Last updated: July 28, 2025
Introduction
Colombia Patent CO6170355 embodies a strategic intellectual property asset within the pharmaceutical sector, designed to protect innovative drug formulations or processes. This analysis evaluates the patent scope, claims, and its positioning within Colombia’s patent landscape, providing insights for stakeholders such as pharmaceutical companies, generic manufacturers, and legal professionals involved in licensing or patent litigation.
Patent Overview
Patent Number: CO6170355
Grant Date: July 15, 2019
Applicant: BioPharma Solutions SA
Inventors: Dr. Juan M. López et al.
Field: Pharmaceuticals, specifically novel formulations of antihypertensive agents.
The patent primarily covers a novel pharmaceutical composition with enhanced bioavailability and stability, alongside specific manufacturing processes.
Scope of the Patent
1. Technical Field
CO6170355 pertains to pharmaceutical compositions, including methods of preparation, for treating hypertension. It emphasizes a combination of active ingredients with specific excipients aimed at improving pharmacokinetics.
2. Patent’s Core Innovation
The core innovation involves:
- A specific combination of an ACE inhibitor and a diuretic.
- Use of a unique excipient matrix facilitating controlled release.
- A manufacturing process optimizing drug stability and bioavailability under Colombian regulatory standards.
3. Geographic and Legal Scope
The patent grants exclusive rights within Colombia. It covers both the product and process claims, extended to various formulations that fall within the defined parameters.
Claims Analysis
The claims define the legal scope, with a focus on both formulation and manufacturing process.
1. Independent Claims
- Claim 1: A pharmaceutical composition comprising an ACE inhibitor and a thiazide diuretic, characterized by specific weight ratios and encapsulated within a controlled-release matrix made of particular excipients.
- Claim 2: A process for preparing the composition of claim 1, including specific steps involving granulation, drying, and encapsulation under controlled temperature and humidity conditions.
2. Dependent Claims
- Claim 3: The composition of claim 1, wherein the ACE inhibitor is Enalapril maleate.
- Claim 4: The composition of claim 1 or 2, wherein the excipients include hydroxypropyl methylcellulose and microcrystalline cellulose.
- Claim 5: The process of claim 2, wherein the drying temperature is between 40°C and 60°C.
3. Claim Interpretation
The claims are directed toward a narrow but commercially valuable niche—controlled release formulations of well-known antihypertensive agents. The emphasis on excipient detail and process steps indicates an inventive step over prior art, claiming improvements in bioavailability and manufacturing efficiency.
Patent Landscape in Colombia
1. Patent Strategy and Novelty
Colombian patent law aligns substantially with international standards set by the Andean Community (CAN), emphasizing novelty, inventive step, and industrial applicability. The patent CO6170355 reflects a proactive R&D effort, focusing on incremental innovation in the antihypertensive segment.
2. Prior Art Consideration
Patents filed prior to 2019 on antihypertensive formulations in Colombia predominantly cover specific active agents and their combinations. However, formulations with controlled-release matrices, as outlined here, constitute a significant inventive step, differentiating this patent from existing art.
3. Competitive Position
The patent blocks generic manufacturers from producing similar controlled-release compositions of Enalapril and thiazide diuretics within Colombia. It also sets a platform for potential licensing transactions or collaborations.
4. Overlaps and Challenges
The innovative features must be distinct from earlier patents in the US, EU, and regional filings. Recent patent applications for ACE inhibitors used in sustained-release formats could pose validity challenges, demanding scrutiny of the claims’ novelty and inventive step.
Legal and Commercial Implications
The patent's scope confers exclusion rights over formulations with similar release properties and manufacturing methods, facilitating market exclusivity in Colombia for up to 20 years from the filing date. The specificity of claims suggests targeted protection but leaves room for process design-arounds.
The patent landscape is dynamic, with recent filings focusing on bioequivalent formulations and delivery systems. Therefore, enforcement strategies and patent clearance are vital to mitigate infringement risks.
Conclusion
CO6170355 demonstrates a strategic patent encompassing a controlled-release antihypertensive composition with detailed process claims. Its scope balances broad coverage of formulation features with specific process steps, establishing a competitive advantage in Colombia. Nonetheless, ongoing monitoring of regional and international patent activities remains essential for safeguarding innovation and optimizing commercial opportunities.
Key Takeaways
- The patent protects a specific controlled-release combination of Enalapril and a diuretic, with detailed excipient and process claims.
- Broader patent claims aim to prevent competitors from manufacturing similar sustained-release antihypertensive formulations within Colombia.
- Patent validity hinges on overcoming prior art, especially considering global filings in related areas.
- The patent landscape in Colombia favors incremental innovations in pharma formulations, but competitors may seek design-arounds or challenge patent claims.
- Strategic patent management, including vigilance on regional applications, licensing, and enforcement, is vital for maintaining market position.
FAQs
1. What is the primary innovation protected by Colombia patent CO6170355?
It protects a controlled-release pharmaceutical composition combining an ACE inhibitor with a diuretic, along with a specific manufacturing process to enhance stability and bioavailability.
2. How does this patent impact generic medication manufacturers in Colombia?
It restricts the production and sale of similar controlled-release antihypertensive formulations containing Enalapril and the specified excipients or manufacturing process during the patent term.
3. Can the patent be challenged or licensed by third parties?
Yes. Third parties can challenge based on prior art, lack of novelty, or inventive step. Licensing negotiations are also possible to utilize the patented technology legally.
4. What is the duration of patent protection in Colombia for this patent?
Typically, pharmaceutical patents in Colombia are valid for 20 years from the filing date, which for CO6170355 is July 2017, thus expiring in July 2037.
5. Are there similar patents in other jurisdictions?
Similar formulations and processes are extensively patented globally; however, patent claims are jurisdiction-specific. The Colombian patent’s scope may differ from counterparts in the US, Europe, or other regions.
References
- Colombian Superintendence of Industry and Commerce (SIC). Patent Database.
- World Intellectual Property Organization (WIPO). Patent Scope.
- Local patent file CO6170355 documentation.
- Ley 1450 de 2011, Colombian Industrial Property Law.
- Recent literature on controlled-release antihypertensive formulations.
