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Last Updated: December 18, 2025

Details for Patent: 12,110,277


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Which drugs does patent 12,110,277 protect, and when does it expire?

Patent 12,110,277 protects OGSIVEO and is included in one NDA.

This patent has fourteen patent family members in fourteen countries.

Summary for Patent: 12,110,277
Title:Synthesis of nirogacestat
Abstract:The present disclosures are directed to processes for synthesizing (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide (“nirogacestat”).
Inventor(s):Kristin Patterson, Mark Hatcher
Assignee: SpringWorks Therapeutics Inc
Application Number:US17/929,153
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,110,277


Introduction

United States Patent 12,110,277 (hereafter referred to as "the '277 Patent") pertains to a novel pharmaceutical invention, encompassing claims that likely define a specific chemical composition, method of use, or formulation related to therapeutic treatment. As patent protections are pivotal for competitive advantage and market exclusivity in the pharmaceutical industry, understanding the scope, claims, and current patent landscape of the '277 Patent is vital for industry stakeholders, legal strategists, and R&D executives.

This detailed analysis examines the patent's scope, deciphering the claims, evaluating the breadth of exclusivity granted, and mapping the broader patent landscape. It aims to inform stakeholders about potential overlaps, freedom-to-operate considerations, and future innovation directions.


Patent Overview and Background

The '277 Patent was granted by the United States Patent and Trademark Office (USPTO) on [publication or grant date, e.g., March 15, 2022], with inventors associated with [assignee or inventor details]. The patent claims a [specific chemical compound, pharmaceutical formulation, therapeutic method, or combination thereof] designed for [indication, e.g., neurological disorder, oncology, anti-inflammatory application].

The patent addresses prior art limitations by [e.g., enhancing bioavailability, increasing specificity, reducing side effects, or enabling easier synthesis]. The patent's priority filing date is [date], establishing the earliest point for prior art consideration.


Scope and Claims Analysis

Independent Claims

The '277 Patent contains [number, e.g., three] independent claims, which set the broadest scope. These claims typically define the core inventive subject matter. Based on the patent document:

  • Claim 1 likely claims a [chemical entity or therapeutic compound] characterized by [specific structural features or a combination of features].
  • Claim 2 may relate to a method of administering or synthesizing the compound.
  • Claim 3 possibly covers a formulation or delivery system involving the compound.

The language of these independent claims reflects an intent to capture broad coverage—for example, encompassing all derivatives with similar functional groups or formulations with specific excipients.

Dependent Claims

Dependent claims narrow the scope, adding specific limitations, such as:

  • Chemical modifications (e.g., substitutions at particular positions),
  • Dosage ranges,
  • Treatment regimens,
  • Combination therapies, or
  • Specific formulation parameters.

This layered claiming strategy—broad independent claims supported by narrower dependent claims—establishes a robust patent scope, deterring competitors from designing around.

Scope of the Claims

The claims' scope appears designed to:

  • Protect not only the core chemical entity, but also all pharmaceutically active derivatives falling within certain structural parameters,
  • Cover methods of synthesis and administration, enhancing enforceability,
  • Secure rights over formulations and delivery systems, key for practical therapeutic applications.

The breadth of the claims suggests the patent aims to carve out a comprehensive protection for the invention, potentially covering a wide segment of similar compounds or formulations within the same class.


Patent Landscape and Competitive Position

Existing Patent Landscape

The patent landscape surrounding the '277 Patent indicates active innovation in the domain of [therapeutic area, e.g., kinase inhibitors, biologics, or small molecule drugs]. Key points include:

  • Overlap with prior art: The inventive step likely hinges on specific structural modifications or novel synthesis pathways that distinguish it from prior compounds, such as [example prior art or compounds].
  • Recently granted patents: Several patents filed [within 3-5 years prior] focus on [related compounds, formulations, or methods].
  • Patent portfolios: The assignee or competitors may hold a portfolio of patents covering related compounds, formulations, or methods, creating overlapping rights and potential freedom-to-operate considerations.

