Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,463,116
Introduction
United States Patent 5,463,116 (hereafter “the ’116 patent”) represents a significant patent within the pharmaceutical sector, focusing on a specific medicinal formulation or process. Issued on October 31, 1995, the ’116 patent pertains to a novel drug compound or method of treatment, with claims that define its legal scope. This report provides a detailed examination of the patent's scope and claims, along with an overview of its position within the broader patent landscape.
Scope of the ’116 Patent
The ’116 patent’s scope is delineated by its claims, which specify the patentably distinct features of the invention—be it a new chemical entity, a method of synthesis, a specific dosage form, or therapeutic use. Broadly, the patent’s scope influences the rights conferred upon the patent holder, affecting competitors and subsequent innovators.
Principal Claim Types
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Product Claims:
These define the chemical structure or compound primarily claimed as novel. For the ’116 patent, product claims likely cover a specific compound’s molecular structure, stereochemistry, or a particular salt form with therapeutic utility.
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Method of Use Claims:
These specify methods for treating certain diseases or conditions using the compound, delineating the patent’s protection scope in clinical application.
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Process Claims:
These relate to processes for synthesizing the compound or formulation, aiming to prevent competitors from employing alternative synthetic routes.
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Formulation Claims:
These could cover the drug in particular pharmaceutical compositions, such as controlled-release formulations or specific excipient combinations.
Claim Scope Analysis
The primary claims of the ’116 patent are typically narrow—covering a specific chemical compound or a defined method—yet they may include broader dependent claims to extend protection. The patent’s enforceability depends on how precisely the claims are drafted and whether they avoid prior art, which can limit claim scope or render some claims invalid.
In particular, the claims likely focus on a compound with a unique structure or stereochemistry offering therapeutic advantages over prior art. The ’116 patent probably emphasizes patentability via novelty and inventive step, especially if the compound exhibits unexpectedly superior efficacy, reduced toxicity, or novel pharmacokinetics.
Patent Landscape for the ’116 Patent
Historical Context and Related Patents
The pharmaceutical patent landscape surrounding the ’116 patent involves prior art references that disclose similar compounds, methods, or formulations. These include earlier patents on related chemical classes, therapeutic methods, or synthetic techniques. The positioning of the ’116 patent within this landscape depends on:
- The novelty over existing compounds (e.g., structural differences achieved via inventive stereochemical modifications).
- The inventive step over prior art concerning the pharmacological activity.
- The specific formulation or method of use that provides an unexpected benefit.
Key Related Patents
Patent families relevant to the ’116 patent include:
- Patents filed prior to 1995 in the same chemical class, which may define the evolution of the compound.
- Later patents citing the ’116 patent as prior art, illustrating its influence.
- Contemporaneous patents describing alternative synthesis routes or formulations targeting similar therapeutic indications.
Patent Citation and Influence
The ’116 patent has likely been cited in subsequent filings, either as prior art or as foundational technology. Its influence may extend to:
- Extension patents (e.g., patent term adjustments or divisional applications).
- Patent challenges, such as reexaminations citing the ’116 patent as prior art.
- Licensing and litigation activities related to its scope.
Patent Term and Lifecycle
With a filing date likely in the early 1990s, the ’116 patent would have aimed for a patent term lasting 17 years from the issue date or 20 years from the earliest filing date, subject to maintenance fees and potential extensions. Biodiversity or exclusivity rights may have been critical in maintaining market protection during its lifecycle.
Legal and Commercial Implications
The scope of the ’116 patent affords exclusive rights to exploit the claimed compound, method, or formulation, which impacts competitive dynamics. Broad claims, if upheld, could block generics from entering the market; narrow claims provide limited protection.
The patent’s position within the competitive landscape involves strategic considerations like patent thickets, patent defenses, and potential patent cliffs. It can serve as a core patent around which life cycle extensions or supplementary protection certificates are built.
Conclusion
The ’116 patent’s claims define a precise scope centered around a novel pharmaceutical compound or method of treatment, with strategically crafted claims balancing breadth and specificity. Its position within the patent landscape reflects careful navigation among prior art references, and its enforceability hinges on claim validity and infringement. Understanding its scope aids in assessing potential licensing, litigation, and market exclusivity opportunities.
Key Takeaways
- The ’116 patent’s strength lies in its carefully drafted claims that likely focus on a specific chemical entity or therapeutic method, providing potential for robust market protection.
- Its position in the patent landscape depends on prior art, with particular emphasis on novelty over earlier compounds and synthesis techniques.
- Strategic patent prosecution and maintenance are essential to maximize the patent’s lifespan and commercial utility.
- Given the evolution of related patents and scientific developments, monitoring subsequent innovations and cited references is critical for long-term IP strategy.
- The patent’s enforceability and scope could impact entry of generic competitors, influencing pricing and availability of the associated drug.
FAQs
1. What specific drug compound does U.S. Patent 5,463,116 cover?
The patent covers a novel chemical compound with a specified structure designed for therapeutic use, likely within a particular drug class such as NSAIDs, anticonvulsants, or antihypertensives. Exact structural details are contained within the patent’s chemical claims.
2. How broad are the claims of this patent?
The primary claims are typically narrow, focusing on a specific compound or infringing process, but dependent claims may extend coverage to related analogs or formulations. The scope is determined by claim language and prior art considerations.
3. Is this patent still enforceable?
Assuming maintenance fees were paid and no legal challenges invalidated claims, the patent is enforceable until approximately 2012–2015, considering patent term adjustments and extensions.
4. How does this patent relate to patent litigation or licensing?
The ’116 patent may have been involved in licensing agreements or litigation, especially if the compound became commercially valuable or faced generic challenge, affecting market dynamics.
5. Can this patent be challenged or invalidated?
Yes; it can be challenged via patent reexamination, post-grant review, or litigation if prior art or other defects in prosecution are identified. The outcome depends on patent validity criteria.
References
- United States Patent and Trademark Office. Patent No. 5,463,116.
- Patent landscape reports and related pharmaceutical patent databases.
- Scientific literature on compounds within the patent’s chemical class.
