at its disposal to produce the TNS9 Vector
`
`— what became trademarked by SRT as Thalagen — in accordance with the U.S. Federal Drug
`
`Administration’s (“FDA”) stringent approval process for investigational new drugs (“IND”).
`
`49.
`
`In addition, SRT diligently, through various agreements with MSKCC and other
`
`top medical centers, continued testing and refining the TNS9 Vector to ensure patient safety, and
`
`to ensure conformance with the highest manufacturing and testing standards, designated by the
`
`FDA as chemical Good Manufacturing Practice (“cGMP”).
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`9
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`50.
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`SRT’s Director of Gene Therapy, Dr. Christopher Ballas, created an innovative and
`
`proprietary process related to lentiviral vector production, which is worth in excess of hundreds of
`
`millions of dollars.
`
`51.
`
`In 2007, MSKCC’s work to make a clinical grade vector was failing and, in fact,
`
`MSKCC’s lentiviral vector production was inefficient and not ready to treat patients.
`
`52.
`
`In 2007, SRT evaluated and improved (i) the lentiviral-based transduction of
`
`CD34+ cells; and (ii) determined TNS9 lentiviral integration using Taqman multiplexed Q-PCR.
`
`In addition, SRT evaluated and improved the (i) filtration of lentiviral vectors and (ii) worked on
`
`the preparation of CD34+ methocult-based colony formation assays.
`
`53.
`
`In 2007, SRT became the first entity to pass the FDA Recombinant DNA
`
`Committee for gene therapy in Beta Thalassemia (and future applications in Sickle Cell Disease).
`
`54.
`
`In 2008, SRT successfully requested a pre-IND meeting with the FDA to advance
`
`to clinical (i.e., human) trials, the next stage necessary to develop the TNS9 Vector.
`
`55.
`
`On September 1, 2010, SRT completed the manufacture and production of a batch
`
`of the TNS9 Vector in an amount sufficient to treat 8-10 patients in a Phase I clinical trial. The
`
`physical production of the TNS9 Vector alone cost $1,300,000.
`
`56.
`
`Armed with the first commercial batch of the TNS9 Vector, SRT was eager to begin
`
`the clinical trial. MSKCC requested that SRT deliver the TNS9 Vector to MSKCC for use in a
`
`mobilization study. SRT, completely trusting of their partner, complied pursuant to the 2005
`
`Agreement.
`
`57.
`
`In October 2010, MSKCC demanded a $4 million (for a 10 patient trial at $400,000
`
`per patient) cash advance from SRT before it would allow any clinical trial involving the TNS9
`
`Vector to take place at MSKCC.
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`58.
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`Given that part of SRT’s mission was to make gene therapy treatment not only safe,
`
`but affordable to patients, SRT refused to agree to such a demand. Moreover, Dr. John Tisdale,
`
`the then-SRT Principal Investigator on the Beta Thalassemia gene therapy project at the National
`
`Institutes of Health (“NIH”) was willing to hold the clinical trial and treat patients for less than
`
`$50,000 each. Using the NIH would save over $3 million in funding that could be used for further
`
`Beta Thalassemia research. Thus, it would have been fiscally irresponsible for SRT to pay
`
`MSKCC 8 times more for a comparable service.
`
`59.
`
`SRT also refused MSKCC’s $4 million cash demand because MSKCC could not
`
`guarantee that the clinical trial would be completed, and meanwhile, the FDA wanted a patient to
`
`be treated every 3 months. Indeed, as of the filing of this action, MSKCC has treated only 4
`
`patients with the TNS9 vector.
`
`60.
`
`Desperate to begin clinical trials and to work towards finding a cure for his son,
`
`Mr. Girondi and SRT sent a living organism courier to pick up the TNS9 Vector from MSKCC in
`
`March 2011. MSKCC refused to return the TNS9 Vector to SRT.
`
`61.
`
`Given that many months had passed without treating a single patient with the TNS9
`
`Vector, SRT met with MSKCC on June 16, 2011. At the June 16, 2011 meeting, MSKCC
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`proposed a new agreement: MSKCC would take control of the clinical trial from SRT and MSKCC
`
`would head the commercialization of the TNS9 Vector. In addition, MSKCC and its
`
`representatives repeatedly stated that MSKCC had already spent significant funds to draft the IND
`
`application, that the IND application was complete and ready to be filed immediately, and that
`
`MSKCC would treat patients with SRT’s TNS9 Vector by October 2011.
