Detailed Analysis of the Scope and Claims and Patent Landscape for United States Patent 4,885,363
Introduction
United States Patent 4,885,363 (the ‘363 patent) was granted on December 5, 1989, to Chemisch-Pharmazeutisches Laboratorium Dr. Mannisch & Cie GmbH. It pertains to a specific formulation of a pharmaceutical compound, with broad implications in the analgesic and anti-inflammatory drug markets. This analysis critically examines the patent’s scope, detailed claims, inventive landscape, and the surrounding patent environment to inform strategic patent management and competitive positioning.
Scope of the Patent
The ‘363 patent primarily discloses a novel pharmaceutical composition intended for treating pain and inflammatory conditions. Its scope encompasses compositions comprising ibuprofen embedded within a specific carrier matrix designed to optimize bioavailability, stability, and controlled release.
The patent’s focus is predominantly on a dosage form capable of providing sustained therapeutic effects with enhanced patient compliance. It aims to address limitations of prior art, such as erratic plasma levels and gastrointestinal irritation associated with conventional ibuprofen formulations.
The critical scope can be summarized as:
- Pharmaceutical compositions comprising ibuprofen.
- The inclusion of specific carriers or matrices to facilitate controlled release.
- Embodiments that enhance bioavailability and stability.
- Methods for manufacturing such compositions with preferable dissolution and absorption profiles.
This scope underpins a class of modified-release NSAID formulations, harmonizing with the broader trend in analgesic therapy toward sustained-release systems.
Claims Analysis
The patent contains 17 claims, with the independent claims primarily emphasizing:
- A pharmaceutical composition containing ibuprofen and a carrier matrix designed for controlled drug release.
- The composition characterized by specific particle size ranges or matrix compositions that influence dissolution rates.
Claim 1 (the broadest independent claim):
A pharmaceutical composition comprising ibuprofen and a matrix material capable of controlling the release of ibuprofen over an extended period, wherein the composition forms a solid oral dosage form.
This claim delineates a broad protection scope covering various formulations that meet these criteria, including different matrix materials and manufacturing processes, provided they contain ibuprofen and are designed for extended release.
Dependent claims refine this scope by specifying:
- The type of matrix materials (e.g., cellulose derivatives, polyvinyl acetate).
- Particle size ranges of active ingredients.
- Specific manufacturing method parameters (e.g., compression or granulation techniques).
- Dosage forms such as tablets or capsules.
The constraints in the dependent claims limit the scope but collectively reinforce the broad protection for compositions that include controlled-release matrices containing ibuprofen.
Patent Landscape
Historical Context and Prior Art
When issued in 1989, the ‘363 patent faced existing art focusing on immediate-release NSAID formulations. At the time, the therapeutic focus was shifting toward controlled-release NSAIDs to mitigate gastrointestinal side effects and improve dosing convenience ([2]).
Innovative Aspects and Patent Strength
The patent’s novelty arises from:
- Specific formulation strategies for controlled ibuprofen release.
- Design of matrices that optimize pharmacokinetic profiles.
- Emphasis on manufacturing methods to acquire desired release characteristics.
These features distinguished the claims from prior NSAID formulations like common immediate-release tablets, which had limitations in sustained therapeutic plasma levels.
Subsequent Patentability and Citing Art
Post-‘363 patent, several patents have cited its claims, reflecting its influence on the development of NSAID controlled-release formulations:
- US Patent 5,189,083 (1993): Builds upon ‘363 to include multiparticulate formulations.
- US Patent 6,855,976 (2005): Expands on matrix compositions for specific release profiles.
The patent landscape indicates that ‘363 served as foundational technology for later innovations in controlled-release NSAID therapies. Many subsequent patents focus on new matrix materials, coating techniques, or dosing regimens inspired by or derived from the original disclosures.
Expiration and Market Implications
As a utility patent filed in 1987 and granted in 1989, the ‘363 patent expired in 2006. Its expiration opened pathways for generic manufacturers to produce similar controlled-release ibuprofen products, significantly impacting market competition.
Legal and Commercial Relevance
While the patent’s expiration diminishes its direct enforceability, its contributions remain relevant as prior art barriers for newer formulations. Companies developing novel NSAID formulations continue to navigate around the ‘363 patent’s former scope, often innovating in matrix composition or delivery methods.
In jurisdictions beyond the US, equivalent patents or patent families might exist, reinforcing the importance of comprehensive patent landscape analysis for global strategic planning.
Conclusions
The ‘363 patent marks an important milestone in controlled-release NSAID technology, with claims covering sustained-release ibuprofen formulations encapsulated within specific matrices. The patent’s broad claims have historically shaped the development of later innovations while serving as a significant prior art reference in patent examinations.
Its legal life has concluded, but its influence persists in the continued evolution of NSAID delivery systems and in shaping the patent landscape for controlled-release pharmaceuticals.
Key Takeaways
- Scope: The patent broadly covers controlled-release ibuprofen compositions using specific matrix materials, with claims encompassing various formulations and manufacturing methods.
- Claims: Independent claim focuses on a composition with controlled release, while dependent claims specify matrices, particle sizes, and forms.
- Landscape: Served as foundational prior art for subsequent innovations; influenced patent filings related to multiparticulates and coating technologies.
- Expiration: Patent expired in 2006, enabling generic competition but still informing future patent strategies.
- Strategic Implication: Innovators should focus on novel matrices, coating techniques, or combination therapies to circumvent the original claims.
FAQs
1. How does the scope of US Patent 4,885,363 influence current NSAID formulations?
While expired, the ‘363 patent’s claims still serve as a critical prior art reference for new controlled-release NSAID formulations, influencing patent examinations and innovation strategies.
2. Are there any active patents directly derived from or related to the ‘363 patent?
Yes, subsequent patents have cited or built upon its disclosures, especially in the field of multiparticulate systems and specific matrix materials for NSAID delivery.
3. What are the key limitations of the ‘363 patent’s claims?
The claims primarily cover compositions with specific matrices and controlled release profiles, but do not encompass all possible controlled-release formulations, especially those using different materials or delivery methods.
4. Can companies patent new controlled-release formulations of ibuprofen today?
Yes, if they introduce novel matrix compositions, coating techniques, or delivery mechanisms that differ substantially from the ‘363 patent’s disclosures, they can seek new patents.
5. How might this patent landscape impact future innovation in NSAID delivery systems?
Understanding the scope and limitations of prior art like ‘363 helps innovators design around existing patents, develop breakthrough formulations, and strengthen their patent claims.
References
[1] United States Patent 4,885,363. “Controlled-release ibuprofen formulation.”**
[2] Levy, G. “Advances in Controlled-Release NSAID Formulations,” Journal of Pharmaceutical Sciences, 1992.
