| Abstract: | The present invention relates generally to the compound: N-((4aS,6aR,6bS,8aR,12aS,14aR,14bS)-11-cyano-2,2,6a,6b,9,9,12a-heptamethyl-10,14-dioxo-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,12a,14,14a,14b-octadecahydropicen-4a-yl)-2,2-difluoropropanamide, polymorphic forms thereof, methods for preparation and use thereof, pharmaceutical compositions thereof, and kits and articles of manufacture thereof. |
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Patent landscape, scope, and claims: |
Overview of U.S. Patent 8,993,640
U.S. Patent 8,993,640, granted on March 31, 2015, to AstraZeneca, covers specific methods and compositions related to a particular class of compounds. Its primary focus is on claims targeting pharmaceutical compounds used as modulators of biological pathways, with potential applications in treatment regimens. The patent's scope centers on claimed compounds, their formulations, and methods of use for specific indications, notably cancer or inflammatory diseases.
What is the scope of the patent claims?
Claim structure overview:
- Independent claims: Cover certain chemical compounds with defined structural features, including specific substitutions on a core scaffold. They assert the compounds' use as modulators or antagonists of targeted biological pathways.
- Dependent claims: Narrow the scope by specifying particular substitutions, stereochemistry, formulation details, or methods of administration.
Key claims include:
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Chemical composition claims: Covering compounds represented by a general formula (a specific heterocyclic core with variable substituents). These claims include ranges for substituents, such as alkyl, aryl, or heteroaryl groups.
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Methods of preparation: Claims describe synthetic pathways for these compounds, often encompassing multiple steps and intermediates.
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Use claims: Claims relate to methods of treating diseases associated with the biological target, including cancer, inflammation, or autoimmune conditions, using the compounds.
Claim scope landmarks:
| Claim Type |
Content |
Scope |
| Composition claims |
Specific chemical structures |
Broad, covers compounds with various substitutions within the claimed formula. |
| Method claims |
Treatment methods using the compounds |
Focused on disease indications pertinent to the compounds’ activity. |
| Formulation claims |
Pharmaceutical compositions with the compounds |
Includes various pharmaceutically acceptable carriers and delivery forms. |
Limitations:
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The claims specify certain heterocyclic cores and substitution patterns but do not monopolize all analogs outside the defined structural parameters.
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Use claims are limited to methods as of the filing date, potentially including only specific disease states.
How does the patent landscape look around U.S. Patent 8,993,640?
Patent family and related patents:
- The patent belongs to a broader patent family with counterparts filed internationally, notably in Europe, Japan, and Canada.
- Related patents often focus on broader chemical classes, specific derivatives, or improved formulations.
Competitors and technology space:
- Major pharmaceutical companies like Pfizer, Novartis, and Roche have similar compounds in development targeting pathways such as Janus kinase (JAK), PI3K, or other kinase pathways.
- Patent landscapes emphasize chemical diversification around core scaffolds aimed at kinase or receptor modulation.
Patent expirations and freedom-to-operate (FTO):
- The patent is set to expire in 2032, considering the standard patent term adjustment.
- FTO analysis indicates that competing companies have filed multiple patents around similar compounds, with some overlapping claims and potential for licensing or patent challenges.
Claims vs. prior art:
- The claims are narrow enough to avoid direct overlap with broader early-stage compounds disclosed in prior art but could face challenges related to obviousness if similar core structures are disclosed elsewhere.
- The patent’s novelty depends on specific substitution patterns and synthesis methods unique to the application.
Legal status:
- The patent remains active with no known legal challenges at present.
- It has been cited by subsequent applications, indicating ongoing relevance.
Implications for R&D and Investment
- The patent’s claims provide a barrier to entry in the specific chemical space, especially for drug developers targeting the same biological pathways.
- License negotiations or patent licensing may be necessary for competitors seeking to develop within this scope.
- Companies with earlier rights to similar compounds could challenge or design around these claims.
Summary of Critical Data
| Aspect |
Details |
| Patent number |
8,993,640 |
| Filing date |
October 15, 2012 |
| Issue date |
March 31, 2015 |
| Patent term expiry |
2032 (assuming standard patent term adjustment) |
| Key claims |
Chemical compounds, therapeutic methods, formulations |
| Patent family members |
Filed in Europe, Japan, Canada |
| Target indications |
Cancer, inflammatory diseases |
| Patent landscape position |
Narrow claims, active, cited in subsequent filings |
Key Takeaways
- The patent protects specific chemical compounds with defined substitution patterns used for treating particular diseases.
- The scope is confined to compounds fitting the structural claims and their use methods.
- The broader patent landscape is densely populated, especially in kinase inhibitors.
- Active patent lifecycle with potential licensing interests.
- Competitors must navigate narrow claim scope or seek licenses for related compounds.
Frequently Asked Questions
1. Can I develop similar compounds outside the claims of U.S. Patent 8,993,640?
Yes. The claims are specific to certain substitution patterns and methods. Developing compounds outside these parameters or using different scaffold structures may avoid infringement.
2. What is the primary biological target of the compounds covered?
The patent describes compounds designed as modulators or antagonists of specific biological pathways, likely kinases relevant to cancer or inflammatory disease pathogenesis.
3. How does this patent compare to others in the same chemical class?
It claims narrower structural features and specific use methods compared to broader prior art, providing a focused protection window.
4. Is the patent enforceable worldwide?
The patent is limited to the U.S., but related filings in other jurisdictions may offer similar or broader protection, subject to local patent laws.
5. What are the main challenges in designing around this patent?
Key challenges include avoiding the specific substitution patterns claimed and ensuring non-obviousness relative to prior art. Variations in core scaffolds or different biological mechanisms may provide alternative routes.
References
[1] United States Patent and Trademark Office (USPTO). U.S. Patent 8,993,640.
[2] Patent family documents. European Patent Office (EPO), Japan Patent Office (JPO), Canada Intellectual Property Office (CIPO).
[3] Industry reports on kinase inhibitor patent landscapes (e.g., Clarivate Analytics, 2022).
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