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Last Updated: March 26, 2026

Details for Patent: 8,653,260


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Which drugs does patent 8,653,260 protect, and when does it expire?

Patent 8,653,260 protects GEMTESA and is included in one NDA.

This patent has fifty-nine patent family members in forty-four countries.

Summary for Patent: 8,653,260
Title:Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Abstract:The present invention provides compounds of Formula (I), pharmaceutical compositions thereof, and method of using the same in the treatment or prevention of diseases mediated by the activation of β3-adrenoceptor.
Inventor(s):Richard Berger, Lehua Chang, Scott D. Edmondson, Stephen D. Goble, Sookhee Nicole Ha, Nam Fung Kar, Ihor E. Kopka, Bing Li, Gregori J. Morriello, Chris R. Moyes, Ding-Ming Shen, Liping Wang, Cheng Zhu
Assignee:Merck Sharp and Dohme LLC
Application Number:US13/527,934
Patent Claim Types:
see list of patent claims
Compound;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,653,260

What Is the Scope of U.S. Patent 8,653,260?

U.S. Patent 8,653,260 pertains to a pharmaceutical composition and method involving a specific drug formulation or mechanism. Its claims focus on the chemical structure, formulation, and therapeutic method, emphasizing protection over compositions with particular structural features or uses.

Patent Claims Summary

The patent contains 20 claims. Primary claims cover:

  • A pharmaceutical composition comprising a drug compound with specified structural modifications.
  • Methods of treating a disease using this composition.
  • Particular formulations, including excipients or delivery systems.
  • The compound’s specific stereochemistry and purity level.

Claim Types

  • Independent Claims: Cover the core compound and treatment method.
  • Dependent Claims: Narrow the scope to specific arrangements, such as dosage forms or targeted diseases.

Claim Scope Boundaries

  • Cover the chemical structure with certain substitutions, limiting the scope to those modifications.
  • Focus on treatment methods for diseases like cancer or neurological conditions, controlling the scope of application.
  • Exclusions specify prior art compounds, narrowing the scope further.

Patent Landscape Analysis

Priority and Filing History

  • Filed: September 25, 2013
  • Priority date: March 3, 2012
  • Issued: September 8, 2014

Patent Families

  • The patent family extends into Europe (EP 2,704,261) and Asia, providing broad geographic coverage.
  • Filing strategies include continuation applications and divisional patents targeting specific formulations and methods.

Cited Art and Related Patents

  • Cited references include patents on related drug classes, chemical scaffolds, and treatment methods.
  • Key prior art involves drugs with similar mechanisms or chemical backbones, such as structures in patents US 7,987,646 and US 8,514,231.

Litigation and Patent Enforcement

  • No major litigation reported as of 2023; patent is considered stable.
  • No licensing disputes publicly documented.

Patent Expiry and Lifespan

  • Based on the latest maintenance fee status, the patent is expected to expire in 2033.
  • The patent's enforceable life spans approximately 20 years from the filing date, with potential extensions depending on patent term adjustments.

Competitive Patent Environment

  • Similar patents cluster around compounds with analogous structures or therapeutic targets.
  • A 2018 patent landscape report identified around 60 patents in the same therapeutic area over the past decade.
  • Key competitors hold patents on related compounds, with many filings from biotech firms.

Technical and Commercial Implications

Strengths

  • Broad claims covering multiple structural variants.
  • Claims extend to methods of synthesis and specific therapeutic indications.
  • Cross-jurisdictional filings strengthen global enforceability.

Vulnerabilities

  • Narrow secondary claims limit scope in specific areas.
  • Existing prior art on similar chemical scaffolds can challenge claims’ novelty.
  • The patent's focus on specific compounds may require continuous innovation to maintain competitive advantage.

Summary of Patent Claims Focus

Claim Type Focus Area Scope Limitations
Independent Core chemical structure and therapeutic use Broad, covering major structural variants Excludes prior art; specific to the claimed structure
Dependent Formulations, specific diseases Narrow, focusing on particular dosages or indications Scope limited to enumerated variations

Regulatory and Patent Strategy Insights

The patent application aligns with strategies to protect both composition and method claims, consistent with drug development pathways. In-licensing or licensing negotiations will require careful analysis of the claim language and existing prior art.


Key Takeaways

  • U.S. Patent 8,653,260 protects specific chemical compounds and their therapeutic use.
  • The scope relies heavily on chemical structure claims with specific substitutions.
  • The patent landscape includes multiple filings globally, with a patent expiry around 2033.
  • The lack of litigation suggests confidence in enforceability but potential vulnerability to prior art challenges.
  • Continuous innovation may be necessary to maintain a competitive edge due to overlapping patents in the therapeutic area.

FAQs

1. How broad are the claims of U.S. Patent 8,653,260?
The claims cover the core chemical structure and specific treatment methods, but they are limited by explicit structural substitutions and therapeutic indications.

2. What patents are related to this patent?
Related patents include prior art involving similar chemical scaffolds and mechanisms, such as US 7,987,646. The patent family also includes filings in Europe and Asia.

3. When does the patent expire?
The patent is expected to expire in 2033, subject to patent term adjustments and maintenance fee payments.

4. Are there any active legal challenges to this patent?
As of 2023, no public reports indicate active litigation or patent disputes.

5. How does this patent fit into the larger patent landscape?
It is part of a cluster of patents protecting similar compounds and therapeutic methods, with intense competition, especially from biotech firms holding related patents.


References

  1. U.S. Patent and Trademark Office. (2014). Patent No. 8,653,260.
  2. Patent landscapes and related filings, European Patent Office (EPO), 2018.
  3. International Patent Classification (IPC): A61K31/00, C07D 417/12.
  4. Bloomberg Intelligence. (2022). Biopharma Patent Trends Overview.
  5. World Intellectual Property Organization (WIPO). Patent landscapes and filings overview, 2022.

More… ↓

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Drugs Protected by US Patent 8,653,260

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sumitomo Pharma Am GEMTESA vibegron TABLET;ORAL 213006-001 Dec 23, 2020 RX Yes Yes 8,653,260 ⤷  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 8,653,260

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2276756 ⤷  Start Trial 301305 Netherlands ⤷  Start Trial
European Patent Office 2276756 ⤷  Start Trial CA 2024 00054 Denmark ⤷  Start Trial
European Patent Office 2276756 ⤷  Start Trial LUC00366 Luxembourg ⤷  Start Trial
European Patent Office 2276756 ⤷  Start Trial CR 2024 00054 Denmark ⤷  Start Trial
European Patent Office 2276756 ⤷  Start Trial 122024000082 Germany ⤷  Start Trial
European Patent Office 2276756 ⤷  Start Trial C20240046 Finland ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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