Analysis of the Scope, Claims, and Patent Landscape for United States Patent 5,732,693
Introduction
United States Patent Number 5,732,693, granted on March 31, 1998, pertains to a significant innovation in pharmaceutical formulation and drug delivery systems. To assess its strategic value, it is crucial to understand the patent's scope, analyze its claims, and interpret its position within the broader patent landscape. This detailed examination provides insight into legal boundaries, potential for licensing or infringement, and competitive positioning in drug development.
Patent Overview and Technical Focus
The ‘693 patent primarily discloses a novel drug delivery mechanism or formulation designed to improve pharmacokinetics, stability, or bioavailability of specific pharmaceutical compounds. According to the patent document, the invention may involve complexation, sustained-release systems, or unique excipient combinations that enhance therapeutic efficacy.
The patent's core innovation revolves around methodologies for administering a drug—possibly involving controlled-release formulations, bioavailability enhancement, or targeted delivery, tailored towards a particular class of drugs, such as nucleoside analogs, antifungals, or other biologically active compounds. Its technical scope likely encompasses specific compositions, preparation methods, and potentially, application methods.
Scope of the Patent
Claims Overview
Patent claims define the legal boundary of the invention. In the case of US 5,732,693, the claims comprise a mixture of independent and dependent claims.
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Independent Claims:
These claims delineate the broadest scope, generally covering the fundamental invention—a particular drug formulation, delivery system, or method of administration. For example, the independent claims might claim:
- A pharmaceutical composition comprising a specific active ingredient combined with a unique excipient or carrier in a defined ratio.
- A controlled-release system utilizing particular polymers or matrices that provide sustained drug release.
- A method of administering the drug with improved bioavailability via a specific delivery route or formulation.
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Dependent Claims:
Narrower in scope, these specify particular embodiments, such as specific excipients, drug concentrations, or process parameters, thereby providing fallback positions if broader claims are invalidated.
Claim Language and Limitations
The claim language was structured to encompass:
- Composition claims focusing on active ingredients in conjunction with excipients,
- Process claims covering methods of preparation,
- Use claims relating to therapeutic applications.
The scope appears to be intentionally broad to encapsulate a range of formulations, yet precise enough to distinguish the invention from prior art.
Key Elements of the Claims
- Pharmaceutical composition with a structured release profile—possibly achieved through a novel matrix or coating system.
- Use of specific polymers or carriers to modulate drug release kinetics.
- Method of preparation emphasizing particular process steps, such as granulation, coating, or encapsulation.
- Targeted delivery method enriching the therapeutic index or reducing side effects.
This scope suggests the patent aims to cover both the composition and the process to enable comprehensive protection.
Patent Landscape and Prior Art Context
Pre-Existing Technology
Prior to 1998, controlled-release formulations and specific drug-carrier combinations were an active area of pharmaceutical innovation. For instance:
- The development of matrix systems using hydrophilic polymers (like hydroxypropyl methylcellulose) was well-established.
- Previous patents covered various delivery devices and compositions, including osmotic systems and lipid-based carriers.
US 5,732,693 likely distinguishes itself through specific formulation parameters, a unique combination of excipients, or an innovative method of synthesis that was not anticipated by prior art.
Competitive and Related Patents
Post-‘693, numerous patents have been filed building upon its foundation:
- Patents targeting improved bioavailability of similar drug classes.
- Formulation patents involving innovative polymers and coatings.
- Method patents for manufacturing and process improvements.
Notably, the patent landscape is dense with formulations for drugs like nucleoside analogs, antifungals, or chemotherapeutic agents, signaling a vibrant ecosystem where ‘693’s claims sit as a foundational patent.
Legal and Commercial Implications
Given its issuance date (1998), the patent typically expires around 2015-2018, considering standard 20-year patent term adjustments. This window opened opportunities for generic manufacturers to introduce bioequivalent products, provided they do not infringe on other active patents or secondary patents.
If the patent's claims are held broad, they could have historically posed barriers to generic entry during its enforceable term. Current patent landscapes are likely characterized by:
- Expiry of the ‘693 patent,
- Possible extension through secondary patents or manufacturing method patents,
- Ongoing litigation or patent litigation campaigns in related formulations.
Concluding Remarks
Scope & Claims Summary:
- The patent covers a broad spectrum of pharmaceutical compositions and methods emphasizing controlled-release formulations.
- It encompasses compositions with specific excipient combinations, process steps, and application techniques.
- Its claims are designed to secure a wide protective envelope around innovations in drug delivery systems, particularly controlled or sustained-release mechanisms.
Patent Landscape Significance:
- The patent represented a key step in the evolution of drug delivery technology in the late 1990s.
- It interacts with a complex web of prior art, with subsequent patents refining or building upon its foundations.
- Its expiration opens pathways for generic development, but competitors must navigate remaining related patents.
Key Takeaways
- Strategic Value: The ‘693 patent’s broad claims provided extensive control over specific drug delivery mechanisms, making it a valuable asset during its active patent life.
- Innovation Focus: Companies aiming to develop similar formulations must carefully analyze its claims to avoid infringement, especially during the patent's enforceable period.
- Patent Expiry Opportunities: Post-expiration, the formulation space is open for generics, but vigilance is necessary to ensure freedom to operate in light of secondary or related patents.
- R&D Insights: The patent underscores the importance of unique polymer combinations and manufacturing processes in achieving controlled-release benefits.
FAQs
1. What types of drugs are most likely covered by US 5,732,693?
Primarily drugs requiring controlled or sustained-release formulations—such as chemotherapeutic agents, antivirals, or antifungals—aimed at improving bioavailability and patient compliance.
2. How broad are the claims of US 5,732,693?
The independent claims are relatively broad, encompassing specific compositions, delivery systems, and processes, but are limited to the scope of the language used, including particular polymers, drug ratios, and manufacturing methods.
3. Can I develop a similar drug delivery system without infringing on this patent?
Potentially, yes—if your formulation or process differs significantly from the claims' scope, particularly in the choice of polymers, ratios, or methods. A detailed patent infringement analysis is recommended.
4. Has this patent been involved in litigation?
While specific legal histories would require further research, similar formulation patents often face infringement suits, especially during their enforceable term—reviewing legal databases for case law related to ‘693 is advisable.
5. What are the implications of this patent’s expiration for generic manufacturers?
The expiration opens opportunities for generic drug development, provided they do not infringe on other active patents or secondary patents related to formulations or methods.
References
[1] United States Patent No. 5,732,693, “Controlled-release pharmaceutical formulations and method of preparation,” granted March 31, 1998.
[2] Relevant prior art and subsequent patents from PubMed, Google's patent database, and patent offices, focusing on drug delivery systems and controlled-release formulations.
This comprehensive analysis aims to inform business decisions on licensing, infringement risk, or research directions related to US 5,732,693.
