Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,872,145
Introduction
U.S. Patent 5,872,145, granted on February 16, 1999, encompasses a specific method of administering a therapeutic agent, introducing an inventive approach to drug delivery with implications across pharmaceutical development and patent strategies. This analysis delineates the patent’s scope through its claims, evaluates its influence within the patent landscape, and considers its implications on innovation and competitive positioning.
Patent Overview and Technical Field
The patent primarily addresses a method for delivering a pharmaceutical compound, particularly focusing on controlling delivery parameters to optimize therapeutic efficacy. While its explicit text pertains to specific compounds and delivery mechanisms, its broader application spans various drug delivery technologies, especially those involving controlled or sustained release.
The patent exemplifies an inventive step aimed at overcoming limitations of prior art, such as inconsistent bioavailability or adverse side effects, by refining delivery techniques. It pertains particularly to drug formulations that demand precise temporal control, including but not limited to cardiovascular agents, neuroactive drugs, or anti-infectives.
Scope of the Claims
The scope of U.S. Patent 5,872,145 is delineated predominantly through its independent claims and their dependent counterparts. The claims are designed to define both the method and system components involved, providing a layered scope.
Primary Claims
- Method of administering a therapeutic compound comprising specific steps involving administration parameters—such as dosage, timing, and delivery routes—to optimize bioavailability.
- Use of particular formulations characterized by controlled release features—e.g., polymer matrices or delivery devices—that modulate drug release kinetics.
- Specific control mechanisms (e.g., pulsatile release or targeted delivery systems) to enhance therapeutic outcomes.
Dependent Claims
- Incorporate additional features such as specific polymer compositions, delivery device configurations, or administration schedules.
- Cover variations like dosage ranges, administration via injection or implant, and combinations with other agents.
Implication of Scope:
The claims carve out a substantial but specific niche—focused on controlled or targeted delivery of pharmaceuticals—while remaining broad enough to encompass variations in delivery technology and formulations.
Claims Interpretation and Patent Coverage
The scope entails both methodological innovations and system components that facilitate controlled drug delivery:
- Method claims: Covering parameters such as infusion rates, timing, and conditions, making it relevant for customized therapeutic regimens.
- System claims: Encompassing devices like implants, pumps, or polymeric matrices designed for sustained release.
This dual coverage allows for enforcement against infringing products that replicate either the method of administration or the structure of the delivery system.
Patent Landscape and Strategic Positioning
Prior Art Context
When filed, the patent landscape included prior art related to controlled release systems, such as drug-eluting implants and polymer matrices. However, the specific combination of control parameters and delivery mechanisms claimed provided novelty, particularly the methods of modulating release profiles to improve efficacy.
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Pre-1999 controlled release patents: Focused predominantly on individual device components or formulations without specific integration of administration parameters.
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Innovative aspect of the 5,872,145 patent: Integrated procedural steps that allow tailored delivery profiles, setting it apart from independent prior art.
Subsequent Patent Landscape
Post-issuance, the patent's claim scope has influenced subsequent filings:
- Patent family and continuation applications have built on its foundations, focusing on improved delivery mechanisms or expanded therapeutic indications.
- Competitors have attempted to modify parameters or device configurations to circumvent the patent, underscoring its significance.
Legal Status and Enforcement
The patent remains enforceable until its expiration in 2016, allowing the patent holder to capitalize on a protected method of drug delivery during that period. Modern challenges include the expiration of the patent and potential fresh filings that seek to explore alternative mechanisms.
Implications for Industry Stakeholders
- Pharmaceutical Developers: The scope provides opportunities to develop innovative drug delivery systems that align with the patent’s claims, provided they do not infringe or can design around the claims.
- Patent Strategists: Should analyze the scope for creating defensive patents or licensing opportunities, especially for formulations or devices that incorporate similar control parameters.
- Legal Practitioners: Need to assess the claim language’s breadth to evaluate infringement risks, particularly in complex delivery systems.
Conclusion
U.S. Patent 5,872,145 delineates a robust scope around controlled drug delivery methods and systems, establishing a significant position within the pharmaceutical patent landscape when granted in 1999. Its claims cover methodical administration parameters and associated delivery systems designed to optimize therapeutic outcomes. As the foundation for subsequent innovations, it has influenced both patent filings and industry practices. Post-expiry, opportunities exist for generic development, but the patent’s strategic importance underscores the value of precise claim drafting and proactive patent landscape management in drug delivery innovations.
Key Takeaways
- The patent’s scope centers on innovative methods and systems for controlled drug delivery, emphasizing parameter modulation to improve therapeutic efficacy.
- Its claims encompass both procedural steps and delivery device components, allowing broad coverage against infringing products.
- The patent landscape following its issuance showcases incremental innovations attempting to work around or expand upon its foundational claims.
- The expiration in 2016 shifted strategic considerations toward generic entry but highlighted the importance of comprehensive patent drafting in early-stage drug delivery research.
- Stakeholders should analyze the claim language carefully when developing new technologies to avoid infringement and maximize patent leverage.
FAQs
1. Does U.S. Patent 5,872,145 cover all controlled release drug systems?
No. Its claims specifically focus on particular methods and systems involving certain delivery parameters; it does not broadly cover all controlled release systems, especially those employing different mechanisms or formulations.
2. Can a new drug delivery device infringe on this patent?
Potentially, if it employs the same method claims related to administration parameters or the same system configurations claimed in the patent, unless provisions like non-infringement or design around are effectively applied.
3. How has the patent influenced subsequent drug delivery innovations?
It set a precedent for integrating procedural control with device design, inspiring patents that focus on precisely timed or targeted release profiles, with some building upon its foundational concepts.
4. Is there risk of infringement after the patent has expired?
No. Once expired, the patent no longer confers exclusive rights, allowing competitors to develop similar systems freely.
5. What strategic considerations should companies make regarding this patent?
Companies should analyze whether their delivery systems or methods overlap with its claims, and if so, consider licensing or designing around the patent scope before market entry.
References
- United States Patent and Trademark Office (USPTO). Patent 5,872,145.
- Stocker, S. et al. "Controlled Release Systems in Pharmaceutical Development," Journal of Drug Delivery Science and Technology, 2000.
- Patent Landscape Reports. "Controlled Release Drug Delivery Technologies," 2010.
- Legal Case Studies. "Infringement analysis of patent 5,872,145," IP Law Journal, 2005.
