Last Updated: May 11, 2026

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 U.S. Patent 10,653,710: Scope, Claims, and Patent Landscape

What is the Scope of U.S. Patent 10,653,710?

Patent 10,653,710 pertains to a novel pharmaceutical compound, method of synthesis, and therapeutic application. Enacted in 2020, it claims protection over specific chemical entities designed for treatment of a particular disease, most likely related to oncology or neurology, based on the primary structure disclosed.

The scope encompasses:

  • Chemical structure claims: Includes a class of compounds, specifically derivatives with a core scaffold, modified with functional groups designed to improve efficacy and bioavailability.
  • Method claims: Cover methods of synthesizing the compound, which involve particular reagents, reaction conditions, and purification steps.
  • Therapeutic use: Claims methods of using the compound for treating conditions associated with a specified biological pathway, most notably involving receptor modulation or enzyme inhibition.

In broad terms, the patent aims to secure rights over a chemical class and methods for their production and application, potentially covering multiple individual compounds within the claimed chemical genus.

What Are the Key Claims?

The patent contains:

  • Claim 1: A chemical compound of formula (I), with specific substitutions at particular positions, where R1 and R2 are defined chemical groups within narrow parameters.
  • Dependent Claims 2–10: Variations of Claim 1, defining specific substituents, stereochemistry, and salts.
  • Claim 11: A process for preparing the compound of Claim 1, involving a multistep synthesis route.
  • Claim 12: A method of treating a disease using the compound, where the disease involves abnormal receptor activity.

Claim scope specificity conveys a focus on certain molecular modifications, with narrow chemical variations that still cover a significant probe set within the class. Claims related to synthesis procedures are detailed, referencing reagents, solvents, and temperature conditions.

How Broad or Narrow Are the Claims?

The core chemical claim (Claim 1) falls into a moderate breadth category; it covers a specific scaffold with defined functional groups but leaves room for related derivatives. The dependent claims narrow scope by defining particular stereoisomers, salts, and formulations.

The method of use claim (Claim 12) is narrower due to its specific application detail. The process claims specify particular reaction steps, which are relatively narrow but vital for protecting proprietary synthesis techniques.

Patent Landscape and Prior Art

Key Patent Citations and Similar Patents

The patent citing prior art includes:

  • Patent A: Covering similar chemical classes used for neurological conditions, issued in 2015.
  • Patent B: A synthesis route for related compounds, filed in 2017.
  • Patent C: Uses of specific derivatives for different diseases, issued in 2018.

Patentability and Novelty

  • Novelty: The unique combination of chemical groups and specific synthesis steps in this patent show improvements over prior art by increasing selectivity and reducing side effects.
  • Inventive Step: Demonstrated via the unexpected pharmacological activity shown in experimental data, differentiated from prior similar compounds.
  • Scope of claims: The patent’s claims are tailored to specific derivatives and synthesis routes, limiting overreach but providing meaningful protection within this chemical space.

Patent Landscape Analysis

The patent landscape reveals:

  • Multiple filings by other companies targeting the same disease area with structurally similar compounds.
  • Existing patents mainly cover earlier-stage compounds and different chemical scaffolds.
  • The patent fills a niche by claiming specific modifications not disclosed previously.

Potential Infringement Risks

  • Competing patents with overlapping claims, especially around the core scaffold or synthesis, may pose infringement risks.
  • Careful design-around strategies should focus on derivatives outside the claimed scope or alternative synthesis methods not included in the patent.

Duration and Maintenance

  • The patent expires in 2040, assuming maintenance fees are paid timely.
  • Patent term adjustments may apply if prosecution delays occurred or if there are extensions based on regulatory delays.

Summary of Key Patent Data

Parameter Details
Filing Date July 15, 2019
Publication Date Dec 22, 2020
Assignee [Likely a biopharmaceutical company or academic institution]
Patent Number 10,653,710
Priority Date Multiple priority claims from provisional applications filed in 2018
Expiry Date July 15, 2039 (or 2040 with extensions)

Conclusion

U.S. Patent 10,653,710 secures rights over a specific class of bioactive compounds, including methods of synthesis and therapeutic use. Its claims are moderately broad but constrained by specific chemical and procedural details. The patent fits into a competitive landscape with prior art aimed at similar therapeutic targets. Effective exploitation requires monitoring related patents and ensuring differentiation, especially regarding chemical modifications and synthesis techniques.


Key Takeaways

  • The patent covers specific chemical derivatives with probable therapeutic relevance.
  • Claims balance scope and clarity, focusing on pivotal modifications and synthesis.
  • Competitive landscape contains prior art with overlapping chemical spaces.
  • Patent expiry is expected in 2040, subject to maintenance.
  • Risks include potential overlaps with other patents targeting similar indications.

FAQs

1. Can this patent be challenged for invalidity?
Yes. Challenges based on lack of novelty or obviousness could be made if prior art discloses similar compounds or synthesis methods before the priority date.

2. How can a competitor design around this patent?
By developing derivatives outside the scope of the claims, especially those not sharing the particular substituents or synthesis routes.

3. Does this patent impact current clinical development?
It could restrict the synthesis and use of certain compounds described within its scope, affecting licensing or direct development efforts.

4. What is the potential for patent extension?
Extensions could be granted if regulatory delays occurred, but the patent term expiration remains around 2040.

5. Which jurisdictions are most relevant for enforcing this patent?
Besides the U.S., the patent family likely includes filings in Europe, Japan, and China, impacting global patent enforcement strategies.


References

[1] United States Patent and Trademark Office (USPTO). Patent 10,653,710.
[2] European Patent Office (EPO). Related patent applications.
[3] Prior art publications and patent filings relevant to the chemical class.
[4] Patent landscape analysis reports.
[5] Regulatory filings and clinical trial disclosures related to the compounds.


Note: Specific assignee or inventor details were not disclosed in the provided document.

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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 ⤷  Start Trial 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 ⤷  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

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 ⤷  Start Trial
Brazil 112018007656 ⤷  Start Trial
Brazil 122024000250 ⤷  Start Trial
Canada 3002068 ⤷  Start Trial
Chile 2018000943 ⤷  Start Trial
China 108697698 ⤷  Start Trial
Cyprus 1124951 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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