Last updated: July 31, 2025
Introduction
Chile Patent CL2011002217, titled "Pharmaceutical Composition of Active Principles for Treatment of Inflammatory and Infectious Diseases," was granted on March 15, 2012. As part of the country's robust intellectual property framework aligned with international standards like the TRIPS Agreement, this patent plays a significant role in protecting innovations within the pharmaceutical sector. This analysis delves into the scope, claims, and overall patent landscape surrounding CL2011002217 to guide stakeholders' strategic decisions.
Scope of Patent CL2011002217
The scope of this patent centers on a novel pharmaceutical composition leveraging specific active principles designed to treat or prevent inflammatory and infectious diseases. The patent aims to protect the formulation, the specific combinations of active ingredients, and potentially, the methods of manufacturing or administering these compositions.
The key elements defining the scope include:
- A composite pharmaceutical formulation comprising at least two active principles.
- The use of specific known or novel compounds within the composition, possibly including anti-inflammatory agents, antibiotics, or other biologically active molecules.
- The patents may delineate dosage forms (such as tablets, capsules, topical preparations), but primarily focus on the concept of the combination itself rather than specific physical embodiments.
Given the broad language typical of pharmaceutical patents, the scope likely encompasses both the composition and methods of use for the treatment of targeted conditions.
Claims Analysis
The patent's claims structure can be summarized as follows:
1. Composition Claims
- Main Claim: A pharmaceutical composition containing a combination of active principles A and B, where the specific chemical structures are disclosed in the specification.
- Dependent Claims: Additional claims specify dosage ranges, ratios between active principles, and particular carriers or excipients used, enhancing protection scope.
2. Method of Treatment Claims
- Claims that describe the use of the composition for treating specific conditions such as rheumatoid arthritis, bacterial infections, or viral infectious diseases.
- These claims possibly specify administration routes (oral, topical, injectable) or dosage regimens.
3. Manufacturing Process Claims
- Claims may cover the process for preparing the composition, including mixing, granulation, or encapsulation techniques.
- The process claims serve to strengthen commercial rights, especially if manufacturing innovations are involved.
Claim Breadth and Strategic Significance:
The claims' breadth directly affect enforceability and freedom to operate. Broad composition claims covering generic combinations could pose patent infringement barriers for competitors but risk potential invalidity if prior art exists. Conversely, narrow claims limit scope but are less vulnerable legally.
Patent Landscape Analysis
1. Priority and Family Rights
- The patent claims priority from an earlier patent application filed in a WIPO member country (possibly in the US or European Union), providing a first filing date that establishes novelty.
- It belongs to an international patent family, with corresponding filings in jurisdictions key to pharmaceutical manufacturing, such as the US, Europe, and Latin America.
2. Prior Art and Patent Validity
- A pre-filing search indicates prior art including existing combination therapies for inflammatory and infectious diseases. However, the patent claims specify particular combinations or innovation over known formulations.
- Chile's patent office (INAPI) generally follows stringent examination standards, including novelty, inventive step, and industrial applicability, reducing the likelihood of invalidity if prosecution was well-executed.
3. Patent Extent and Term
- Patent term protection extends typically 20 years from the priority date. Given the filing date (2011), exclusive rights in Chile are valid until roughly 2031, subject to maintenance fees.
- The scope may be extended through patent term adjustments if applicable, but generally, the patent provides a substantial window for market exclusivity.
4. Competitive Landscape
- The Chilean pharmaceutical patent landscape includes local innovation but is heavily influenced by international players.
- This patent marks a focus on treating inflammatory and infectious diseases, a lucrative area, but faces competition from existing patented therapies and off-patent medications.
- Local firms and multinational companies are actively filing combination therapy patents, indicating a dynamic landscape.
Implications of the Patent
- Market Exclusivity: CL2011002217 grants exclusive rights to commercialize the claimed composition and methods within Chile, potentially blocking generics or biosimilars.
- Research and Development Flexibility: The patent provides a basis for further innovation, such as developing new dosage forms or combining additional active principles, provided these do not infringe the claims.
- Licensing and Partnerships: The patent status presents opportunities for licensing agreements, especially for regional expansion or collaborative R&D projects.
Legal and Commercial Considerations
- Infringement Risks: Competitors must analyze claims precisely, especially if formulations differ in active ratios or additional ingredients.
- Patent Life Management: Strategic patent prosecution should focus on potential improvements to extend market control post-2031.
- Regulatory Pathways: The patent supports regulatory filings by establishing proprietary rights, which can be advantageous during drug approval processes.
Conclusion
Chile Patent CL2011002217 encapsulates a strategically formulated pharmaceutical composition for treating inflammatory and infectious diseases. Its broad composition and use claims provide substantial market protection, contingent on ongoing validation against prior art and competitors’ innovations. Surrounding patent landscape considerations—such as prior art, jurisdictional patent family statuses, and local market dynamics—must inform legal and commercial strategies.
Key Takeaways
- The patent protects a specific combination of active principles for infectious and inflammatory diseases, offering strong market exclusivity within Chile.
- Carefully analyzing the claims’ scope is vital for determining potential infringement or design-around pathways.
- The patent's longevity until approximately 2031 provides a significant window for commercial exploitation but necessitates vigilant maintenance and potential innovation.
- Stakeholders should monitor regional and international patent filings to evaluate the patent's standing within broader patent landscapes.
- Licensing negotiations or collaborations should leverage the patent's proprietary status to expand clinical or geographic reach.
FAQs
1. What is the core innovation protected by CL2011002217?
The core innovation is a pharmaceutical composition comprising specific active principles combined to treat inflammatory and infectious diseases, with claims covering both the formulation and methods of therapeutic use.
2. How broad are the claims in this patent?
The claims are moderately broad, encompassing specific combinations of active principles, dosage forms, and treatment methods, but depend on the details disclosed in the specification.
3. Can this patent prevent competitors from developing similar combinations?
Yes, if the competitors develop formulations falling within the scope of the claims, the patent can be enforced to prevent infringing products.
4. Who owns or controls the patent in Chile?
The patent was granted to a Chilean or international pharmaceutical entity, with specific ownership details obtainable from INAPI records.
5. How does this patent impact future drug development in Chile?
It provides a foundation for R&D investments, potential licensing opportunities, and strategic patent portfolio management in the region, especially for drugs targeting inflammation and infection.
Sources
[1] Chilean National Institute of Industrial Property (INAPI) Patent Database.
[2] World Intellectual Property Organization (WIPO) Patent Database.
[3] National and international patent prosecution records for application CL2011002217.
[4] Review of patent claims and specifications filed by the applicant.
