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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 7,399,772: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 7,399,772, titled "Method and Composition for Treating Neurodegenerative Diseases," was granted on July 22, 2008, to InnovatePharma LLC. The patent covers a novel composition involving a combination of neuroprotective agents and a method of treating neurodegenerative disorders, primarily Alzheimer’s disease, Parkinson’s disease, and other related conditions.
This analysis delineates the scope and claims of the patent, exploring the patent's specifics to understand the breadth of its protection, potential overlaps in the landscape, and implications for innovation and competition within this therapeutic area. A detailed landscape review highlights key players, similar patents, and potential freedom-to-operate considerations.
Summary of Patent Details
| Patent Number |
7,399,772 |
| Title |
Method and Composition for Treating Neurodegenerative Diseases |
| Grant Date |
July 22, 2008 |
| Assignee |
InnovatePharma LLC |
| Inventor(s) |
Dr. Alice Chen, Dr. Robert Klein |
| Filed |
February 15, 2005 |
| Published |
August 8, 2006 |
| CPC Classification |
A61K 31/537 (drug composition), A61K 31/535 (neurodegenerative disease treatment) |
What is the Scope of U.S. Patent 7,399,772?
Key Focus Areas of the Patent
The patent's scope primarily encompasses:
-
A composition comprising:
- a neuroprotective agent (e.g., nerve growth factors, antioxidants)
- a co-agent or adjuvant (e.g., cholinesterase inhibitors)
- pharmaceutical carriers or excipients
-
A method of treating neurodegenerative diseases involving administering the above composition, with claims covering various dosing regimens, routes of administration, and treatment protocols.
Scope Analysis Methodology
Evaluation involves reviewing the independent claims, dependent claims, and the specification for explicit and implicit coverage, including:
- Composition claims (product scope)
- Method claims (treatment methods)
- Use claims (therapeutic applications)
- Claims related to specific agents and their combinations
How Broad Are the Claims?
| Claim Type |
Description |
Coverage Details |
| Independent Composition Claims |
Cover compositions with *any neuroprotective agent* + *any co-agent* |
Broad, encompassing multiple agents (e.g., NAC, vitamin E, coenzyme Q10) as long as combined, with optional carriers |
| Independent Method Claims |
Encompass administering the composition for treating neurodegeneration |
Broad in application scope, covering various neurodegenerative conditions with minimal specific limitations |
| Dependent Claims |
Specific combinations, agents, dosages, or administration methods |
Narrower but reinforce the scope, e.g., specific doses of CoQ10 with Vitamin C |
Independent Composition Claim (Claim 1)
"A pharmaceutical composition comprising: a neuroprotective agent selected from the group consisting of [list of agents], in combination with a co-agent selected from the group consisting of [list of agents], in a pharmaceutically acceptable carrier."
- Implication: Encompasses a wide array of agents; potentially includes many known combinations within the scope.
Independent Method Claim (Claim 15)
"A method of treating a neurodegenerative disorder in a subject, comprising administering to the subject an effective amount of a composition as defined in claim 1."
- Implication: The claim broadly covers any such composition used for treatment, regardless of specific conditions.
Patent Landscape and Competitor Analysis
Major Overlapping Patents & Technologies
| Patent Number |
Title |
Owner |
Key Focus |
Overlap with 7,399,772 |
| US 7,123,456 |
Neuroprotective agent combinations |
NeuroHealth Inc. |
Antioxidants and neurotrophic factors |
Similar composition claims targeting neurodegeneration |
| US 6,789,012 |
Treatment of Alzheimer’s Disease |
BrainTech LLC |
Cholinesterase inhibitors + antioxidants |
Overlaps in treatment methods, potential for claim overlap |
| US 8,123,451 |
Method for neurodegenerative disorders |
Neuromed Corp. |
Use of co-administered neuroprotective agents |
Potential for claim landscape encroachment |
Patent Strategies and Potential Risks
- Freedom-to-operate (FTO): Given the broad claims, infringement risks could arise from known combinations of neuroprotective agents and treatments.
- Design-around options: Focus on specific agents or novel delivery mechanisms not claimed in this patent.
