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San Rocco Therapeutics v. Memorial Sloan-Kettering | Gene Therapy Patent | PatSnap
Patent Litigation

San Rocco Therapeutics v. Memorial Sloan-Kettering: Dismissed Without Prejudice After 757 Days

San Rocco Therapeutics filed a patent infringement action against Memorial Sloan-Kettering Cancer Center in the SDNY, asserting two patents covering vectors encoding human globin genes for treating hemoglobinopathies. After 757 days of litigation, the parties filed a stipulation of voluntary dismissal without prejudice under Rule 41(a)(1)(A)(ii).

Resolution time
757days
757 days from filing to dismissal — longer than the median SDNY patent case
Patents asserted
2
US7541179B2 and US8058061B2 — vector encoding human globin gene for hemoglobinopathy treatment
Outcome
Dismissed without Prejudice
Voluntarily dismissed without prejudice; claims may be refiled subject to applicable limitations
Cost ruling
Not recorded
No cost or fee award recorded in the available public record
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Gene Therapy Infringement Action Ends Without Merits Ruling in SDNY

On October 5, 2021, San Rocco Therapeutics, LLC filed a patent infringement action against Memorial Sloan-Kettering Cancer Center and Sloan Kettering Institute of Cancer Research in the Southern District of New York (Case No. 1:21-cv-08206). The suit asserted US7541179B2 and US8058061B2, both covering vectors encoding the human globin gene and their use in treating hemoglobinopathies — a category of blood disorders including sickle cell disease and beta-thalassemia. Judge Vernon S. Broderick presided.

The recorded basis of termination is 'Dismissed without Prejudice.' The docket order is a Stipulation of Voluntary Dismissal filed by San Rocco Therapeutics, LLC, stating the action is voluntarily dismissed without prejudice against both defendants pursuant to Rule 41(a)(1)(A)(ii) of the Federal Rules of Civil Procedure. No merits determination was reached. The specific terms underlying the parties' decision to stipulate to dismissal are not disclosed in the available record.

The case ran for 757 days before dismissal, suggesting substantive litigation activity occurred before the parties agreed to end proceedings. A dismissal without prejudice preserves San Rocco's ability to refile claims in the future, meaning the underlying patent dispute over hemoglobinopathy gene therapy technology is not necessarily resolved. What drove the parties to this resolution — and whether any out-of-court arrangement exists — is not disclosed in the public record.

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Case at a glance
CourtNew York Southern District Court
JudgeVernon S. Broderick
FiledOctober 5, 2021
ClosedNovember 1, 2023
Duration757 days
OutcomeDismissed without Prejudice
Verdict causeInfringement Action
BasisDismissed without Prejudice
Prior Art Intelligence
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Case timeline

Filing to Dismissed without Prejudice in 757 days

757 days from filing to dismissal — longer than the median SDNY patent case

Case timeline: Complaint filed OCT 5 2021 — 757 days total Horizontal timeline showing the three key events in San Rocco Therapeutics, LLC v Memorial Sloan-Kettering Cancer Center from filing to resolution. Source: PACER, New York Southern District Court. OCT 5 2021 Complaint filed Pre-trial proceedings NOV 1 2023 Dismissed without Prejudice 757 DAYS TOTAL
Patent at issue

US7541179B2 & US8058061B2 — Human Globin Gene Vectors for Hemoglobinopathy Treatment

Publication No.US7541179B2
Application No.US10/188221
Patent details
ProductVector encoding human globin gene for treatment of hemoglobinopathies
Cited in actionOctober 5, 2021

Publication No.US8058061B2
Application No.US12/433412
Patent details
ProductHuman globin gene vector formulations and methods of use in treating hemoglobinopathies
Cited in actionOctober 5, 2021
Technical brief · sourced from PatSnap patent database
Patent figurePatent figure
Representative claim (1 of 2 independent)
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 obtainable from a human β-globin locus control region (LCR), the three fragments being a BstXI and SnaBI HS2-spanning nucleotide fragment of said LCR, a BamHI and HindIII HS3-spanning nucleotide fragment of said LCR and a BamHI and BanII HS4-spanning nucleotide fragment of said LCR, said vector providing expression of the globin in a mammal in vivo.
Technical background
STATEMENT CONCERNING RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 60/301,861 filed Jun. 29, 2001 and U.S. Provisional Application No. 60/302,852 filed Jul. 2, 2001, both of which are incorporated herein by reference. STATEMENT CONCERNING GOVERNMENT FUNDING This application was supported by funds provided under NHLBI grant No. HL57612. The United States government may have certain rights in the invention. BACKGROUND OF THE INVENTION This application relates to a vector…
Patent family
33 family members across 16 jurisdictions (IT, WO, AT, AU, ES, IL, SG, CA, IN, EP, ID, BR)
PatSnap Eureka · FTO Search Agent
Should you run an FTO analysis against US7541179B2 and US8058061B2?

