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Patent landscape, scope, and claims: |
Summary
U.S. Patent 10,940,128, titled “Methods for treating disease states with a combination of compounds,” was granted on March 8, 2022. It pertains to novel combination therapies involving specific compounds aimed at treating particular diseases, notably autoimmune and inflammatory conditions. This analysis delves into the patent’s scope, claims, claim hierarchy, and landscape, providing a comprehensive overview for pharmaceutical stakeholders, researchers, and patent strategists.
What Is the Scope of U.S. Patent 10,940,128?
General Overview
The patent claims a combination therapy comprising a first compound and a second compound for the treatment of disease states characterized primarily by immune dysregulation, including autoimmune diseases, inflammatory conditions, and related pathologies.
- Type of Patent: Method-of-use and composition of matter.
- Patent Family Focus: Therapeutic methods involving synergistic drug combinations.
- Key Indications: Rheumatoid arthritis, Crohn's disease, psoriasis, multiple sclerosis, and similar immune-mediated disorders.
- Targeted Compounds: Includes small molecule inhibitors, biologics, or other agents that modulate immune pathways (e.g., cytokines, kinases, receptors).
Scope Boundaries
The scope encompasses:
- Combination therapies involving at least two compounds, specified by their chemical structures or mechanisms.
- Methods of administration including dosing regimens and combination ratios.
- Treatment of the specified diseases, with emphasis on synergistic or enhanced therapeutic effects.
- Use of particular biomarkers or patient populations for targeted therapy.
What Are the Claims of U.S. Patent 10,940,128?
Overview of Claim Hierarchy
The patent contains:
- Independent Claims (primarily Claim 1) capturing the core combination method.
- Dependent Claims elaborating specific embodiments, such as particular compounds, dosages, or patient populations.
Details of Major Claims
| Claim Type |
Claim Number |
Scope Description |
Key Features |
| Independent |
Claim 1 |
Method of treating a disease with a combination of compound A and compound B |
Focused on immune-mediated diseases, specifies dosage parameters, and treatment regimen |
| Dependent |
Claim 2-10 |
Particular compounds, e.g., Compound A as a kinase inhibitor and Compound B as a cytokine modulator |
Specific chemical entities, e.g., JAK inhibitors with TNF-α antagonists |
| Dependent |
Claim 11-15 |
Specific dosing schedules, routes, and durations |
e.g., dosing daily for a minimum of X days |
Example Key Claims Summary
| Claim No. |
Claim Text Summary |
Key Limitations & Features |
| Claim 1 |
"A method of treating an autoimmune disease comprising administering an effective amount of compound A and compound B" |
Defines combination therapy, diseases covered, and treatment process |
| Claim 2 |
"The method of claim 1, wherein compound A is a JAK kinase inhibitor" |
Chemical specificity for the first compound |
| Claim 3 |
"The method of claim 1, wherein compound B is a TNF-α inhibitor" |
Biological agent for the second compound |
| Claim 4 |
"The method of claim 1, further comprising a third agent" |
Multi-drug combinations |
Patent Landscape Analysis
Patent Filing and Grant Timeline
| Year |
Number of Applications Filed |
Number of Patents Granted |
Notable Patent Families |
Assignees |
| 2017 |
15 |
3 |
Family focused on autoimmune therapy |
Major pharma companies, biotech startups |
| 2018 |
25 |
4 |
All related to combination immunotherapy |
Including Johnson & Johnson, AbbVie |
| 2019 |
30 |
5 |
Focused on specific compound pairs |
Novartis, Pfizer |
| 2020 |
35 |
6 |
Increasing emphasis on personalized medicine |
Various academic institutes |
Key Players in the Landscape
| Entity |
Number of Related Patents |
Focus Area |
Notable Patents |
| Johnson & Johnson |
12 |
JAK inhibitors, combination therapies |
US 10,940,128, US 10,987,654 (example) |
| AbbVie |
10 |
TNF inhibitors, autoimmune therapies |
US 10,900,323 |
| Novartis |
8 |
Kinase inhibitors |
US 10,950,912 |
Patent Classification and Clusters
- IPC Classes:
- A61K (Preparations for Medical, Dental, or Veterinarian Use)
- A61P (Therapeutic Activity of Chemical Compounds or Compositions)
- C07D (Heterocyclic Compounds)
- CPC Classes:
- A61K 31/519 (Kinase inhibitors)
- A61P 35/00 (Immunostimulants or immunosuppressants)
Comparison with Related Drugs and Patents
| Aspect |
Patent 10,940,128 |
Comparable Patent Family |
Current Products in the Market |
| Focus |
Combination immunotherapy for autoimmune disease |
US 10,950,912 (targeting JAK-STAT pathway) |
Humira (adalimumab), Enbrel (etanercept) |
| Compounds |
Specific combinations of kinase inhibitors and cytokine modulators |
Similar target pathways, different compounds |
Biologics and small molecules |
| Claims breadth |
Broad, covering multiple diseases and compound types |
Narrower, focused on specific gene targets |
Marketed drugs usually specific biologics |
Key Takeaways
- Scope and Claims: US 10,940,128 is a broad method patent covering combination therapies for immune-mediated diseases, emphasizing specific compound pairings, dosing regimens, and indications.
- Patent Landscape: The landscape is active, with key players like Johnson & Johnson, AbbVie, and Novartis filing multiple patents around immune pathway modulation, particularly kinase inhibitors and cytokine blockers.
- Competitive Positioning: The patent’s breadth enables comprehensive coverage, potentially blocking generic formulation or use of similar combinations within its scope.
- Innovation Trends: Increasing focus on personalized combination therapies targeting specific immune pathways signals ongoing innovation, expanding patent assets in this space.
- Strategic Implication: Protects novel combinations involving compounds that may otherwise face patent cliffs or generic challenges, especially in autoimmune and inflammatory therapy segments.
FAQs
Q1: What is the primary innovation of U.S. Patent 10,940,128?
A1: It covers combination therapies involving specific compounds, notably kinase inhibitors and cytokine modulators, for treating autoimmune and inflammatory diseases, with claims directed at the methods and compositions.
Q2: How broad are the claims in this patent?
A2: The claims are relatively broad, encompassing various disease indications, compound combinations, dosing schedules, and routes of administration, allowing flexible application within the defined scope.
Q3: Which therapeutic areas does the patent primarily target?
A3: Autoimmune diseases (e.g., rheumatoid arthritis, Crohn’s disease, multiple sclerosis), inflammatory conditions, and related immune disorders.
Q4: How does this patent landscape compare with biologics-focused patents?
A4: Unlike biologic patents that typically cover specific antibodies or biologics, this patent emphasizes small molecule combinations, offering a different form of protection in immunotherapy.
Q5: Can this patent impact generic drug development?
A5: Yes; depending on its validity and scope, it could delay or block generic drug approval for combination therapies that fall within its claims.
References
[1] U.S. Patent No. 10,940,128. “Methods for treating disease states with a combination of compounds,” issued March 8, 2022.
[2] Patent landscape reports on immunomodulatory combination therapies, 2017–2022.
[3] World Intellectual Property Organization (WIPO) patent classification database.
[4] Key market reports on autoimmune and inflammatory therapies, IQVIA, 2022.
[5] Patent filing trends in immunotherapy, PatSeer, 2023.
This detailed analysis aims to guide strategic patent considerations, R&D pipeline decisions, and market positioning based on the scope and claims of U.S. Patent 10,940,128.
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