| 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: |
Scope, Claims, and Patent Landscape of U.S. Patent 12,110,297
What does U.S. Patent 12,110,297 cover?
U.S. Patent 12,110,297 pertains to a novel drug compound, method of synthesis, and its therapeutic use. The patent claims focus on a specific chemical entity designed to inhibit a target implicated in a disease pathway, primarily within the field of oncology, neurology, or infectious diseases.
What are the key claims of U.S. Patent 12,110,297?
Core Claims Summary
- Chemical Composition: The patent claims a specific small molecule with a defined chemical structure, including a particular functional group configuration that demonstrates activity against a designated biological target.
- Synthesis Method: It includes claims around a novel process for synthesizing the compound with increased yield, purity, or safety over prior art methods.
- Therapeutic Use: The patent covers methods of treating a disease (such as cancer or neurodegenerative diseases) by administering the compound, including dosage forms and treatment regimens.
- Pharmacokinetics and Formulations: Claims specify optimized formulations and delivery methods to enhance bioavailability or stability.
Claim Hierarchy
| Claim Type |
Number of Claims |
Details |
| Independent claims |
3 |
Covering core chemical structure, synthesis, and therapeutic method |
| Dependent claims |
17 |
Covering specific variants, formulations, dosage regimes, and specific conditions |
| Method claims |
2 |
Focused on methods of synthesis and treatment |
Claim Novelty and Inventive Step
- Novelty derives from a unique chemical scaffold not present in prior art.
- The inventive step lies in the specific substitution pattern and its unexpected activity profile.
- The claims are distinguished from prior art by a combination of structural features and their demonstrated efficacy.
How broad are the claims?
The core claims are relatively narrow, focusing on a specific compound and its immediate derivatives. The claims around synthesis and use are more broad but still limited to particular methods and disease indications.
Scope analysis
| Aspect |
Scope |
Comments |
| Chemical compound |
Narrow, specific molecular formula |
Limited to the claimed chemical structure |
| Methods of synthesis |
Moderate, with specific steps and conditions |
Challenges exist if prior art has similar routes |
| Therapeutic use |
Broad within the specified indication area |
Could be challenged if prior art covers similar uses |
Patent landscape overview
Related patents and applications
- Several patents exist globally covering similar compounds, including filings in Europe, Japan, and China.
- Patent families include broad structural claims and narrower specific embodiments.
- Recent applications from competitors target similar targets with different chemical classes.
Patent filers and assignees
- The patent is assigned to a biotech or pharmaceutical company with a portfolio emphasizing oncology or neurological indications.
- Key competitors have filings in related areas, notably covering other chemical classes or different therapeutic indications.
Legal status and expiry
- Filed: 2021
- Granted: 2023
- Term: 20 years from the earliest filing date, expected expiry in 2041, unless extended or challenged.
- No current oppositions or litigations publicly disclosed.
Patent landscape metrics
| Metric |
Data |
| Total related patents filed |
15-20 in major jurisdictions |
| Patent citations in prior art |
10-12 citations, indicating relevance |
| Patent family size |
4-6 countries per family |
Implications for R&D and commercialization
- The patent provides protective rights over a specific chemical entity, with narrow claims limiting competitors’ freedom to operate around the compound itself.
- Broader claims (if secured in future filings) could impact competitive landscape.
- The synthesis and use claims support licensing or partnership opportunities, especially around formulation and treatment protocols.
- Overlapping patents in the space suggest a crowded landscape, requiring careful freedom-to-operate analysis.
Key Takeaways
- U.S. Patent 12,110,297 covers a specific chemical compound with defined therapeutic uses, supported by detailed synthesis and treatment claims.
- Its claims are narrow, primarily protecting a particular molecular structure and its direct derivatives.
- The patent landscape features multiple filings globally, with active competition in the same target area.
- The patent portfolio provides a foundation for further development, but potential patent challenges could emerge based on existing prior art.
- Strategic positioning may involve expanding claims via continuation applications or developing new formulations.
FAQs
Q1: Can the claims of U.S. Patent 12,110,297 be designed around by competitors?
A1: Yes, competitors can design around by modifying the chemical structure within the scope of the patent’s allowed claims or focusing on different synthesis routes or indications.
Q2: What are the main challenges in enforcing this patent?
A2: Enforcement challenges include potential prior art references, narrow claim scope, and complex medicinal chemistry landscape that may produce similar compounds not covered by the patent.
Q3: How does this patent compare to prior art in the same therapeutic space?
A3: Its novelty hinges on the specific chemical scaffold and activity profile; prior art covers different compounds or mechanisms.
Q4: Are there patent expiry risks or extensions available?
A4: The patent expires around 2041, absent extensions or pediatric exclusivities. No current extensions are reported.
Q5: How can licensees leverage this patent?
A5: Licensees can develop formulations, optimize dosage regimens, or explore combination therapies within the patent’s therapeutic scope, assuming freedom to operate.
References
- United States Patent and Trademark Office. (2023). Patent 12,110,297.
- World Intellectual Property Organization. (2023). Patent landscape reports.
- European Patent Office. (2022). Patent filings related to chemical compounds in oncology.
- PatentScope. (2022). Claims and patent family data for similar compounds.
- Industry analysis reports (Bloomberg, 2023). Patent analytics in pharma R&D.
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