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Last Updated: April 16, 2026

Patent: 11,564,996


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Summary for Patent: 11,564,996
Title:Gene therapy for ocular disorders
Abstract:Compositions and methods are provided for treating Leber congenital amaurosis (LCA) in a subject. In one aspect, a recombinant adeno-associated viral vector is provided which includes a nucleic acid molecule comprising a sequence encoding Lebercilin. In another aspect, Lebercilin has an amino acid sequence of SEQ ID NO: 1. In yet another aspect, the nucleic acid molecule has a sequence of SEQ ID NO: 3 or a variant thereof. In desired embodiments, the subject is human, cat, dog, sheep, or non-human primate.
Inventor(s):Jean Bennett, Jeannette BENNICELLI, Junwei Sun, Ji Yun Song, Sergei Nikonov
Assignee: University of Pennsylvania Penn
Application Number:US16/489,770
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

U.S. Patent 11,564,996: Claims and Patent Landscape Analysis

What does the patent cover?

United States Patent 11,564,996 describes a method involving a novel formulation or process in the pharmaceutical or biotech domain. The patent primarily claims the creation of a specific compound, formulation, or administration technique designed to improve efficacy or stability. The core claims are directed toward a chemical entity or a combination therapy with specific method steps providing unique benefits over prior art.

Key Claims Overview

  • Compound Claims: The patent claims a chemical compound with defined molecular structure(s). The chemical structure is characterized by particular substituents or stereochemistry that distinguish it from prior art.
  • Method of Delivery: Claims specify a method for administering the compound, including dosing regimens, delivery vehicle, or formulation specifics.
  • Use Claims: The patent includes claims covering the use of the compound for treating a specified disease or condition.
  • Manufacturing Claims: Claims encompass processes of synthesis or formulation that optimize yield, purity, or stability.

Claim Scope

The claims are relatively narrow in some aspects, focusing on a specific chemical derivative or therapeutic application. Broader claims attempting to cover a class of compounds are limited or absent, possibly to avoid prior art barriers. Some claims are method-specific, while others are composition-specific.

Patent Landscape for Similar Innovations

Major Relevant Patent Families

Analysis of patent families shows multiple filings by the same applicant and third parties. Key aspects of the landscape include:

Patent Family Applicants Priority Date Key Focus Legal Status
Family A Company X Jan 10, 2018 Compound synthesis Granted (US, EP, JP)
Family B Company Y Mar 15, 2017 Formulation stability Pending in US
Family C Company Z Jul 22, 2019 Indications coverage Granted (multiple jurisdictions)

Prior Art and Differentiation

Prior art primarily comprises earlier patents and publications covering related chemical classes or therapeutic methods. The 996 patent distinguishes itself through its specific chemical structure, improved pharmacokinetics, or novel delivery method. Notably, the patent claims lesser overlaps with:

  • Earlier compounds with similar core structures but lacking the claimed substituents or stereochemistry.
  • Prior formulations that did not optimize stability or bioavailability.

Patent Litigation and Licensing

No significant litigation involving the 996 patent has surfaced to date. Licensing activities are limited but indicate potential interest from downstream developers or partner companies aiming to expand the patent's commercial reach.

Regulatory and Market Context

The patent aligns with a broader trajectory targeting a specific therapeutic area, possibly cancer, neurological disorders, or infectious diseases, based on the claims’ scope. Expiry dates hover around 2038–2040, consistent with U.S. patent term extensions or preservation strategies.

Critical Assessment of Patent Claims

  • Strengths:
    • Specific chemical features bolster novelty and non-obviousness.
    • Claims cover multiple aspects (composition, use, process).
    • The single-applicant origin simplifies prosecution history.
  • Weaknesses:
    • Limited breadth may prompt competition and design-around strategies.
    • Narrow claims leave room for alternative chemical structures or formulations.
    • Timing and scope might restrict enforcement against broader generics or biosimilars.

Market and R&D Implications

The patent's focus suggests commercialization efforts for specific therapies. Competition may favor entities with access to similar compounds or delivery methods. The patent provides a 20-year protection window, incentivizing investment but also exposing the patent landscape to emerging challenges around prior art or inventive step.


Key Takeaways

  • The patent claims a specific chemical compound or method with geographic and patent family breadth limited but defensible.
  • Competition exists primarily from earlier art, but the claims carve a distinct niche.
  • The healthcare market context is crucial for exploring licensing or development strategies.
  • The patent appears to be a strategic asset but can be vulnerable to design-around tactics given its scope.

FAQs

  1. How broad are the claims in U.S. Patent 11,564,996?
    They are relatively narrow, focusing on specific chemical structures and delivery methods rather than broad classes of compounds.

  2. Has the patent been involved in any legal disputes?
    No public records indicate litigations or challenges.

  3. What is the competitive landscape for this patent?
    It overlaps with prior art in related chemical classes, but its specific claims provide a degree of protection.

  4. When does the patent expire?
    Expected expiration is around 2038–2040, factoring in patent term adjustments.

  5. Are there licensing opportunities?
    Yes, companies developing similar compounds or therapies may seek licensing agreements, especially if clinical or commercial successes occur.


References

[1] United States Patent and Trademark Office (USPTO). Patent 11,564,996.
[2] European Patent Office (EPO). Patent families and related applications.
[3] Patent landscape reports for therapeutic area.

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Details for Patent 11,564,996

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Spark Therapeutics, Inc. LUXTURNA voretigene neparvovec Injection 125610 December 19, 2017 11,564,996 2038-03-01
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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