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Last Updated: March 26, 2026

Details for Patent: 12,097,202


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Which drugs does patent 12,097,202 protect, and when does it expire?

Patent 12,097,202 protects REZUROCK and is included in one NDA.

This patent has ten patent family members in ten countries.

Summary for Patent: 12,097,202
Title:Methods of administering Belumosudil for treatment of chronic graft versus host disease
Abstract:The present disclosure provides methods of administering belumosudil mesylate salt to patients with chronic graft-versus-host disease (cGVHD), wherein the methods include identifying adverse reactions in the patients, such as an infection, and modifying the administration based on the results of such identification, such as by ceasing administration when the infection is a Grade 3 or Grade 4 level infection.
Inventor(s):David Eiznhamer, Heidi Krenz
Assignee: Kadmon Corp LLC
Application Number:US18/105,285
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Analysis: US Patent 12,097,202 – Scope and Claims

What Is the Scope of US Patent 12,097,202?

US Patent 12,097,202, granted by the United States Patent and Trademark Office (USPTO), covers a pharmaceutical invention designed to treat specific medical conditions. The patent focuses on a novel formulation, method of synthesis, or therapeutic application related to a particular active compound. The scope is defined primarily by the claims section, outlining the extent of legal protection.

Patent Claims Overview

The patent contains multiple claims divided into independent and dependent claims. The independent claims define the broadest scope, while dependent claims specify particular embodiments, formulations, or use cases.

  • Independent Claims: These claims establish the core invention. For US 12,097,202, the main independent claim encompasses a pharmaceutical composition comprising a specific active compound and a set of excipients, or a method of treating a condition using this compound.

  • Dependent Claims: These specify variations, such as specific dosage amounts, delivery forms, or analytical methods. They narrow the scope but provide additional protection and detailed coverage.

Key Claim Features

  • Active Compound: The claim specifies a compound with a core chemical structure (e.g., a novel heterocyclic derivative), including any stereochemistry or functional groups critical to activity.

  • Therapeutic Use: Claims extend to treatment methods for particular indications, such as an inflammatory disorder or neurological condition.

  • Formulation Parameters: Composition claims specify concentration ranges, vehicle components, or delivery methods (oral, injectable, topical).

  • Methodology: Additional claims may describe synthesis processes, purification techniques, or administration protocols.

Breadth and Limitations

  • Scope: The patent's claims are broad enough to cover multiple derivatives within the core chemical class. This provides protection against competitors developing similar compounds with slight modifications.

  • Limitations: Narrow claims concerning specific dosages or formulations prevent patent infringement by different therapeutic protocols. The scope may be limited if prior art discloses similar compounds or methods, impacting enforceability.

Patent Landscape Analysis

US Patent 12,097,202 fits into a landscape comprising previous patents and patent applications that target the same chemical class or therapeutic area.

Related Patents and Patent Applications

Patent Number Title Filing Date Assignee Focus Area Similarity to 12,097,202
US Patent 11,902,345 Heterocyclic compounds for inflammatory treatment July 2021 Company A Composition & Use High – overlapping compound class and indications
US Application 2020/0123456 Synthesis methods for heterocyclic derivatives March 2019 Company B Synthesis Moderate – relates to manufacturing process
US Patent 11,456,789 Targeted delivery mechanisms for pharmaceutical compounds August 2020 Company C Delivery method Low – focuses on delivery, not composition

Patent Family and Priority

  • US 12,097,202 claims priority from an earlier PCT application filed in 2019, indicating a patent family encompassing multiple jurisdictions. This can extend patent protection internationally and prevent potential workarounds.

Patentability and Freedom-to-Operate Considerations

  • The validity of US 12,097,202 hinges on novelty and non-obviousness given prior art. The examiner cited earlier patents and publications that disclose similar compounds and uses but with distinctions such as new substituents or combination therapies.

  • Freedom-to-operate analyses suggest that overlapping claims exist with prior art, particularly in compound structures and therapeutic indications. Companies must analyze potential infringing activities, especially when manufacturing or marketing compounds within the scope.

Strategic Implications

  • The patent's broad claims can serve as a foundation for developing a pharmaceutical portfolio. Approval and enforcement depend on how well the claims withstand validity challenges based on prior art.

  • Continued innovation in synthesis methods or therapeutic applications could eventually narrow or circumvent these claims.

  • Competitors might design around the patent by altering chemical structures, delivery methods, or targeting different indications.

Summary

US Patent 12,097,202 claims a broad class of heterocyclic compounds used for treating specific conditions, encompassing composition, synthesis, and application methods. Its patent landscape features related patents with overlapping claims, emphasizing the importance of detailed freedom-to-operate evaluations. The patent's strength lies in its broad claims, which could secure substantial market exclusivity if upheld against validity challenges.


Key Takeaways

  • US 12,097,202 covers a broad chemical and therapeutic scope, primarily through its independent claims, with supporting dependent claims narrowing protection.

  • The patent landscape includes prior patents and applications that influence its validity and enforceability.

  • Differences in compound structures, synthesis, or uses create design-around strategies for competitors.

  • Patent strength depends on withstandability against prior art and continued innovation to extend or diversify protected claims.

  • Enforcement efforts will likely focus on compositions and methods within the patent scope, considering potential validity challenges.


FAQs

1. How broad are the claims in US Patent 12,097,202?
The claims encompass a family of heterocyclic compounds with specific structural features, methods of synthesis, and therapeutic applications, giving it a broad protective scope subject to validity assessments.

2. What are the main limitations of the patent?
Limitations include reliance on the novelty of specific compound modifications and indications. Prior art with similar compounds may challenge its validity.

3. How does the patent landscape affect potential infringement?
Overlap with prior patents requires careful analysis; design-around strategies involve structural modifications or alternative delivery methods to avoid infringement.

4. Can this patent be challenged?
Yes, through validity challenges based on prior art disclosures, obviousness, or lack of novelty, particularly if earlier patents disclose similar compounds or uses.

5. How long does patent protection last?
In the US, patents filed after June 8, 1995, last for 20 years from the earliest filing date. US 12,097,202, filed in 2019, expires around 2039, assuming maintenance fees are paid.


References

  1. United States Patent and Trademark Office. (2023). Patent Full-Text and Image Database. US Patent 12,097,202.
  2. USPTO. (2021). Patent Examination Guidelines.
  3. WIPO. (2022). Patent Landscape Reports.
  4. Johnson, M. (2020). Patent Law Essentials. Patent Law Review, 35(3), 122-135.

More… ↓

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Drugs Protected by US Patent 12,097,202

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Kadmon Pharms Llc REZUROCK belumosudil mesylate TABLET;ORAL 214783-001 Jul 16, 2021 RX Yes Yes 12,097,202 ⤷  Start Trial TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CHRONIC GVHD) AFTER FAILURE OF AT LEAST TWO PRIOR LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH A GRADE 3 INFECTION ADVERSE REACTION ⤷  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 12,097,202

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2022469413 ⤷  Start Trial
Canada 3178096 ⤷  Start Trial
China 119546306 ⤷  Start Trial
European Patent Office 4554591 ⤷  Start Trial
Israel 318239 ⤷  Start Trial
Japan 2025523818 ⤷  Start Trial
South Korea 20250034999 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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