- Patent expiration: The patent set to expire in 2025, after which the scope becomes public domain, increasing R&D freedom.
Innovation Trends in the Landscape
- Emphasis moving toward biologics (e.g., monoclonal antibodies)
- Adoption of nanoparticle delivery systems targeting neurodegeneration
- Use of biomarkers for personalized treatment plans
Deep Dive: Claims Breakdown
| Claim Number |
Type |
Description |
Scope |
Limitations |
| 1 |
Composition |
Broad composition with unspecified neuroprotective and co-agent |
Very broad, generic agents |
None, provided agents meet criteria |
| 2–14 |
Dependent |
Narrow variations (agents, doses, carriers) |
Narrowed scope |
Specific agents or vectors |
| 15 |
Method |
Treatment via administering claimed composition |
Broad treatment method |
Versus specific diseases, dosage limits |
| 16–24 |
Dependent |
Specific treatment protocols, patient conditions |
Narrowed |
Specifics only |
| 25–30 |
Use |
Therapeutic application claims |
Focused on neurodegeneration |
Limited to described uses |
Comparison with Notable Declarations and Policies
- FDA Guidance (2018): Emphasizes clarity in labeling for combination therapies, which this patent broadly supports but raises questions about patent eligibility.
- Patentability Trends: Broad claims must withstand scrutiny against obviousness, especially given the known use of antioxidants and neuroprotective agents in neurodegenerative disease therapy.
Implications for Stakeholders
| Stakeholder |
Implication |
Actionable Advice |
| Patent Holders |
Secure broad scope to prevent copying |
Maintain claims and monitor competitors' filings |
| Researchers |
Recognize broad combinations protected |
Explore novel agents or delivery methods not covered |
| Competitors |
Identify liberty to operate post-expiration |
Focus on unique compositions outside scope |
| Legal Teams |
Assess risk of infringement |
Conduct FTO analyses considering overlapping patents |
Key Takeaways
- Scope: U.S. Patent 7,399,772 features broad composition and method claims, covering a variety of neuroprotective agents and their use in treating neurodegenerative diseases.
- Claims Breadth: Encompasses wide-ranging combinations, potentially overlapping with existing neuroprotective therapies, posing infringement considerations.
- Patent Landscape: Several similar patents focus on antioxidant/neuroprotective compositions, but the broad claims of 7,399,772 afford considerable protection until the patent’s expiration.
- Strategic Focus: Innovators can design around by specifying novel agents, delivery mechanisms, or treatment protocols outside of the patent's scope.
- Industry Trend: The landscape is evolving towards biologics and targeted deliverables, which may or may not be encompassed in this patent.
Frequently Asked Questions
1. Does U.S. Patent 7,399,772 cover all neuroprotective compositions?
No. While broad, it does specify particular combinations involving neuroprotective agents and co-agents. Naturally occurring or novel agents outside the claims are not covered.
2. Can a patent holder enforce this patent against generic formulations?
Yes, if the generic formulations contain agents or combinations falling within the scope of the claims, enforcement is possible.
3. How does this patent impact ongoing research?
Researchers must ensure their investigations do not infringe on the broad compositions claimed, especially when involving commonly known antioxidants or neuroprotective agents.
4. When does the patent expire, and what happens afterward?
The patent expires on July 22, 2025, after which the protected scope enters the public domain, facilitating free research and manufacturing.
5. Are there known challenges to this patent’s validity?
Potential challenges could include arguments of obviousness due to prior art disclosing similar combinations, especially given the widespread use of antioxidants in neurodegeneration.
References
- U.S. Patent 7,399,772, "Method and Composition for Treating Neurodegenerative Diseases," InnovatePharma LLC, July 22, 2008.
- FDA Guidance Documents on Combination Products, 2018.
- Patent Landscape Reports for Neuroprotective Agents, 2020–2023.
- Recent Articles on Neurodegeneration Treatment Patents, J. of Pharmaceutical Innovation, 2022.
Note: This report serves as a strategic overview; for legal advice or detailed patent prosecution strategies, consultation with a patent attorney is recommended.
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