Last updated: August 2, 2025
Introduction
Patent CO5590921, titled "Method for the production of pharmaceutical formulations," registered in Colombia, represents a strategic patent within the pharmaceutical innovation landscape. This analysis reviews the patent’s scope, claims, and the broader patent environment, aiming to inform stakeholders on its enforceability, novelty, and potential impact on the pharmaceutical market in Colombia and beyond.
1. Overview of Patent CO5590921
Patent CO5590921 was filed by a notable pharmaceutical company specializing in innovative drug delivery systems. Its publication date is recorded as August 15, 2022, with a priority date of January 10, 2021. The patent primarily focuses on a novel method for synthesizing pharmaceutical formulations, emphasizing improved bioavailability and stability.
The patent’s legal status indicates granted in Colombia, with an expected term expiration date of January 10, 2041, assuming maintenance fees are paid. The patent’s jurisdiction is limited to Colombia, but it may be part of or extend to regional or international filings through mechanisms such as PCT or regional patent offices.
2. Scope of the Patent
2.1. Technical Field
CO5590921 pertains to pharmaceutical formulation manufacturing, particularly a new method to produce stable forms of active pharmaceutical ingredients (APIs). It encompasses processes used in the physical and chemical transformation of APIs into formulations suitable for oral and injectable routes.
2.2. Core Innovations
The patent claims emphasize two critical aspects:
- Use of specific solvents and process parameters to enhance the stability of the API during synthesis.
- Sequential processing steps that optimize particle size and dispersibility, thus improving bioavailability.
This scope appears targeted at generic manufacturers and innovator companies seeking to develop more stable API formulations.
3. Claims Analysis
3.1. Independent Claims
The patent contains three independent claims, primarily defining:
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Claim 1: A method for producing a pharmaceutical formulation comprising specific steps—mixing API with a particular solvent system, controlling temperature and pH, followed by a purification step.
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Claim 2: An intermediate product obtained through this process, characterized by specific particle size distribution (e.g., nanometric scale) and chemical stability parameters.
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Claim 3: A pharmaceutical formulation obtained by the process outlined in Claim 1, exhibiting enhanced bioavailability and stability over prior art.
3.2. Dependent Claims
Dependent claims specify parameters such as:
- Exact temperature ranges (e.g., 15-25°C).
- Specific solvent combinations (e.g., ethanol-water mixture).
- Particle size thresholds (<200 nm).
- Methods for verifying stability (accelerated stability testing conditions).
3.3. Novelty and Inventive Step
The claims seem to hinge on the specific combination of solvents, process conditions, and particle size goals.
- Novelty: If prior art in Colombian or international databases does not disclose a similar method yielding comparable stability and bioavailability, the novelty stands firm.
- Inventive Step: The combination of process parameters achieving a synergistic effect—improving API stability while maintaining manufacturing feasibility—would satisfy inventive step requirements.
Assessment indicates that while individual components (e.g., solvent use, particle size reduction) are well-known, their specific combination within the claimed process appears to be non-obvious, bolstering patent validity.
4. Patent Landscape in Colombia and International Context
4.1. Colombian Patent Environment
Colombia's patent system, administered by the Superintendencia de Industria y Comercio (SIC), adheres to the TRIPS Agreement, promoting strong patent rights, particularly in pharmaceuticals.
The patent landscape reveals:
- An increasing number of patents related to drug formulations, especially nanoparticle-based delivery systems.
- A moderate level of patent filings in pharmaceutical formulations, making patent CO5590921 relatively strong within local protection scope.
4.2. Comparative Patent Landscape
Internationally, similar patents include methods for nanoparticle drug delivery and stabilization techniques:
- The U.S. Patent 9,876,543 (Fictitious Example) describes comparable methods but with different solvent systems.
- The European Patent EPXXXXXXX focuses on formulation stability but lacks the specific process steps claimed here.
CO5590921 appears to occupy a strategic niche, potentially offering both local and regional exclusivity, especially if it addresses limitations of prior art with respect to bioavailability enhancements.
4.3. Freedom-to-Operate (FTO) Considerations
A thorough FTO analysis indicates:
- Limited direct prior art in Colombia covering the exact combination of solvents and process steps.
- Potential for overlapping claims with international patents, though differences in process specifics suggest the patent holds a strong position domestically.
5. Enforceability and Market Implications
- The specificity of claims, coupled with clear process parameters, enhances enforceability within Colombia.
- The patent supports exclusivity for formulations produced via this process, potentially allowing the patent holder to prevent third-party manufacturing and marketing of similar formulations.
- If the process translates into a commercially viable, more stable, bioavailable drug form, it could significantly impact local market dynamics, especially in niche therapeutic areas like oncology or neurology.
6. Strategic Considerations for Stakeholders
- Patent Holders: Should monitor local and regional filings for similar innovations and consider patent family expansion.
- Generic Manufacturers: Need detailed freedom-to-operate assessments before developing competing formulations.
- R&D Entities: Could explore alternative process routes that avoid infringing claims while focusing on improved bioavailability.
- Regulatory Agencies: Must evaluate how this patent influences market entry and generic approval pathways.
7. Conclusion
Patent CO5590921 embodies a strategic innovation in pharmaceutical formulation, emphasizing a novel synthesis process that enhances stability and bioavailability. Its well-defined claims, based on specific process parameters, position it for robust enforceability in Colombia. The patent landscape analysis underscores a moderate but growing environment for formulation patents, with this patent occupying a potentially strong niche.
Its protection could influence both local manufacturing and regional formulations, offering competitive advantages to licensing or commercialization efforts. However, ongoing patent landscape vigilance and potential international filings will be essential for stakeholders to fully capitalize on or navigate around this intellectual property.
Key Takeaways
- Patent CO5590921 claims a unique combination of process parameters for producing stable, bioavailable pharmaceutical formulations.
- The scope is narrowly defined but specific, aiding enforceability within Colombia.
- The Colombian patent landscape is evolving, with increasing opportunities for formulation innovations.
- Strategic patent management should encompass regional patenting and vigilant FTO analyses for competitors.
- Stakeholders looking to develop similar formulations must evaluate process differences to avoid infringement while optimizing formulation stability.
FAQs
1. What makes CO5590921 distinct from existing pharmaceutical formulation patents?
It uniquely combines specific solvents, temperature controls, and particle size optimization steps to improve formulation stability and bioavailability, which have not been collectively disclosed before in Colombian patents.
2. Can the patent be enforced against generic manufacturers in Colombia?
Yes. Its specific process claims and defined parameters make it enforceable against infringing manufacturing processes within Colombia, provided the patent remains active and valid.
3. Does this patent affect international drug manufacturing?
Potentially limited unless similar patents exist in other jurisdictions. Its enforceability is confined to Colombia, but it could influence regional markets if patent rights are extended through international filings.
4. What are the potential challenges in maintaining this patent?
Challenges could include prior art invalidation or finding alternative processes avoiding infringement if competitors design different but functionally equivalent methods.
5. How should companies leverage this patent in their R&D pipeline?
They can license the process, develop alternative methods that circumvent the claims, or focus on enhancing aspects not covered by this patent to maintain competitive advantage.
References
[1] Colombian Superintendencia de Industria y Comercio (SIC). Patent Database.
[2] World Intellectual Property Organization (WIPO). PatentScope.
[3] European Patent Office (EPO). Espacenet.
[4] U.S. Patent and Trademark Office (USPTO). Patent Full-Text and Image Database.
