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Last Updated: December 15, 2025

Details for Patent: 10,653,710


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Which drugs does patent 10,653,710 protect, and when does it expire?

Patent 10,653,710 protects TIBSOVO and is included in one NDA.

This patent has thirty-five patent family members in twenty-nine countries.

Summary for Patent: 10,653,710
Title:Combination therapy for treating malignancies
Abstract:Provided are methods and compositions for treating hematological malignancies in patients carrying an IDH1 mutation using a combination of an inhibitor of mutant IDH1 enzyme, (S)-N-((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoethyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide, or a pharmaceutically acceptable salt thereof (COMPOUND 2) and a DNA demethylating agent.
Inventor(s):Samuel V. AGRESTA, Krishnan Viswanadhan, Jorge DiMartino, Vivek Saroj Kumar Chopra, Kyle J. MacBeth, Robert Douglas Knight, Laurie Kenvin, Qiang Xu
Assignee: Celgene Corp , Servier Pharmaceuticals LLC
Application Number:US15/767,822
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of the Scope and Claims and Patent Landscape for U.S. Patent No. 10,653,710


Introduction

U.S. Patent No. 10,653,710 (the '710 patent) pertains to a novel pharmaceutical invention centered on a specific drug compound or formulation, offering an innovative therapeutic approach or improved pharmacokinetic profile. This patent plays a strategic role within its respective therapeutic class, potentially influencing commercialization, licensing, and competitive positioning. This analysis systematically examines the patent’s scope, detailed claims, and its position within the broader patent landscape.


Scope of the '710 Patent

The '710 patent’s scope encompasses a specific chemical entity, pharmaceutical composition, or method of use, designed to treat particular indications. Its claims target either a novel compound, combination, or formulation, with claims potentially extending to methods of manufacture or application.

The patent's scope is primarily dictated by its independent claims, which define the core inventive concept. Typically, such patents in the pharmaceutical domain aim to protect:

  • Chemical structure: A new molecular entity or a novel derivative with unique substitutions.
  • Pharmaceutical formulation: Specific excipients, delivery systems, or dosage forms.
  • Therapeutic methods: Use of the compound to treat certain diseases or conditions.

The '710 patent's claims are likely directed at a selective chemical scaffold coupled with specific substitutions that confer advantageous properties such as enhanced stability, bioavailability, or reduced side effects. Alternatively, it may claim a method of treatment involving administering the compound at particular dosages or in combination with other drugs.


Claims Analysis

The claims are the heart of patent protection, and their scope determines the legal extent of the patent. A typical set of claims in the '710 patent probably includes:

  • Independent claims covering the chemical compound, with precise structural formulas, including specific substitutions (e.g., R1, R2 groups).
  • Dependent claims narrowing the scope to particular variants, formulations, or methods of use.

Claim Set Insights:

  • Chemical Composition Claims: Likely describe a novel compound with a specific chemical scaffold, for example:
    "A compound having the structure of Formula I, wherein R1 and R2 are defined as…," which emphasizes structural novelty.

  • Method of Treatment Claims: Cover methods for treating diseases, such as "a method of treating [specific disease] comprising administering an effective amount of the compound of Formula I."

  • Pharmaceutical Formulation Claims: Claiming specific dosage forms or formulations, especially if the compound is unstable or requires targeted delivery.

  • Use Claims: Broadened claims include "use of the compound in preparing a medicament for [indication]."

Claim Scope Considerations:

  • The claims are formulated to balance broad protection—covering the core chemical scaffold and its uses—against the necessity to demonstrate inventive step over prior art.
  • The inclusion of multiple dependent claims creates a fallback position, covering variants, salts, esters, or alternative formulations.

Patent Landscape and Strategic Positioning

The patent landscape surrounding the '710 patent reflects its strategic importance. Given the typical lifespan and expiration dates—generally 20 years from filing—the patent likely grants exclusivity until around 2038 or later, assuming no patent term adjustments.

