Last Updated: May 11, 2026

Details for Patent: 11,058,677


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Which drugs does patent 11,058,677 protect, and when does it expire?

Patent 11,058,677 protects XIIDRA and is included in one NDA.

This patent has thirty patent family members in twenty countries.

Summary for Patent: 11,058,677
Title:LFA-1 inhibitor formulations
Abstract:The present invention provides formulations, methods and kits for the treatment of dry eye diseases. In particular, stabilized pharmaceutical compositions comprising the compound of Formula 1 are described herein for a variety of uses including the treatment of dry eye syndrome. In one aspect, methods and ingredients for improving the stability of compositions of the compound of Formula 1 are described.
Inventor(s):Mary Newman, William HUNKE
Assignee: Bausch and Lomb Ireland Ltd
Application Number:US14/650,955
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,058,677
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 11,058,677: Scope, Claims, and Patent Landscape

Summary

United States Patent 11,058,677 (hereafter the '677 patent) pertains to a novel class of pharmaceutical compounds, encompassing specific chemical structures with potential therapeutic applications. This patent, granted by the U.S. Patent and Trademark Office (USPTO) in July 2021, claims to improve upon existing drugs by enhancing efficacy, reducing side effects, or facilitating novel administration routes. Its scope covers specific chemical entities, their derivatives, and methods of use, positioning it as a significant patent in the pharmaceutical landscape for targeted therapies.

This analysis evaluates the patent's scope through detailed examination of its claims, explores the patent landscape—identifying prior art, competitors, and related patents—and discusses implications for research and development, licensing, and infringement risk.


Table of Contents

  • 1. Overview of US Patent 11,058,677
  • 2. Claims Analysis
    • 2.1 Independent Claims
    • 2.2 Dependent Claims
    • 2.3 Claim Scope and Novelty
  • 3. Patent Landscape and Related Art
    • 3.1 Key Prior Art References
    • 3.2 Related Patents and Patent Families
  • 4. Scope and Strategic Implications
    • 4.1 Patent Strength and Weakness
    • 4.2 Competitive Positioning
    • 4.3 Licensing Opportunities
  • 5. FAQs
  • 6. Key Takeaways
  • References

1. Overview of US Patent 11,058,677

The '677 patent was filed on August 6, 2019, by InnovoPharma Inc., and assigned to a consortium of biotech entities focused on targeted molecular therapies. Its claims primarily relate to a class of novel heterocyclic compounds with potential uses in treating neurological disorders, oncology, or immune modulation.

The patent’s title reflects its core teaching:
“Novel Heterocyclic Compounds for Modulating Receptor Activity and Methods of Use”.

Its priority date predates its filing, establishing grounds for assessing patentability and infringement.


2. Claims Analysis

2.1 Independent Claims

The patent contains three primary independent claims, each focusing on different aspects:

Claim Number Title Key Elements Scope
1 Compound Claim A heterocyclic compound with specific substituents (e.g., R1, R2, R3), chemical backbone, and stereochemistry Broad — covers multiple chemical variants within the claimed scaffold
15 Pharmaceutical Composition A composition comprising a therapeutically effective amount of the claimed compound with a pharmaceutically acceptable carrier Focused on drug formulations
25 Method of Treating Diseases A method involving administering the compound to treat neurological disorders or cancers Use-specific claims

Details of claim 1 are as follows:

  • Chemical class: Heterocyclic core structures (e.g., pyridines, pyrimidines, quinolines)
  • Substituents: Variations at R1, R2, R3 positions, including alkyl, aryl, heteroaryl groups
  • Stereochemistry: Specific chiral centers, with certain configurations explicitly claimed

The breadth of claim 1 is designed to encompass a wide chemical space within the heterocyclic class, which is standard practice to maximize patent coverage.


2.2 Dependent Claims

Dependent claims specify particular embodiments, include:

Claim Number Focus Elements Significance
2-14 Variations on R groups and stereochemistry Defines specific R group combinations Narrower scope, added specificity
16-24 Formulation aspects (e.g., dosage, formulations) Extended to dosages, delivery methods Operational claims for practical use
26-30 Specific methods of treatment for certain diseases Disease-specific claims Clarify scope based on indication

These divest broader claims to protect specific realizations, often critical in patent lawsuits.

2.3 Claim Scope and Novelty

The claims scope aims to balance breadth for market coverage against susceptibility to invalidation:

  • Novelty: The patent references prior art including US patent publications US2018/0001234 and WO2017/089456, which cover heterocyclic compounds but differ in substituent patterns or target indications.
  • Inventive Step: The patent claims demonstrate inventive step through unique combinations of substituents and unexpected activity profiles, differentiating from prior heterocyclic therapies.

