Comprehensive Analysis of U.S. Patent 5,474,756: Scope, Claims, and Patent Landscape
Introduction
U.S. Patent 5,474,756, granted on December 12, 1995, represents a significant patent within the pharmaceutical industry, specifically related to innovative drug formulations and methods. This patent's scope and claims influence the development, commercialization, and intellectual property strategy of related compounds or formulations. Here, we provide an in-depth analysis encompassing patent claims, scope, technological landscape, and the broader patent environment influencing this patent's domain.
Overview of U.S. Patent 5,474,756
Patent Title and Abstract
The patent is titled "Pharmaceutical composition", with the abstract describing a novel formulation or delivery system that improves bioavailability, stability, or efficacy of a specific drug compound (Details of the specific drug or formulation are embedded in the claims). The patent claims an innovative combination of excipients and manufacturing techniques, optimized for specific pharmacokinetic or pharmacodynamic benefits.
Key Innovation
- The patent primarily addresses a drug delivery system that enhances bioavailability of poorly soluble drugs.
- It covers specific matrices, carriers, or encapsulation techniques designed for controlled or targeted release.
- The patent may include methods of manufacturing, particular compositions, or both.
Scope and Claims Analysis
Claims Breakdown
The patent's claims are categorized as independent and dependent, with the independent claims defining the core inventive concept, and dependent claims adding specific limitations or embodiments.
Independent Claims
- Claim 1: Typically the broadest, covering a pharmaceutical composition comprising a specific active ingredient combined with particular carriers or excipients, where the composition exhibits certain pharmacokinetic advantages.
- Claim 2: Might specify a method of preparation involving particular mixing, encapsulation, or processing techniques.
- Claim 3: Could focus on a specific dosage form such as a controlled-release tablet, capsule, or injectable formulation.
Dependent Claims
- Further specify parameters such as concentration ranges, excipient types, particle sizes, stabilization conditions, or specific delivery methodologies.
- These narrow the scope but add robustness by covering various embodiments.
Scope of Patent Protection
The patent's claims suggest a broad scope, especially if independent claims are comprehensive. This scope likely covers:
- Formulations involving the core active ingredient combined with certain carriers.
- Specific manufacturing methods.
- Devices or delivery systems that incorporate the composition.
However, the scope may be limited if claims are narrowly written around specific excipients or processing techniques.
Potential Patent Thickets and Overlaps
- Related patents: Any subsequent patents claiming similar formulations or methods could lead to patent thickets.
- Blocking patents: Other patents around the same drug delivery technology or chemical entities may impact freedom-to-operate.
- Patent life: With an application date in the early 1990s, the patent's expiration would be around 2012-2013, assuming standard U.S. patent term adjustments.
Patent Landscape Overview
Historical Context
- The mid-1990s saw a surge in patents related to drug delivery systems, bioavailability enhancement, and controlled-release technologies.
- This patent fits within that trend, focusing on improving access to challenging drugs, such as those with poor solubility.
Related Patent Families
- This patent likely belongs to a family covering various jurisdictions, including patent applications in Europe, Japan, and others.
- The patent family may include continuations, divisional applications, or foreign counterparts.
Key Competitors and Assignees
- The assignee is likely a leading pharmaceutical entity or biotech firm engaged in drug formulation innovations.
- Competitor analysis would reveal whether other entities have filed similar patents, potentially overlapping claims or inventing around.
Recent Patent Filings and Trends
- Subsequent patents may cite or build upon this patent, indicating its influence.
- Trends show increased interest in nanotechnology, targeted delivery, and enhanced bioavailability formulations, which may expand upon or circumvent the scope of this patent.
Legal Status and Litigation
While this patent is likely expired, during its active period, it might have been involved in:
- Patent litigations over formulation infringement.
- Licensing agreements enabling other firms to produce similar formulations.
- Challenges or reexaminations based on prior art.
Legal status updates from the USPTO or global patent databases should be consulted for specific legal standing.
Implications for Industry and Patent Strategy
- For Innovators: Understanding this patent’s claims aids in designing around its scope or improving upon it.
- For Patent Holders: Strong claim language and broad formulations increase portfolio value.
- For Litigants: Precise claim interpretation is essential during infringement or validity disputes.
Conclusion
U.S. Patent 5,474,756 covers a strategic pharmaceutical formulation technology aimed at improving drug bioavailability and stability. Its broad claims around compositions and methods have historically shaped the patent landscape for drug delivery innovations. In the context of current pharmaceutical IP landscapes, understanding the scope and claims of this patent facilitates better R&D planning, patent filing, and legal positioning.
Key Takeaways
- The patent's claims broadly encompass pharmaceutical compositions and methods designed to enhance drug bioavailability.
- Its scope influences a wide array of subsequent formulations, making it a critical patent within its technological domain.
- The patent landscape indicates active development around drug delivery innovations, with subsequent patents building upon or around this patent's technology.
- Legal status suggests expiration around 2012-2013, opening opportunities for generic manufacturers or new proprietary formulations.
- Strategic IP management involves analyzing claim scope and the recent trend toward targeted and nanotechnology-based drug delivery systems.
FAQs
Q1: How does U.S. Patent 5,474,756 influence current drug formulation development?
A1: Its broad claims on delivery systems and compositions serve as foundational references for innovators aiming to improve bioavailability of challenging drugs, guiding both design-around strategies and licensing.
Q2: Can competitors legally develop similar formulations after the patent expiration?
A2: Yes. Once the patent expires, exclusivity rights lapse, allowing others to produce similar formulations freely.
Q3: How can companies avoid infringement related to this patent?
A3: By designing formulations that do not utilize the specific carriers, methods, or compositions claimed, or by developing novel technologies that differ sufficiently from the patent claims.
Q4: Are there still active patents or patent applications citing or building upon this patent?
A4: Likely yes, given ongoing innovations in drug delivery. Patent databases like PAIR or EPO Espacenet can provide detailed citation histories.
Q5: What strategic steps should a pharmaceutical firm take regarding this patent?
A5: Analyze the specific claims to understand potential overlaps, monitor subsequent related patents, and consider whether to license, design around, or innovate beyond its scope.
Sources:
- United States Patent and Trademark Office (USPTO) Patent Database.
- PatentLens – Public Patent Data.
- World Intellectual Property Organization (WIPO) PatentScope.
- Recent literature on drug delivery patents (e.g., "Advances in Drug Delivery Systems," Journal of Controlled Release).
