United States Patent 10,919,881: Scope, Claims, and Patent Landscape
What is the scope of Patent 10,919,881?
Patent 10,919,881 (the "patent") covers a novel chemical compound, method of synthesis, and its particular therapeutic application. The patent claims a specific class of small-molecule inhibitors targeting a defined biological pathway. It encompasses compositions comprising the compound, methods of administering the compound for treating specific diseases, and methods of manufacturing the compound.
The patent claims coordinates on five specific chemical compositions and their intermediates, emphasizing chemical structure variations that influence pharmacokinetics and efficacy. It claims a preferred embodiment comprising a specific substituent pattern on a core scaffold, with broad coverage across analogs that maintain essential functional groups.
The claims extend to medical use claims—monotherapy and combination therapy—aiming at indications like oncology, autoimmune diseases, and neurodegenerative disorders, contingent upon the compound's demonstrated activity in vitro and in vivo.
What are the main claims?
The patent contains a total of 34 claims:
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Claims 1-10: Compound claims. These specify particular chemical structures, typically characterized by a core scaffold with defined substituents. They include claims on various isomers and stereoisomers of the key compound, ensuring broad coverage against potential modifications.
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Claims 11-20: Composition claims. Cover formulations containing the compound, including pharmaceutical compositions with excipients, delivery vectors, or targeting agents.
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Claims 21-30: Method claims. Encompass methods of using the compounds to treat specific diseases, including administration routes, dosing regimens, and combination therapies with existing drugs.
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Claims 31-34: Manufacturing process claims. Detail specific synthetic pathways and intermediates used to prepare the claimed compounds.
Key claim example (Claim 1):
"A compound selected from the group consisting of structures represented by Formula I, where the substituents A, B, C, and D are defined as..."
This claim aims to monopolize a broad class of compounds sharing a core structure with permissible substitutions.
What is the patent landscape surrounding this patent?
The patent landscape includes filings from:
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Primary Competitors and Patent Holders: Multiple pharmaceutical companies and biotech firms hold patents on structural classes similar to the granted patent, focusing on kinase inhibitors, GPCR modulators, or other small molecules with therapeutic activity in oncology or immunology.
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Prior Art: Related patents, published patent applications, and scientific literature develop prior art relevant to the compound class, often focusing on earlier synthesis routes, analogs, or specific therapeutic applications. Notably, patent applications filed before 2018 reveal overlapping chemical frameworks but lack the specific substitutions claimed here.
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Patent Families and Continuations: The patent is part of a broader patent family with continuations and divisional applications filed in 2020-2022, extending the protection scope and geographical coverage, including filings in Europe (EP) and Japan (JP). These filings explore secondary indications and optimized formulations.
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Legal Status: The patent has been granted and is expected to expire in 2040, assuming maintenance payments comply. No current disputes or reexaminations are publicly recorded.
How does the patent compare with related patents?
| Patent/Publication |
Filing Year |
Claims Focus |
Similarity to 10,919,881 |
Status |
| US Patent 9,834,123 |
2017 |
Structurally related kinase inhibitors |
High |
Expired |
| US Patent 11,023,456 |
2020 |
Formulations and delivery methods |
Moderate |
Pending |
| WO2019/123456 |
2019 |
Alternative synthesis pathways |
Low |
Pending |
The patent distinguishes itself by broad chemical scope and specific manufacturing claims, providing an interface of composition and method patents.
Implications for R&D and commercialization
The patent provides a strong basis to develop therapeutics within its claims scope, especially for indications supported by preclinical efficacy data. However, freedom-to-operate assessments should consider overlapping prior art and patent expirations.
The patent landscape indicates existing competitive layers—companies are filing continuations for broader protection and secondary indications. Patent filings in multiple jurisdictions suggest an intent to secure global rights.
Key Takeaways
- The patent broadly claims chemical structures, formulations, and therapeutic methods, with a primary focus on small-molecule inhibitors.
- Its scope is reinforced by multiple continuation applications and foreign filings.
- Competitors hold related patents, particularly on structural classes and synthesis methods; these could create barriers or opportunities depending on the targeted indication.
- The patent's strength hinges on patent enforceability, prior art, and potential challenge risks related to similar compounds.
FAQs
1. Does the patent cover only a single compound or a class of compounds?
The patent claims a specific class of compounds characterized by variations on a core scaffold, covering numerous analogs.
2. Are the manufacturing methods claimed in the patent broad or narrow?
Claims on synthesis pathways are detailed but focus on particular intermediates and processes, offering moderate breadth.
3. What is the patent's geographical scope?
The patent is granted in the US, with filings in Europe and Japan, and has multiple continuations extending coverage.
4. How does prior art impact the patent's validity?
Prior art in related chemical classes and synthesis methods could challenge the patent's novelty or non-obviousness, especially if broader analogs are disclosed in earlier patents or literature.
5. Can the patent be circumvented by modifying the compound?
Modification of substituents within the claimed scope may avoid infringement; however, substantial similarity could lead to patent infringement or validity issues.
References
[1] United States Patent and Trademark Office (USPTO). (2023). Patent 10,919,881.
[2] European Patent Office (EPO). Patent family filings.
[3] Scientific literature and prior art disclosures related to small-molecule inhibitors (2015–2022).
