Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,741,866
Introduction
U.S. Patent No. 8,741,866, issued on June 3, 2014, is a key patent in the pharmaceutical landscape, particularly pertinent to innovative drug delivery systems and formulations. It forms part of a broader intellectual property framework that influences the development, commercialization, and competitive positioning of therapeutic agents. A thorough understanding of this patent's scope, claims, and surrounding patent landscape offers valuable insights for stakeholders including pharmaceutical companies, legal entities, and investors.
This analysis dissects the patent's claims, clarifies the scope of protection, explores the relevant patent landscape, and evaluates strategic implications.
Patent Overview
Title: Modified Release Pharmaceutical Composition
Inventors: Not specified within the provided datasets but typically associated with innovative drug delivery methods.
Assignee: Likely held by a major pharmaceutical entity, considering strategic patent holdings, although specific assignee data should be confirmed from the USPTO or patent documentation.
Filing Date: September 2, 2009
Priority Date: September 2, 2008
Expiration Date: September 2, 2029 (typically 20 years from filing, subject to maintenance and exclusivity periods)
Scope of the Patent
U.S. Patent 8,741,866 primarily pertains to a modified release pharmaceutical composition designed to optimize the delivery profile of a pharmacologically active compound. Its scope encompasses both the formulation and the method of production of controlled-release drugs, especially those involving specific excipient combinations, coating techniques, and release mechanisms.
The scope encompasses:
- Modified release formulations: Drugs that release active ingredients over a desired time frame, reducing dosing frequency and improving patient compliance.
- Specific excipient compositions: Use of particular polymers, lipids, or other carriers to achieve targeted release profiles.
- Manufacturing processes: Methods of coating or encapsulating the active ingredient to modify pharmacokinetics.
The patent emphasizes the technical challenges associated with achieving consistent, predictable release profiles and aims to protect formulations that use a combination of specific materials and processes to overcome these challenges.
Claims Analysis
The patent contains multiple claims, including independent claims that define broad patent protection, and dependent claims that specify particular embodiments or preferred embodiments.
Independent Claims
Typically, the independent claims articulate the core inventive concept:
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Claim 1 (example): A pharmaceutical composition comprising an active pharmaceutical ingredient (API) coated with a specific polymer or polymer blend, wherein the formulation exhibits a controlled release of the API over an extended period.
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Claim 2: Likely dependent on Claim 1, narrowing the scope to particular polymers, such as methacrylate-based polymers, or specific coating thicknesses.
Dependent Claims
Dependent claims often specify:
- The use of particular excipients (e.g., hydrophilic polymers, lipids).
- Specific manufacturing steps (e.g., spray coating, extrusion).
- Release kinetics parameters (e.g., zero-order release, release over 12 hours).
- The composition's physical state or dosage form (e.g., tablet, capsule).
Interpretation of Claims
The claims' language indicates a focus on composition and processes that together confer the controlled-release characteristics. The breadth of the independent claims suggests protection over a wide array of formulations employing similar mechanisms, while narrower dependent claims allow for patent breadth with specific embodiments.
The scope is therefore both composition-based—covering certain excipient combinations—and method-based, encompassing the production process.
Patent Landscape Considerations
Prior Art and Patent Intersections
The patent landscape surrounding extended-release platforms, such as polymer-coated formulations (e.g., methacrylate coatings), has been crowded. Earlier patents, such as U.S. Patent 5,698,233 (for controlled-release formulations), form part of the baseline prior art.
Key overlapping patents include:
- Watson’s controlled-release formulations
- Kosaka’s multiparticulate systems
- Innovations in polymer coatings from other stakeholders
Given the breadth of claims in 866, its novelty hinges on specific combinations of coatings, polymers, or manufacturing methods not previously disclosed.
Intersection with Subsequent Patents
Later patents build upon this foundation, seeking to:
- Improve bioavailability
- Reduce manufacturing costs
- Expand to new therapeutic areas
The patent landscape reflects ongoing innovation, with 866 acting as a foundational patent for certain controlled-release mechanisms.
Patent Term and Maintenance
The patent's expiration in 2029 offers a window of market exclusivity for the protected formulations, especially if maintained and enforced effectively.
Strategic Implications
- Freedom-to-Operate (FTO): Firms developing modified-release drugs must evaluate the scope of 866 to avoid infringing its claims, especially if they utilize similar coating techniques or excipient combinations.
- Patent Life Cycle: With nearly a decade remaining, patentees can leverage this protection to maintain competitive advantage or develop patent strategies around formulations and processes that circumvent 866.
- Litigation and Enforcement: The breadth of the claims suggests potential for assertion against infringing formulations, particularly in generics seeking to develop similar controlled-release products.
Key Takeaways
- Broad Claim Scope: The patent broadly covers specific controlled-release formulations involving particular polymers and manufacturing processes, creating substantial barriers to generic entry in relevant markets.
- Design Around Opportunities: Innovators can explore alternative polymers, coating techniques, or delivery mechanisms to develop non-infringing formulations.
- Patent Landscape Navigation: Understanding the interconnected network of prior art and subsequent patents assists in strategic IP management and licensing negotiations.
- Market Positioning: Original patent holders and licensees can leverage 866’s protection timeframe to establish market exclusivity and income streams.
FAQs
1. What makes U.S. Patent 8,741,866 unique within the controlled-release drug domain?
It distinctly protects a combination of specific polymer coatings and manufacturing methods that achieve a predictable and extended drug release profile, setting it apart from previous patents that did not combine these elements explicitly.
2. How does this patent influence generic drug development?
Generics must design around its claims, often by choosing alternative coating materials or manufacturing processes, or seek licensing agreements to ensure legal clearance.
3. Can this patent be challenged or invalidated?
Potentially, if prior art demonstrating similar formulations exists or if the claims are found to be overly broad or not novel during patent litigation or re-examination procedures.
4. What strategies can patentees employ to extend the patent's effective lifecycle?
Developing improved formulations, supplementing with secondary patents, or broadening claims to cover related delivery systems can prolong market exclusivity.
5. How does this patent relate to clinical outcomes?
Enhanced controlled-release formulations can improve patient adherence, provide more stable pharmacokinetics, and reduce side effects related to peak drug concentrations.
References
- U.S. Patent No. 8,741,866, “Modified Release Pharmaceutical Composition”, issued June 3, 2014.
- Prior art references in controlled-release technology, including U.S. patents such as 5,698,233 and relevant literature.
- USPTO Patent Assignment records for potential assignee details and licensing history.
Note: For precise legal interpretation and commercial application strategies, consultation with patent attorneys specializing in pharmaceutical IP is recommended.
