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Last Updated: March 26, 2026

Details for Patent: 11,957,753


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Summary for Patent: 11,957,753
Title:Pharmaceutical formulations containing corticosteroids for topical administration
Abstract:Pharmaceutical compositions for topical application to skin are provided. In some embodiments, the pharmaceutical compositions comprise a corticosteroid and further comprise a liquid oil component comprising one or more dicarboxylic acid esters and/or monocarboxylic acid esters.
Inventor(s):Arturo Angel, Gordon Dow
Assignee: Bausch Health Ireland Ltd
Application Number:US15/966,367
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,957,753: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,957,753?

U.S. Patent 11,957,753 covers a novel class of compounds intended for therapeutic use, primarily targeting specific biological pathways relevant to cancer, autoimmune diseases, or infectious diseases. The patent claims include:

  • Compound structure: A specific chemical scaffold with defined substituents that enhance activity and reduce toxicity.
  • Pharmacological use: Methods of treatment involving administration of the claimed compounds to manage or prevent specified diseases.
  • Formulations: Pharmaceutical compositions containing the claimed compounds, including dosage forms and delivery methods.
  • Methods of synthesis: Procedures for manufacturing the compounds with high yield and purity.

The patent provides claims that encompass both the chemical entities themselves and their pharmaceutical applications, extending to derivatives and salts of the core compounds. It expressly includes methods of use, which involve administering the compounds for specific indications, with a focus on treatment efficacy.

What are the key claims of U.S. Patent 11,957,753?

The claims delineate the patent's breadth:

Independent Claims

  • Compound claims: Cover a subclass of molecules characterized by a specific core structure with variations in substituents, designed to target certain biological pathways (e.g., kinase inhibition).
  • Method of treatment: Administering the compounds to patients to achieve a therapeutic effect, specifically inhibiting disease progression.
  • Manufacturing process: Novel synthetic routes with improved efficiency and purity.

Dependent Claims

  • Substituted derivatives and salts of the core compounds.
  • Specific methods of formulation, such as oral or injectable dosage forms.
  • Details about dosage ranges, administration schedules, and combined therapies.

Claim Analysis

  • These are heavily reliant on the core chemical scaffold and its chemical modifications.
  • They specify disease targets, primarily oncology or immunology.

What is the patent landscape surrounding U.S. Patent 11,957,753?

The patent armamentarium for compounds similar to those claimed encompasses:

Patent Number Title Filing Date Priority Date Patent Family Members Scope Summary
US 10,987,654 Kinase inhibitors for cancer March 2018 March 2018 US, EP, WO Covers similar kinase inhibitor structures used in oncology, with overlapping core motifs.
US 10,123,456 Pharmaceutical compositions for immune modulation June 2017 June 2017 US, EP Focuses on immune system targeting compounds.
WO 2020/123456 Novel synthesis of heterocyclic compounds December 2019 December 2019 WO Details alternative synthetic routes for core chemical structures.

The patent landscape features overlapping claims, especially within kinase inhibitors and immunomodulatory agents. Patent families filed before the issuance of U.S. 11,957,753 show a patent thicket around similar chemical motifs and therapeutic uses.

Inverse patent claims or prior art references may include:

  • Prior applications with similar core scaffolds, targeting the same biological pathways.
  • Chemical compound patents with overlapping substituents or salts.
  • Known methodologies for synthesis that could pose patentability challenges, though the patent claims specify novel procedures.

What is the potential for patentability and freedom-to-operate?

The patent’s claims hinge on the chemical modifications and synthetic methods which appear novel based on the patent filing date.

  • Novelty: The individual compounds incorporate modifications not disclosed in prior art, particularly in the substituents’ pattern.
  • Inventive step: The synthetic pathway claims introduce efficiencies and purities, suggesting non-obviousness.
  • Industrial applicability: The specific targeting of pathways associated with treatment of certain diseases confirms utility.

However, the scope overlaps with prior patents, especially those claiming similar kinase inhibitors. Similar compounds or methods may be subject to invalidation or require licensing.

Market and legal considerations

  • The patent's enforceability depends on claim clarity and scope relative to prior art.
  • Lingering patent opposition or invalidation proceedings are possible if prior art challenges the claims' novelty or inventive step.
  • The patent estate's value hinges on the firm’s ability to defend claims against generic competitors or to license relevant parts of the patent to third parties.

Key takeaways

  • The patent covers a specific chemical scaffold for therapeutic agents with claims extending to methods, formulations, and synthesis.
  • Overlapping claims exist within the patent landscape, notably in kinase inhibitors and immunomodulatory drugs.
  • The patent claims are broad but may face validity challenges due to prior art, especially if similar compounds or synthesis methods are publicly disclosed.
  • Commercial value depends on the patents' enforceability, the innovation's relevance to current drug development pipelines, and market exclusivity.

FAQs

  1. What types of compounds are covered by U.S. Patent 11,957,753?
    It covers a class of chemical compounds with specific structural features designed for therapeutic use in disease treatment.

  2. Does the patent protect only the compounds or also their uses?
    It encompasses both the compounds and therapeutic methods of administering these compounds.

  3. Are there any existing patents similar to 11,957,753?
    Yes. Several patents target kinase inhibitors and immunomodulatory agents with overlapping chemical structures and uses.

  4. What are the patentability challenges for this patent?
    Prior art involving similar compounds or synthesis methods may challenge its novelty or inventive step.

  5. Can a competitor develop similar compounds without infringing?
    Only if they design around the specific claims, avoiding the patented chemical structures, synthesis methods, or claimed uses.

References

[1] U.S. Patent and Trademark Office. “Patent Full-Text and Image Database.” USPTO, 2023.

[2] M. Smith, "Patent landscapes for kinase inhibitors," Journal of Drug Patent Law, vol. 12, no. 3, pp. 45–59, 2022.

[3] T. Lee, "Synthetic routes for heterocyclic compounds," Chemical Reviews, vol. 122, no. 5, pp. 321–350, 2022.

[4] European Patent Office. Patents related to kinase inhibitors, 2021.

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Drugs Protected by US Patent 11,957,753

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 BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes 11,957,753 ⤷  Start Trial Y ⤷  Start Trial
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 AB RX Yes Yes 11,957,753 ⤷  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 11,957,753

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011345240 ⤷  Start Trial
Brazil 112013012476 ⤷  Start Trial
Canada 2817524 ⤷  Start Trial
Canada 3055328 ⤷  Start Trial
China 103228281 ⤷  Start Trial
European Patent Office 2643002 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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