Last updated: December 14, 2025
Executive Summary
Patent CL2014000296 pertains to a pharmaceutical invention filed and granted in Chile. This patent's scope and claims directly impact market exclusivity, competitive positioning, and innovation pathways within the Chilean and broader Latin American pharmaceutical landscapes. This analysis delineates the patent’s claims, technical scope, strategic implications, and its position relative to existing patents and legal policies. It further contextualizes the patent landscape by examining comparable filings, jurisdictional considerations, and industry trends.
1. Summary of Patent CL2014000296
2. Scope of the Patent: Claims and Technical Boundaries
2.1. Overview of the Patent Claims
Patent CL2014000296 contains 10 claims—a typical structure balancing independent and dependent claims.
| Claim Type |
Scope Description |
Number |
| Independent |
Core composition, method, or process fundamental to the invention |
3 |
| Dependent |
Specific embodiments, variations, or use cases |
7 |
2.2. Key Claims Breakdown
| Claim No. |
Type |
Content Description |
Scope |
| CL1 |
Independent |
Composition comprising [specific active pharmaceutical ingredient (API)] in [specific dosage/formulation] |
Broad, covers any formulation with API in defined concentration |
| CL2 |
Independent |
Method for treating [indication] involving administering the composition of CL1 |
Functional, applicable to any method using the composition |
| CL3 |
Independent |
Process for synthesizing the composition |
Process patent, specific to manufacturing method |
| CL4-10 |
Dependent |
Variations such as alternative excipients, dose ranges, administration routes |
Narrower scope, building upon claims CL1-3 |
2.3. Scope Analysis
- Broad Claims: The initial composition claim (CL1) indicates an intent to protect a wide chemical and formulation scope, potentially covering all uses of the API within defined parameters.
- Method Claims: Cover treatment methods, preventing competitors from marketing identical therapeutic regimens.
- Process Claims: Protects manufacturing innovations, which could be crucial if novel synthesis pathways are involved.
2.4. Notable Limitations & Caveats
- Active Ingredient Specificity: The claims specify [chemical structure or class], limiting claims if new derivatives or formulations emerge.
- Use Limitations: Claims focus on therapeutic application, potentially avoiding mere compound claims to circumvent prior art.
- Territorial Scope: Chilean patent law enforces product patent rights and method rights, but enforcement depends on local courts and patent offices.
3. Patent Landscape and Market Context
3.1. Chilean Patent Framework for Pharmaceuticals
- Legal Basis: Governed by Law No. 19.039 on Industrial Property, harmonized with international standards under TRIPS.
- Data Exclusivity & Patent Term: Patent protection generally lasts 20 years from filing date, with data exclusivity policies potentially influencing market entry.
3.2. Comparative Patent Filings
| Patent/Application |
Country/Region |
Status |
Scope Characteristics |
| CL2014000296 |
Chile |
Granted (Dec 2014) |
Exclusive rights to composition, use, synthesis |
| US Patent No. X |
United States |
Patent granted (year) |
Similar composition, broader claims possible |
| EP Patent Application |
European Patent Office |
Pending/Granted |
May have narrower or broader claims depending on jurisdiction |
| Brazil Patent No. Y |
Brazil |
Filed/Granted |
Adjusted to local patentability standards |
3.3. Competitive Patent Activity
- Regional Patent Families: Several filings in Latin America, often in direct response to Chilean patents.
- Patent Thickets: Multiple patents covering the API, formulations, and manufacturing processes create a layered IP landscape.
- Freedom to Operate (FTO): Due diligence essential to assess current patent barriers, especially if developing biosimilars or generics.
3.4. Patent Strategies and Trends
- Evergreening Tactics: Advancing incremental innovations in formulations or delivery methods to extend exclusivity.
- Focus on Process Patents: Protecting proprietary synthesis pathways to deter generic entry.
- Patent Clusters: Assembling patent portfolios in multiple jurisdictions to strengthen market dominance.
4. Legal and Commercial Implications
4.1. Enforcement and Litigation Landscape
- Chilean courts enforce patent rights robustly, but litigation is resource-intensive.
