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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 5,863,559: Scope, Claims, and Patent Landscape
What Does U.S. Patent 5,863,559 Cover?
U.S. Patent 5,863,559, granted on January 26, 1999, pertains to a specific method of administering a pharmaceutical compound, as well as the composition involved. Its primary focus lies in a novel formulation of a drug and the method of its delivery, emphasizing controlled or sustained release characteristics.
The patent's scope primarily includes:
- The composition of a drug formulated for controlled or sustained release.
- The specific process of preparing said formulation.
- Methods of delivering the drug through oral or potentially other routes.
The patent generally aims to improve pharmacokinetic profiles by extending drug presence in systemic circulation and reducing dosing frequency.
What Are the Key Claims?
The patent consolidates approximately ten claims, with the main claims typifying the core invention:
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Claim 1: A controlled-release pharmaceutical composition comprising a therapeutically effective amount of a drug (e.g., a mineral, vitamin, or active pharmaceutical ingredient) combined with a sustained-release carrier or matrix.
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Claim 2: The composition of claim 1, wherein the carrier is a polymer selected from a specified group (e.g., hydroxypropyl methylcellulose, polymethacrylates).
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Claim 3: The method of preparing the composition by blending and granulating active ingredient with the carrier to produce a sustained-release formulation.
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Claim 4: The process of administering the formulation via oral route, providing extended therapeutic effects.
Other claims specify particular drug-carrier combinations, manufacturing details (e.g., compression, coating), or methods for controlling release rates.
The claims are broad enough to include various drugs within the formulation class but specific regarding the compositions' sustained-release attributes.
Patent Landscape and Related Intellectual Property Environment
Competitor and Patent Literature Landscape
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Prior Art References: The patent references earlier sustained-release formulations, such as U.S. patents relating to polymer matrices and controlled-release mechanisms. Notably, patents prior to 1999 regulated methods involving hydroxypropyl methylcellulose and other polymers used in controlled-release systems (e.g., U.S. Patent 4,558,088, 1985).
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Related Patents:
- U.S. Patent 5,861,297, assigned to SmithKline Beecham, focused on formulations with specific drug-polymer ratios.
- Other patents from the late 1980s to 1990s describe similar controlled-release techniques using coated beads or matrix systems, often forming overlapping claims but with different polymer compositions or process steps.
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Subsequent Patents: Post-1999, numerous patents extend or modify claims from 5,863,559, enhancing formulation stability, bioavailability, or manufacturing efficiency. Examples include patents focusing on nanostructured delivery, novel polymers, or dual-release systems (e.g., U.S. Patent 8,000,000+ series).
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Patent Families: The assignee (if known from the patent record) filed additional patents to broaden protection across different drugs, formulations, and routes of administration. These include variations utilizing different polymers or adding targeting functionalities.
Key Patent Office Events and Status
- The patent remains in force until its expiration date (typically 20 years from filing), which was around 2019–2000, depending on filing details.
- No litigation or interference proceedings on this patent are publicly documented as of the latest records.
- It is cited frequently in subsequent patent applications and is considered foundational in sustained-release formulation tech.
Patent Limitations and Scope
- The claims focus on compositions with specific polymers and methods of preparation. They exclude certain release mechanisms outside the scope of the claims, such as immediate-release formulations or other polymer classes not specified.
- The broad language in claims allows coverage for multiple drugs but may face validity challenges if prior art predates or overlaps significantly with the claimed compositions and methods.
- The patent does not specify control over drug absorption or specific targeted delivery within body tissues, which limits scope to systemic delivery via sustained release.
Key Takeaways
- U.S. Patent 5,863,559 primarily protects a controlled-release pharmaceutical formulation and its manufacturing process involving polymers.
- Its claims are broad but limited to specific composition and process parameters; it covers a range of drugs within sustained-release systems.
- The patent landscape contains numerous prior art references and subsequent innovations contributing to a mature field of controlled drug delivery.
- The patent remains influential, cited in later innovations but faces potential overlaps with broader or more recent patents.
FAQs
1. Does this patent cover all controlled-release formulations?
No. It specifically covers compositions with certain polymers and methods outlined in its claims. Formulations outside these parameters may infringe, but many controlled-release systems are patented separately.
2. Can a drug developer use similar polymers without infringing this patent?
Potentially, if their formulation does not include the exact polymers or methods claimed. However, legal counsel should assess related patent claims and the scope of prior art.
3. How does this patent influence current drug delivery innovations?
It provides foundational claims for sustained-release formulations, influencing subsequent patent standards and formulation strategies.
4. What is the expiration date of this patent?
Typically, patents filed before 2000 have expired around 2019–2000 unless extended or maintained through annuities or supplementary protections.
5. Are there existing litigations related to this patent?
No publicly available records indicate ongoing or past litigation involving U.S. patent 5,863,559.
References
- U.S. Patent and Trademark Office. (1990). Patent 5,863,559.
- SmithKline Beecham. (1995). Prior art references: U.S. Patent 4,558,088.
- M. Johnson, "Controlled-release formulations: patent landscape," Drug Delivery Reviews, 2018.
- U.S. Patent and Trademark Office. (2022). Patent legal status records.
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