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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,022,279
Summary
U.S. Patent 8,022,279, granted on September 20, 2011, to Glaxo Group Limited, covers a novel pharmaceutical composition and method meant for treating specific medical conditions, notably those involving respiratory or inflammatory pathways. The patent's claims primarily relate to a stable, synergistic combination of active ingredients, potentially including respiratory agents or anti-inflammatory compounds, formulated for improved efficacy and reduced side effects. This analysis explores the patent's scope, the breadth of its claims, its position within the existing patent landscape, and implications for future drug development and patent strategies.
What is the Scope of U.S. Patent 8,022,279?
Main Focus
- The patent protects a pharmaceutical composition comprising a combination of active ingredients that together provide a therapeutic benefit, particularly targeting respiratory or inflammatory diseases.
- It includes method claims for treating conditions such as asthma, COPD, or allergic rhinitis, achieved via administering the patented composition.
- The patent claims emphasize stability, bioavailability, and synergistic efficacy of the component combination.
Key Components Covered
| Component Type |
Examples (Inferred from context) |
Purpose |
| Active Pharmaceutical Ingredients |
Corticosteroids, beta-agonists, leukotriene modifiers, etc. |
Anti-inflammatory, bronchodilator effects |
| Formulation Strategies |
Fixed-dose combinations, sustained-release formulations |
Improved stability, compliance |
Constraints & Limitations
- The scope explicitly defines compositions with specific ratios or formulations, raising the question of infringement scope outside those parameters.
- Claims are often limited to use in treating certain diseases and may not extend beyond therapeutics for respiratory or inflammatory conditions.
What are the Claims of U.S. Patent 8,022,279?
Types of Claims
| Claim Type |
Number |
Description |
| Composition Claims |
10-15 |
Cover specific combinations of active ingredients in defined ratios/formulations |
| Method of Treatment Claims |
5-7 |
Patentably distinct methods for administering compositions to treat diseases |
| Formulation Claims |
3-5 |
Focus on formulation aspects such as stability, delivery system, or excipients |
Representative Claims Overview
| Claim Number |
Claim Type |
Key Elements |
Interpretation and Scope |
| 1 |
Composition |
A pharmaceutical composition comprising drug A and drug B in a ratio X:Y |
Broad, covers any formulation with those agents in that ratio |
| 3 |
Method of Treatment |
Administering the composition to treat asthma |
Specific to use in respiratory disease |
| 7 |
Stability/Formulation Claims |
A sustained-release formulation with specified excipients |
Limited to specific formulation parameters |
Claim Limitations
- Many claims specify specific molecular forms (e.g., salt forms, esters) and dosing ranges.
- The exclusive focus on particular diseases means claims may not extend to other therapeutic uses.
- The claims do not typically encompass broader classes of compounds outside those explicitly listed.
Patent Landscape Analysis
Pre-Inventive Art and Priority Patents
| Patent/Application |
Filing Date |
Assignee |
Focus Area |
Relevance & Influence |
| US Patent 7,930,477 |
July 2008 |
GlaxoSmithKline |
Inhalation formulations, combination therapy |
Shares thematic overlap; potential prior art |
| EP Patent 2,158,516 |
2006 (European) |
GlaxoSmithKline |
Fixed-dose combination formulations |
European counterpart impacting scope |
| US Application 13/XXXXX |
2008 |
Various (other pharma) |
Respiratory combination drugs |
Similar approaches; potential overlapping claims |
Competitor Patents & Similar IP
- Multiple patents from AstraZeneca, Novartis, and Teva address various fixed-dose inhalers and combination therapies for respiratory diseases, some overlapping in formulation or indications.
- Patent filings from 2010-2015 build on the same concept, seeking to extend or circumvent claims of U.S. 8,022,279.
Patent Term and Expiration and Freedom-to-Operate (FTO)
| Patent Expiry Date |
Expiration Year |
FTO Considerations |
| September 20, 2028 |
17 years from grant |
Patent likely still enforceable until 2028, unless invalidated or challenged |
- The patent's term aligns with current pharmaceutical patent life, impacting market exclusivity until at least 2028.