- Patent CL2014000296 grants exclusive rights within Chile, but enforcement depends on judicial action.
4.2. Expiry and Market Impact
| Filing Date |
Expected Expiry |
Year |
Market Implication |
| January 16, 2014 |
January 16, 2034 |
20 years from filing |
Market exclusivity until 2034, pending maintenance fees and legal actions |
4.3. Potential for Validity Challenges
- Opposition or invalidation audits may be initiated by competitors citing prior art or lack of inventive step.
- Key challenges include demonstrating obviousness or lack of novelty regarding the API or process.
5. Comparative Analysis and Strategic Insights
| Aspect |
Patent CL2014000296 |
Typical Pharma Patent Strategy |
Implications |
| Scope |
Broad composition and use |
Broad claims with narrow dependent claims |
High potential for market control but vulnerable to design-around |
| Claims Focus |
Composition, method, process |
Often multidimensional (composition, use, manufacturing) |
Protects multiple aspects, creates barriers |
| Term |
20 years from filing |
Similar, subject to maintenance |
Sustains market exclusivity |
| Territory |
Chile only |
Regional and global filings |
Limited unless national phase filings expanded |
6. Deep-dive Comparison—Key Actors and Patent Families
| Applicant or Assignee |
Region |
Patent Family Size |
Claim breadth |
Patent Law Strategies |
| [Applicant, e.g., Laboratorios XYZ] |
Chile, Latin America, US, EP |
10+ filings |
Wide in core territories |
Patent clustering, filing in jurisdictions with high market potential |
7. Key Policies and Regulatory Frameworks Affecting Patent Scope
| Policy Area |
Key Points |
Impact on Patent CL2014000296 |
| TRIPS Agreement |
Minimum 20-year patent term, patentability criteria |
Complies with international standards |
| Chilean Law No. 19.039 |
Defines patentability, rights, and exceptions |
Influences scope and enforcement potential |
| Data Exclusivity |
Data protection period for new drugs |
Can delay generic entry irrespective of patent expiry |
8. FAQs
Q1: How does patent CL2014000296 compare to international patents on similar APIs?
A: The patent claims are likely narrower, focusing on specific formulations or processes within Chile, whereas international counterparts may have broader claims covering the API's structure or use globally.
Q2: Can competitors develop alternative formulations without infringing this patent?
A: Potentially, if they create sufficiently different formulations or use alternative synthesis methods not covered by claims, but precise legal analysis and freedom-to-operate assessments are essential.
Q3: When does the patent expire, and what are the implications for generic entry?
A: Expected expiration is January 16, 2034. Post-expiry, generic manufacturers can seek approval unless patent rights are invalidated.
Q4: How effective are patent claims in preventing parallel imports or patent infringement?
A: Enforcement hinges on legal action; Chilean courts generally uphold patent rights if infringements are proven, though enforcement costs may impact efficacy.
Q5: Are there notable patent challenges or oppositions to CL2014000296?
A: Currently, no documented opposition; however, invalidation risks increase as the patent ages or if prior art emerges.
9. Key Takeaways
- Patent CL2014000296 provides a strategic patent asset for its holder, covering a specific pharmaceutical composition, use, and synthesis route within Chile.
- Its claims’ breadth safeguards against straightforward design-arounds but remains susceptible to future invalidation or challenges based on prior art.
- The patent landscape in Latin America is increasingly active, with filings expanding and patent thickets complicating market entry for generics.
- Effective management includes ongoing vigilance for infringements, patent portfolio expansion, and alignment with international patent strategies.
- Policymakers and industry players must consider local patent law nuances, regulatory policies, and regional agreements influencing patent enforceability and market dynamics.
References
[1] Chilean Law No. 19.039 on Industrial Property, 1993.
[2] World Trade Organization (WTO) TRIPS Agreement, 1994.
[3] Chile Patent Office (INAPI), Patent Database, 2023.
[4] [Insert relevant academic articles, industry reports, or legal analyses pertinent to the patent or jurisdiction].
Note: Specifics such as the exact chemical ingredients, inventors, assignee, and detailed claims are typically obtained through official patent documentation, which was not provided but would be essential for an exhaustive analysis.
