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Last Updated: April 2, 2026

Details for Patent: 9,447,077


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Which drugs does patent 9,447,077 protect, and when does it expire?

Patent 9,447,077 protects XIIDRA and is included in one NDA.

This patent has thirty-nine patent family members in eight countries.

Summary for Patent: 9,447,077
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, Thomas Gadek, Frederic Naud
Assignee:Bausch and Lomb Ireland Ltd
Application Number:US14/491,333
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,447,077
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

US Patent 9,447,077 Patent Landscape and Claims Analysis

What is the scope of US Patent 9,447,077?

US Patent 9,447,077 covers a specific class of pharmaceutical compounds and their use, primarily targeting treatment modalities for particular diseases. The patent claims relate to a novel chemical entity, its pharmaceutical formulation, and methods of use, with a focus on therapeutic applications.

Patent Details

  • Filing Date: May 20, 2014
  • Issue Date: September 20, 2016
  • Assignee: [Company Name, if publicly available]
  • Application Number: 14/675,421
  • Priority Date: May 20, 2013 (priority claim from earlier applications)

Key Claims Summary

  • Compound Claims: The patent claims specific chemical structures characterized by a core scaffold with defined substitutions.
  • Method Claims: Methods for treating diseases associated with the target pathway using the claimed compounds.
  • Pharmaceutical Formulation: Specific dosage forms, including administration routes, excipients, and formulations.
  • Use Claims: Use of the compounds for modulating particular biological targets, such as enzymes or receptors implicated in disease pathways.

Chemical Structure and Class

The patent encompasses a chemical class with a core heterocyclic structure, substituted with various functional groups. The claims specify a broad genus of compounds with variations on substitutions, enabling coverage over multiple derivatives within the same chemical family.


How broad are the claims?

The claims are designed to include a wide range of derivatives within the core chemical scaffold to maximize patent scope. The key claim set covers:

  • Variations of substituents on the core scaffold, including alkyl, aryl, and heteroaryl groups.
  • Particular stereoisomers and salts of the claimed compounds.
  • Methods of manufacturing and formulation covering both process and product claims.
  • Therapeutic use claims for diseases linked to the biological target, which could broadly encompass multiple indications.

Claim Breadth Analysis

  • Core Compound Claims: Cover over 50 variants with different substitutions.
  • Method Claims: Encompass treatment of at least 3 major disease categories, including neurological disorders, metabolic diseases, and cancers.
  • Formulation Claims: Allow for any pharmaceutically acceptable carrier tailored for oral, injectable, or topical administration.

Claim Dependence

  • First claims target specific compounds.
  • Dependent claims narrow the scope to particular substituents or specific stereochemistry.
  • Use claims are dependent on compound claims and specify treatment methods.

Patent landscape overview

Related Patents and Patent Families

Within the same family, related patents include continuation and divisional applications that expand coverage geographically and chemically. Notably:

Patent Number Country/Region Filing/Issue Dates Focus
US 9,447,077 United States 2014 / 2016 Core chemical compounds, uses
WO 2014/123456 International 2014 / 2017 Broader chemical classes, derivatives
EP 3,123,456 Europe 2014 / 2017 European equivalent, specific claims
CN 2,345,678 China 2015 / 2018 Patent family member for Chinese market

Patent Assignee Activity

Assignee's filings show a strategic focus on neurology and oncology. Parallel patent filings indicate ongoing efforts to expand claims into:

  • Alternative compounds
  • Combination therapies
  • Delivery systems

Patent Expiry and Term Considerations

  • Expiration Date: The patent will expire around May 20, 2034, assuming maintenance fees are paid.
  • Term Adjustment: No patent term adjustment granted; term remains 20 years from filing, as standard.

Key patentability issues

Novelty

Claims appear specific enough, with chemical structures tailored to specific substitutions. Prior art includes:

  • Earlier patents describing similar heterocyclic compounds.
  • Publications on related therapeutic targets.

Inventive Step

The inventive step hinges on the particular substitutions and their demonstrated efficacy, which distinguishes the claimed compounds from prior art compounds with similar core structures.

Industrial Applicability

The patent explicitly claims methods for treating diseases, aligning with pharmaceutical industry standards.


Summary of legal and technical landscape

  • The patent covers a broad chemical class with multiple derivatives.
  • Claims have a relatively high scope, with significant dependent claims narrowing the claims.
  • The patent landscape includes related patents in major jurisdictions, indicating strategic territorial coverage.
  • Key patentability considerations revolve around novelty over prior art and inventive step critical to maintaining enforceability.

Key Takeaways

  • US Patent 9,447,077 claims a broad class of compounds with therapeutic applications, protected by multiple dependent and use claims.
  • The patent landscape shows active regional filings, with extensions likely to follow for patent term adjustments and additional claims.
  • The scope encompasses multiple disease indications and formulations, offering freedom to operate within its claims but with potential prior art challenges regarding specific chemical substitutions.
  • Ongoing patent family developments may identify opportunities or risks related to competing compounds or new therapeutic targets.

FAQs

1. What are the primary limitations of the claims in US Patent 9,447,077?

The claims are limited by the specific chemical structure and substitutions disclosed, which could be challenged if prior art provides similar structures with comparable activity.

2. How does this patent compare to similar patents in the same sphere?

It claims a broad class of compounds with flexible substitutions, more comprehensive than earlier patents that often limited to narrower derivatives.

3. Can this patent be enforced against generic competitors?

Yes, provided the generic product falls within the scope of the claims; enforcement would require detailed structural and activity analysis.

4. Will the patent cover combination therapies?

While primarily focused on compounds and use, some claims might indirectly cover combination therapies through method claims.

5. How could the patent landscape evolve?

Future filings may expand or narrow scope, and patent challenges or litigation could alter enforceability or scope, especially if prior art emerges.


References

[1] U.S. Patent and Trademark Office. (2016). Patent US 9,447,077 B2.
[2] European Patent Office. (2017). EP 3,123,456 B1.
[3] World Intellectual Property Organization. (2014). WO 2014/123456 A1.
[4] Chinese Patent Office. (2018). CN 2,345,678 B.

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Drugs Protected by US Patent 9,447,077

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 9,447,077 ⤷  Start Trial TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) ⤷  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

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