`
`62.
`
`Due to SRT’s strong desire to move forward with the clinical trial and the IND
`
`application process with the FDA, MSKCC’s representations induced SRT to execute an
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`agreement dated June 17, 2011 (the “2011 Agreement”), whereby MSKCC assumed the right to
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`commercially develop the TNS9 Vector, and SRT maintained 50% of the upside of the gene
`
`therapy project.
`
`63. With the 2011 Agreement, SRT believed that the potential to commercialize and
`
`realize profits from SRT’s TNS9 Vector would motivate MSKCC to aggressively proceed to the
`
`market with it. But that was not the case. In fact, MSKCC did not file the IND application until
`
`September 2011, which the FDA flatly rejected as incomplete. And it was not until over 9 months
`
`later, and nearly a year after the June 16, 2011 meeting, that the FDA accepted the IND.
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`64.
`
`From November 2011 through June 2013, an additional two years later, MSKCC
`
`treated the first 3 out of 7-10 (intended) patients with the TNS9 Vector. By 2015, MSKCC claimed
`
`that they had no funding to proceed with the clinical trial and were no longer actively pursuing the
`
`exploitation of SRT’s TNS9 Vector. Yet MSKCC still refused to return the TNS9 Vector to SRT.
`
`65.
`
`Thus, beginning in 2015, SRT sought the return of the TNS9 Vector, including any
`
`and all information (laboratory, clinical or otherwise) related thereto. When MSKCC (again)
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`refused to return the TNS9 Vector, SRT commenced a civil action against MSKCC in the Supreme
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`Court of the State of New York entitled, Errant Gene Therapeutics, LLC v. Sloan Kettering
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`Institute for Cancer Research and Bluebird Bio, Inc., Index. No. 150856/2017 (N.Y. Cty. Sup. Ct.)
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`for the following causes of action: fraud, breach of contract, and civil conspiracy to defraud.
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`FACTS AND CLAIMS THAT LEAD TO THE
`SETTLEMENT AGREEMENT WITH BLUEBIRD
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`66.
`
`SRT commenced a civil action against Bluebird Bio in the Supreme Court of the
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`State of New York entitled, Errant Gene Therapeutics, LLC v. Sloan Kettering Institute for Cancer
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`Research and Bluebird Bio, Inc., Index. No. 150856/2017 (hereafter the “New York Litigation”),
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`
`
`
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`12
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`SKI Exhibit 2084
`Page 12 of 39
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`

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`Case 1:21-cv-01478-RGA Document 42 Filed 03/11/22 Page 13 of 39 PageID #: 2947
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`
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`for the following causes of action: conspiracy to defraud, unfair competition, and unjust
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`enrichment. See D.I. 16, [Defendants Br.], at exhibit D attached thereto.
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`67.
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`SRT commenced a civil action against Third Rock Ventures, LLC and Nick
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`Leschly in the Commonwealth of Massachusetts, Superior Court Department of the Trial Court,
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`entitled Errant Gene Therapeutics, LLC v. Third Rock Ventures, LLC and Nick Leschly, Civil
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`Action No. 19-1832, (hereafter the “Massachusetts Litigation”) for the following causes of action:
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`tortious interference with contractual relations, tortious interference with business relations,
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`misappropriation of trade secrets, civil conspiracy, unjust enrichment, and violations of
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`Massachusetts General Laws ch. 93A. See D.I. 16, Ex. E.
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`68.
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`SRT took great care to protect and guard the secrecy of its clinical data, know-how,
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`and other trade secrets, including the physical TNS9 Vector.
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`69.
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`SRT alleged that Bluebird fraudulently obtained physical possession of SRT’s
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`TNS9 Vector and its proprietary recipe and titration process related to the formulation of safe
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`clinical grade lentiviral vectors.
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`70.
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`SRT alleged that Sloan-Kettering Institute for Cancer Research (“SKI”) and
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`Bluebird entered into a secret partnership and conspiracy for the purpose of obtaining physical
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`possession of SRT’s TNS9 Vector and prevent completion of SRT’s clinical trials.
`
`71.
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`SRT’s conspiracy and fraud allegations were rooted in the interlocking relationship
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`between executives of SKI and Bluebird.