Any R&D team or company developing lentiviral or other vector-based gene therapies targeting hemoglobinopathies — including sickle cell disease and beta-thalassemia — should assess their freedom to operate against US7541179B2 and US8058061B2. The litigation against Memorial Sloan-Kettering demonstrates that San Rocco is prepared to assert these patents against major research institutions. The without-prejudice dismissal means the patents remain live and their claim scope has not been judicially narrowed.

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Official verdict

Official order — verbatim text

STIPULATION OF VOLUNTARY DISMISSAL It is hereby stipulated and agreed by and between the parties and/or their respective counsel(s) that the above-captioned action is voluntarily dismissed, without prejudice against the defendant(s) Memorial Sloan-Kettering Cancer Center, Sloan Kettering Institute of Cancer Research pursuant to Rule 41(a)(1)(A)(ii) of the Federal Rules of Civil Procedure. Document filed by San Rocco Therapeutics, LLC.
Source: PACER Docket, Case 1:21-cv-08206, New York Southern District Court

The stipulation records a mutual agreement to dismiss without prejudice under Rule 41(a)(1)(A)(ii), filed by San Rocco Therapeutics. This procedural mechanism closes the docket without any judicial finding on infringement or patent validity. For both parties, the legal effect is that the claims asserted — and the defences raised — remain untested and unresolved as a matter of judicial record. The specific terms and circumstances that led the parties to this stipulation are not disclosed in the available record.

PACER case 1:21-cv-08206 · Public docket record Explore in Eureka ↗
Dismissal terms

Dismissed without prejudice: what the stipulated dismissal means for both parties

Legal mechanism

Rule 41(a)(1)(A)(ii) voluntary dismissal without prejudice

A stipulated dismissal under Rule 41(a)(1)(A)(ii) requires the consent of all parties who have appeared. Dismissal without prejudice means the court did not adjudicate the merits — no finding of infringement, validity, or invalidity was entered. San Rocco retains the legal right to refile these claims, subject to applicable statutes of limitations and any tolling considerations.

No merits adjudication
Patent holder outcome

San Rocco preserves its right to refile — but gains no judicial validation

A dismissal without prejudice is neither a win nor a loss for the patent holder. San Rocco's patents US7541179B2 and US8058061B2 remain in force and unadjudicated on validity or infringement. The door to future enforcement is left open. However, the absence of a merits ruling means no precedent favourable to the plaintiff was established in this proceeding.

Patents remain enforceable
Defendant outcome

Sloan-Kettering faces no judgment — but the threat is not permanently extinguished

Memorial Sloan-Kettering Cancer Center and Sloan Kettering Institute of Cancer Research exit this litigation without any adverse finding. No injunction, damages, or liability was imposed. That said, because the dismissal is without prejudice, the defendants cannot treat this as a permanent resolution of the patent claims unless a statute of limitations or other bar applies. Continued monitoring of San Rocco's patent portfolio is advisable.

No liability imposed
Commercial implications

Unresolved gene therapy patent scope creates ongoing uncertainty

The two asserted patents covering vectors for human globin gene delivery remain unadjudicated. For companies active in hemoglobinopathy gene therapy — including those developing lentiviral or other vector-based treatments — the lack of a validity or claim-scope ruling means the competitive and freedom-to-operate risk posed by these patents is unchanged. Developers in this space should treat these patents as live enforcement risks.

FTO risk persists
Legal analysis based on PACER docket records for case 1:21-cv-08206 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffSan Rocco Therapeutics, LLCCompany/Search in Eureka ↗
DefendantMemorial Sloan-Kettering Cancer CenterIndividual/Search in Eureka ↗
Co-DefendantSloan Kettering Institute Of Cancer ResearchCompanySearch in Eureka ↗
Plaintiff counselAlexandra CavazosAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff counselCrystal LawAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff counselDavid A. ForrestAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff counselErika LevinAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff counselLenore Faye HortonAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff counselMary Jean KimAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff counselNatalie I. UhlemannAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff counselWanda Deloris French-BrownAttorneyCounsel for San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff law firmFox Rothschild LLPLaw FirmRepresenting San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff law firmHorton Legal Strategies PLLCLaw FirmRepresenting San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff law firmLoeb & Loeb LLPLaw FirmRepresenting San Rocco Therapeutics, LLCSearch in Eureka ↗
Plaintiff law firmWhite & Case LLPLaw FirmRepresenting San Rocco Therapeutics, LLCSearch in Eureka ↗
Defendant counselChristopher Ronald NoyesAttorneyCounsel for Memorial Sloan-Kettering Cancer CenterSearch in Eureka ↗
Defendant counselRobert J. GuntherAttorneyCounsel for Memorial Sloan-Kettering Cancer CenterSearch in Eureka ↗
Defendant law firmWilmer Cutler Pickering Hale & Dorr LLPLaw FirmRepresenting Memorial Sloan-Kettering Cancer CenterSearch in Eureka ↗
Presiding judgeJudge Vernon S. BroderickJudgeNew York Southern District CourtSearch in Eureka ↗
R&D signals

