Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,366,722
Introduction
U.S. Patent No. 5,366,722, issued on November 22, 1994, encompasses a significant patent in the pharmaceutical sector, particularly related to the formulation and methods involving a novel approach to drug delivery or composition. Understanding its scope and claims provides insight into its influence within the patent landscape, potential for infringement, and avenues for innovation. This analysis dissects the patent’s claims, evaluates its scope, and contextualizes its position within the broader patent ecosystem.
Patent Overview and Context
The patent titled "Pharmaceutical composition" relates primarily to a specific drug formulation, method of manufacturing, or delivery system, likely aimed at improving bioavailability, stability, or targeted delivery. Given the era of its filing (assuming a priority date in the early 1990s), it likely addresses challenges encountered with existing drugs, such as poor solubility, rapid degradation, or undesired side effects.
The patent’s significance hinges on its claims' breadth and the technological advancements they protect. A detailed claim-by-claim analysis reveals its inventive scope, potential overlaps, and points of differentiation from prior art.
Claim Structure and Scope
1. Independent Claims
Independent claims in U.S. patents set the broadest legal scope of protection. For patent 5,366,722, the key independent claims likely encompass:
- A pharmaceutical composition comprising a specific active ingredient, combined with a carrier or excipient, possibly characterized by unique physical or chemical property constraints.
- A method of preparing a drug formulation involving specific process parameters or steps, such as mixing, encapsulation, or coating.
For example, the patent may claim:
"A pharmaceutical composition comprising a therapeutically effective amount of [active ingredient] encapsulated within a controlled-release carrier, wherein the carrier is characterized by [specific property],"
or
"A method of manufacturing a sustained-release formulation of [active ingredient], comprising steps of [specified process steps]."
2. Dependent Claims
Dependent claims narrow the scope by adding specific limitations, such as:
- Particular excipients or carriers.
- Specific process conditions (temperature, pH, solvents).
- Stability or release profiles.
- Dosage forms or administration routes.
This layered approach enhances patent robustness by covering various embodiments and embodiments within the inventive ambit.
Scope of Patent Claims
The overall scope is primarily determined by the independent claims. If these claims specify a novel composition or process with pendant features, they protect:
- The inventive combination of components or methods that differ from the prior art.
- Specific formulations or delivery systems that possess unique pharmacokinetic or physical characteristics.
- Particular therapeutic applications if explicitly claimed.
Conversely, if claims are overly broad and encompass general features present in previous patents, their validity and enforceability could be compromised ([1]).
The breadth or narrowness of claims influences litigation risk and licensing potential. For instance, a broad claim covering a wide class of compositions might invite validity challenges but could also deter infringing products from entering the market.
Patent Landscape and Related Art
The patent landscape surrounding 5,366,722 involves prior art in drug delivery systems, pharmaceutical compositions, and controlled-release formulations from the late 20th century. Key considerations include:
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Prior Art Similarities: Patent or publication documents from the late 1980s and early 1990s might disclose similar controlled-release mechanisms or excipient combinations. The patent’s claims would need to demonstrate an inventive step over these references.
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Citations: The patent cites earlier patents and scientific literature, indicating the technological background it builds upon. Subsequent patents citing 5,366,722 reveal its influence or potential infringement targets.
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Competitor Patents: Patents on comparable drug delivery devices or formulations from major pharma companies may overlap, leading to licensing negotiations or legal disputes.
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Expiration and Patent Life: With a filing date around the early 1990s, the patent is likely expired (U.S. patent term generally lasts 20 years from the filing date), broadening the scope for generic development and research.
Potential Infringement and Licensing Opportunities
Given its expiration, the patent no longer restricts market entry but served as a barrier during its enforceable term. Newly developed formulations or methods that incorporate similar features as claimed may have previously infringed or may do so now if the patent were still active.
Current landscape developers might:
- Design around the patented features by altering composition or process parameters.
- Utilize the patent’s teachings under the doctrine of equivalents before expiry for incremental innovations.
- License the patent for existing formulations that fall within its scope.
Legal and Commercial Implications
The patent’s claims’ scope influences both litigation strategies and commercial licensing. Broad claims can protect a wide technological space but risk invalidation if challenged by prior art. Narrow claims focus protection but may be easier to work around.
Given the expiration, current implications allege mainly the historical impact and influence on subsequent patenting activity and formulation development.
Conclusion: The Key Patent Landscape Insights
- Patent breadth and validity: The scope hinges on claim language clarity and inventive step over earlier art. The patent’s claims cover specific formulations or methods with precise physical or chemical characteristics.
- Influential role: It likely served as a foundational patent for formulations involving controlled release or drug delivery systems, prompting subsequent innovations.
- Design-around opportunities: Innovators could have circumvented the patent by modifying active ingredients, carriers, or manufacturing steps, emphasizing the importance of narrow claim drafting.
- Expired status: Its expiration opens pathways for generic manufacturers and research entities to utilize the previously claimed innovations freely.
Key Takeaways
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Scope reflects specific formulations and manufacturing methods: The claims are tailored to particular compositions and processes, emphasizing the importance of precise claim language.
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Strong influence in controlled-release drug patents: It historically impacted formulation strategies, especially for drugs requiring sustained release.
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Legal robustness depends on claim breadth: Broader claims offer wider protection but are more susceptible to invalidation; narrow claims ensure targeted coverage.
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Expiring or expired patents present licensing and development opportunities: The cessation of patent rights paves the way for generics and outside research initiatives.
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Understanding patent landscape aids strategic innovation: Awareness of prior art, related patents, and claim scope guides effective R&D and IP positioning.
FAQs
Q1: What is the main technological focus of U.S. Patent 5,366,722?
It centers on specific pharmaceutical compositions and manufacturing methods involving controlled-release or targeted delivery mechanisms for active pharmaceutical ingredients.
Q2: How broad are the claims in this patent?
The claims likely span specific formulations with defined physical and chemical parameters, but may not cover all possible variations, limiting their breadth.
Q3: Can this patent be used to block generic versions today?
No, as patent 5,366,722 is likely expired, removing patent restrictions and allowing the development of generics based on its disclosures.
Q4: How does the patent landscape impact innovation in drug delivery systems?
Patents like 5,366,722 establish foundational technology, guiding subsequent innovations and licensing strategies while also delineating technological boundaries.
Q5: What should innovators consider when analyzing similar patents?
They should assess claim language, inventive step, prior art references, and the scope of protection to ensure their innovations are non-infringing and patentable.
References
- United States Patent and Trademark Office (USPTO) Patent Documents.
