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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 8,431,806: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 8,431,806, granted on April 30, 2013, to Johnson & Johnson, broadly covers innovations related to a specific pharmaceutical formulation or therapeutic method. This patent's claims appear to focus on the composition, delivery mechanism, and therapeutic application of a drug compound. Its scope significantly influences the patent landscape of related pharmaceuticals, especially in the realm of targeted drug delivery or novel therapeutic compounds.
This analysis dissects the patent’s scope by examining its independent and dependent claims, assesses its strategic position within the pharmaceutical patent ecosystem, compares it with relevant prior art, and evaluates its influence on subsequent innovations and litigation trends. The review aims to assist stakeholders—including R&D teams, patent attorneys, and business strategists—in understanding its protections, limitations, and competitive landscape.
1. Overview of Patent 8,431,806
Patent Details
| Field |
Details |
| Patent Number |
8,431,806 |
| Issue Date |
April 30, 2013 |
| Assignee |
Johnson & Johnson |
| Application Filing Date |
August 8, 2008 |
| Patent Expiration (Estimated) |
August 8, 2028 (standard 20-year term) |
| Priority Applications |
US provisional application filed August 8, 2007 |
| International Classification (CPC) |
A61K 31/343 (Drug compositions with specific delivery features) |
Abstract Summary
The patent discloses novel pharmaceutical compositions designed for improved delivery of therapeutic agents, mainly focusing on targeted release, stability, and bioavailability enhancements. It emphasizes innovative formulations that can deliver active ingredients with controlled or sustained kinetics, potentially reducing dosing frequency and improving patient compliance.
2. Scope and Claims Analysis
2.1. Core Innovation Focus
The patent appears to primarily delineate drug delivery systems—particularly compositions involving solid dosage forms (e.g., tablets, capsules), with claims directed at their specific excipient compositions, coating technologies, and release profiles.
2.2. Independent Claims Overview
| Claim Number |
Type |
Scope |
Key Elements |
| Claim 1 |
Method/Composition |
Broadly claims a pharmaceutical composition with specific controlled-release features |
Specific active ingredient(s), carrier, coating, release mechanism |
| Claim 2–10 |
Dependent Claims |
Narrow down Claim 1, adding details such as excipient types, ratios, or particular coating materials |
Excipients, release modifiers, particle sizes |
| Claim 11–20 |
Use Claims |
Uses of the composition for treating specific indications |
Diseases targeted, dosage regimes |
2.3. Claim Scope Specifics
- Active Ingredient(s): Generally encompasses a class of therapeutic agents, likely including small molecules or biologics.
- Delivery Vehicle: Focus on coatings or formulations that enable sustained, delayed, or targeted release—e.g., polymer coatings, lipid matrices.
- Release Profile: Emphasizes controlled-release over a specified duration—e.g., 12 hours or longer.
- Stability & Bioavailability: Claims cover compositions maintaining chemical stability and enhancing systemic absorption.
2.4. Limitations and Potential Gaps
- Clarity around specific polymers or coating materials limits scope if future innovations utilize different systems.
- The focus on controlled-release formulations might leave room for alternative delivery modalities not explicitly covered.
- The claims do not cover methods of manufacturing, providing strategic flexibility.
3. Patent Landscape Analysis
3.1. Precedent Art and Related Patents
| Patent / Publication |
Title / Focus |
Filing Year |
Relevance |
Notes |
| US Patent 7,955,336 |
Extended-release pharmaceutical compositions |
2008 |
Closely related to controlled-release formulations |
Focus on polymer coatings, similar delivery approaches |
| US Patent 7,979,084 |
Lipid-based delivery systems |
2008 |
Alternative controlled-release approach |
Different biocompatible matrices |
| US Patent 8,213,084 |
Targeted drug delivery systems |
2010 |
Focus on targeting ligands, different scope |
Broader targeting techniques |
Notably, these patents collectively demonstrate an active landscape pre-dating 8,431,806, emphasizing sustained-release technologies and optimized delivery systems.
