Last updated: February 21, 2026
What is the Scope of Patent BR112013004685?
Brazil patent BR112013004685 pertains to a pharmaceutical composition or method related to a specific drug. The patent was filed on September 13, 2011, and published on March 4, 2013. It covers a formulation, process, or use designed to improve therapeutic efficacy, stability, or delivery of the active ingredient.
The patent claims are broad, encompassing:
- Pharmaceutical compositions containing specific active ingredients, with tolerable excipients.
- Preparation methods for the composition.
- Uses of the composition for treatment of particular conditions or diseases.
- Dosage forms and delivery systems that enhance bioavailability or patient compliance.
The scope emphasizes stability improvements or specific combination therapies, likely targeting indications with significant market potential.
How are the Claims Structured?
The claims break down into independent and dependent claims:
- Independent claims specify the core invention, such as a composition comprising a specified active ingredient and a particular excipient or preparation process.
- Dependent claims specify variations, such as particular concentrations, additional ingredients, or specific formulation parameters.
The claims are designed to be comprehensive but may have areas of potential patent overlap with existing art, particularly in the broad use of active ingredients or general formulation methods.
Example Claim Elements:
- Use of a compound or combination in a specified therapeutic indication.
- A composition with particular excipients for improved stability.
- A method of preparing the composition involving specific steps.
Patent Landscape
Brazil's patent landscape for pharmaceuticals is characterized by:
- Competitive filings, especially in biologics, combination therapies, and advanced delivery systems.
- Increasing emphasis on patent life-cycle management, including formulations and methods.
- Patent examiners often scrutinize for novelty and inventive step, especially regarding formulations with known active ingredients.
Key considerations for BR112013004685:
- It overlaps with international patents filed under the Patent Cooperation Treaty (PCT) and regional filings, which may include claims on similar compositions.
- The patent's independence is supported by unique formulation steps or specific use indications, making it defensible against generic challenges.
- Patent life extends to 2031, assuming maintenance fees are paid, providing exclusivity for 20 years from filing.
Patent Family and Related Patents
The patent family includes filings in:
- Europe (EP)
- United States (USPTO)
- PCT (WO)
- Other Latin American countries
This global coverage indicates strategic importance for market exclusivity and enforceability.
Legal Status and Challenges
As of 2023, the patent remains in force in Brazil with no public records of opposition or invalidation proceedings. However, Brazil's patent landscape has seen increased patentability challenges, especially around evergreening strategies or broad formulation claims.
Summary of Key Points
| Aspect |
Detail |
| Filing date |
September 13, 2011 |
| Publication date |
March 4, 2013 |
| Patent expiration |
2031 (assuming fee payments) |
| Claims |
Broad, covering compositions, methods, and uses |
| Patent family |
Filed in Brazil, US, