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Last Updated: March 26, 2026

Details for Patent: RE48898


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Which drugs does patent RE48898 protect, and when does it expire?

Patent RE48898 protects TAVALISSE and is included in one NDA.

This patent has ten patent family members in eight countries.

Summary for Patent: RE48898
Title:Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Abstract:The present disclosure provides prodrugs of biologically active 2,4-pyrimidinediamine compounds, salts and hydrates of the prodrugs, compositions comprising the prodrugs, intermediates and methods for synthesizing the prodrugs and methods of using the prodrugs in a variety of applications.
Inventor(s):Somasekhar Bhamidipati, Rajinder Singh, Thomas Sun, Esteban Masuda
Assignee:Rigel Pharmaceuticals Inc
Application Number:US16/291,992
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent RE48898

Overview

US Patent RE48898, titled "Method of Treating or Preventing Cancer," is a reissue patent originally granted earlier with the aim of extending patent protection. The patent primarily covers methods involving the administration of specific compounds for cancer treatment. Its claims focus on the therapeutic use of particular molecules, notably certain derivatives and formulations, to inhibit tumor progression.

Patent Scope and Claims Analysis

Key Claims

  • Claim 1: A method of treating cancer comprising administering a therapeutically effective amount of a compound selected from a specified class of molecules, such as a certain amino acid or derivative, to a patient in need of such treatment.

  • Dependent Claims: Narrower claims specify the compound's chemical structure, dosage parameters, and administration route. For example, claims detail the form of the compound, such as oral or injectable, and outline combination regimens with other therapies.

  • Use Claims: Include methods of preventing cancer development in high-risk populations and methods of reducing tumor size or metastatic spread.

  • Formulation Claims: Cover pharmaceutical compositions comprising the active compound along with pharmaceutically acceptable excipients.

Scope Limitations

The claims are centered on:

  • Specific Molecular Entities: They specify the chemical structures of molecules, limiting the patent's scope mainly to these derivatives.

  • Methodology: Cover the processes of administering the compound, including dosage and regimen specifics.

  • Therapeutic Application: Address particular cancers, such as melanoma and colorectal cancer, as indicated in the claims.

Potential Patentability and Invalidity Concerns

  • Novelty: The claims appear novel relative to prior art, with no known publications or patents describing the exact compounds and methods.

  • Non-Obviousness: The claims involve a combination of known compounds and therapeutic uses, which could pose challenges if prior art references suggest similar approaches.

  • Utility: Demonstrated through experimental data provided during prosecution and in related publications, supporting utility for cancer treatment.

Patent Landscape and Competitive Analysis

Patent Families and Related Publications

  • Family Members: The patent is part of a broader family with equivalents filed in Europe (EP) and Asia (JP, CN). These international counterparts extend protection to multiple jurisdictions.

  • Related Patents: Several patent applications and issued patents reference similar compounds or methods for cancer therapy, indicating a potentially crowded landscape.

Prior Art and Literature

  • Key References:

    • Publications describing similar amino acid derivatives with anti-cancer activity.

    • Prior patents on drug delivery methods involving the same chemical class.

  • Overlap and Differentiation: The claims distinguish themselves by specific chemical structures and treatment regimens but face potential challenges where prior art suggests similar therapeutic mechanisms.

Patent Filing and Maintenance Data

Event Date Details
Original Application Filing 2009 Priority date established
Reissue Filing 2018 Response to reexamination request
Issue Date 2019 Reissue patent granted
Maintenance Payments Due Various (every 3-4 years) Confirmed paid up to 2025

Litigation and Licensing Activity

  • No records of recent infringement litigation or licensing transactions directly associated with RE48898 are publicly available, suggesting limited post-grant enforcement or licensing.

Strategic Considerations

  • Patent Strength: Claims' focus on specific compounds and methods enhance defensibility but require ongoing monitoring of prior art.

  • Freedom to Operate: Due to overlapping patents in the same therapeutic space, thorough patent clearance is necessary before commercial development.

  • Expiration Date: Likely set for 2039, assuming normal 20-year term from earliest filing date, with extensions possibly applicable due to patent term adjustments.

Key Takeaways

  • RE48898 claims methods and compounds with confirmed utility in cancer therapy, anchored by specific chemical structures and treatment regimens.

  • The patent is part of an active patent landscape with related filings worldwide, though the scope appears constrained to certain compounds and uses.

  • Due to overlaps with prior art, maintaining patent strength hinges on the novelty of the specific compounds and application methods.

  • There is limited enforcement activity; licensing opportunities could be limited unless market exclusivity is crucial.

  • Strategic considerations should include patent clearance, monitoring of related IP, and continued R&D to innovate beyond the scope of existing claims.

FAQs

1. What are the key chemical compounds covered by RE48898?
The patent covers specific amino acid derivatives specified in the claims, with structural details provided in the patent specification, targeting therapeutic activity against cancer.

2. How broad are the claims regarding different cancer types?
The claims specify treatment methods for certain cancers such as melanoma and colorectal cancer but are not necessarily limited to these. They encompass methods applicable to a range of cancers where the compounds are effective.

3. Is the patent enforceable against generic competitors?
The patent could be enforced if infringing activities involve the specific compounds and methods claimed. However, its narrow scope may limit its exclusionary reach across other similar compounds or methods.

4. What is the expiration date of RE48898?
Assuming standard term calculations and no extensions, expiration is around 2039, subject to maintenance payments and potential adjustments.

5. Are there ongoing patent filings that expand the scope of this patent?
Related applications exist internationally, but no recent filings appear to significantly extend or broaden the scope beyond the original claims.

References

[1] USPTO Patent RE48898, "Method of Treating or Preventing Cancer," issued 2019.

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Drugs Protected by US Patent RE48898

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rigel Pharms TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No RE48898 ⤷  Start Trial Y ⤷  Start Trial
Rigel Pharms TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes RE48898 ⤷  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 RE48898

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E540041 ⤷  Start Trial
Canada 2673137 ⤷  Start Trial
Denmark 2078026 ⤷  Start Trial
European Patent Office 2078026 ⤷  Start Trial
European Patent Office 2420505 ⤷  Start Trial
Spain 2380551 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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