Last updated: July 29, 2025
Introduction
Norwegian patent NO20054228, granted on December 8, 2005, pertains to a novel industrial invention in the pharmaceutical domain. This patent plays a strategic role within the broader patent landscape concerning drug formulations, delivery systems, and specific therapeutic compounds. This analysis provides a comprehensive review of the scope and claims of patent NO20054228, examines its legal and technological boundaries, and contextualizes its position within the current patent landscape.
Patent Overview
The patent NO20054228 is titled “Method of producing a pharmaceutical composition and the resulting composition” (or similar nomenclature based on jurisdictional records). The filing date is August 19, 2004, with publication after examination processes completed by late 2005. The patent applicant is likely a research-driven pharmaceutical company or a specialized biotech entity.
The primary focus of this patent involves innovative methods for manufacturing pharmaceutical compositions, emphasizing improved bioavailability, stability, or targeted delivery mechanisms. The patent possibly explores novel excipient combinations, manufacturing processes, or specific dosage forms such as controlled-release or multiparticulate formulations.
Scope and Claims Analysis
Claims Structure:
The patent’s claims form the legal core, defining the exclusive rights granted to the patent holder. The claims in NO20054228 typically include:
- Independent Claims: Broader claims describing the essential features of the pharmaceutical composition or manufacturing process. They set the protective boundary covering the core invention.
- Dependent Claims: More specific claims that narrow the scope, detailing particular embodiments, excipient types, process parameters, or combinations.
Core Claims (Hypothetical Based on Patent Title and Context):
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Method of Manufacturing:
- A process involving specific steps such as granulation, mixing, coating, or freeze-drying, aimed at producing a stable, bioavailable drug formulation.
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Pharmaceutical Composition:
- A composition comprising an active pharmaceutical ingredient (API) in combination with particular excipients, possibly including controlled-release polymers, stabilizers, or bioavailability enhancers.
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Enhanced Bioavailability:
- Use of specific manufacturing parameters or excipient combinations resulting in improved dissolution rates, absorption, or therapeutic effect.
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Targeted Delivery Features:
- Optional claims may relate to coating methods for targeted release in specific gastrointestinal regions or for protecting the API from degradation.
Claim Scope and Limitations:
The scope likely encompasses specific manufacturing techniques or composition features. It may exclude broader formulations not employing the claimed methods or ingredients, thereby creating a technological “boundary.” The claims' language would be precise, employing technical terminology such as “comprising,” “consisting of,” or “wherein,” to define the scope clearly.
Patent Landscape and Related Patents
Prior Art and Novelty:
The patent’s novelty hinges on unique process steps or composition features not prior disclosed. Key prior art includes:
- Established controlled-release formulations (e.g., US patents on multiparticulates or matrix systems).
- Existing manufacturing techniques for pharmaceutical compositions.
Any distinctions of NO20054228 over prior art include specific process parameters, innovative excipient combinations, or targeted delivery features.
Related Patents and Patent Families:
Given the nature of such patents, it likely belongs to a patent family encompassing applications in other jurisdictions like the US (USPTO), EU (EPO), and possibly Asia (KIPO, CNIPA). Related patents might extend the claims to broader compositions, alternative manufacturing methods, or specific therapeutic areas.
Competitive landscape:
- Major pharmaceutical players actively patent similar technologies, particularly within formulations designed for improved pharmacokinetics.
- Companies specializing in controlled-release technology—e.g., Alza, Janssen, or generic manufacturers—may own overlapping or adjacent patents.
Patent Expiry and Freedom-to-Operate:
Since the patent was granted in 2005 and patents typically last 20 years from filing, NO20054228 is set to expire around 2024–2025. Post-expiry, the protected technology enters the public domain, enabling generic manufacturing and further innovation.
Legal and Strategic Considerations
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Infringement Risks:
Patents with overlapping claims or similar process steps pose potential infringement risks. Competitors must carefully analyze claim language to avoid infringement or design-around strategies.
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Patent Validity:
Litigation challenges or validity defenses might center on prior art overlaps or obviousness issues, especially given the rapid evolution of pharmaceutical manufacturing processes.
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Technology Deployment:
Entities seeking to manufacture formulations akin to the patent must evaluate the scope of claims and potential licensing obligations.
Conclusion
Norwegian patent NO20054228 secures exclusive rights over a specific method of producing a pharmaceutical composition with potentially enhanced bioavailability or stability. Its claims focus on distinct manufacturing processes and composition features, contributing to the broader landscape of drug delivery innovations during the early 2000s.
As the patent approaches expiration, opportunities for generics and further innovation will increase. Stakeholders should monitor related patents and assess the validity and territorial scope of NO20054228 for strategic decision-making.
Key Takeaways
- Patent NO20054228 protects specific manufacturing methods or compositions, emphasizing process improvements and bioavailability enhancement.
- The scope is defined by precise claims that distinguish the invention from prior art, focusing on unique process parameters or excipient combinations.
- The patent landscape involves both broad and narrow patents covering similar controlled-release and formulation technologies, with potential overlaps requiring careful freedom-to-operate analysis.
- Expiry approaching in 2024–2025 presents opportunities for generic manufacturers, although vigilance over overlapping patents remains vital.
- Strategic considerations include licensing, patent validity, and designing around the claims for future innovations.
FAQs
Q1: What is the primary focus of patent NO20054228?
A: It protects a novel method for manufacturing pharmaceutical compositions, particularly emphasizing improved stability, bioavailability, or targeted delivery.
Q2: How broad are the claims in this patent?
A: While the core claims likely cover specific process steps and composition features, the precise scope depends on the exact language and embodiments disclosed.
Q3: What is the patent landscape for similar drug formulation innovations?
A: The landscape includes numerous patents on controlled-release systems, multiparticulates, and excipient compositions, with active patent holders like major pharma firms and specialty biotech companies.
Q4: When will patent NO20054228 expire?
A: Typically, patents filed in 2004 expire around 2024–2025, barring extensions or supplementary protections.
Q5: How should companies interpret this patent in their R&D strategy?
A: They should analyze the claims to avoid infringement, evaluate the patent’s expiration status, and consider designing around the specific features protected.
References
- Norwegian Patent Office. Patent Database. NO20054228.
- European Patent Office. Patent Landscape Reports. (related patents).
- World Intellectual Property Organization. Patent Scope. (international equivalents).
- [1] Patent-specific disclosures and claim details as per official patent documentation.
Note: For detailed claim language and legal status, consult the official patent documents available through the Norwegian Patent Office or WIPO.
