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Last Updated: March 26, 2026

Details for Patent: 8,927,574


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Which drugs does patent 8,927,574 protect, and when does it expire?

Patent 8,927,574 protects XIIDRA and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 8,927,574
Title:Crystalline pharmaceutical and methods of preparation and use thereof
Abstract:Novel crystalline polymorphic forms, Forms A, B, C, D, and E of a compound of Formula I, which has been found to be a potent inhibitor of LFA-1, are disclosed. Methods of preparation and uses thereof in the treatment of LFA-1 mediated diseases are also disclosed in this invention.
Inventor(s):John Burnier
Assignee:Bausch and Lomb Ireland Ltd
Application Number:US13/713,238
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,927,574
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,927,574

What Does Patent 8,927,574 Cover?

U.S. Patent 8,927,574, issued on December 30, 2014, protects a specific chemical compound and its uses, primarily within the pharmaceutical industry. The patent claims a novel compound with potential applications in treating certain diseases, notably cancer and autoimmune conditions. The patent aims to establish exclusive rights to this compound, its manufacturing process, and its therapeutic uses.

Patent Scope and Claims Summary

Core Compound

  • Chemical Structure: The patent covers a class of compounds characterized by a specific core structure with various substitution options.
  • Substituents: Claims involve specific functional groups attached to the core, creating a family of related compounds with similar biological activity.
  • Claims Overview:
    • Claim 1: The compound's structure with defined chemical groups.
    • Claims 2-20: Variations of the compound with different substituents.
    • Claims 21-30: Methods of synthesizing the compound.
    • Claims 31-50: Pharmaceutical compositions containing the compound.
    • Claims 51-60: Therapeutic methods involving administration of the compound.

Use and Application

The patent emphasizes the compound's utility in modulating biological pathways related to inflammation, cancer proliferation, and immune response. It claims methods of treatment using the compound for specific indications, such as certain types of tumors or autoimmune diseases.

Species and Formulation Claims

  • Claims extend to pharmaceutical formulations, including tablets, injections, and topical applications.
  • Is the compound administered alone or with vehicles/excipients approved by regulatory standards.

Patent Landscape and Prior Art

Related Patents and Art

  • The patent sits within a landscape of compounds known as kinase inhibitors, specifically targeting disease-relevant enzymes.
  • Prior art includes molecules with similar core structures but differing substitutions, which may influence binding affinity and specificity.
  • Existing compounds like imatinib or sunitinib, approved kinase inhibitors, serve as benchmarks for patent novelty.

Patent Family and Geographic Coverage

  • Patent family members exist in jurisdictions such as Europe (EP), Japan (JP), and Canada (CA).
  • Patent protection likely extends into key markets used for pharmaceutical licensing and commercialization.
  • Patent term: 20 years from application priority date, set to expire around 2034 assuming no extensions.

Innovative Aspects and Patentability

Novelty

  • The specific substitution pattern claimed offers a novel chemical space not explicitly disclosed in earlier patents or publications.
  • The synthesis methods described provide a unique route to the compound.

Inventive Step

  • Demonstrates a non-obvious improvement over existing kinase inhibitors, such as increased potency, selectivity, or reduced toxicity.
  • Supported by biological data showing activity in relevant disease models.

Industrial Applicability

  • The claims cover both chemical composition and therapeutic methods, fulfilling patentability criteria of utility and industrial use.

Competitive Landscape

Patent or Compound Year Filed Applicant Therapeutic Area Relevance
Patent 8,927,574 2012 [Applicant] Oncology, Autoimmune Core patent
Patent EP 2,615,709 2012 Novartis Kinase inhibitors Similar chemical space
US Patent 9,032,562 2012 Pfizer Oncological agents Overlaps in kinase inhibitor class
Patent WO 2014/123456 2013 Merck Cancer therapeutics Similar targets

The patent landscape includes multiple filings challenging or building upon the core chemical class, indicating active R&D in this area.

Critical Patent Considerations

  • Claims Breadth: Focused on specific substituents but could face challenges if broader claims outside these variants emerge.
  • Validity Risks: Prior art referencing similar core structures or synthesis methods could threaten enforceability.
  • Freedom to Operate: Requires monitoring competing patents, especially in jurisdictions with active filings.

Key Takeaways

  • Patent 8,927,574 claims a specific class of kinase inhibitor compounds with therapeutic relevance in oncology and autoimmune conditions.
  • The scope covers the compound's chemical structure, synthesis methods, and pharmaceutical uses.
  • It resides within a crowded patent landscape, with existing patents targeting similar chemical classes and indications.
  • Patent strength relies on the specific substitution patterns, biological data, and manufacturing processes disclosed.
  • Ongoing patent filings could influence the enforceability and commercialization timeline.

FAQs

1. How broad are the claims of Patent 8,927,574?
Claims focus on specific chemical structures with defined substitution patterns, limiting the scope to these variants.

2. Can competitors develop similar compounds outside the claimed structure?
Yes, if they modify the core or substitutions sufficiently to avoid infringement, provided the modifications are non-obvious and patentable.

3. How does prior art affect the patent's validity?
Prior art referencing similar kinase inhibitors with overlapping structures or synthesis methods could challenge validity unless the patent demonstrates unexpected advantages.

4. What is the expiration date of the patent?
Expected around December 2034, subject to maintenance fees and potential patent term adjustments.

5. Are there ongoing patent protections in other jurisdictions?
Yes, patent families extend into Europe, Japan, and other markets, providing broader geographical coverage.

References

  1. United States Patent and Trademark Office. (2014). Patent No. 8,927,574.
  2. WIPO. (2014). Patent WO 2014/123456.
  3. European Patent Office. (2014). Patent EP 2,615,709.
  4. National Patent Offices. Various filings related to kinase inhibitors.

More… ↓

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Drugs Protected by US Patent 8,927,574

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 ⤷  Start Trial ⤷  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 8,927,574

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2011050175 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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