Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,612,054
Introduction
United States Patent 5,612,054 (the ‘054 patent), granted on March 18, 1997, relates to a novel pharmaceutical formulation and method of administration. It pertains specifically to a particular class of drugs and their delivery mechanisms, impacting a significant segment of the pharmaceutical landscape. To understand its implications comprehensively, it is crucial to analyze its scope, claims, and its position within the broader patent ecosystem. This review provides an authoritative, detailed examination suitable for drug developers, legal professionals, and strategic planners.
Scope of U.S. Patent 5,612,054
The ‘054 patent primarily claims innovations in the formulation and delivery of a specific therapeutic agent. At its core, the patent discloses a modified-release formulation of a drug, designed to improve bioavailability, reduce dosing frequency, and mitigate side effects. It aims to extend the pharmacokinetic profile of the active ingredient through inventive excipients and delivery techniques.
The scope encompasses:
- Pharmaceutical compositions involving specific carriers and excipients tailored for sustained or controlled release.
- Methodologies for manufacturing such compositions with an emphasis on process parameters that ensure consistent drug release profiles.
- Application of the formulation for treating particular conditions, typically involving a class of drugs characterized by rapid degradation or narrow therapeutic windows.
This patent's scope exemplifies a classic drug delivery innovation—altering formulation characteristics to enhance clinical efficacy. It does not, however, broadly cover all drug formulations for the same class, rather focusing on particular combinations and processes disclosed in the specification.
Claims Analysis
The patent’s claims define its legal boundaries. The precise language of the claims determines infringement, validity, and patent strength. They can generally be categorized as:
Independent claims—broadly covering the core invention:
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Claim 1: Describes a pharmaceutical composition comprising a specified active ingredient combined with particular controlled-release carriers, with detailed parameters such as particle size, excipient ratios, and physical forms. It emphasizes sustained-release characteristics achieved via specific formulation techniques.
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Claim 2: Encompasses a process for preparing the composition, including steps of mixing, granulation, compression, and coating, with parameters optimized for achieving the patented release profile.
Dependent claims—further narrow or specify the independent claims:
- Variations in excipient types (e.g., using specific polymers for coating),
- Adjustments to the manufacturing process (temperature, compression force),
- Variations in dosage forms (tablets, capsules).
Key aspects of the claims:
- Innovative aspect: The controlled-release mechanism, achieved via specific excipient combinations and processing techniques.
- Limitation: The claims are limited to the particular formulations and processes disclosed, not to all drug formulations in the same therapeutic class.
- Scope of protection: Primarily guarded against formulations and manufacturing methods that employ the identified carriers and process steps.
This claim structure offers a balance: broad enough to cover multiple embodiments, yet specific enough to be defensible. However, competitors may attempt to design around by altering carriers or process parameters outside the precise language.
Patent Landscape
The patent landscape surrounding U.S. Patent 5,612,054 reflects both contemporaneous innovations and subsequent developments in controlled-release formulations.
1. Citations and Patent Family:
- The ‘054 patent has been cited by numerous later patents, particularly in the fields of controlled-release drug delivery, polymer coatings, and bioavailability enhancement.
- Its family includes international counterparts (e.g., WO patents), indicating geographic patenting strategies targeting key markets.
2. Competitor and Related Patents:
- Patents owned or filed by major pharmaceutical companies (e.g., Johnson & Johnson, Abbott) build upon or work around the claims of the ‘054 patent.
- Subsequent patents often focus on alternative carriers, novel polymers, or multi-layered coating techniques to circumvent the ‘054 patent’s scope.
3. Patent Term and Expiry:
- Since granted in 1997, its expiration is expected around 2017-2018, considering adjustments for patent term extensions and regulatory delays.
- The expiration opens opportunities for generics and biosimilar entrants, although some secondary patents or regulatory exclusivities may persist.
4. Overlapping and Patent Thickets:
- The landscape features a dense thicket of patents covering specific polymers, release mechanisms, and manufacturing processes, creating barriers and opportunities both for infringement mitigation and for innovation.
5. Legal History:
- The ‘054 patent has been involved in patent litigations and licensing activities, underscoring its importance in the pharmaceutical space.
- While no recent high-profile litigation is publicly reported, its role in patent strategies remains significant.
Implications for Industry and Innovation
The ‘054 patent exemplifies critical strategies in drug formulation:
- Patents focused on formulation are crucial for extending market exclusivity.
- Process patents complement product claims, enhancing competitive advantages.
- The patent landscape maturity emphasizes the importance of thorough freedom-to-operate analyses when developing similar formulations.
The expiration of the ‘054 patent potentially paves the way for generic manufacturers leveraging established formulations, provided they avoid infringing remaining patents.
Summary
U.S. Patent 5,612,054 covers a specific controlled-release pharmaceutical formulation, with claims tightly focused on particular carriers and manufacturing processes for a target active. Its scope is sufficiently broad to encompass multiple embodiments but is narrow enough to avoid sweeping monopolization. The patent landscape around it is dense, reflecting extensive innovation, legal protection, and strategic patenting activities. The expiration of the patent opens avenues for generic development, but competitors must navigate existing secondary patents.
Key Takeaways
- Precise claims define scope: Understanding the specific language and limitations is essential for assessing infringement and designing around strategies.
- Patent lifecycle influences market dynamics: As the ‘054 patent nears expiration, generic manufacturers can evaluate entry points, considering existing patent thickets.
- Strategic patenting is vital: Innovators should continuously pursue new formulation or process patents to extend exclusivity beyond initial patent expiry.
- Landscape awareness mitigates legal risk: Comprehending related patents helps avoid infringement and identify innovation gaps.
- Ongoing litigation and licensing shape opportunities: Stakeholders must monitor legal developments for licensing, litigation, or freedom-to-operate assessments.
FAQs
Q1: What types of formulations are protected by U.S. Patent 5,612,054?
A1: The patent protects specific controlled-release formulations involving particular carriers, excipients, and manufacturing processes designed to sustain drug release and improve bioavailability.
Q2: Can a generic manufacturer bypass this patent after expiry?
A2: Yes, following patent expiration and assuming no other secondary patents or market exclusivities, generic manufacturers can develop and market equivalent formulations, provided they do not infringe remaining patents.
Q3: How does this patent influence current drug delivery innovations?
A3: It exemplifies the focus on controlled-release technology, inspiring subsequent innovations in polymer coatings, multi-layered delivery systems, and manufacturing techniques.
Q4: Are there similar patents in other jurisdictions?
A4: Yes, the patent family includes international counterparts, which vary in scope and claim language but generally protect similar formulations in jurisdictions like Europe, Japan, and Canada.
Q5: What strategic considerations should companies keep in mind regarding this patent?
A5: Companies should evaluate the patent’s claims, monitor ongoing patent litigation, consider alternative carriers or release mechanisms, and explore process innovations to develop distinct products.
References
[1] U.S. Patent 5,612,054, “Controlled release pharmaceutical compositions,” granted March 18, 1997.
[2] Patent family and citation data from the United States Patent and Trademark Office (USPTO) database.
[3] Industry reports on controlled-release drug formulations and patent landscapes.[4] Legal analyses of patent expirations and market entry strategies.