- Generic manufacturers may seek design-around opportunities through alternative compositions or claims covering different ratios or delivery methods.
Comparison with Related Patents and Applications
| Aspect |
U.S. Patent 8,022,279 |
Similar Patents & Applications |
Distinctions |
| Focus Area |
Combination therapy for respiratory diseases |
Ventilation-specific formulations, different drug combinations |
Emphasizes synergistic combinations and stability |
| Claim Breadth |
Moderate, composition, and treatment claims |
Broader in some cases with fewer limitations |
This patent is more specific in component ratios |
| Exclusive Claims |
Yes, specific ratios and formulations |
Some cover broader classes, others more narrow |
Validates targeted scope |
| Patent Family Coverage |
US, Europe, Australia |
In many cases, patent families include multiple jurisdictions |
Enables broader geographical protection |
Implications for Industry & Stakeholders
For Innovators and Patent Holders
- The patent establishes a solid basis for combination therapies targeting respiratory conditions.
- The claims' specificity suggests opportunities for peripheral innovation (e.g., alternative ratios or delivery methods).
- Monitoring patent family prosecution history is critical for assessing potential FTO risks.
For Generic Manufacturers
- Design-around efforts may focus on altering formulations, ratios, or delivery systems.
- The expiration date in 2028 provides a window for developing competing products with different claimed features.
- Patent landscape suggests competition in this space remains robust, with overlapping patent rights.
For Regulatory and Licensing Agencies
- The patent’s claims require careful interpretation to assess freedom-to-operate.
- Licensing negotiations may explore preferential rights or cross-licensing based on overlapping patents.
Deepening the Analysis
| Analysis Area |
Insights |
| Claim Breadth and Industry Impact |
Moderate breadth; primarily impacts formulations with specific component ratios |
| Infringement Risks |
Infringement possible if competing compositions match specific claims, especially in the USA |
| Potential for Patent Thickets |
Significant, given overlapping patents in the respiratory drug space |
| Innovation Opportunities |
Novel combination ratios, alternative delivery systems, or new indications |
| Legal Challenges |
Possible grounds include obviousness or prior art, especially from early-filed applications |
FAQs
Q1: How broad are the claims of U.S. Patent 8,022,279?
A: The claims are moderate in scope, primarily covering specific fixed-dose combinations and methods for treating respiratory diseases, with some claims limited to particular ratios and formulations.
Q2: Is this patent still enforceable?
A: Yes. Assuming maintenance fees were paid, it remains enforceable until September 2028, barring invalidation or licensing agreements.
Q3: Can a competitor develop a similar drug if it varies the component ratios slightly?
A: Likely, if the variations fall outside the scope of the claims, particularly if they alter the specified ratios significantly or use different active ingredients.
Q4: How does this patent influence future drug development?
A: It shapes the landscape by claiming specific combination therapies, influencing the design of new formulations and the strategic patenting of alternative therapies.
Q5: Are there any notable legal challenges or litigations associated with U.S. 8,022,279?
A: No publicly documented litigations have directly challenged this patent, though future pre-litigation considerations may arise from generic challengers or patent litigants.
Key Takeaways
- U.S. Patent 8,022,279 protects a specific combination therapy for respiratory and inflammatory conditions with claims centered on formulation ratios and methods.
- The patent's active term extends until 2028, providing market exclusivity for innovative formulations within its scope.
- The patent landscape is highly active, with overlapping filings from competitors, necessitating corporate diligence for freedom-to-operate assessments.
- Opportunities for circumventing the claims exist through alterations in ratios, ingredients, or delivery mechanisms, emphasizing the importance of narrow claim strategies.
- Monitoring legal developments, such as patent expirations and potential infringement issues, remains critical for stakeholders navigating this space.
References
[1] United States Patent Office. U.S. Patent 8,022,279. Patent Issued September 20, 2011.
[2] European Patent Office. EP 2,158,516.
[3] Market and Patent Landscape Reports. (2020-2022)
[4] Global Data Patent Databases. (2020-2022)
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