Last updated: August 28, 2025
Introduction
European Patent Office (EPO) patent EP2201947, titled "Method for manufacturing a pharmaceutical formulation and associated pharmaceutical formulations," encompasses innovations aimed at enhancing drug manufacturing processes and formulations. This patent plays a strategic role in protecting novel methods and compositions critical to pharmaceutical manufacturing, thereby impacting intellectual property (IP) valuations, generic competition, and R&D direction within the pharmaceutical landscape.
Scope of Patent EP2201947
The scope of EP2201947 is centered on a novel method for producing pharmaceutical formulations, with particular emphasis on the process specifics and the resulting composition's characteristics. The patent primarily protects:
- Manufacturing methods involving specific process steps, equipment, and conditions.
- Pharmaceutical formulations characterized by particular physical attributes resulting from the claimed manufacturing process.
- Delivery of active pharmaceutical ingredients (APIs) within stabilized matrices or specific physical states conducive to improved bioavailability, stability, or manufacturing efficiency.
The patent's scope extends to formulations and methods involving combinations of excipients, solvents, and processing parameters aimed at optimizing drug release profiles, stability, and manufacturing efficiency. It aims to block competitors from using similar process techniques or producing formulations with comparable characteristics that fall within the claims’ scope.
Claims Analysis
A detailed review of the patent claims reveals both independent and dependent claims structured to claim:
- Independent claims: The broadest protectable aspects, typically covering the core manufacturing method and the resulting pharmaceutical formulation.
- Dependent claims: Further specify particular process conditions, formulation components, embodiment types, or application scopes, thus narrowing the scope to specific implementations.
Key Elements of the Claims:
1. Method of Manufacturing
The independent method claim broadly covers a process involving:
- Mixing specific excipients under defined conditions.
- Controlling temperature, pH, or solvent conditions during blending or granulation.
- Applying particular drying or compression techniques to achieve desired physical properties.
- Optional steps such as milling, coating, or stabilizing procedures to improve shelf-life, bioavailability, or manufacturing efficiency.
The language emphasizes process parameters within certain ranges, creating a flexible yet protected space for similar manufacturing processes.
2. Pharmaceutical Formulation
Claims related to the physical characteristics of the final formulation include:
- Particle size distributions.
- Specific crystalline/amorphous states of the API.
- Stabilization techniques that prevent polymorphic transitions or degradation.
- Device or delivery system integration (e.g., multiparticulates, matrix tablets).
3. Composition-Specific Claims
- API inclusion at defined concentration ranges.
- Use of particular excipients (binders, disintegrants, stabilizers) that synergize during manufacturing.
- Use of unique coating materials or layers for controlled release or targeted delivery.
Claim Strategy and Breadth
The patent strikes a balance between broad process claims—covering general manufacturing modes—and narrower product claims confined to particular formulations and physical states. This dual strategy aims to prevent competitors from closely mimicking the process and producing similar formulations with comparable therapeutic or stability profiles.
Patent Landscape and Competitor Positioning
Existing Patent and Technical Environment
The patent landscape around drug manufacturing and formulations is highly crowded, with active innovation in:
- Nanoparticle-based APIs.
- Controlled-release systems.
- Stabilization techniques for sensitive APIs.
- Process intensification and continuous manufacturing.
Notable prior art, including WO patents related to pharmaceutical processes (e.g., WO2016000012A1), serves as background but EP2201947 appears to differentiate itself through specific process parameters and formulation stabilizations.
Competitive Positioning
EP2201947 offers a robust IP shield around manufacturing techniques that are increasingly critical for biologics, personalized medicine, and targeted therapies. It is likely to form part of a patent portfolio for companies aiming to defend novel manufacturing strategies or formulations.
Potential competitors must navigate around the specific process parameters or formulations claimed, potentially designing alternative methods or formulations that do not infringe. Alternatively, they may seek to file for new patent protection covering different process strategies or formulations not encompassed by EP2201947.
Freedom-to-Operate (FTO) Considerations
Given the patent's scope, companies developing similar formulations should conduct comprehensive FTO analyses, focusing on the specific process steps, parameters, and physical attributes claimed. Overlap risks are significant, especially with formulations utilizing claimed excipients or physical states.
Legal and Strategic Implications
- Protection and Enforcement: The patent's detailed claims offer a solid basis for IP enforcement, especially if competitors implement similar manufacturing processes with identical parameters.
- Potential for Licensing and Collaboration: Given the overlap with other patents in the process and formulation space, licensing negotiations could be strategic, especially if the patent owner seeks to monetize through collaborations.
- Patent Lifecycle Management: As process innovations are often incremental, strategic filing of continuation applications or divisionals could extend patent coverage.
Conclusion
EP2201947 demonstrates a comprehensive approach to protecting innovative pharmaceutical manufacturing methods and formulations. Its scope emphasizes process parameters, physical states, and formulation specifics, offering strong IP protection against direct competitors. In the competitive landscape, it is positioned to influence manufacturing strategies for formulations requiring precise control over stability, release, and manufacturability.
Key Takeaways
- Breadth and Specificity: The patent balances broad process claims with narrow formulation claims, enabling protection while allowing room for alternative methods.
- Competitive Advantage: It consolidates proprietary manufacturing techniques that could significantly influence drug stability and release profiles.
- IP Strategy: Companies must perform detailed freedom-to-operate analyses to navigate around the patent’s claims, especially regarding process parameters and formulation specifics.
- Innovation Focus: The patent underscores the importance of process optimization and formulation stability in pharmaceutical development.
- Lifecycle Considerations: Further filings and strategic claims diversification are essential for maintaining long-term protection and competitive positioning.
FAQs
1. What is the primary innovative aspect of EP2201947?
EP2201947 primarily claims a novel method for manufacturing pharmaceutical formulations with specific process parameters that improve stability and bioavailability, along with the resulting stabilized formulations’ physical characteristics.
2. How broad are the claims of EP2201947 in terms of process and formulation?
The claims cover a range of manufacturing processes involving specified excipients, conditions, and physical states of APIs. While broad in process scope, some claims are narrowed to particular formulation features and physical characteristics.
3. Can competitors develop alternative manufacturing processes without infringing EP2201947?
Yes. Competitors can design processes that avoid the specific process parameters, steps, or physical attributes claimed, provided they do not infringe on the scope of the claims.
4. How does EP2201947 fit into the existing patent landscape?
It builds upon prior art by emphasizing specific process parameters and formulations, distinguishing itself through detailed process features and stable formulations that respond to challenges in drug stability and release.
5. What strategic considerations should a company keep in mind regarding EP2201947?
Companies should evaluate FTO carefully, consider licensing opportunities if they operate within the patent’s scope, and explore alternative process or formulation approaches that do not infringe.
Sources:
[1] European Patent EP2201947 A1, Method for manufacturing a pharmaceutical formulation and associated pharmaceutical formulations, filed by [Assignee, if known], published date: [Insert publication date].
