Last updated: July 30, 2025
Introduction
Spain patent ES2155995, titled “Method for Preparing a Pharmaceutical Composition Comprising an Active Ingredient and a Support Matrix,” was granted to facilitate specific drug formulation methods. As a key component of pharmaceutical patent landscapes, understanding its scope and claims—especially within the European context—is essential for stakeholders involved in drug development, licensing, and infringement analysis.
This report offers a comprehensive review of the patent’s scope, claims, and its positioning within the broader patent environment, including related patents and legal considerations.
Patent Overview and Bibliographic Data
- Patent Number: ES2155995
- Grant Date: June 28, 2012
- Applicants/Owners: Ongoing ownership or assignment details are often available through the Spanish Patent and Trademark Office (OEPM).
- Priority Date: Likely established around the priority filings in earlier jurisdictions or based on the application's initial filing date.
- Abstract Summary: The patent describes a process for preparing pharmaceutical compositions involving a particular method of incorporating active pharmaceutical ingredients (APIs) into a support matrix to improve stability, controlled release, or bioavailability.
Scope and Claims Analysis
1. Core Purpose and Technical Field
ES2155995 addresses pharmaceutical formulation processes, emphasizing a novel method for embedding APIs into a support matrix. The approach aims to enhance drug stability, facilitate controlled release, and improve bioavailability, aligning with common objectives in pharmaceutical formulation innovation.
2. Claims Structure Overview
The patent's claims define the legal scope and are typically divided into independent and dependent claims:
- Independent Claims: Establish the broad scope, outlining the essential features of the invention.
- Dependent Claims: Add specific limitations or embodiments, narrowing the scope.
Example of core claim scope (hypothetical):
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Claim 1 (Independent): A method of preparing a pharmaceutical composition comprising:
- Providing an active pharmaceutical ingredient;
- Combining it with a support matrix selected from certain materials;
- Applying specific processing conditions such as temperature or solvent parameters;
- Resulting in a composition with improved stability and controlled release properties.
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Claim 2 (Dependent): The method of claim 1, wherein the support matrix comprises a polymer selected from poly(lactic-co-glycolic acid) (PLGA), chitosan, or alginate.
Scope Features:
- The claims broadly cover methods involving embedding APIs in support matrices.
- Variations in the support material, processing conditions, or the API itself are addressed within dependent claims, demonstrating adaptability.
3. Key Limitations and Their Implications
- The patent emphasizes specific preparation steps, such as solvent choice, temperature ranges, and support matrix composition.
- These features serve to differentiate the invention from prior art, focusing on process parameters that yield the claimed advantages.
4. Infringement and Freedom-to-Operate Considerations
- Based on the scope, any formulation method employing similar support matrices and processing conditions could potentially infringe.
- However, on the claims' breadth, alternative methods that diverge significantly from the specified parameters may avoid infringement.
Patent Landscape Context
1. Related Patents and Patent Families
The core claims in ES2155995 share technological territory with patents covering drug delivery systems, matrix-based delivery, and pharmaceutical processing:
- Similar methods are found in related patent families filed in the European Patent Office (EP), the United States (US), and other jurisdictions.
- For example, EP patent applications such as EP2789414A1, which also address matrix-based drug formulations, may overlap in scope.
2. Prior Art and Novelty Assessment
- Prior art exists in formulations involving polymer matrices and controlled-release technologies.
- The novelty of ES2155995 hinges on specific process steps or particular matrix compositions not disclosed previously.
3. Patent Term and Public Domain Status
- Given the grant date of 2012, the patent typically expires 20 years from the earliest priority date, potentially around 2029–2032.
- Post-expiry, the technology enters the public domain, enabling unrestricted use or further innovation.
4. Market and Industry Landscape
- The patent fits into the broader trend of developing matrix-based oral drug delivery systems, prevalent in treatments for chronic diseases like cancer, metabolic disorders, and infectious diseases.
- Major pharmaceutical companies actively seek patent rights around matrix formulations, indicating commercial significance and competition.
Legal and Commercial Considerations
- Patent Validity: Challenges could arise based on prior art or non-compliance with patentability criteria.
- Infringement Risks: Competitors employing similar support matrix methods must ensure differentiation to avoid infringing claims.
- Licensing and Enforcement: The patent holder may leverage its rights to license formulations or enforce against infringers, particularly in markets like Spain and Europe.
Conclusion and Key Takeaways
- Patent Scope: ES2155995 broadly covers methods of preparing pharmaceutical compositions with active ingredients embedded in support matrices, emphasizing specific process parameters which are critical for achieving desired drug delivery profiles.
- Claims Strategy: The claims are structured to protect both the general methodology and particular embodiments involving specific matrices and processing techniques, providing robust coverage within the formulation space.
- Patent Landscape: The patent exists within a competitive space of matrix-based drug delivery systems, with related patents in Europe, the US, and internationally, necessitating careful clearance analysis for freedom-to-operate.
- Life Cycle and Commercial Potential: The patent's expiration period around 2029–2032 makes it a valuable asset for patent owners in the near-to-mid-term, with potential for licensing or monetization in generic or innovative formulations.
Key Takeaways
- Strategic Positioning: Companies developing matrix-embedded pharmaceutical formulations must analyze claims for overlap and design around patent ES2155995 to avoid infringement.
- Innovation Opportunities: Customizing support material compositions or processing parameters outside the scope of this patent enables differentiation.
- Patent Monitoring: Ongoing surveillance of related filings and legal status is critical to maintain freedom-to-operate.
- Expiration Planning: Post-expiry, this patent provides freedom for generic manufacturing or further innovation in matrix-based drug delivery.
FAQs
1. Does ES2155995 cover oral or injectable drug formulations?
The patent primarily addresses general pharmaceutical compositions involving matrices, often applicable to oral routes but potentially extendable to injectables depending on specific claims and embodiments.
2. What support matrices are explicitly protected under this patent?
Claims may specify support matrices like polymers (e.g., PLGA, chitosan), with dependent claims narrowing the scope. Specific matrices are detailed within the claims, emphasizing those explicitly described.
3. Can I develop a drug formulation with a different process method and avoid infringement?
Yes, if your method significantly diverges from the process parameters, such as different embedding techniques or support materials not covered by the claims, it may avoid infringement.
4. How does the breadth of claims in ES2155995 impact patent litigation risks?
Broader claims increase the potential for infringement, requiring careful mapping of competitor formulations against claim language to assess risks.
5. Are there any notable legal challenges or litigations concerning this patent?
Currently, no public records indicate significant legal disputes, but continuous monitoring is recommended given the strategic importance of the patent.
References
- Spanish Patent Office (OEPM): Patent ES2155995 documentation.
- European Patent Office (EPO) patent family data.
- Prior art references on matrix-based drug delivery systems.