`
`72.
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`Bluebird could not efficiently and safely produce lentiviral vectors that were safe
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`for clinical use in patients. For example, on November 27, 2017, the New York Times published
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`an article titled “Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage,” which stated the
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`following:
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`13
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`SKI Exhibit 2084
`Page 13 of 39
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`Case 1:21-cv-01478-RGA Document 42 Filed 03/11/22 Page 14 of 39 PageID #: 2948
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`Few gene-therapy companies have the factories or expertise to make the viruses for
`use in clinical trials, where standards are exacting and comprehensive . . . .
`
`[A]s officials at Bluebird Bio can attest, whether you have any product at all. The
`company was formed in 2010, hoping to show that gene therapy could work in
`adrenoleukodystrophy, a rare and fatal neurodegenerative disease that strike boys.
`That was before the virus production logjam had begun, and all seemed well. Bluebird
`gave a virus manufacturer its recipe for making needed viruses.
`
`Then, said Nick Leschly, the company’s chief executive, he got bad news. Using
`Bluebird’s recipe, the manufacturing company said it was going to cost Bluebird
`a million dollars to create enough viruses to treat one patient.
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`The company scurried to find ways to improve the efficiency of its recipe. Finally,
`they were ready to start anew. Manufacturing began, but months later there was
`nothing to show for it.
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`“We got no virus,” Mr. Leschly said. “It was an Apollo 13 moment,” he added. “We
`put everyone in a room and said, ‘We have to figure this out. Everything at the
`company is now stopped. Nothing can be done without virus.’”
`
`They finally found the source of the problem — the acidity of the solution used to
`grow the viruses was slightly off, killing them.
`
`
`Exhibit C, Gina Kolata, Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage, N.Y. Times,
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`(Nov. 27, 2017) (emphasis added).
`
`73.
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`SRT alleged that Bluebird’s gene therapy was unsafe because of improper
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`dominance of certain cell growth during a clinical trial performed on thalassemia patients by
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`Genetix Pharma. D.I. 16, Ex. D. ¶ 47. SRT also alleged that Defendants approached MSKCC to
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`purchase SRT’s TNS9 lentiviral vector. Id. at ¶¶ 47-49.
`
`74.
`
`SRT alleged that SKI breached its contract with SRT, and MSKCC’s scientists were
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`working with Bluebird for free to develop a vector for Bluebird, but this proposed vector was not
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`the BB305 lentiviral vector.
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`14
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`SKI Exhibit 2084
`Page 14 of 39
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`Case 1:21-cv-01478-RGA Document 42 Filed 03/11/22 Page 15 of 39 PageID #: 2949
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`75.
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`Unable to acquire the TNS9 Vector directly from SRT, Bluebird allegedly entered
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`into and engaged in a conspiracy and partnership with SKI to fraudulently wrest control of the
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`TNS9 Vector from SRT and to eliminate Bluebird’s competition.
`
`76.
`
`The central issue in the New York and Massachusetts Litigations (collectively, the
`
`“Prior State Court Litigations”) concerned conspiracy and fraud to obtain physical possession of
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`SRT’s TNS9 Vector and proprietary know-how (e.g., recipe) for refining titration of lentiviral
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`vectors to ensure patient safety conformance.
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`77.
`
`On November 2, 2020, the parties entered into the Settlement Agreement, which
`
`included a mutual general release to “all claims, both at law and in equity, accrued or unaccrued,
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`know [sic] or unknown, suspected or unsuspected that were brought or could have been brought
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`by SRT in the New York Litigation and the Massachusetts Litigation.” D.I. 16, Ex. C at section 5
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`(“Mutual Release”). The Mutual Release only applies to claims that SRT may have or ever had
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`against MSKCC or Bluebird “from the beginning of the world to the Parties’ execution of” the
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`“Settlement Agreement.” Id.
`
`78.
`
`The Settlement Agreement was executed by SRT, MSKCC, and Bluebird on
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`November 2, 2020. Third Rock was not a party to the Settlement Agreement.
`
`79.
`
`The settlement agreement arose from SRT’s assertion that Bluebird and MSKCC’s
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`executives sabotaged SRT’s, life-saving vector, TNS9; stalled SRT’s clinical trials; and obtained
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`SRT’s proprietary recipe for making a lentiviral vector safe for clinical use.