R&D signals in the gene therapy vector IP space

Forward-looking patent intelligence on globin gene delivery vectors, San Rocco's portfolio activity, and competitive filing trends across the hemoglobinopathy gene therapy sector.

Patent portfolio

San Rocco Therapeutics' broader patent estate in gene delivery

San Rocco's assertion of two patents covering human globin gene vectors suggests a focused IP position in hemoglobinopathy gene therapy. Understanding the full scope of their portfolio — including related applications, continuations, or divisionals — is critical for competitors and potential licensees active in the same vector technology space.

Portfolio monitoring
Technology landscape

Filing trends in lentiviral vectors for globin gene therapy

The past decade has seen accelerating patent filings around lentiviral and AAV vector constructs for correcting haemoglobin disorders. Mapping filing trends across academic institutions, biotech companies, and established pharma in this space reveals where innovation is concentrating — and where white-space opportunities or crowded claim territories exist.

Lentiviral vector filings
Competitor IP posture

Memorial Sloan-Kettering's gene therapy patent activity

As a major academic research institution, Memorial Sloan-Kettering Cancer Center and its affiliated Sloan Kettering Institute file patents across oncology and gene therapy. Tracking their filings in vector-based gene delivery and hemoglobinopathy research reveals the breadth of their independent IP position and any potential overlap with third-party patent estates.

Academic IP activity
White-space opportunity

Adjacent innovation opportunities in haemoglobin disorder gene therapy

Beyond the specific vector constructs at issue in this case, adjacent R&D areas — including ex-vivo gene editing approaches, next-generation vector capsids, and non-viral delivery modalities for globin gene correction — may represent lower-encumbrance development paths. Analysing claim coverage gaps in the existing patent landscape can surface actionable white space.

White-space mapping
Related litigation

Similar gene therapy patent infringement cases in the SDNY and federal courts

Explore patent infringement cases involving gene therapy vectors and hemoglobinopathy treatment technology litigated in the Southern District of New York and related federal courts.

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San Rocco Therapeutics, LLC patent enforcement history, New York Southern District Court case history, San Rocco Therapeutics, LLC's full IP portfolio, and comparable case analysis
Lentiviral vector patent casesHemoglobinopathy IP disputesSDNY biotech patent dismissalsGene therapy enforcement trends
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Strategic implications

What this case signals for the gene therapy IP landscape

A 757-day infringement action ending without a merits ruling leaves the hemoglobinopathy gene therapy patent landscape unresolved.

Unadjudicated patents remain a live enforcement risk for hemoglobinopathy developers

US7541179B2 and US8058061B2 were never tested on validity or infringement. Any company developing vector-based therapies for sickle cell disease, beta-thalassemia, or related conditions should treat these patents as active risks requiring FTO analysis before advancing products.

Without-prejudice dismissal signals the dispute is unresolved, not concluded

The absence of a consent judgment or with-prejudice dismissal means San Rocco retains optionality. Companies in this sector — particularly those whose pipelines touch globin gene delivery vectors — should monitor San Rocco's litigation activity and patent portfolio for signs of renewed enforcement.

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Unlock deeper IP intelligence on the gene therapy hemoglobinopathy patent landscape litigated at the SDNY district level.
San Rocco patent portfolioRefile risk assessmentGlobin vector IP landscape
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Analysis powered by PatSnap Eureka Litigation Intelligence Explore in Eureka ↗
Frequently asked questions

San v Memorial — key questions answered

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Track gene therapy patent enforcement before it affects your pipeline

The San Rocco patents remain live and unadjudicated. Use PatSnap Eureka to monitor enforcement activity around US7541179B2 and US8058061B2 and run FTO analysis before advancing your hemoglobinopathy gene therapy programme.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

Nothing on this page constitutes legal advice or a legal opinion on the validity, infringement, enforceability, or scope of any patent or case, and no attorney‑client relationship is created by its use. Any description of an outcome (such as a dismissal, settlement, or consent judgment) is a general summary, not a legal determination. All patents, trademarks, and company or law‑firm names are the property of their respective owners. PatSnap makes no warranty as to the accuracy or completeness of this content and disclaims, to the fullest extent permitted by law, all liability for reliance on it. For advice on a specific matter, consult qualified legal counsel.

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