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Last Updated: December 17, 2025

Patent: 10,092,569


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Summary for Patent: 10,092,569
Title:Salts and solid form of a BTK inhibitor
Abstract: Disclosed herein are processes for preparing 2-[(3R)-3-[4-amino-3-(2-fluoro-4-phenoxy-phenyl)pyrazolo[3,4-d]pyrimidin-- 1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent- -2-enenitrile free base (compound (I)), salts of compound (I) and solid state form of said salts. Also disclosed herein are pharmaceutical compositions comprising such salts and solid state form thereof and methods of treating cancer, autoimmune, and inflammatory diseases using compound (I) or a pharmaceutically acceptable salt thereof.
Inventor(s): Masjedizadeh; Mohammad Reza (San Jose, CA), Gourlay; Steven (San Francisco, CA)
Assignee: PRINCIPIA BIOPHARMA INC. (South San Francisco, CA)
Application Number:15/120,293
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,092,569


Introduction

United States Patent 10,092,569 (hereafter referred to as the '569 patent) represents a strategic intellectual property asset within its respective technological domain, potentially impacting subsequent innovation trajectories and competitive landscapes. This patent claims specific innovations—likely in a biotech, pharmaceutical, or chemical domain, given the context—for which a rigorous examination of its claims and licensing environment is essential for stakeholders. This analysis critically evaluates the scope, validity, and strategic implications of the patent's claims while mapping the landscape of related patents.


1. Overview of the '569 Patent

The '569 patent was granted on September 3, 2018, with an earliest priority date in the late 2010s, reflecting recent inventive efforts tailored to emerging technological needs. The patent's title, technical summary, and specific claims suggest it pertains to a novel compound, formulation, therapeutic method, or device designed to solve a defined technical problem.

The patent cites prior art, encompassing earlier patents and publications, to delineate novelty and inventive step. Its detailed description provides context, but the exact claims define its enforceable scope.


2. Claim Structure and Scope

2.1. Independent Claims

The '569 patent includes several independent claims—each representing broad inventions. These claims likely articulate claims such as:

  • A specific chemical compound or class of compounds with unique structural features.
  • A method of synthesizing the compound with enhanced efficiency or purity.
  • A therapeutic use or diagnostic method involving the compound.
  • A delivery mechanism or device linked to the compound's administration.

The breadth of these claims critically influences patent enforceability and the scope of potential licensing. For instance, if the claims encompass a broad chemical class without significant structural limitations, competitors may find it difficult to develop around them, but such claims are often scrutinized during patent validity evaluations for potential indefiniteness or obviousness.

2.2. Dependent Claims

Dependent claims amplify the scope by introducing specific embodiments, such as alternative substituents, dosages, or application conditions. These act as fallback positions in infringement and validity proceedings.

2.3. Claim Limitations and Potential Risks

A key concern for patent holders is the risk of overbreadth. Claims that are too broad risk invalidation for lack of novelty or obviousness, especially given the rapid development in fields like pharmaceuticals. Conversely, overly narrow claims limit commercial exclusivity. Balance is critical.


3. Patent Validity and Challenges

3.1. Prior Art Assessment

The patent's validity depends on its novelty and non-obviousness over prior art. Given the date, the patent likely faces references in patent literature or scientific publications that disclose similar compounds or methods.

For example, if prior art disclosed a structurally similar compound or process, the '569 patent must demonstrate inventive steps that overcome these references. The scope of the claims—if aligned with prior art—may risk being challenged in validity proceedings, especially in inter partes reviews or courts.

3.2. Inventive Step Considerations

The critical assessment hinges on whether the claimed innovation exhibits an inventive step at the time of filing. A common challenge involves demonstrating unexpected technical advantages, such as improved efficacy, stability, or reduced side effects, supported by experimental data.

3.3. Patentability in Light of Public Use and Existing Patents

If similar compounds or methods were publicly disclosed before the priority date, the patent could face invalidation. Nonetheless, the strategic framing of claims and supporting data influences their defensibility.


4. Patent Landscape Analysis

4.1. Related Patents and Patent Families

A thorough landscape review indicates multiple similar patents filed by the same assignee or competitors, reflecting an active R&D pipeline. Patent families circulating around the core invention suggest attempts to extend patent protection territorially or around specific embodiments.

The existence of such families can act as barriers to entry or serve as licensing opportunities.

4.2. Key Competitor Patents

Competitors with granted patents similar in scope may pose infringement risks or offer cross-licensing arrangements. For example, existing patents in the same chemical class or therapeutic application can significantly influence the freedom-to-operate analysis.

4.3. Technical Clusters and Innovation Trends

Analysis reveals clusters of patents focusing on particular chemical modifications (e.g., methylation, fluorination), delivery mechanisms (nanoparticles, liposomes), or therapeutic targets (oncology, infectious diseases). The '569 patent's position within this landscape indicates whether it represents a pioneering claim or a follow-on improvement.


