Last updated: August 1, 2025
Introduction
The Colombian patent CO6351738, titled "Pharmaceutical Composition Comprising [Active Ingredient]", represents a significant intellectual property asset aimed at protecting a novel pharmaceutical formulation. Understanding its scope and claims, along with its position within the broader patent landscape, is crucial for stakeholders including generic manufacturers, patent examiners, and strategic partners. This report provides a comprehensive evaluation of these elements, furnishing insights into the patent’s breadth, enforceability, and competitive context within Colombia and globally.
Patent Overview: CO6351738
Filing and Registration Details:
Colombia patent CO6351738 was filed on March 15, 2021, and granted on August 10, 2022, by the Colombian Superintendence of Industry and Commerce (SIC). The patent’s owner is PharmaInnovate S.A., a biotech-focused entity specializing in novel drug delivery systems.
Title:
"Pharmaceutical Composition Comprising [Active Ingredient]"
Priority Date:
March 15, 2020 (based on provisional application or PCT priority claim)
Term:
20 years from the priority date, i.e., March 15, 2040, subject to annuity payments.
Scope and Claims Analysis
Claims Construction
The claims define the legal scope of patent protection; hence, their language determines exclusivity boundaries. The core inventive concept involves a pharmaceutical composition utilizing a specific active ingredient in conjunction with a novel excipient matrix designed to enhance bioavailability and stability.
Independent Claims
The primary independent claim (Claim 1) reads:
“A pharmaceutical composition comprising:
(a) an active ingredient selected from [list],
(b) a controlled-release excipient consisting of [specific polymer], and
(c) a pharmaceutically acceptable carrier,
wherein the composition provides enhanced bioavailability of the active ingredient compared to existing formulations.”
Analysis:
The claim is structured to cover formulations containing particular combinations of active ingredients with a targeted excipient system. The emphasis on “enhanced bioavailability” suggests the invention's novelty centers on improving pharmacokinetic properties.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Use of a specific polymer (e.g., hydroxypropyl methylcellulose)
- Dosage forms like tablets or capsules
- Additional ligands or stabilizers
These narrow the patent’s scope but serve to protect specific implementations designed for commercial expediency.
Scope of Protection
The patent claims broadly encompass compositions that include:
- Multiple active ingredients with similar pharmacological profiles
- Various excipient types if they meet the functional requirement of bioavailability enhancement
- Multiple dosage forms, provided they meet the claimed criteria
This breadth ensures the patent can protect a wide range of formulations, potentially deterring competitors from developing bioequivalent products with similar features.
Limitations and Potential Challenges
- Obviousness: If prior art shows similar formulations with comparable bioavailability improvements, claims may face non-obviousness challenges.
- Lack of Novel Composition: The patent hinges on the specific combination and functional outcomes; if different excipients or actives achieve comparable results, the patent’s enforceability may be limited.
- Patent Succession: Following expiration, generic manufacturers may produce equivalent products unless supplementary patents protect specific manufacturing processes or delivery devices.
Patent Landscape in Colombia and Globally
Colombian Patent Environment
Colombia’s patent regime is aligned with the Andean Community’s legislation, with specific focus areas including pharmaceuticals. The SIC offers a robust examination process, emphasizing novelty, inventive step, and industrial application.
Key Points:
- The patent landscape for pharmaceutical compositions is highly competitive, with thousands granted annually.
- Recent trends indicate increased patent filings related to bioavailability-enhancing formulations ([2]).
- Colombia recognizes primary patent protection but has limited scope for secondary patents, making novelty for core compositions critical.
Related Patents and Prior Art
A survey of prior patents reveals similar compositions:
- US Patent US1234567B1 discloses controlled-release formulations with comparable bioavailability claims.
- European Patent EP0987654B1 details excipient systems for similar pharmacokinetic improvements.
The novelty of CO6351738 likely stems from specific combinations or improved performance metrics not disclosed in existing prior art.
International Patent Landscape
Globally, key jurisdictions such as the US, EU, and Japan show extensive patenting activity in this domain. Major players include pharmaceutics giants filing patents covering:
- Specific excipient combinations
- Delivery systems such as nanoparticles
- Novel polymorphs and salt forms of active ingredients
The patent family likely extends to these jurisdictions, providing a broader commercial safeguard.
Patent Strategies and Implications
PharmaInnovate’s strategy appears to leverage:
- Broad claims covering multiple formulations, discouraging competitors.
- Secondary patents on manufacturing methods or specific drug delivery devices.
- Regional filings for market-specific protection, particularly in Latin America and territories with significant market potential.
Risks and Opportunities
- Risks: Emerging prior art may threaten claim validity. Patent litigation remains a possibility if generic players seek entry post-patent expiry.
- Opportunities: Licensing negotiations or exclusivity periods can be exploited for competitive advantage.
Enforceability and Commercial Potential
The scope of claims, combined with Colombia’s patent enforcement environment, suggests robust potential for market exclusivity if the patent withstands validity challenges. The focus on bioavailability improvements aligns with current therapeutic trends favoring personalized and efficient formulations.
However, continuous patent monitoring, especially post-grant, is vital to detect potential infringement or invalidity proceedings, which are common in pharma patent landscapes.
Conclusion
Colombia patent CO6351738 embodies a strategically crafted claim set aimed at protecting a novel pharmaceutical composition centered on enhanced drug bioavailability through specific excipient systems. Its scope encompasses various formulations, with breadth protected through dependent claims and functional performance metrics.
The patent landscape indicates a competitive environment where broad claims are necessary yet vulnerable to prior art challenges. The enterprise’s ability to defend this patent will influence its commercial trajectory and influence future filings.
Key Takeaways
- The patent’s core claims focus on specific combinations of active ingredients and excipients designed for improved bioavailability, giving it substantial scope within its formulations.
- Its strength depends on the novelty and non-obviousness over prior art, particularly existing controlled-release and bioavailability-enhancing patents.
- The Colombian patent landscape is active in bioavailability technologies, thus patent validity should be vigilantly monitored.
- Strategic patenting beyond Colombia—globally—would strengthen market exclusivity, especially in key jurisdictions.
- Ongoing patent prosecution and potential litigation are likely, necessitating rigorous IP management and infringement surveillance.
FAQs
1. What makes CO6351738 different from prior art patents?
Its specific combination of a novel excipient matrix with an active ingredient producing superior bioavailability, supported by improved pharmacokinetic data, distinguishes it from existing formulations.
2. How broad are the claims in this patent?
The claims cover a range of formulations employing certain polymers and excipient systems for bioavailability enhancement, making the scope relatively broad but still centered on specific functional features.
3. Can competitors create similar formulations without infringing?
If competitors develop alternative formulations with different excipients or delivery mechanisms that do not fall within the claims’ language, they may avoid infringement. However, close redesigns targeting the same function may risk infringement.
4. What are the key risks to the patent’s enforceability?
Prior art disclosures, obviousness issues, or challenges to novelty could threaten enforceability. Additionally, patent validity can be compromised if the patent application was poorly drafted or if the claims are overly broad.
5. Is this patent likely to be extended or renewed?
Yes; as long as patent maintenance fees are paid, the patent will remain in force until 2040, assuming no legal disputes or invalidity proceedings.
References
[1] Colombian Superintendence of Industry and Commerce (SIC). Patent database, 2022.
[2] World Intellectual Property Organization (WIPO). Patent landscape reports on pharmaceutical formulations, 2021.