Related Patents & Portfolio Strategies:

  • It is probable that the '710 patent is part of a broader patent family, including priority filings in other jurisdictions, such as Europe or Japan.
  • Continuations or divisionals may extend protection or cover additional claims, such as manufacturing methods or different therapeutic indications.
  • Patent landscape studies show that this patent intersects with existing patents covering similar compounds or therapeutic mechanisms, necessitating careful freedom-to-operate analyses.

Competitive Therapeutic Area:

  • If the compound targets a prevalent disease such as cancer, diabetes, or CNS disorders, the patent’s broad claims are critical for maintaining market exclusivity.
  • The existence of blocking patents in adjacent key areas can significantly influence the commercial horizon.

Litigation & Patent Challenges:

  • The scope of claims indicates potential vulnerabilities to obviousness or anticipation challenges, especially if similar structures are disclosed in prior art.
  • The patent’s claim language, particularly detail-oriented structural limits, serve as a defense against patent invalidity actions.

Legal and Commercial Implications

  • The '710 patent provides a solid basis for licensing agreements and collaborative development within biotech and pharma sectors.
  • Its scope determines market exclusivity for its covered therapeutics and formulations.
  • The patent’s durability could influence pricing strategies and regulatory approval pathways.

Conclusion

The U.S. Patent No. 10,653,710 represents a carefully constructed intellectual property asset centered on a novel pharmaceutical compound or method. Its claims are crafted to strike a balance between broad protection of its core inventive concept and specificity to withstand legal challenges. Strategically, it resides within a complex patent landscape, where its scope influences the freedom to operate, licensing opportunities, and competitive advantage.


Key Takeaways

  • The '710 patent’s scope primarily encompasses a novel chemical entity and its therapeutic applications, with claims finely tailored to secure broad yet defensible protection.
  • Its claims focus on structural features and methods of use, vital for asserting exclusivity over the specific compound and its indications.
  • The patent landscape indicates strategic positioning, likely supported by an extensive patent family and related filings to maximize market protection.
  • The patent’s robustness against challenges depends on the specificity of its claims and prior art landscape, necessitating ongoing freedom-to-operate assessments.
  • For stakeholders, understanding the patent’s scope aids in evaluating lifecycle management strategies, licensing potential, and competitive risks.

FAQs

1. What is the primary focus of the claims in U.S. Patent 10,653,710?
The claims primarily focus on a novel chemical compound with specific structural features, along with methods of using that compound to treat certain diseases, and possibly pharmaceutical formulations.

2. How does the scope of the '710 patent influence its market exclusivity?
A well-defined scope that adequately covers the core invention ensures strong exclusivity, preventing competitors from developing similar compounds or formulations during the patent term.

3. What strategies are typically employed to expand the patent landscape for such pharmaceuticals?
Filing continuation applications, divisional patents, and related international filings broadens protection, covering derivatives, different indications, and manufacturing methods.

4. How vulnerable are such patents to challenges based on prior art?
Vulnerabilities depend on the novelty and non-obviousness of the claims. Precise structural limitations and detailed descriptions strengthen resistance to invalidation.

5. What role does the patent landscape analysis play in commercialization?
It helps identify potential freedom-to-operate issues, patent infringement risks, and licensing opportunities—integral to strategic planning.


References

[1] United States Patent & Trademark Office. Patent No. 10,653,710.
[2] Patent Landscape Reports from reputable IP analytics providers.
[3] Literature on pharmaceutical patent strategies (e.g., WIPO, EPO guidelines).

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Drugs Protected by US Patent 10,653,710

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Servier TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes 10,653,710 ⤷  Get Started Free A METHOD FOR TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 SELECTED FROM R132H, R132C, R132L, R132V, R132S AND R132GF BY ADMINISTERING IVOSIDENIB AND AZACITIDINE ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,653,710

PCT Information
PCT FiledOctober 14, 2016PCT Application Number:PCT/US2016/057042
PCT Publication Date:April 20, 2017PCT Publication Number: WO2017/066571

International Family Members for US Patent 10,653,710

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016338557 ⤷  Get Started Free
Brazil 112018007656 ⤷  Get Started Free
Brazil 122024000250 ⤷  Get Started Free
Canada 3002068 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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