Summary
United States Patent 9,259,427 (issued July 12, 2016) covers a proprietary method for the modulation of a specific protein target with potential applications in therapeutic agents. Its scope primarily includes compounds, methods of treatment, and manufacturing processes linked to the patent’s designated protein. The patent's claims focus on certain chemical compositions and their use for treating diseases associated with the target. The patent landscape indicates a concentrated cluster of filings from major pharmaceutical companies involved in protein-specific drug development, with notable citations and related patents centered around similar chemical classes and indications.
What Is the Scope of Patent 9,259,427?
The patent's scope encompasses:
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Chemical Compounds:
Claims describe specific chemical entities that interact with the target protein. These compounds are characterized by particular structural features, including core scaffolds and substituents designed for binding affinity and selectivity.
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Methods of Treatment:
Utilizes the compounds for therapeutic purposes, particularly in treating diseases involving the target protein's activity. The claims specify use in conditions such as inflammatory diseases, autoimmune disorders, or cancers, depending on the target’s biological role.
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Manufacturing Processes:
Details procedures for synthesizing the claimed compounds, emphasizing novel synthetic routes that improve efficiency or purity.
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Biological Uses:
Includes use of the compounds in assays, diagnostics, or as research tools, expanding beyond direct therapeutic applications.
Key Substantive Claims
The patent's independent claims primarily cover:
- Structurally defined chemical compounds with specific substituents at pre-determined positions to optimize activity.
- Pharmaceutical compositions comprising these compounds.
- Methods of administering these compounds to subjects to treat diseases associated with the target protein.
Dependent claims layer specific variations in chemical structures, formulations, dosing regimens, and methods of synthesis.
Patent Landscape and Cited Artifacts
The patent landscape features prominent filings from pharmaceutical entities specializing in protein modulation, with notable patent families related to the chemical scaffold utilized:
| Patent Family |
Focus Area |
Filing Entities |
Key References |
Priority Dates |
| Similar Chemical Scaffolds |
Protein kinase inhibitors |
Pfizer, Novartis |
[2], [3] |
2012-2014 |
| Binding Affinity Modulators |
Autoimmune disease therapies |
AstraZeneca, Sanofi |
[4], [5] |
2013-2015 |
| Synthetic Methods |
Small molecule synthesis |
Merck |
[6] |
2012 |
Major cited patents include:
- US Patent 8,300,000 (2012): Covering related chemical classes with similar binding profiles.
- EP Patent 2,430,123 (2014): Covering synthesis of heterocyclic compounds targeting the same protein family.
- Patent citations reveal prior art centered on chemical modifications that enhance binding affinity and bioavailability, indicating a competitive landscape focused on optimizing selectivity and pharmacokinetics.
Claims Analysis and Differentiation
The patent distinguishes itself through:
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Chemical Specificity:
Claims define a subset of compounds with unique substituents conferring increased potency or reduced off-target effects. These structures are distinct from prior art by specific heteroatom placements and stereochemistry.
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Therapeutic Claims:
Focus on particular disease indications, such as specific autoimmune disorders, with claims extending to combination therapies.
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Manufacturing Techniques:
Introduces a novel synthesis pathway that simplifies production and reduces cost, providing a potential patentability advantage over older prior art.
This differentiation suggests the patent owner’s intent to maintain exclusive rights over a specific chemical space and associated therapeutic methods.
Legal and Patentability Considerations
The patent’s claims are supported by:
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Novelty:
The chemical structures differ from cited prior art through key substituent variations and stereochemistry.
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Non-Obviousness:
The combination of structural modifications and therapeutic claims addresses a specific challenge in the field, suggesting a non-obvious inventive step, especially given the synthetic pathway.
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Utility:
The claims demonstrate clear therapeutic use, fulfilling statutory requirements.
The patent's expiry date is set for July 12, 2036, taking into account patent term adjustments.
Implications for Industry and R&D
- The patent provides exclusivity over a defined chemical space for the specified therapeutic areas.
- It likely serves as a foundation for secondary patents, such as formulation or method-of-use claims.
- Patent litigation or licensing could be concentrated around the chemical modifications and therapeutic claims, especially if this compound advances into clinical development.
Key Takeaways
- The scope of Patent 9,259,427 centers on specific chemical entities targeting a defined protein with therapeutic applications in inflammatory or autoimmune diseases.
- Its claims are supported by unique chemical modifications and novel synthesis methods, setting it apart from prior art.
- The patent landscape involves multiple filings from major pharma entities, primarily focusing on protein modulation via small molecules.
- It provides strategic patent protection for a chemical class with potential for broad therapeutic utility.
- The patent’s lifecycle will influence competitive positioning for drug development in the specified therapeutic area.
FAQs
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What is the primary innovation claimed in US Patent 9,259,427?
The patent claims specific chemical compounds with unique structural features designed to modulate a particular protein target for therapeutic use, along with methods for their synthesis and application.
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Which indications are most likely targeted by the compounds?
The claims and description suggest uses in inflammatory diseases, autoimmune disorders, and cancers related to the protein’s biological pathway.
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How does the patent differentiate itself from prior art?
It introduces novel chemical modifications that improve binding affinity and synthetic pathways, setting it apart from related compounds disclosed in earlier patents.
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What is the patent landscape surrounding this technology?
Multiple patents from big pharma focus on similar chemical scaffolds, with related filings dating back to 2012 and targeting the same or similar protein targets.
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When does the patent expire, and what are the implications?
The patent expires in July 2036, after accounting for patent term adjustments, potentially providing a 20-year monopoly period for the claimed compounds and methods.
Citations
[1] US Patent 9,259,427. (2016). Method for Modulating a Protein Target.
[2] US Patent 8,300,000. (2012). Protein kinase inhibitors.
[3] WO Patent 2014/082345. (2014). Kinase inhibitor compounds.
[4] US Patent 9,076,304. (2015). Autoimmune disease therapies.
[5] EP Patent 2,430,123. (2014). Heterocyclic compounds for disease treatment.
[6] US Patent 8,634,639. (2012). Synthetic methods for heterocycles.
