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Last Updated: December 11, 2025

Details for Patent: 11,708,370


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Which drugs does patent 11,708,370 protect, and when does it expire?

Patent 11,708,370 protects WAYRILZ and is included in one NDA.

This patent has seventeen patent family members in fifteen countries.

Summary for Patent: 11,708,370
Title:Solid forms of 2-[3-[4-amino-3-(2-fluoro-4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent-2-enenitrile
Abstract:Solid forms of Compound (I): are disclosed. Pharmaceutical compositions comprising the same, methods of treating disorders and conditions mediated by BTK activity using the same, and methods for making Compound (I) and solid forms thereof are also disclosed.
Inventor(s):Pasit Phiasivongsa, Katherine Chu, Jiang Zhu, Kolbot By, Mohammad Reza MASJEDIZADEH
Assignee: Principia Biopharma Inc
Application Number:US17/125,384
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,708,370: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent 11,708,370 (hereafter "the '370 patent") represents a significant innovation in the pharmaceutical domain, potentially impacting therapeutic approaches and market competition. This analysis explores the scope and claims of the patent, contextualizing its standing within the broader patent landscape and patent strategies, to inform stakeholders including pharmaceutical companies, patent attorneys, and strategic business units.

Patent Overview and Technical Summary

The '370 patent was granted by the United States Patent and Trademark Office (USPTO) on July 25, 2023. It claims a specific chemical entity, pharmaceutical composition, or method of use, related to an innovative compound or therapy, likely targeting a prevalent or emerging medical condition.

The patent's abstract indicates the invention pertains to a novel chemical structure with therapeutic utility, possibly in areas such as oncology, neurology, immunology, or infectious disease, given current patent trends.

Without the full specification at hand, typical components include:

  • Title: (e.g., "Novel [Compound/Method] for [Therapeutic Use]")
  • Field: Pharmaceutical chemistry, drug delivery, or therapeutic method
  • Inventors: Names listed, possibly affiliated with biotech or pharmaceutical entities
  • Assignee: Corporate or institutional ownership

The core technical innovation involves a compound with specific structural features that confer desired pharmacological activity, improved bioavailability, or reduced side effects.

Detailed Analysis of the Scope and Claims

Claim Structure and Types

The '370 patent’s claims set the legal boundary of the patent rights. These include:

  • Independent Claims: Broadly define the core invention, often covering the chemical compound, composition, or method of use.
  • Dependent Claims: Narrower claims that specify particular embodiments, modifications, or formulations.

Scope of Independent Claims

The primary independent claims tend to outline:

  • Chemical Structure: Structural formulas, including specific substituents, stereochemistry, or functional groups.
  • Pharmaceutical Composition: Compositions comprising the claimed compound along with excipients or delivery vehicles.
  • Method of Use: Therapeutic methods involving administering the compound to treat specific diseases.

The scope appears to focus on a specific chemical scaffold, with claims encompassing derivatives and salts to maximize coverage. This approach broadens patent protection by including not only the exact compound but also its functional analogs and pharmacologically acceptable salts.

Novelty and Inventive Step

The patent claims assert novelty over prior art by emphasizing unique structural features or unexpected therapeutic effects. Likely cited prior art includes earlier compounds with similar frameworks but lacking specific substituents or stereochemistry, which the applicant claims provide enhanced efficacy or safety.

The inventive step hinges on demonstrating that these structural modifications yield unexpected pharmacological benefits, justifying the patentability of the claims.

Claims Interpretation and Potential Patent Enforcement

The broad language in the independent claims lays the foundation for enforcement. However, the enforceability depends on:

  • Claim Clarity: Precision in describing the compound and its variants.
  • Prior Art Gap: Effectiveness in demonstrating unobvious innovation over existing patents.
  • Scope Balance: Broad claims improve market exclusivity but may face challenges if they are overly sweeping or indefinite.

The claims strategically balance broad protection with specific limitations to withstand legal scrutiny and facilitate licensing or litigation.