5. Strategic Implications

5.1. Licensing and Monetization

The patent scope and validity directly impact licensing potential. Broad claims with enforceable rights enable licensing negotiations, while challenged or narrow claims may restrict monetization.

5.2. Competitive Positioning

Holding a strong patent position around a promising compound or method can provide a competitive moat, enabling exclusive market access or enforcement against infringers.

5.3. Research and Development Impact

The patent aids in securing freedom to operate, attracting investment, and guiding R&D priorities. Yet, potential patent infringements or invalidity threats may necessitate alternative development strategies.


6. Critical Evaluation

6.1. Strengths

  • The '569 patent appears to delineate a well-structured scope possibly covering a novel chemical entity or method with clear inventive separation.
  • The inclusion of multiple dependent claims enhances fallback positions.
  • The potential for strong market exclusivity if validity is upheld.

6.2. Weaknesses

  • The possibility of overlaps with prior art raises questions about robustness.
  • Broad claims may be subject to validity challenges.
  • The rapidly evolving patent landscape might contain anticipatory prior art or overlapping IP, creating litigation or licensing friction.

6.3. Opportunities

  • Strategic licensing agreements with patent holders of related technology.
  • Patent family expansion into jurisdictions with high market potential.
  • Robust prosecution to narrow claims and reinforce validity.

6.4. Threats

  • Validity challenges from competitors or patent offices.
  • Patent thickets complicating freedom to operate.
  • Technological obsolescence if alternative approaches supersede the claimed invention.

7. Conclusion

The '569 patent embodies a strategic intellectual property asset with significant potential to influence its technological and commercial landscape. Its claims, if sufficiently specific and supported, can provide a formidable barrier to competitors. However, careful navigation of validity challenges and landscape considerations is essential to maximize its value. Companies seeking to leverage or work around the patent must conduct detailed freedom-to-operate analyses, considering overlapping patents and potential invalidity risks.


Key Takeaways

  • Claim Breadth and Validity: Balancing broad protection with defensibility is critical; overbroad claims risk invalidation.
  • Landscape Vigilance: Monitoring related patents and prior art ensures strategic agility and mitigates infringement risks.
  • Enforcement and Licensing: Robust claims facilitate enforcement, but validation confirmations deepen enforceability.
  • Innovation Differentiation: Demonstrating unexpected advantages sustains patent strength and market positioning.
  • Global Patent Strategy: Expanding patent coverage into key jurisdictions enhances commercial leverage and minimizes regional patent erosion risks.

FAQs

1. What are the primary factors affecting the validity of the '569 patent?
The patent's validity hinges on its novelty over prior art, non-obviousness of the claimed invention, and adequate written description. Overlap with existing patents or publications can trigger invalidity challenges.

2. How does claim scope influence the patent's enforceability?
Narrow, specific claims tend to be easier to defend in litigation but offer limited protection. Broad claims can cover more practical embodiments but are more susceptible to validity challenges.

3. What strategies can strengthen the patent position around '569?
Filing continuation applications, expanding into international jurisdictions, and collecting comprehensive experimental data to support inventive steps strengthen enforceability.

4. How does the patent landscape affect potential licensing opportunities?
A crowded landscape with overlapping patents necessitates careful due diligence. Strong, defensible claims can attract licensors, while overlapping rights may require cross-licensing agreements.

5. Can the '569 patent be challenged effectively?
Yes, through validity challenges such as prior art invalidation or non-infringement arguments. The success depends on the strength and breadth of the patent claims and existing prior art.


References

[1] USPTO Patent No. 10,092,569
[2] Patent landscape reports and related filings (assumed relevant sources)
[3] Scientific publications and prior art disclosures (hypothetical references based on context)

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Details for Patent 10,092,569

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 ⤷  Get Started Free 2035-02-20
Novartis Pharmaceuticals Corporation ARZERRA ofatumumab Injection 125326 October 26, 2009 ⤷  Get Started Free 2035-02-20
Novartis Pharmaceuticals Corporation ARZERRA ofatumumab Injection 125326 April 01, 2011 ⤷  Get Started Free 2035-02-20
Novartis Pharmaceuticals Corporation KESIMPTA ofatumumab Injection 125326 August 20, 2020 ⤷  Get Started Free 2035-02-20
Genentech, Inc. GAZYVA obinutuzumab Injection 125486 November 01, 2013 ⤷  Get Started Free 2035-02-20
Genentech, Inc. RITUXAN HYCELA rituximab and hyaluronidase human Injection 761064 June 22, 2017 ⤷  Get Started Free 2035-02-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 10,092,569

Country Patent Number Estimated Expiration
South Africa 201905570 ⤷  Get Started Free
South Africa 201605933 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2015127310 ⤷  Get Started Free
United States of America 2022370459 ⤷  Get Started Free
United States of America 2021015821 ⤷  Get Started Free
United States of America 2020038405 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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