Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,566,460
Introduction
U.S. Patent No. 7,566,460, granted on July 7, 2009, to Abbott Laboratories, represents a significant patent in the pharmaceutical domain, particularly within the landscape of drug formulations and delivery systems. This patent encompasses a novel method for administering pharmaceutical compounds, with specific claims aimed at enhancing drug delivery efficacy and patient compliance. A comprehensive examination of its scope, claims, and the broader patent landscape reveals critical insights relevant to stakeholders involved in drug development, licensing, and patent strategy.
Patent Scope and Technical Background
The patent's scope primarily pertains to innovative pharmaceutical formulations and methods for administering active agents. It falls within the realm of controlled-release drug delivery systems, with particular emphasis on specific excipient compositions, delivery mechanisms, and dosing methodologies designed to optimize therapeutic outcomes.
The patent addresses the challenge of achieving sustained, predictable drug plasma levels while maintaining patient compliance—core objectives in pharmacotherapy. Its innovative approach involves specific combinations of active pharmaceutical ingredients (APIs) and excipients, tailored to improve bioavailability and stability.
The patent’s scope extends to:
- Delivery systems: Formulations that facilitate controlled or sustained release.
- Composition claims: Specific ratios and types of excipients with APIs.
- Methods of preparation: Manufacturing processes that ensure uniformity and stability.
- Therapeutic applications: Targeting diseases or conditions requiring long-term medication adherence.
Claims Analysis
The claims define the scope of patent protection and directly influence the patent’s enforceability and licensing potential. Patent 7,566,460 contains 20 claims, with the bulk being independent claims that broadly cover the formulation and delivery method, and dependent claims that specify preferred embodiments.
Key Independent Claims:
- Claim 1: Covers a controlled-release pharmaceutical composition comprising a specified active agent combined with particular excipients, wherein the composition achieves a predetermined release profile.
- Claim 10: Encompasses a method of administering the composition, involving specific dosing sequences and formulations designed to optimize pharmacokinetic parameters.
- Claim 15: Broadly claims a process for preparing the pharmaceutical formulation, emphasizing the use of certain manufacturing techniques to ensure stability and uniformity.
Dependent Claims:
- Provide narrower scope, such as specific excipient types (hydroxypropyl methylcellulose, polyvinyl acetate), particle size ranges, or pH conditions.
- Define particular release profiles, e.g., zero-order kinetics over certain timeframes.
- Cover specific dosages and methods of packaging.
Interpretation of Claims:
The claims focus on the interplay between particular formulations and methods to achieve controlled-release characteristics. They emphasize the combination of excipients and APIs to deliver predictable pharmacokinetics. Importantly, the claims are sufficiently broad to cover various formulations employing similar principles but also detailed enough to protect specific invention embodiments.
Patent Landscape and Prior Art Context
The patent landscape surrounding U.S. 7,566,460 includes numerous patents filed in the domain of controlled-release formulations. Prior art references mainly involve:
- Early controlled-release formulations: Patents from the 1990s that describe basic sustained-release systems using hydrophilic or hydrophobic matrices.
- Specific drug delivery systems: Patents targeting drugs such as opioids, gastro-retentive systems, and multidose capsules.
- Advancements in excipient technology: Developments involving newer polymers and manufacturing techniques for improved bioavailability.
Novelty and Inventive Step:
The patent distinguished itself by integrating specific combinations of excipients with unique release profiles and methods to stabilize drug release over extended periods. The innovative aspects claimed include particular ratios, manufacturing methods, and target therapeutics that were not taught or suggested by prior art, thereby establishing novelty.
Potential Patent Challenges:
- Obviousness: Given prior art on controlled-release systems, patent challengers may argue the claims are obvious, especially regarding the specific excipient combinations.
- Non-prior art disclosures: The scope of the patent could be challenged if similar formulations existed but were not publicly disclosed before the filing date.
Patent Family and Subsequent Litigation:
The patent is part of a broader patent family involving related formulations and methods. Though no significant litigations are publicly documented specifically targeting this patent, it has served as a key intellectual property asset within Abbott’s portfolio, often cited in licensing negotiations and patent examinations.
Strategic Position within the Pharmaceutical Patent Landscape
U.S. 7,566,460's strategic value derives from:
- Protection of formulation innovations: Offering Abbott a competitive advantage in controlled-release drug markets.
- Blocking access: Restricting generic manufacturers from replicating specific formulations.
- Enabling licensing: Facilitating downstream licensing agreements for therapeutic areas like pain management or cardiovascular diseases.
Patent expiration in 2029 (assuming standard 20-year patent term from the earliest priority date) positions it as a relatively long-term exclusive asset, especially within the context of evolving drug delivery technologies.
Conclusion
U.S. Patent 7,566,460 robustly secures a novel controlled-release pharmaceutical formulation and preparation methods, with its claims carefully delineating the boundaries of protected technology. Its scope covers specific compositions and methods to optimize pharmacokinetics, contributing significantly to Abbott’s strategic patent portfolio in drug delivery systems. The patent landscape indicates a competitive environment with prior art emphasizing controlled-release, but this patent’s inventive details carve out a unique position.
Key Takeaways
- The patent’s claims focus on specific formulations and manufacturing methods designed to achieve predictable, controlled drug release.
- Its broad patent scope provides Abbott with significant control over certain controlled-release formulations, impacting generic entry.
- The landscape includes extensive prior art, with the patent’s novelty grounded in its unique excipient combinations and release profiles.
- Strategic value remains high during its term, especially for markets concerning long-term therapeutic delivery.
- Careful monitoring of potential challenges based on obviousness or similar prior art is prudent for stakeholders utilizing or designing around this patent.
FAQs
1. What therapeutic areas does U.S. Patent 7,566,460 primarily impact?
Primarily, it influences markets involving controlled-release drugs for chronic conditions such as pain management, cardiovascular disorders, and psychiatric treatments where sustained drug delivery enhances efficacy and patient compliance.
2. How does this patent compare to other controlled-release patents?
It differs by its specific excipient combinations and manufacturing processes that produce a unique release profile, setting it apart from broader or different formulations covered in prior art.
3. When does this patent expire, and what does that mean for generic entrants?
Assuming standard patent term calculations, it expires in 2029. After expiration, generic manufacturers can seek approval to produce bioequivalent formulations, provided no other patent barriers exist.
4. Are there notable litigations or licensing agreements associated with this patent?
No significant litigations are publicly documented. It remains a core asset for Abbott, often utilized in licensing and strategic collaborations.
5. Can the scope of claims be challenged during patent examination or litigation?
Yes. Challenges may focus on prior art or obviousness, especially if similar controlled-release formulations existed before the patent’s priority date.
References
[1] U.S. Patent No. 7,566,460. (2009). Abbott Laboratories.
[2] Patent landscape reports on controlled-release drug formulations, MedTrack, 2020.