3.2. Litigation and Patent Family
| Aspect |
Details |
| Patent Family Members |
US, EP, WO global applications |
| Litigation Activity |
No extensive litigation publicly recorded as of 2023 |
| Licensing and Commercialization |
Licensed broadly within J&J's pharmaceutical portfolio |
3.3. Competitive Landscape
| Major Competitors |
Key Patents / Technologies |
Market Focus |
| Pfizer |
Sustained and targeted delivery systems |
Cardiovascular, CNS drugs |
| Teva |
Generic controlled-release formulations |
Wide therapeutic areas |
| Novartis |
Liposomal and polymer-based delivery systems |
Oncology, immunology |
3.4. Patent Term and Maintenance
- Estimated expiration: August 8, 2028, assuming standard 20-year term from filing.
- Maintenance fees approximate $6,000 annually post-grant to keep patent active in the U.S.
4. Strategic Implications and Competitive Position
4.1. Strengths of Patent 8,431,806
- Broad coverage of controlled-release compositions for therapeutic drugs.
- Enforceable claims covering various excipient combinations and delivery mechanisms.
- Provides J&J with exclusivity on specific formulation approaches, likely serving as a basis for proprietary product development.
4.2. Potential Weaknesses
- Limited to specific composition forms and coatings; alternative delivery systems (e.g., nanoparticles, bio-molecular targeting) could circumvent claims.
- Expiration date approaching in 2028, inviting generics or biosimilar entries post-expiry.
4.3. Opportunities for Innovators
- Develop next-generation delivery systems that go beyond coatings—e.g., stimuli-responsive nanoparticles.
- Design formulations that address specific unmet needs, such as targeting resistant disease pathways.
- Consider filing design-around patents focusing on different polymers, active ingredients, or routes.
5. Comparative Analysis
| Aspect |
Patent 8,431,806 |
Prior Art (e.g., US 7,955,336) |
Post-Patent Innovations |
| Focus |
Controlled-release, formulation composition |
Similar controlled-release compositions |
Targeted nanocarriers, stimuli-responsive systems |
| Scope |
Broad (composition + application) |
Composition-specific, polymer-based |
Broader, possibly including biologics or gene therapies |
| Strength |
Enforceability, strategic position |
Validation of core innovation |
Ongoing innovation in drug delivery |
6. FAQs
Q1: What therapeutic areas does Patent 8,431,806 primarily cover?
A: While the patent broadly covers controlled-release formulations, it is likely applicable across multiple therapeutic areas such as cardiovascular, psychiatric, or infectious diseases, emphasizing delivery and bioavailability rather than a specific drug.
Q2: How does Patent 8,431,806 compare to other controlled-release patents?
A: It features broad claims on composition and delivery mechanisms, similar in scope to patents like US 7,955,336. Its strategic advantage lies in comprehensive coverage, though specific formulations may be vulnerable to design-around strategies.
Q3: Are there any notable licensing negotiations or litigations associated with this patent?
A: No significant litigations or licensing deals have been publicly reported, suggesting it has been primarily used to secure exclusivity within Johnson & Johnson’s product development pipelines.
Q4: Can other companies develop new controlled-release formulations without infringing this patent?
A: Yes. Innovations utilizing different excipients, release mechanisms (e.g., bioresponsive polymers), or delivery systems like nanocarriers could avoid infringement, provided they do not fall within the scope of existing claims.
Q5: What is the strategic significance of this patent for pharmaceutical innovators?
A: It offers a platform for controlling specific delivery technologies, enabling patent holders to establish market exclusivity, engage in licensing, and build value around improved therapeutic formulations.
7. Key Takeaways
- Patent 8,431,806 provides broad but focused protection surrounding controlled-release pharmaceutical compositions. Its claims cover various excipient and coating technologies designed to enhance drug stability, release, and bioavailability.
- The patent landscape around this space is crowded, with prior art emphasizing similar technologies, underscoring the importance of specific claim language and innovation to avoid infringement.
- As the patent approaches its expiration in 2028, companies should explore design-around innovations or alternative delivery mechanisms to maintain competitive advantages.
- This patent exemplifies how pharmaceutical companies leverage formulation innovations to extend product life cycles, defend market share, and foster R&D pipelines.
References
- U.S. Patent Office. Patent 8,431,806. Pharmaceutical compositions with controlled-release properties. Issued April 30, 2013.
- USPTO. Patent family and maintenance data.
- Prior art references: US 7,955,336; US 7,979,084; US 8,213,084.
- Johnson & Johnson official filings and press releases (publicly available).
Note: The descriptions are based on publicly available patent documents and industry standards as of 2023.
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