Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,683,102
Introduction
United States Patent No. 6,683,102 (the '102 patent) was granted on January 27, 2004, to Alza Corporation. The patent pertains to oral controlled-release drug formulations, specifically compositions and methods designed to optimize pharmacokinetics through controlled-release mechanisms. An in-depth understanding of the scope and claims of this patent reveals its influence on the pharmaceutical landscape, especially in the realm of sustained-release formulations.
Scope of the Patent
The '102 patent focuses on innovative controlled-release pharmaceutical compositions, particularly oral dosage forms that facilitate prolonged and controlled drug release profiles. Its scope encompasses both the composition of the formulations and methods related to their preparation. The patent specifically targets drugs that benefit from extended-release formulations, aiming to optimize therapeutic outcomes, improve patient compliance, and reduce dosing frequency.
The patent’s scope extends to:
- Composition of matter: Drug formulations incorporating specific polymer matrices or coating systems to control drug release.
- Methodology: Processes for preparing these controlled-release formulations that ensure uniformity, stability, and predictable pharmacokinetics.
- Application: Particularly relevant for drugs with narrow therapeutic windows, short half-lives, or those requiring steady plasma concentrations.
Claims Analysis
The '102 patent contains a series of claims—broad and dependent—that delineate the scope and enforceability of the invention. A summary of the critical claims provides insights into patent protection and potential overlaps.
Independent Claims
The primary independent claim (e.g., Claim 1) generally defines the core invention:
-
Composition Claim: Claims directed to a controlled-release oral drug formulation comprising:
- An active pharmaceutical ingredient (API).
- A polymer matrix or coating material capable of modulating drug release.
- Specific parameters such as polymer types, drug-to-polymer ratios, or physical properties ensuring extended-release characteristics.
-
Method Claims: Claims encompassing the process of preparing such controlled-release formulations, often emphasizing specific steps like granulation, coating, or compression techniques.
Dependent Claims
Dependent claims elaborate on specific embodiments, such as:
- Use of particular polymers (e.g., methacrylate copolymers, hydroxypropyl methylcellulose).
- Specific release kinetics profiles (e.g., zero-order, first-order).
- Particular drug classes or molecules (e.g., opioids, NSAIDs, etc.).
- Additional features like taste-masking, stabilization, or rate-modifying excipients.
Claim Scope and Limitations
The claims aim to protect formulations that:
- Achieve sustained or controlled release over a predetermined period.
- Employ specified polymer systems or coating methodologies.
- Are suitable for oral administration and compatible with various APIs.
However, the scope is bounded by prior art, limiting claims to formulations with novel combinations or specific parameters not obvious in existing technologies. For example, patentability hinges on demonstrating unexpected results—such as improved bioavailability or reduced dose dumping.
Patent Landscape and Related Patents
The patent landscape surrounding the '102 patent includes:
- Prior Art: Pertinent references such as earlier sustained-release patents, like U.S. Patent No. 5,756,417 (Alza), and European counterparts.
- Cited Art: The '102 patent references multiple prior art documents that describe controlled-release polymer matrices, coatings, and process technologies.
- Follow-on Patents: Numerous subsequent patents have cited or built upon the '102 patent, exploring advanced polymer systems, multi-layer formulations, or targeted delivery mechanisms.
Notably, the '102 patent's lifespan overlaps with significant patent families covering phoneline and bioavailability enhancements, encouraging competitors to design around its claims via alternative polymers or novel release mechanisms.
Legal Status and Patent Term
As a patent granted in 2004, the '102 patent's original term would expire around 2022, considering the standard 20-year term from filing. However, patent term extensions or supplementary protection certificates (SPCs) could have extended exclusivity for certain jurisdictions or formulations, particularly if regulatory delays occurred.
Impact on Industry and Innovation
The '102 patent played a strategic role in the development of controlled-release formulations for various drugs—particularly those requiring steady plasma levels—by providing a robust patent estate around advanced polymer matrices and manufacturing processes. It fostered subsequent innovations and settlement agreements, shaping competitive landscapes in the sustained-release drug industry.
Conclusion
The '102 patent's scope primarily covers controlled-release oral pharmaceutical compositions utilizing specific polymer matrices and processes that modulate drug release. Its claims protect formulations with particular release kinetics, drug-to-polymer ratios, and manufacturing routes. The patent landscape remains complex, with overlapping patents and continuous innovations building upon its foundational concepts.
Key Takeaways
- The '102 patent's claims are broad in defining sustained-release formulations but are bounded by prior art, demanding specificity for patentability.
- Its enforcement and licensing strategies influence market access for controlled-release drug products.
- The patent landscape indicates ongoing innovation in polymer technology and delivery mechanisms in the controlled-release space.
- Companies developing new formulations must consider existing patents like the '102 patent to avoid infringement or to design around protected claims.
- Patent expiration or legal challenges could open opportunities for generic manufacturers and biosimilar developers to introduce similar products.
FAQs
1. What therapeutic areas does the '102 patent primarily impact?
It mainly influences formulations for drugs requiring controlled plasma concentrations, including analgesics, cardiovascular drugs, and neurological agents.
2. Can the claims of the '102 patent be directly enforced against generic competitors?
Enforcement depends on the specific claims and whether the generic formulations infringe these claims. Post-expiration, these formulations typically enter the market freely unless extended protections apply.
3. How does the '102 patent relate to other patents in the same space?
It is part of a broader patent family addressing controlled-release systems; many subsequent patents cite or seek to improve upon aspects disclosed here.
4. Are there known legal disputes involving the '102 patent?
There are no publicly documented litigations directly involving the '102 patent, but it has influenced settlement agreements and licensing deals within the industry.
5. What innovation opportunities exist after the patent's expiration?
Post-expiration, companies can explore new polymers, multi-layered systems, or targeted delivery methods to develop alternative sustained-release formulations.
References
[1] U.S. Patent No. 6,683,102, granted Jan. 27, 2004.
[2] Prior art: U.S. Patent No. 5,756,417, Alza (1998).
[3] Relevant literature on controlled-release formulation strategies and polymer matrices.