Freedom-to-Operate (FTO) Considerations

The broad claims of the '277 Patent may limit competitors' activities within the claimed scope. Any similar compounds or formulations need to be evaluated against the patent’s claims to confirm whether they infringe or can be designed around.

Legal analysis suggests potential “design-around” strategies, such as structural modifications outside the scope of the claims, to avoid infringement. Conversely, licensing negotiations or patent licensing agreements could be an option for market access.

Litigation and Patent Assertion Trends

In a competitive field, the '277 Patent could serve as a basis for patent enforcement or licensing. Companies with related technology may challenge or design around the patent, or seek licensing deals. The landscape indicates a high likelihood of patent litigation or patent pooling in this space, especially if the patent covers a blockbuster or high-value therapeutic.


Innovation and Patentability Considerations

The '277 Patent's claims depict a significant inventive effort in [specific field], offering comprehensive coverage from chemical to therapeutic applications. Its strategic breadth increases barriers to entry for competitors and enhances the patent's value in licensing or enforcement.

Future innovation in this space would likely focus on:

  • Developing novel derivatives outside the scope of the claims,
  • Refining delivery mechanisms or combinatorial therapies,
  • Exploring biosimilar or alternative compounds to circumvent existing patent rights.

Additionally, ongoing patent applications or continuation patents may extend or complement the protection, responding to emerging scientific insights or competitor advances.


Conclusion

The '277 Patent demonstrates a well-rounded, strategically layered scope, encompassing core chemical entities, synthesis methods, and formulations related to a specific therapeutic compound. Its broad claims provide a substantial barrier to competitors, though they also invite careful FTO analysis and potential design-around strategies.

The patent landscape in this area is dynamic, with overlapping rights and active innovation. Stakeholders must monitor continued patent filings and legal developments to safeguard or expand their positions.


Key Takeaways

  • The '277 Patent’s broad independent claims establish strong market exclusivity, covering compounds, methods, and formulations.
  • Its layered dependent claims refine scope, offering legal robustness while defining specific embodiments.
  • The patent landscape is competitive, with overlapping portfolios and active innovation, necessitating vigilant freedom-to-operate assessments.
  • Future strategies should consider derivative compounds, delivery innovations, and licensing opportunities.
  • Continuous patent prosecution may extend patent life and coverage, maintaining a competitive edge.

FAQs

1. What is the primary innovation claimed in U.S. Patent 12,110,277?
The patent primarily claims a novel chemical compound or formulation designed for specific therapeutic use, with claims covering its structure, synthesis, and application methods.

2. How broad are the claims in the '277 Patent?
The independent claims are broad, encompassing the core chemical entity, its derivatives, and related formulations, thereby providing extensive legal protection within the defined structural parameters.

3. What potential challenges could competitors face regarding this patent?
Competitors may seek to develop compounds outside the scope of the claims or refine delivery systems to design around the patent, subject to patent validity and enforceability considerations.

4. How can this patent influence the competitive landscape?
It acts as a significant barrier, potentially blocking competitors from entering the market with similar compounds or formulations, and may serve as a basis for licensing negotiations or patent enforcement.

5. What should patent owners or licensees consider moving forward?
They should monitor ongoing patent filings, explore patent extensions or continuations, and develop innovative derivatives or delivery methods to sustain competitive advantages.


References

[1] USPTO Patent Database, U.S. Patent 12,110,277.
[2] Latest patent filings in the relevant therapeutic area.
[3] Industry patent landscape reports and analysis.

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Drugs Protected by US Patent 12,110,277

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes No 12,110,277 ⤷  Get Started Free Y ⤷  Get Started Free
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-002 Apr 4, 2024 RX Yes No 12,110,277 ⤷  Get Started Free Y ⤷  Get Started Free
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-003 Apr 4, 2024 RX Yes Yes 12,110,277 ⤷  Get Started Free Y ⤷  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

International Family Members for US Patent 12,110,277

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 126961 ⤷  Get Started Free
Australia 2022339841 ⤷  Get Started Free
Canada 3230245 ⤷  Get Started Free
Chile 2024000608 ⤷  Get Started Free
China 118043305 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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