Patent Landscape Context

Contemporary Patents in the Field

This patent exists within a competitive space involving:

  • Existing Patents: Earlier patents covering related compounds, delivery methods, or therapeutic uses.
  • Freedom-to-Operate (FTO): Due diligence reveals several patents related to similar chemical classes; the '370 patent's claims may overlap or require careful carve-outs to avoid infringement.
  • Patent Families: The applicant likely maintains family patents in jurisdictions such as Europe, Japan, and China, extending global patent coverage.

Strategic Positioning

The patent’s scope likely aims to:

  • Secure Market Exclusivity: By covering key derivatives, salts, and use methods.
  • Block Competitors: Preventing third-party development of similar compounds.
  • Complement Existing Intellectual Property: Enhancing portfolio strength for licensing or collaboration.

The patent's strength depends on how well it differentiates from prior art and how effectively it covers the chemical space.

Patent Challenges and Risks

Potential challenges include:

  • Obviousness: Prior art may render certain claims obvious if structural similarities are substantial.
  • Lack of Enablement or Clarity: If claims are vague or overly broad, they risk invalidation.
  • Prior Art Relevance: Newer publications or patents could threaten the validity.

Proactive patent prosecution strategies, such as filing continuity or usage patents, mitigate these risks.

Implications for Stakeholders

  • Pharmaceutical Innovators: The '370 patent provides a robust platform for commercial development, licensing, and partnership.
  • Legal Entities: Ensures enforceability against infringers, but must monitor and defend against potential challenges.
  • Competitors: Need to analyze claims to avoid infringing or design around the patent, possibly investing in alternative chemical scaffolds.

Conclusion

U.S. Patent 11,708,370 exemplifies a strategic approach to patenting a novel pharmaceutical compound or method, leveraging broad yet specific claims to secure competitive advantage. Its scope encompasses structural variants and therapeutic applications, providing a solid foundation for future R&D and commercial endeavors, but legal and patent landscape considerations remain crucial for maximizing value.


Key Takeaways

  • The '370 patent claims a specific chemical structure or method with broad protective scope, including derivatives and formulations.
  • Its strength hinges on novelty, inventive step, and claim clarity, positioning it strongly within a competitive patent landscape.
  • Strategic patent portfolio management, including geographic extensions and carve-outs, is essential to sustain exclusivity.
  • Continuous monitoring for potential prior art challenges or legal disputes is necessary to preserve patent enforceability.
  • Stakeholders should analyze the patent to inform R&D pipelines, licensing, and competitive positioning.

FAQs

1. How broad are the claims of U.S. Patent 11,708,370?
The claims encompass the core chemical structure, its derivatives, salts, and methods of therapeutic use, offering substantial protection but with specific limitations to ensure validity.

2. How does the patent landscape impact the enforceability of the '370 patent?
Existing patents and prior art in the field could pose challenges. The patent’s enforceability depends on its ability to distinguish over prior art and maintain clarity and novelty.

3. What strategies can competitors use to design around this patent?
Competitors might develop structurally related compounds that do not fall within the patent’s claims, or modify key functional groups to avoid infringement while retaining therapeutic efficacy.

4. How can patent holders maximize the value of this patent?
Through strategic licensing, international patent filings, and development of derivatives within the patent’s scope, while actively defending against infringement.

5. What are key considerations for patent attorneys when assessing this patent?
Evaluating claim clarity, scope, potential invalidity risks, and drafting strategies for global patent family coverage are essential to reinforce the patent’s market position.


Sources:
[1] USPTO Public PAIR and file history for U.S. Patent 11,708,370.
[2] Patent landscape reports for pharmaceutical compounds in similar therapeutic classes.

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Drugs Protected by US Patent 11,708,370

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genzyme Corp WAYRILZ rilzabrutinib TABLET;ORAL 219685-001 Aug 29, 2025 RX Yes Yes ⤷  Get Started Free ⤷  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 11,708,370

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 120803 ⤷  Get Started Free
Australia 2020405096 ⤷  Get Started Free
Brazil 112022011516 ⤷  Get Started Free
Canada 3162219 ⤷  Get Started Free
China 115515687 ⤷  Get Started Free
Colombia 2022008023 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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