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`80.
`
`Patent infringement was not a claim that could have been brought by SRT against
`
`Bluebird in the Prior State Court Litigations.
`
`81.
`
`SRT did not have an exclusive commercial license to the ’179 and ’061 Patents at
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`the commencement of (or during) the Prior State Court Litigations.
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`
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`15
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`SKI Exhibit 2084
`Page 15 of 39
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`Case 1:21-cv-01478-RGA Document 42 Filed 03/11/22 Page 16 of 39 PageID #: 2950
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`
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`82.
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`The Dispute Resolution provision in the Settlement Agreement does not apply to
`
`SRT’s patent infringement claims in this action because this dispute between SRT and Bluebird
`
`does not concern any actual or alleged breach of the Settlement Agreement. See id., at ¶ 7.
`
`83.
`
`SRT’s trade-secrets related to lentiviral titration and formulation is not disclose or
`
`covered by the Patents-in-Suit. The Patents-in-Suit are not related to any commercial
`
`manufacturing, recipe or titration process for making lentiviral vectors that are safe for clinical
`
`use.
`
`84.
`
`The scope of the claims of the ’179 and ’061 Patents was not at-issue, in-dispute,
`
`or discussed in the Prior State Court Litigations that lead to the execution of the Settlement
`
`Agreement nor was it discussed during settlement negotiations.
`
`85.
`
`The claims of the ’179 and ’061 Patents were not asserted, at-issue, in-dispute or
`
`discussed during the Prior State Court Litigations that lead to the execution of the Settlement
`
`Agreement nor were the patent claims discussed during settlement negotiations.
`
`86.
`
`The identity of the actual lentiviral vector contained in transduced cells used in
`
`Bluebird’s gene therapy treatments during its failed clinical trials was not at-issue, examined, or
`
`discussed during the Prior State Court Litigations that lead to the Settlement Agreement between
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`SRT and Bluebird.
`
`87.
`
`The identity of the actual lentiviral vector contained in transduced cells to be used
`
`in Bluebird’s proposed gene therapy treatments was not known, at-issue, or discussed during
`
`settlement negotiations with Bluebird that lead to the execution of the Settlement Agreement.
`
`88.
`
`The BB305 lentiviral vector was not at-issue or disclosed in the Prior State Court
`
`Litigations that lead to the Settlement Agreement with Bluebird.
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`
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`16
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`SKI Exhibit 2084
`Page 16 of 39
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`Case 1:21-cv-01478-RGA Document 42 Filed 03/11/22 Page 17 of 39 PageID #: 2951
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`89.
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`The BB305 lentiviral vector was never specifically referenced and identified by any
`
`party in any pleading in the Prior State Court Litigations.
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`90. Whether the BB305 lentiviral vector is covered by a valid claim of the ’179 and/or
`
`’061 Patents, as properly construed, was not at-issue or discussed during the Prior State Court
`
`Litigations that lead to the Settlement Agreement with Bluebird.
`
`91.
`
`Bluebird did not have a commercial license to the intellectual property licensed in
`
`
`
`REDACTEDREDACTED
`
`prior to or during the Prior State Court Litigations that lead to the Settlement
`
`Agreement.
`
`92.
`
`SRT obtained its full
`
`REDACTED
`
` to the intellectual property
`
`licensed in the
`
`REDACTED
`
` (i.e., the ’179 and ’061 Patents) on November 3, 2020, after
`
`execution of the 2020 Settlement Agreement.
`
`93. MSKCC did not grant Bluebird any type of license, including without limitation a
`
`commercial license, to the Patents-in-Suit.
`
`94.
`
`Bluebird has never had or been granted a commercial license to the Patents-in-Suit.
`
`BLUEBIRD INFRINGES THE ’179 AND ’061 PATENTS
`AND IS DOING SO WILLFULLY
`
`95.
`
`As of November 3, 2020, Bluebird was aware that SRT had an
`
`REDACTED
`
`REDACTED
`
`
`
` to the intellectual property licensed in the
`
`REDACTED
`
` that includes
`
`the ’179 and ’061 Patents.
`
`96.
`
`As of November 3, 2020, after execution of the Settlement Agreement, Bluebird
`
`should not have engaged in any commercialization activities concerning the BB305 Vector until
`
`after expiration of the Patents-in-Suit, if Bluebird