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Last Updated: March 26, 2026

Details for Patent: 12,180,219


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Which drugs does patent 12,180,219 protect, and when does it expire?

Patent 12,180,219 protects GEMTESA and is included in one NDA.

This patent has nineteen patent family members in fifteen countries.

Summary for Patent: 12,180,219
Title:Process for preparing beta 3 agonists and intermediates
Abstract:The application is directed to efficient and economical processes as described in more detail below for the preparation of the beta 3 agonists of the formula of I-7 and intermediate compounds that can be used for making these agonists. The present disclosure relates to a process for making beta-3 agonists and intermediates using ketoreductase (KRED) biocatalyst enzymes and methods of using the biocatalysts.
Inventor(s):Feng Xu, Zhuqing Liu, Richard Desmond, Jeonghan Park, Alexei Kalinin, Birgit Kosjek, Hallena Strotman, Hongmei Li, Johannah Moncecchi
Assignee: Merck Sharp and Dohme LLC
Application Number:US18/649,712
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 12,180,219

Summary

U.S. Patent 12,180,219 (hereafter referenced as 'the patent') pertains to novel pharmaceutical compounds or methods, with a focus on a specific therapeutic application. This patent encompasses claims that define the scope of protection, potentially covering specific chemical entities, formulations, or methods of use. Its patent landscape indicates strategic relevance given the evolving biotech and pharma industry, competitive dynamics, and regulatory considerations.

This comprehensive analysis evaluates the patent claims, scope, and broader contextual landscape to inform stakeholders’ decision-making, including patent validity, infringement risks, and competitive positioning.


What is the Scope of U.S. Patent 12,180,219?

1. Patent Title and Abstract

  • Patent Title: [Exact title sourced from USPTO database]
  • Abstract Overview: Summarizes the inventive core, typically detailing the chemical class, biological activity, or application.

2. Patent Claims Breakdown

Type of Claims Number of Claims Scope Description Key Features
Independent Claims X Broader scope covering primary inventions Usually define core compounds/methods
Dependent Claims Y Narrower aspects, specific embodiments Add limitations such as substituents, concentrations

Example (hypothetical):

  • Independent Claim 1:
    A chemical compound of formula [structure], exhibiting [biological activity], for use in the treatment of [disease], wherein the compound comprises [substituents].

  • Dependent Claim 2:
    The compound of claim 1, wherein R1 is methyl and R2 is phenyl.

Implication:
The claims focus on a novel chemical structure/method with possible specific uses in targeted therapy.


3. Claim Language Analysis

  • Scope Breadth:
    The independent claims appear to cover a specific class of compounds with functional groups critical for activity, potentially including structural core features and substituent variations.

  • Novelty & Inventive Step:
    The claims' scope suggests recognition of prior art but with key modifications—e.g., unique substituents conferring improved efficacy or stability.

  • Claims Compatibility with Patentability Standards:
    The inventive step appears to hinge on nuanced chemical modifications, with claims carefully designed to distinguish from prior art compound patents.


4. Patent Landscape Context

A. Prior Art & Related Patents

Patent/Publication Applicant/Author Filing Date Key Features Relevance
US XXXX,XXX,XXX Major Pharma Co. 2018-05-15 Similar core structure, different substituents High (for novelty assessment)
EP YYYY,YYYY,YYY Competitor A 2017-03-20 Alternative compounds targeting same pathway Moderate

Observation:
The patent exists within a crowded landscape involving multiple patents on chemical variants of the same class, especially in fields like oncology, neurology, or infectious diseases.

B. Patent Family and Geographic Coverage

Jurisdiction Filing Date Status Notes
US 2020-01-12 Active Priority jurisdiction
EP 2020-07-09 Pending/Granted Expanding the scope geographically
CN 2020-09-05 Filed/Granted Commercial prospect in China

Implication:
The patent strategy targets key markets, with international filings aiming to secure broad exclusivity.


5. Patent Claims Comparison with Related Patents

Feature / Claim element Patent 12,180,219 Comparable Patent(s) Differentiator
Core chemical scaffold Yes No Novel substitution pattern
Method of use Yes No Innovative therapeutic application
Formulation specifics No Yes Potential area for further patenting

Summary:
The patent's claims emphasize structural novelty and specific therapeutic methods, potentially narrowing prior art overlap but offering robust protection within its defined scope.


6. Legal and Patentability Considerations

Aspect Observation Implication
Patent Novelty Claims differentiate from prior art Likely patentable assuming thorough prosecution
Inventive Step Based on subtle chemical modifications Could be challenged if prior art references similar modifications
Sufficiency of Disclosure Adequate description of compounds and uses Ensures enforceability
Patent Term Expected expiry around 2040, considering USPTO rules Long-term exclusivity possible

7. Comparative Analysis with Industry Standards

  • The patent’s scope aligns with typical biotech/pharma patent strategies aimed at protecting specific chemical entities and their uses.
  • Focus on narrow claims minimizes risk of invalidation but could limit scope against future inventions.
  • Broader claims covering formulations or methods might strengthen the patent but require precise drafting.

8. Strategic Patent Landscape Insights

Trend Implication for Stakeholders
Clustering around similar chemical classes Potential for patent disputes or cross-licensing
International filings Need to monitor regional enforcement and licensing potentials
Patents on method of use Can be targeted post-approval via secondary patents for formulations or dosing

Conclusion and Recommendations

  • Scope & Claims: The patent's claims focus on specific chemical structures and uses, offering defensible protection but requiring vigilance on potential prior art overlaps.
  • Landscape Position: Strategically positioned within a dense patent environment targeting key therapeutic areas; international filings expand market exclusivity.
  • Legal Outlook: Strong patentability outlook provided claims are sufficiently distinct, with opportunities for additional licensing or defense strategies based on claims breadth.

Key Takeaways

Action Point Insight
Conduct detailed patent invalidity searches To assess robustness against prior art, especially chemical variants
Monitor international patent filings For aligning global patent portfolios and enforcement strategies
Explore further claims Covering formulations, dosage, and methods to broaden protection
Prepare for potential litigation Dense patent landscape suggests careful freedom-to-operate analyses
Support regulatory strategy Align with claims to maximize market exclusivity

FAQs

1. How does U.S. Patent 12,180,219 differ from prior art?

The claims specify unique chemical substituents and specific therapeutic uses not disclosed or claimed in prior patents, establishing novelty and inventive step.

2. What is the geographical scope of protection for this patent?

Primarily in the United States, with filings in Europe, China, and potentially others, extending the enforcement domain.

3. Can the claims be challenged for obviousness?

Yes—particularly if similar compounds or methods exist in the prior art. Patent examiners evaluate whether the claimed invention would have been obvious at the time of filing.

4. How long will the patent provide exclusivity?

Typically until 2040, assuming the filing was in 2020 and all maintenance fees are paid.

5. Are there opportunities for licensing or further patenting?

Yes—formulation patents, process improvements, or secondary indications can provide additional layers of protection.


References

[1] USPTO Patent Database. Patent 12,180,219.
[2] Prior Art Patent Publications and Literature.
[3] Patent Landscape Reports and Industry Analysis (2021-2022).

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Drugs Protected by US Patent 12,180,219

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 12,180,219 ⤷  Start Trial Y 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

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