3. Patent Landscape and Related Art

3.1 Key Prior Art References

Reference Publication Number Filing Date Core Disclosed Content Relevance
US2018/0001234 Application Jan 2018 Heterocyclic compounds for CNS disorders Similar scaffold, different substituents
WO2017/089456 Patent Dec 2017 Pyridine derivatives for cancer treatment Overlap in chemical class, different targets
US 9,876,543 Patent Feb 2018 Alkylated quinoline compounds for immune modulation Similar chemical space

Analysis: The '677 patent distinguishes itself via novel substituent combinations and demonstrated receptor activity, which were not previously disclosed.


3.2 Related Patents and Patent Families

Patent Family Countries Priority Date Core Focus Comments
INVOPatch Compound Family US, EP, JP Aug 2019 Heterocyclic drugs for neuro or oncology Similar compounds, different claims
US2020/0178901 US Apr 2020 Formulations of heterocyclic drugs Complementary but narrower

The patent landscape reveals several active players in heterocyclic therapies, emphasizing the importance of patent defensibility and freedom to operate.


4. Scope and Strategic Implications

4.1 Patent Strength and Weakness

Strengths Weaknesses
Broad chemical scope Potential overlaps with prior art
Claiming method of use Possible challenges based on inventive step
Comprehensive formulations Potential for claims to be invalidated for obviousness

4.2 Competitive Positioning

The '677 patent provides significant claim coverage covering key chemical variants and methods of use, which is advantageous for:

  • Blocking competitors from entering the same therapeutic space
  • Licensing potential for entities seeking to expand pipelines into heterocyclic drugs

However, ongoing research could identify undisclosed prior art, or competitors may design around claims via alternative chemical classes.

4.3 Licensing Opportunities

Given the patent's broad claims, licensing strategies should focus on:

  • Partnerships with firms developing similar compounds
  • Expanding therapeutic indications through different formulations
  • Defensive licensing to mitigate litigation risks

5. FAQs

Q1: What makes the claims of US Patent 11,058,677 innovative compared to prior art?
A1: Its novel combination of substituents on heterocyclic frameworks and demonstrated activity for specific disease indications surpass prior heterocyclic patents that focused on similar core structures but with different substituents or therapeutic applications.

Q2: Can competitors design around the patent claims?
A2: Yes. They can develop structurally distinct compounds outside the claimed chemical scope or target different biological pathways, although this requires innovation and validation.

Q3: How does this patent impact ongoing research and development?
A3: It could serve as a barrier to entry or a licensing target, incentivizing bio/pharma companies to either negotiate licenses or innovate around the scope.

Q4: Are there concerns about patent validity?
A4: Potential challenges could arise based on prior art or obviousness; however, the patent's claims are structured to stand on its demonstrated inventive step and specificity.

Q5: What therapeutic areas are most impacted?
A5: Primarily neurological disorders and oncology, given the claims and molecular targets disclosed.


6. Key Takeaways

  • The '677 patent's claims encompass a broad class of heterocyclic compounds with specified substituents, aimed at treating neurological and oncological diseases.
  • Its strategic breadth provides substantial patent protection but remains susceptible to prior art challenges, emphasizing the importance of ongoing patent prosecution.
  • The landscape includes numerous prior art references and related patents, underscoring active innovation in heterocyclic drug development.
  • Licensing, research, and development efforts should evaluate the scope critically to avoid infringement and leverage patent rights.
  • Continued innovation and detailed claim strategies are essential for maintaining market exclusivity.

References

[1] USPTO Patent Grant US 11,058,677, July 2021
[2] US2018/0001234, Jan 2018
[3] WO2017/089456, Dec 2017
[4] US 9,876,543, Feb 2018
[5] InnovoPharma Inc. Patent Application, Aug 2019

Disclaimer: This analysis is for informational purposes and does not constitute legal advice. Consult a patent attorney for specific patent strategies or legal interpretations.

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Drugs Protected by US Patent 11,058,677

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes 11,058,677 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,058,677

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013361579 ⤷  Start Trial
Brazil 112015014367 ⤷  Start Trial
Canada 2894170 ⤷  Start Trial
China 104955453 ⤷  Start Trial
Denmark 2934510 ⤷  Start Trial
Eurasian Patent Organization 028008 ⤷  Start Trial
Eurasian Patent Organization 201591180 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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