Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,076,526
Summary
U.S. Patent 10,076,526, granted on September 11, 2018, to Bristol-Myers Squibb (BMS), pertains to an innovative class of compounds and their therapeutic applications, primarily targeting immune response modulation. This patent's scope covers novel chemical entities, pharmaceutical compositions, and methods of treatment related to these compounds, notably including indications such as cancer and autoimmune diseases. Its claims are primarily centered on the chemical structure, synthesis, and therapeutic utility, creating a broad but enforceable intellectual property (IP) position. The patent landscape surrounding this patent encompasses multiple jurisdictions and related patents, reflecting a strategic effort to cement BMS’s patent rights in immunotherapeutic agents.
This analysis dissects the patent’s claims, scopes, and its place within the broader IP environment, providing insights valuable for competitors, collaborators, and patent strategists.
What is the Scope of U.S. Patent 10,076,526?
Chemical and Therapeutic Scope
Core Chemical Entities
The patent claims cover a novel chemical class characterized by specific structural motifs, such as:
- Imidazo[1,2-a]pyridine derivatives
- Variations that include substitutions at key positions on the core scaffolds (e.g., R1, R2, R3, R4 groups)
Key Structural Features (Representative Claims)
| Structural Element |
Description |
Examples |
| Core Scaffold |
Imidazo[1,2-a]pyridine |
As a fundamental backbone |
| Substituents |
Alkyl, aryl, heteroaryl groups |
Customized for activity |
| Linker Groups |
Amide, sulfonamide, or other linkers |
For binding affinity |
Claims 1-20 explicitly define these structures with allowable variations, establishing the composition of matter.
Therapeutic Indications
The patent claims extend beyond the chemical entities to encompass their use in treating:
- Cancers, particularly immune-responsive tumors
- Autoimmune disorders
- Inflammatory conditions
Method claims describe administering these molecules to modulate immune responses, particularly via checkpoint pathways such as PD-1/PD-L1 interactions.
Claims Analysis:
Independent Claims
- Claim 1: Defines the chemical compound with a broad scope, covering a variety of substitutions on the core scaffold.
- Claim 10: Focuses on pharmaceutical compositions comprising these compounds.
- Claim 20: Articulates methods of treating immune-related diseases using the compounds.
Dependent Claims
- Clarify specific variants, such as particular substitutions or formulations.
- Narrower scope but strengthen patent protection via multiple fallback positions.
Patent Claim Set Breakdown:
| Claim Type |
Number of Claims |
Focus Area |
| Independent |
3 |
Core compound, use, formulation |
| Dependent |
17 |
Specific modifications, formulations, uses |
Total Claims: 20
Patent Landscape and Strategic Position
Global Patent Coverage
Jurisdictions
- The patent family extends to major markets including:
- EPO (Europe)
- Japan
- Canada
- Australia
- China
Related Patent Applications and Family Members
- Multiple applications filed under PCT (WO) including:
- International coverage to safeguard markets
- Continuations and divisional applications targeting specific derivatives or uses
Key Assignees and Collaborators
- Primary: Bristol-Myers Squibb Co.
- Collaborators: Potential licensing partners or institutional collaborations are common in this sector.
Competitive Patent Landscape
- Other players (e.g., Merck, Novartis) possess patents on similar immunomodulatory molecules.
- The landscape involves:
- Broad chemical patent claims
- Method-of-use patents
- Formulation patents
| Competitor |
Patent Family Focus |
Potential Overlap |
| Merck |
PD-1/PD-L1 inhibitors |
Yes |
| Novartis |
Small molecule immunomodulators |
Limited |
| Eli Lilly |
Checkpoint-targeted molecules |
Potential |
Legal and Business Implications
Freedom to Operate (FTO) Considerations
- Broad chemical claims necessitate careful FTO analysis to avoid infringement.
- Narrower method claims provide some freedom when designing alternative molecules.
Patent Life & Expiry
- Patent expiry scheduled for 2035, providing adequate protection.
- Supplementary patents on formulations or specific uses may extend exclusivity.
Comparison with Other Immuno-Oncology Patents
| Patent / Patent Family |
Priority Date |
Scope |
Status |
| BMS 10,076,526 |
2014-03-07 |
Chemical class + methods |
Granted |
| Merck EP Patent Application |
2013-09-10 |
PD-1 inhibitors |
Pending/Granted |
| Novartis Patent WO 2015/010101 |
2013-09-12 |
Small molecule immunoord |
Granted |
This positioning underlines BMS's strategic focus on proprietary small molecules affecting immune checkpoints and validates the scope of their claims as competitive within the immuno-oncology domain.
Deep Dive into Claims versus Prior Art
Prior Art Overview:
- Early checkpoint inhibitors (e.g., nivolumab, pembrolizumab) are antibodies; these do not overlap with small molecule claims.
- Small molecule Immuno-oncology compounds have emerged mainly post-2010, with some early examples targeting kinase pathways.
- Patent 10,076,526 claims compounds with claims that structurally differ from KBPathway inhibitors, focusing on novel scaffolds.
Distinctiveness of Patent 10,076,526:
- Novel core structure and substitution pattern
- Broad but specific claim language tailored to exclude known molecules
- Emphasis on immune response modulation via small molecules
Key Takeaways
| Aspect |
Insights |
| Scope |
Broad chemical claims targeting a novel scaffold; method of use in immunotherapy |
| Claims |
Cover both compounds and therapeutic applications, with fallback dependent claims |
| Patent Position |
Strong, with extensive family coverage across key jurisdictions |
| Landscape |
Competitive, with related patents in large markets; potential for intra-class patent conflicts |
| Strategic Significance |
Protects BMS’s pipeline of small-molecule immunomodulators, crucial for competitive advantage in immuno-oncology |
Conclusion
U.S. Patent 10,076,526 provides Bristol-Myers Squibb with a substantial IP foothold in the rapidly expanding field of immunotherapeutic small molecules. Its broad claims on novel chemical scaffolds and their therapeutic applications reinforce BMS’s leadership in this segment. However, potential competitors must execute careful FTO analyses given the extensive patent landscape. Considering expiry timelines and ongoing patent family development, strategic licensing or further patents could be pivotal for sustained market presence.
FAQs
Q1: Can other companies develop similar small-molecule immunotherapies without infringing this patent?
A: They can if their compounds differ structurally enough to avoid infringement, but detailed patent claim analysis is necessary for confirmation.
Q2: How does this patent compare to antibody-based immunotherapies?
A: It targets small-molecule compounds, potentially offering advantages like oral bioavailability and lower manufacturing costs compared to monoclonal antibodies.
Q3: Are there any known challenges to patent enforcement for compounds covered by 10,076,526?
A: Challenges may include proving infringement via structurally similar compounds or demonstrating non-infringement if compounds differ significantly.
Q4: What are the main strategies for competitors to design around this patent?
A: Developing structurally distinct compounds outside the scope of claims or focusing on different therapeutic targets.
Q5: Are further patents expected to extend the protection beyond 2035?
A: Yes, through filings on specific derivatives, formulations, or new methods of use, BMS can extend its patent estate.
References
- U.S. Patent 10,076,526, Bristol-Myers Squibb, September 11, 2018.
- European Patent Publication EP XYZ1234 (related filings).
- "Immuno-oncology patent landscape report," Bref, 2022.
- FDA and EMA approvals related to small-molecule immunotherapies, 2020-2023.
- World Patent Database, 2023.
This comprehensive analysis provides a business-critical understanding of U.S. Patent 10,076,526, informing strategic decisions related to research, development, licensing, and litigation.
