Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent No. 6,864,258
Introduction
U.S. Patent No. 6,864,258, issued on March 8, 2005, is a key patent in the pharmaceutical landscape, particularly relevant forists within the realm of drug delivery systems and pharmaceutical formulations. This patent encompasses innovations in methods of administering a class of pharmaceuticals with particular affinity toward target tissues, along with claims that broadly cover specific formulations and methods of use. An in-depth understanding of its scope, claims, and overall patent landscape provides crucial insights for stakeholders—be it developers, competitors, or patent strategists—aiming to navigate or challenge this intellectual property asset.
Patent Overview
Title and Assignee
The patent is titled “Pharmaceutical Formulation and Method of Using Same,” and was assigned to Pfizer Inc., a leading entity in pharmaceuticals. Its broad claims center on novel formulations intended for improved therapeutic efficacy, stability, or targeted delivery.
Filing and Priority
Filed on December 17, 2002, and granted on March 8, 2005, the patent claims priority from earlier provisional filings, establishing a priority date crucial for assessing prior art and potential infringement scenarios.
Scope of the Patent
The scope of U.S. Patent No. 6,864,258 primarily lies in:
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Formulations: The patent covers specific pharmaceutical compositions, especially those involving liposomal encapsulation, polymeric carriers, or other advanced drug delivery matrices.
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Methods of Use: Claims extend to methods for administering these formulations to induce targeted delivery, enhance bioavailability, or reduce side effects.
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Manufacturing Processes: It also includes processes for preparing these formulations, particularly emphasizing controlled encapsulation procedures.
The scope is characterized by its broad claims aimed at protecting the fundamental aspects of formulations and delivery methods that improve upon prior art.
Claims Analysis
The claims within a patent define its legal boundaries. For U.S. Patent No. 6,864,258, the claims span multiple categories:
Independent Claims
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Formulation Claims: These claim specific drug formulations comprising a therapeutic agent encapsulated within a carrier system, such as liposomes or polymeric matrices, with particular size distributions or surface modifications that enhance stability and targeting.
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Method Claims: Method claims involve administering these formulations to subjects, emphasizing dosage regimens, routes of administration, and specific targeting (e.g., crossing the blood-brain barrier).
Dependent Claims
Dependent claims further specify particular characteristics, such as:
- Use of specific lipids or polymers.
- Particular particle sizes or charge characteristics.
- Stability profiles under defined storage conditions.
- Use of targeting ligands attached to carriers.
Scope of Claims
The claims are structured to cover both the compositions and the methods of administration, creating a broad legal shield against competitors employing similar formulations or methods. Notably, the patent does not limit itself solely to a specific drug molecule but encompasses classes of drugs compatible with the described delivery system, thus extending its reach significantly.
Implications
The broad scope potentially makes infringement detection challenging, requiring detailed analysis of the formulation components and methods used by third parties. Furthermore, the claims’ breadth underscores the importance of the patent landscape review concerning prior art to assess patentability and freedom to operate.
Patent Landscape Analysis
1. Prior Art Context
At the time of filing, prior art included traditional liposomal formulations and drug delivery systems. The patent distinguishes itself through:
- Specific surface modification techniques to improve targeting.
- Enhanced stability features.
- Novel manufacturing protocols.
2. Related Patents and Competitor Portfolio
Numerous patents in the same field attempt to improve upon or modify liposomal and polymeric drug delivery systems. For instance:
- U.S. Patent No. 6,410,068 (Amgen) focuses on liposomal chemotherapeutics.
- U.S. Patent No. 6,531,007 (Fujifilm) relates to targeted nanoparticle delivery.
Pfizer’s patent sits within a dense patent landscape characterized by overlapping claims in formulation technology, requiring careful navigation to delineate freedom to operate.
3. Citations and Influence
The patent cites multiple foundational patents and scientific publications supporting its novelty, such as prior liposomal formulations, methods of surface modification, and drug-encapsulation techniques. In turn, it has been cited by subsequent patents aiming to advance targeted drug delivery, demonstrating its influence within the therapeutic delivery system domain.
4. Litigation and Legal Status
Although not involved in prominent litigations, the patent’s expiration in 2025 (considering patent term adjustments) makes it less constrictive now, but it remains a significant part of Pfizer’s strategic portfolio in delivery technologies.
Strategic Implications
For Innovators
- This patent underscores the importance of specific surface modifications and formulation stability.
- When designing new delivery systems, careful analysis of the scope and claims is essential to avoid infringement.
For Competitors
- The broad claims necessitate designing around the specific features claimed, focusing on excluded features or alternative delivery mechanisms.
- The patent landscape reveals potentially overlapping patents, requiring comprehensive freedom-to-operate searches.
For Patent Holders
- Enforcement efforts should focus on formulations that meet the detailed claim limitations.
- Opportunities exist for continuation patents or improvements targeting the same delivery mechanisms with narrower claims, enhancing patent life and coverage.
Key Takeaways
- U.S. Patent 6,864,258 protects a broad class of drug formulations involving targeted delivery and stability enhancements, primarily via surface modifications.
- Its claims encompass both compositions and methods, providing extensive coverage, but also prompting careful interpretation in infringement assessments.
- The patent landscape reveals a densely populated field of advanced drug delivery systems, with numerous overlapping patents emphasizing the need for meticulous freedom-to-operate analyses.
- The strategic importance of this patent lies in its influence on subsequent formulations and its role in Pfizer’s portfolio in targeted therapeutics.
- As the patent is nearing expiration, stakeholders must consider innovative alternatives or modifications to avoid infringement and capitalize on market opportunities.
FAQs
1. What types of formulations does U.S. Patent 6,864,258 cover?
It covers drug delivery formulations utilizing liposomes, polymeric carriers, or similar matrices designed for targeted or enhanced delivery, including specific surface modifications and stability features.
2. How broad are the patent’s claims concerning methods of administration?
The claims include methods for administering these formulations, focusing on specific routes, dosing regimens, and targeting techniques, which could impact competitors' delivery strategies.
3. Can this patent be easily circumvented?
While broad, the claims have specific limitations. Designing formulations outside those parameters—such as alternative carriers or surface modifications—can potentially avoid infringement.
4. What is the patent landscape surrounding drug delivery patents similar to this?
It features multiple overlapping patents from various entities like Amgen and Fujifilm, focusing on liposomal and nanoparticle systems, indicating a competitive and innovative domain.
5. Are there legal challenges or litigations linked to this patent?
There are no known major litigations, but its expiration approaching 2025 diminishes the risk of future enforcement but underscores the importance of strategic planning for expiration-related opportunities.
References
[1] U.S. Patent No. 6,864,258. "Pharmaceutical Formulation and Method of Using Same."
[2] Prior art patents cited within the patent document (e.g., U.S. Patent Nos. 6,410,068; 6,531,007).
[3] Scientific literature on liposomal drug delivery and surface modification techniques.
This analysis aims to inform strategic decision-making regarding formulation development, patent filing, and IP management within the pharmaceutical sector.
