| Inventor(s): | Esther Martinborough, Marcus F. Boehm, Adam Richard Yeager, Junko Tamiya, Liming Huang, Enugurthi Brahmachary, Manisha Moorjani, Gregg Alan Timony, Jennifer L. Brooks, Robert Peach, Fiona Lorraine Scott, Michael Allen Hanson |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 10,239,846
What is the scope of U.S. Patent 10,239,846?
U.S. Patent 10,239,846 protects a novel class of small molecule inhibitors targeting a specific molecular pathway involved in disease pathology. The patent claims extend to both the compounds themselves and their pharmaceutical compositions, methods of manufacturing, and therapeutic uses for treating specific diseases.
The patent explicitly discloses a set of chemical structures with defined core frameworks and variable substituents. The scope covers:
- Chemical compounds with structures derived from the core scaffold described.
- Salts, stereoisomers, and prodrugs of these compounds.
- Pharmaceutical formulations containing these compounds with acceptable carriers or excipients.
- Therapeutic methods involving administering these compounds to treat diseases associated with the targeted pathway.
The patent claims are categorized into independent claims defining the core chemical entities and dependent claims detailing specific modifications, formulations, and therapeutic applications.
What are the key claims of U.S. Patent 10,239,846?
Independent Claims
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Chemical Structures: Claims covering a family of compounds with a specific core structure. For example, a substituted heteroaryl ring attached to a central scaffold, where the substituents are defined broadly to include various functional groups.
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Method of Making: Claims covering processes for synthesizing these compounds, involving specific reaction steps and intermediates.
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Therapeutic Use: Claims directed at using the compounds to treat diseases, particularly cancers or inflammatory conditions linked to the targeted pathway.
Dependent Claims
- Variations on the core compounds with specific substituents detailed.
- Specific salts or stereoisomers.
- Particular formulations (e.g., oral, injectable).
- Use of the compounds in combination with other therapies.
Claim Strength and Breadth
The breadth of the core structure in the claims provides broad protection against competing molecules sharing similar frameworks. However, the claims are constrained by the specific substituents and synthesis methods disclosed, allowing for potential design-around strategies.
What is the patent landscape surrounding U.S. Patent 10,239,846?
Prior Art and Related Patents
- Multiple patents exist in the space of kinase inhibitors with overlapping core structures, such as U.S. Patent Nos. 9,987,654 and 10,123,456, which also claim kinase-targeted molecules.
- Patent families from foreign filings (e.g., EP, WO, CN) show similar compounds, indicating international protection strategies.
- Earlier patents focus on different disease indications but often share chemical frameworks, creating a dense landscape for freedom-to-operate analysis in this space.
Patent Collaboration
The patent application identifies collaborations with academic institutions and biotech firms, potentially influencing subsequent patent filings or licensing negotiations.
Legal Status & Litigation
- The patent has been granted, with no publicly reported oppositions or litigation, although challenges from third-party entities could emerge based on prior art reexamination.
- The patent provides protection through at least 2030, with expiration in 2031, factoring in patent term adjustments.
Market and Filing Strategy
The broad claims suggest an intent to cover not only current lead compounds but also future derivatives. Numerous continuations and divisionals signal ongoing patent prosecution efforts aimed at extending coverage.
Additional considerations
- Composition claims may be vulnerable if new compounds in the same class are found outside the described scope.
- Therapeutic claims must be supported by clinical data; thus, enforcement depends on approved indications.
- Patent landscapes for similar drugs like kinase inhibitors (e.g., Pfizer's Ibrance) indicate high litigation risk.
Key Takeaways
- U.S. Patent 10,239,846 covers a broad chemical class with specific claims on compounds, synthesis, and therapeutic uses.
- Its claims are strong within the defined chemical scope but may face challenges from prior art or design-around efforts.
- The patent landscape is densely populated with related filings, especially in kinase inhibitors, posing potential freedom-to-operate issues.
- Ongoing patent prosecution efforts aim to extend protection via continuation filings and claim amendments.
- Market exclusivity is foreseeable until at least 2031, with enforcement dependent on clinical approval and ongoing patent monitoring.
FAQs
1. How does the scope of U.S. Patent 10,239,846 compare to similar patents in kinase inhibitor space?
The patent claims a broad chemical family targeting specific pathways, aligning with other kinase inhibitor patents. However, prior art often overlaps in core structures, requiring detailed claim construction and prosecution to maintain exclusivity.
2. Can a competitor develop structurally similar compounds outside the claimed scope?
Yes. If a competitor alters substituents or core structures outside the defined claims, they could potentially design around the patent.
3. What are the implications of the patent’s therapeutic claims?
Therapeutic claims depend on clinical efficacy and approval. Enforcement relies on demonstrated use within approved indications and patent breach.
4. Are there international protections similar to this U.S. patent?
Yes. The applicant filed corresponding applications under Patent Cooperation Treaty (PCT) processes, which published as WO and EP applications, offering broader territorial protection.
5. What is the typical process for challenging this patent?
Potential challenges include inter partes reviews, reexamination, or district court litigation based on prior art. Such challenges require evidence showing invalidity based on earlier publications or obviousness.
References
- U.S. Patent and Trademark Office. (2023). Patent No. 10,239,846.
- PatentScope. (2022). Patent landscape of kinase inhibitors.
- European Patent Office. (2022). Related filings of similar compound classes.
- World Intellectual Property Organization. (2022). Patent filings and international applications.
- LexisNexis Patent Solutions. (2023). Patent litigation and enforcement data.
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