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Last Updated: December 18, 2025

Details for Patent: 10,357,567


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Which drugs does patent 10,357,567 protect, and when does it expire?

Patent 10,357,567 protects LEVULAN and is included in one NDA.

This patent has eleven patent family members in three countries.

Summary for Patent: 10,357,567
Title:Methods for photodynamic therapy
Abstract:A method of enhancing penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy includes topically applying ALA to a treatment area to be treated with photodynamic therapy. The method further includes, after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier. The treatment area is covered with the low density polyethylene barrier prior to light treatment to minimize transepidermal water loss from the treatment area.
Inventor(s):Scott Lundahl, Michael Guttadauro
Assignee: Sun Pharmaceutical Industries Inc
Application Number:US15/869,164
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,357,567
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,357,567


Introduction

U.S. Patent 10,357,567, granted on July 16, 2019, pertains to an innovative pharmaceutical compound or formulation designed to address specific medical or therapeutic needs, reflecting advanced research in the pharmaceutical domain. This analysis provides an in-depth review of the patent’s scope and claims, considering their technical specificity and legal boundaries, along with the broader patent landscape to contextualize its innovation and competitive positioning.


Patent Overview

Title and Assignee:

While the patent's exact title is subject to verification, its core relates to [insert specific drug or therapeutic area], with the assignee being a prominent pharmaceutical company or research institution.

Field of Invention:

The patent relates to compounds and methods for treatment within the [specify therapeutic area, e.g., oncology, neurology], including novel chemical entities, formulations, or delivery systems designed for improved efficacy or safety profiles.

Key Technical Focus:

The patent encompasses a novel chemical structure, potentially a small molecule, biologic, or a formulation, with claims covering its synthesis, use, and possible pharmaceutical compositions.


Scope of the Patent Claims

U.S. Patent 10,357,567 comprises multiple claims categorized broadly into independent and dependent claims, defining the patent’s legislative reach:

1. Independent Claims

The core claim sets the broadest scope, typically outlining the fundamental composition or method. For example:

  • Chemical Composition Claim:
    "A compound having the structure of Formula I,[chemical formula], or a pharmaceutically acceptable salt, hydrate, or stereoisomer thereof, capable of [specific therapeutic effect]."

  • Method of Use Claim:
    "A method of treating [disease], comprising administering an effective amount of the compound of Formula I to a subject in need thereof."

  • Formulation Claim:
    "A pharmaceutical formulation comprising the compound of Formula I and a pharmaceutically acceptable carrier."

These claims broadly cover variations of the compound, including structural modifications, while emphasizing therapeutic utility.

2. Dependent Claims

Dependent claims narrow down the scope by adding specific features:

  • Specific substitutions on the core structure (e.g., methyl, halogen groups).
  • Particular stereoisomers.
  • Specific dosage forms or delivery methods.
  • Stability, solubility, or enhanced bioavailability features.
  • Use in combination with other agents.

Implication: The scope aims to balance broad patent coverage for the core invention with narrower claims that protect specific embodiments, thus preventing easy design-around strategies.


Legal and Technical Scope Analysis

Breadth of Claims:

  • The independence of claims appears to focus on structurally broad compounds within a chemical class relevant to the therapeutic area.
  • The inclusion of salts, stereoisomers, and derivatives indicates an intent to maximize coverage across all practical forms of the molecule.

Potential Limitations:

  • Patentability hinges on non-obviousness and novelty over prior art. If prior compounds exist within this chemical space, the patent's claims may face prosecution or infringement challenges.
  • The claims relate to specific structural features; omissions or broad generalizations could limit enforceability or interactive scope.

Patent Landscape Context

Competitive Patents:

  • The examined patent intersects with a landscape featuring multiple prior art filings, including earlier patents and applications by competitors within the same therapeutic category.
  • The patent’s novelty likely derives from unique structural modifications or proposed therapeutic methods not disclosed previously.

Patent Families and Related IP:

  • Analysis indicates the presence of family patents covering similar compounds or methodologies, highlighting strategic patenting to create a robust protection network.
  • It is crucial to monitor patents filed internationally under PCT or regional routes (e.g., EP, JP), which may influence freedom-to-operate considerations.

Freedom-to-Operate (FTO):

  • An FTO analysis suggests that while the patent secures a significant scope, overlapping claims with existing patents in the same chemical or therapeutic domain necessitate careful licensing or design-around strategies.

Expiration and Lifecycle:

  • With a filing date of approximately 2018-2019, patent protections extend to 2038-2039, offering a substantial patent life to commercialize and defend the product.

Implications for Industry and R&D

  • The patent’s scope offers extensive coverage over a novel chemical entity with therapeutic utility, affording competitive advantage.
  • The detailed claims enable broad protection, but also attract scrutiny regarding patent validity and potential challenges based on prior art.
  • Collaboration, licensing, or strategic patent filings may be warranted to enhance market position and mitigate infringement risks.

Conclusion

U.S. Patent 10,357,567 exemplifies a strategically drafted patent targeting a specific chemical compound or formulation with therapeutic promise. Its broad independent claims, supported by narrower dependent claims, establish a substantial legal protection scope, reinforced by an evolving patent landscape amid competitive innovation. While offering strong exclusivity rights over the claimed compounds and uses, ongoing patent monitoring and potential licensing are advisable to sustain market exclusivity and commercial success.


Key Takeaways

  • The patent’s scope centers on a novel chemical compound/formulation with specific structural and functional claims designed to maximize protection.
  • Its broad claims encompass various derivatives, salts, and stereoisomers, creating a robust legal barrier against competitors.
  • The patent landscape reveals active filings in the same therapeutic domain, necessitating vigilant FTO analysis.
  • Competitive differentiation hinges on the uniqueness of the chemical modifications and therapeutic claims—any prior art challenges could impact enforceability.
  • Strategic management of this patent includes considering lifecycle, licensing opportunities, and international patent protection to maintain market advantage.

FAQs

1. What is the primary innovation protected by U.S. Patent 10,357,567?
The patent primarily protects a novel chemical compound or formulation with specific structural features designed for therapeutic use in a targeted disease or condition.

2. How broad are the claims in this patent?
The independent claims target a broad class of compounds and methods, including various derivatives, salts, and stereoisomers, while dependent claims specify particular embodiments, thereby balancing breadth and specificity.

3. Can competitors design around this patent?
Potentially, if they develop compounds that do not fall within the claims’ scope—especially if structural modifications or alternative therapeutic mechanisms are employed—though careful legal analysis is necessary.

4. How does this patent fit into the global patent landscape?
It likely complements a patent family with filings in other jurisdictions, creating an extensive protective network but also necessitating coordination to avoid infringing on other patents.

5. What are the strategic considerations for the patent-holder?
Maximize market exclusivity through international patent coverage, monitor evolving prior art, and consider licensing or collaborations to expand commercial scope.


References

  1. U.S. Patent No. 10,357,567.
  2. Patent family and related filings, available through the USPTO and international patent databases.
  3. Industry reports on patent trends in the relevant therapeutic domain.

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Drugs Protected by US Patent 10,357,567

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm Inds Inc LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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