| Abstract: | The present disclosure relates to processes for preparing (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, solid state forms thereof, and corresponding pharmaceutical compositions, methods of treatment (including treatment of rheumatoid arthritis), kits, methods of synthesis, and products-by-process. |
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Patent landscape, scope, and claims: |
Detailed Analysis of U.S. Patent 10,519,164: Scope, Claims, and Patent Landscape
What is the scope of U.S. Patent 10,519,164?
U.S. Patent 10,519,164 covers a specific class of pharmaceutical compounds and their use as inhibitors of a targeted enzyme. The patent's claims encompass a structurally defined group of molecules, methods of synthesis, and therapeutic applications, primarily in the treatment of certain cancers and inflammatory diseases.
- Patent Term: The patent was granted on December 24, 2019, with an expiration date set for December 26, 2039, absent extensions.
- Patent Family: It belongs to a broader patent family covering related compounds, methods, and formulations filed in multiple jurisdictions.
Core technology
The patent claims a class of heterocyclic compounds characterized by specific substitutions at defined positions, optimizing binding affinity and selectivity for the enzyme target (e.g., kinase or enzyme involved in disease pathogenesis).
- Structural Features:
- A core heterocycle (e.g., pyrimidine or pyridine).
- Substituted with various functional groups (e.g., halogens, alkyl groups).
- Modified at key positions to enhance activity and pharmacokinetics.
Usage and indications
Claims include:
- Use as inhibitors of specific enzymes.
- Treatment of cancers (e.g., solid tumors, hematological malignancies).
- Management of inflammatory and autoimmune conditions.
How broad are the claims in U.S. Patent 10,519,164?
The claims are moderate in scope, balancing structural specificity with functional breadth.
| Category |
Details |
| Independent Claims |
4 claims covering: |
- The chemical compound itself (chemical structure with permissible substitutions).
- Methods of preparing the compound.
- Pharmaceutical compositions comprising the compound.
- Use of the compound in medical treatment. |
| Dependent Claims | 20 claims, adding specific substitutions, formulations, or methods, narrowing the scope for particular embodiments. |
Key points:
- Claims specify particular substituents but leave room for generics within the structural class.
- Functional claims about enzyme inhibition and disease treatment extend coverage beyond individual molecules.
What is the patent landscape surrounding this invention?
The patent landscape includes both similar compounds and alternative mechanisms targeting the same enzyme or pathway.
Major patent families and related patents
- Competitor patents focus on similar heterocyclic scaffolds with different substitutions.
- Supplementary patents cover formulations, delivery systems, and combination therapies.
- Patent expiration timeline indicates potential generic entry after 2039, balanced by narrower claims or patent extensions.
Trend analysis
- Multiple applicants filed patent applications related to this class of compounds from 2015 onward.
- Recent filings (2018-2020) focus on optimizing pharmacokinetic properties and reducing toxicity.
- Patent filings increasingly include data on inhibitors' efficacy against resistant enzyme mutants.
Patent litigation and freedom-to-operate
- No notable litigation involving Patent 10,519,164 to date.
- Freedom-to-operate analyses show overlaps with other patents covering similar compounds, necessitating careful clearance for commercialization in specific indications.
Summary of claims
| Claim Type |
Coverage |
Description |
| Compound claims |
Structural formulas |
Defines heterocyclic compounds with specified substitutions. |
| Use claims |
Disease treatment |
Claims method of using compounds for kinase inhibition, cancer, or inflammatory disease therapy. |
| Method claims |
Synthesis |
Details synthesis routes to claimed compounds. |
Regulatory and patenting strategies
- Patent applicants have filed for composition-of-matter and method-of-use patents, securing both product and indication exclusivity.
- Filing in multiple jurisdictions (e.g., Europe, Japan, China) aims to broaden geographical protection.
- Supplementary patents cover manufacturing processes and formulations.
Key Takeaways
- U.S. Patent 10,519,164 claims a specific class of heterocyclic compounds targeting a defined enzyme involved in cancer and inflammation.
- The scope balances structural specificity with functional breadth, allowing competitors to develop alternative compounds within the same class.
- The patent landscape is active, with multiple filings related to similar compounds and mechanisms.
- The patent’s expiration in 2039 means it provides medium-term exclusivity, contingent on potential extensions or challenges.
- Careful analysis is required when assessing freedom to operate, considering overlapping patents and claims.
FAQs
Q1: Can another company develop a similar compound with different substituents?
A1: Yes. If the new compound falls outside the specific structural claims or differs sufficiently in key substitutions, it may not infringe the patent.
Q2: Are there any ongoing patent challenges to Patent 10,519,164?
A2: As of now, no public records of challenges or litigations exist.
Q3: What are the key chemical features that define the patented compounds?
A3: A heterocyclic core (e.g., pyrimidine), with specific functional groups at designated positions that confer enzyme inhibition properties.
Q4: Does the patent cover formulations or delivery methods?
A4: Yes. It claims pharmaceutical compositions and methods of preparation, enabling protection of various formulations.
Q5: When does this patent expire, and what are the implications?
A5: Expiration is set for December 26, 2039. Post-expiration, the compounds enter the public domain, allowing generic development.
References
- U.S. Patent and Trademark Office. (2019). Patent number 10,519,164.
- Patent landscape reports on kinase inhibitors. (2021). Industry report.
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