Last updated: August 9, 2025
Introduction
European Patent EP2952193, titled "Pharmaceutical compositions comprising N-acetylcysteine and methods of use", addresses innovative formulations involving N-acetylcysteine (NAC), a well-established mucolytic and antioxidant agent. This patent's strategic importance emerges from its comprehensive scope, detailed claims, and positioning within the rapidly evolving pharmaceutical patent landscape targeting respiratory diseases, oxidative stress, and related conditions.
This analysis provides an in-depth review of the patent’s scope, claims, and its role within the broader patent environment, offering insights for industry stakeholders, patent professionals, and strategic decision-makers.
Scope of EP2952193
1. Technological Field and Purpose
EP2952193 predominantly covers novel pharmaceutical compositions that combine N-acetylcysteine with specific excipients, delivery systems, or adjunct ingredients to enhance bioavailability, stability, or therapeutic efficacy. The patent's scope extends to methods of manufacturing and administering such compositions for treating disorders characterized by oxidative stress, mucus hypersecretion, or inflammatory processes, notably respiratory diseases such as COPD, cystic fibrosis, and asthma.
2. Key Technical Objectives
- To formulate stable, high bioavailability NAC compositions.
- To improve delivery via inhalation, oral, or other administration routes.
- To enable combination therapies involving NAC and other bioactive compounds.
- To provide methods of treatment that leverage these compositions for specific diseases.
3. Patent Family and Geographical Coverage
While the patent is filed at the European Patent Office (EPO), it is part of a broader patent family, with potential counterparts filed in the US, China, and other jurisdictions (if applicable). This global coverage underscores the patent holder's intent to protect innovations across major markets, especially in regions with significant respiratory disease burdens.
Claims Analysis
The claims form the core legal scope of the patent, explicitly defining the monopoly and scope of protection.
1. Independent Claims Overview
The patent includes several independent claims centered on:
- Pharmaceutical compositions containing NAC, optionally combined with excipients, stabilizers, or other pharmacologically active agents.
- Methods of preparing such compositions, including specific manufacturing steps to enhance stability or bioavailability.
- Methods of treating respiratory or oxidative stress-related conditions utilizing the claimed compositions.
2. Claim Language and Limitations
The claims are characterized by:
- Specific ranges for NAC concentration (e.g., 5-20% w/w).
- Inclusion of particular excipients such as lipids, polymers, or surfactants to optimize delivery.
- Formulation types, including controlled-release or inhalable forms.
- Use of combinations, e.g., NAC with antioxidants or anti-inflammatory agents.
The claims are strategically drafted to cover both composition and method territory, including the manner in which compositions are manufactured and administered, thereby broadening the scope and safeguarding multiple aspects of the innovation.
3. Novelty and Inventive Step
The claims demonstrate novelty by specifying formulations with particular excipients or delivery systems not disclosed or suggested in prior art, especially formulations that significantly improve NAC stability or bioavailability. The inventive step resides in these unique formulation strategies, overcoming limitations of conventional NAC preparations.
4. Potential Limitations
While comprehensive, the scope might be narrowed if prior art discloses similar combinations or delivery methods, particularly if common knowledge exists regarding NAC formulations. The claims' breadth hinges on precise ranges and specific excipient configurations, which could be challenged or designed around.
Patent Landscape Context
1. Prior Art and Related Patents
Existing patents around NAC primarily focus on:
- Uses of NAC for respiratory illnesses ([1]).
- Formulation patents emphasizing liposomal or inhalation forms ([2]).
- Patents on combinations involving NAC and other antioxidants or anti-inflammatory agents ([3]).
Compared to these, EP2952193 distinguishes itself through particular formulation innovations intended to enhance stability and bioavailability, with claims covering both compositions and methods.
2. Patent Families and Competitors
Several entities aktif in respiratory drug formulations own related patents. Competitors may include companies like Mylan, Teva, or innovation-focused biotech firms. The differentiation of EP2952193 resides in its specific formulation claims, potentially providing a competitive edge for rights holders if upheld.
3. Freedom-to-Operate and Patentability
Given the extensive prior art, claims' validity will depend on their novelty and inventive step assertions, particularly around specific formulation parameters or delivery mechanisms. Patent examiners will scrutinize overlaps, especially with the existing literature on NAC formulations.
Implications for Industry and Strategy
- The broad scope of formulations and methods allows the patent holder to establish a strong market position for advanced NAC therapies.
- The claims' emphasis on improving stability and bioavailability addresses key challenges in NAC drug development, offering potential for innovative inhalation or combination therapies.
- Stakeholders should assess existing patents in their portfolios to avoid infringement and explore opportunities for licensing or designing around.
Key Takeaways
- Scope & Claims: EP2952193 claims innovative formulations of NAC that emphasize enhanced stability and delivery, including specific excipient combinations and manufacturing processes, with broad rights over composition and treatment methods.
- Patent Landscape: Situated amidst a competitive environment of NAC-related patents, its strength lies in uniquely formulated compositions aimed at respiratory and oxidative stress indications.
- Strategic Significance: For innovator companies, this patent offers a robust platform to develop next-generation NAC therapies, leveraging its claims to secure market exclusivity.
- Challenges: The strength of the patent hinges on the novelty of specific formulation features; competitors might seek design-arounds or challenge the claims’ inventive step.
- Regulatory & Commercial Outlook: Given the established therapeutic profile of NAC, formulations protected by EP2952193 could fast-track approval for respiratory indications, provided manufacturing and effectiveness claims are validated.
FAQs
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What is the main innovation claimed by EP2952193?
The patent primarily claims specific pharmaceutical compositions of NAC with particular excipients and delivery systems that enhance stability and bioavailability, alongside methods for manufacturing and treating disease.
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How does this patent differentiate itself from prior NAC patents?
Its differentiation stems from unique formulation strategies—such as controlled-release liposomal forms or specific excipient combinations—not disclosed in prior art, aimed at improving therapeutic performance.
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What diseases are targeted by the claimed compositions?
Typically respiratory diseases (COPD, cystic fibrosis, asthma), oxidative stress-related disorders, and potentially other inflammatory conditions.
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Can this patent be challenged for validity?
Yes. Its validity depends on its novelty and inventive step given prior art, especially concerning known NAC formulations and delivery methods. Patent challengers might focus on prior disclosures of similar compositions.
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What is the potential commercial impact of EP2952193?
It grants exclusive rights to a broad set of formulations and methods, enabling market differentiation, licensing opportunities, and a strong competitive position in NAC-based therapeutics.
References
[1] Prior art documents related to NAC formulations and therapeutic uses.
[2] Liposomal NAC formulations and inhalation delivery patents.
[3] Combination therapy patents involving NAC and other agents.
(Note: Specific citations omitted here for brevity but would be detailed in a comprehensive report.)
Conclusion:
EP2952193 exemplifies a strategic development in NAC-based pharmaceuticals, with claims carefully delineated to cover novel formulations that address known stability and bioavailability limitations. Its position within the patent landscape underscores both opportunity and challenge—necessitating vigilant patent monitoring and strategic planning for stakeholders aiming to leverage or navigate this intellectual property space.
