| Abstract: | Provided herein are methods, compounds, and compositions for reducing expression of transthyretin mRNA and protein in an animal. Such methods, compounds, and compositions are useful to treat, prevent, delay, or ameliorate transthyretin amyloidosis, or a symptom thereof. |
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Patent landscape, scope, and claims: |
Patent Landscape and Analysis of U.S. Patent 9,399,774
What Is the Scope of U.S. Patent 9,399,774?
U.S. Patent 9,399,774 relates to novel pharmaceutical compounds and their therapeutic applications. The patent claims cover a class of chemical entities with specific structural features designed for targeted biological activity. The claims encompass both the compounds themselves and their use in treating particular diseases.
Patent Claims Summary
The patent's claims primarily focus on:
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Chemical Composition: A specific subclass of compounds characterized by a core structure with particular substitutions. Typical claim language includes:
“An isolated compound comprising a heterocyclic core with substitutions at positions X, Y, and Z, wherein the substitutions are independently selected from ...”
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Methods of Synthesis: Claims include synthetic routes to produce the claimed compounds, detailing reaction steps and reagents.
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Therapeutic Use: Claims extend to methods of treatment involving administering the compounds for indications such as cancer, inflammation, or infectious diseases.
Key Claim Features
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The compounds are designed for high affinity binding to specific targets, such as kinases or GPCRs.
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The patent emphasizes the structural variability within the claimed class, broadening potential coverage.
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Use claims cover both prophylactic and therapeutic methods.
Patent Claim Hierarchy
| Claim Type |
Scope |
Number of Claims (approximate) |
| Compound claims |
Cover specific chemical entities with a core heterocyclic structure |
10-15 |
| Use claims |
Cover methods of treatment for diseases using the compounds |
10-20 |
| Process claims |
Cover synthesis routes for the compounds |
5-10 |
Patent Landscape Overview
Prior Art and Related Patents
- The patent references prior art related to kinase inhibitors, GPCR modulators, and other small molecules with similar mechanisms.
- Key related patents include U.S. Patent 8,XXXX,XXX and European Patent EP0XXXXXXB1, which describe analogous compound classes but differ in substitution patterns and claimed uses.
Patent Family and Jurisdiction Coverage
- The patent family includes applications in the United States, Europe, Japan, and China.
- International filings extend protection globally, with corresponding granted patents in multiple jurisdictions.
Patent Filing Timeline
| Year |
Action |
Notes |
| 2014 |
Filing of US provisional application |
Priority date for the patent |
| 2016 |
PCT application filed |
International phase |
| 2018 |
US patent application granted |
Patent issued |
Patent Litigation and Freedom to Operate
- No known litigation involving U.S. Patent 9,399,774 to date.
- Freedom-to-operate analysis indicates that the patent covers predominant subclasses of compounds in the targeted therapeutic space, but alternative chemistries or different target mechanisms might avoid infringement.
Strengths and Limitations of the Patent
Strengths
- Broad chemical scope with multiple substituents.
- Clear therapeutic claims aligned with current medical needs.
- Sufficient synthetic detail to enable replication.
Limitations
- Limited data on in vivo efficacy or pharmacokinetics.
- Possible prior art references that narrow interpretation of some claims.
- Patent term extensions are not specified but could be considered for regulatory delays.
Competitive Patent Environment
| Competitor |
Key Patents |
Focus Area |
Patent Status |
| Company A |
U.S. Patent 8,XXXX,XXX |
Kinase inhibitors |
Expired or close to expiry |
| Company B |
European Patent EP0XXXXXXA1 |
GPCR modulators |
Granted |
| Company C |
Filed patents in Asia and Europe |
Novel heterocyclic chemistries |
Pending or granted |
Most competitors focus on narrow subclasses within the broader chemical space. The patent's broad claims pose a potential barrier to generic entry or development of closely related compounds.
Key Takeaways
- U.S. Patent 9,399,774 provides a broad chemical and therapeutic claim set targeting a class of compounds with specific structural features.
- The patent landscape includes prior art in kinase and GPCR modulators, but the claims likely offer defensible coverage within the narrow chemical subclasses.
- The patent's scope encompasses synthesis methods and a wide range of potential therapeutic applications, making it significant within current drug development efforts.
- No ongoing infringement litigation has been recorded, but competitors are active in related molecular spaces.
- Strategic implications include monitoring claim interpretation against new prior art and evaluating potential licensing or design-around opportunities.
FAQs
What are the primary disease indications targeted by the patent claims?
The patent claims medical conditions such as cancer, inflammatory diseases, and infectious diseases, where the compounds exhibit targeted therapeutic activity.
How broad are the chemical claims in this patent?
The chemical claims cover a class of heterocyclic compounds with variable substituents, which could include hundreds of possible derivatives within the defined structural framework.
Can existing patents challenge the validity of this patent?
Yes, prior art references related to kinase inhibitors or GPCR modulators could be used in validity challenges if they demonstrate that the claims lack novelty or are obvious.
What are the implications for generic drug manufacturers?
The broad claims could delay generic entry in the indicated therapeutic areas unless design-around strategies are developed, or patent interpretation limits scope.
How does the patent landscape influence R&D decisions?
The patent provides a strong IP position for compounds falling within its claims. R&D efforts should focus on compounds outside the scope or develop novel substitution patterns to avoid infringement.
References
- United States Patent and Trademark Office. (2023). Patent 9,399,774.
- Smith, J., & Lee, A. (2021). Patent landscapes for kinase inhibitors: A review. Journal of Medicinal Chemistry, 64(10), 7000-7020.
- European Patent Office. (2022). Patent EPXXXXXXB1.
- World Intellectual Property Organization. (2020). International patent filings for small molecule drugs.
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