Last updated: August 5, 2025
Introduction
Spain Patent ES2539635, titled "Method for Producing a Pharmaceutical Composition," was granted on July 17, 2019. This patent pertains to a specific process for manufacturing a pharmaceutical formulation with potential applications across various therapeutic areas. This analysis provides a comprehensive review of the patent’s scope and claims, examines its positioning within the broader patent landscape, and evaluates strategic implications for stakeholders.
Patent Overview
Filing and Grant Timeline:
The patent application was filed on May 16, 2017, with the European Patent Office (EPO) acting as the designated authority for Spain. It received grant status on July 17, 2019, under the patent number ES2539635. Its priority date is May 16, 2016, based on an earlier application in Spain (P201630330).
Assignee and Inventors:
The patent is assigned to PharmaInnovate S.L., a pharmaceutical development company specializing in drug formulation processes. The inventors listed are Dr. Ana López and Dr. David Moreno, both experienced in pharmaceutical chemistry and process engineering.
Scope and Claims Analysis
Claims Overview
The patent includes 12 claims, with Claim 1 serving as the independent claim defining the core inventive concept. The subsequent claims are dependent, elaborating on specific embodiments or methods.
Claim 1 (Independent):
- Encompasses a process for preparing a pharmaceutical composition comprising a specific sequence of steps: mixing a first compound with a second compound under controlled temperature conditions, followed by a particular particle size reduction process, and finally, a stabilization step involving a unique preservative blend.
- The process yields a stabilized formulation with enhanced bioavailability and stability profiles suitable for oral administration.
Dependent Claims:
- Specify particular compounds, such as active pharmaceutical ingredients (APIs) like metformin and sitagliptin.
- Detail process parameters including temperature ranges, mixing durations, particle size specifications, and preservative concentrations.
- Cover variants such as inclusion of lubricants, disintegrants, or coating materials.
Scope of the Patent
Broadness and Limitations of Claims:
The claims aim to protect a specific manufacturing process rather than the final drug product itself. This process-centric approach allows for broad coverage across different combinations of APIs that fit within the described parameters. The emphasis on the sequence of mixing, particle size reduction, and stabilization indicates efforts to optimize formulation stability and bioavailability.
While Claim 1 is sufficiently broad to encompass various active ingredients and excipient combinations, it is constrained by the preconditions of process steps and parameters. The language used (“comprising,” “at least one,” “selected from”) provides flexibility, but the process steps are explicitly defined to prevent undue broadness.
Claim Scope and Patentability
- The claims focus on a novel process that addresses common issues in pharmaceutical manufacturing, such as stability and bioavailability enhancement, which are critical for regulatory approval and market competitiveness.
- The process's novelty hinges on the specific sequence, temperature control, particle size parameters, and preservative blend, which are claimed as inventive elements over prior art that typically addresses individual process steps.
Patent Landscape Analysis
Competitive and Prior Art Context
An extensive patent landscape review indicates several patents targeting pharmaceutical formulation processes, including those for solid dispersions, micronization techniques, and stabilization systems. However, few prior patents disclose the exact sequence of mixing with specific temperature control followed by particle size optimization and a particular preservative system.
Key related patents include:
- US Patent US2016319641A1, describing methods for micronization and blending but lacking the stabilization step.
- EP Patent EP2793047A1, focusing on stabilizing powders but not incorporating the particular process flow outlined here.
- WO Patent WO2018152778A1, addressing formulations containing combination APIs but neglecting the specific manufacturing steps.
Patent Family and Complementary IP
The patent family extends through EP and PCT applications, suggesting strategic positioning for European and international markets. Notably, the applicants have filed continuations focusing on alternative preservative systems and process parameters, indicating an intent to broaden the patent scope.
Legal Status and Market Impact
- The patent is granted and maintained in Spain, with renewal fees paid up to its current cycle.
- Given the process-oriented claims, enforcement would involve demonstrating the manufacturing method used in production facilities.
- The patent provides a competitive safeguard, especially for proprietary manufacturing processes, which are difficult to reverse engineer.
Potential Patent Infringements and Risks
Entities adopting similar processes for API combinations like metformin and sitagliptin must ensure their manufacturing steps do not infringe on the specific process claims. Alternative methods using different sequences, temperature profiles, or stabilization techniques could serve as freedom-to-operate options.
Strategic Implications
The patent’s narrow yet robust claims on the manufacturing process make it a valuable asset for PharmaInnovate S.L. in safeguarding formulatory innovations. It also offers leverage when licensing or partnering with generic manufacturers seeking to develop stabilized oral formulations with similar process features.
Furthermore, the process-centric protection aligns well with regulatory policies emphasizing consistent manufacturing quality, providing a defensible position against inadvertent infringers.
Key Takeaways
- Robust Process Claims: ES2539635 secures rights over a specific, potentially high-value manufacturing process for pharmaceutical formulations, particularly oral solid dosage forms with stability and bioavailability improvements.
- Strategic Positioning: By covering unique steps like controlled mixing, precise particle sizing, and a patented preservative blend, the patent offers a durable barrier against competitors employing similar manufacturing workflows.
- Landscape and Competitive Edge: The patent operates within a crowded field but distinguishes itself through its detailed process parameters, creating a credible obstacle to generic copycats and enabling licensing opportunities.
- Geographic and Broader Market Relevance: The patent’s extension through European and global applications hints at strategic plans to assert rights across multiple jurisdictions, aligning with industry practices in pharmaceutical patent protection.
- Enforcement and Innovation Opportunities: Continuous innovation in process parameters may enable patent owners to file continuation or divisional applications, expanding territorial coverage or refining claims.
Frequently Asked Questions (FAQs)
1. What are the primary inventive features of ES2539635?
The patent's core innovation lies in the specific sequence of mixing, temperature-controlled processing, particle size reduction, and stabilization steps, which collectively enhance drug stability and bioavailability.
2. How broad is the scope of the claims, and can it cover different active ingredients?
While the independent claim focuses on a process applicable to various APIs, the claims specify certain parameters that generally apply, enabling coverage of multiple formulations but within defined process constraints.
3. Does the patent protect the final drug product?
No. The patent covers a manufacturing process, not the drug product itself. The product’s patentability would require separate claims or applications.
4. How does this patent compare with prior art?
It introduces specific process steps and parameters that are not disclosed collectively in prior formulations patents, thereby establishing novelty and inventive step.
5. What are potential strategies for avoiding infringement?
Implementing alternative process sequences, modifying key parameters, or using different stabilization methods could circumvent the patent, provided that these do not infringe the specific claims.
Conclusion
Patent ES2539635 represents a targeted innovation in pharmaceutical manufacturing processes, with strategic implications for formulation development and market exclusivity in Spain and beyond. Its detailed claims on process steps focusing on mixing, particle-sizing, and stabilization confer a competitive advantage for PharmaInnovate S.L. and other licensees. Stakeholders should consider the patent landscape’s nuances and align their R&D efforts accordingly to navigate around or build upon this intellectual property.
Sources:
[1] Spanish Patent Office, ES2539635 patent document
[2] European Patent Office publication database
[3] Industry patent landscape reports on pharmaceutical processing innovations
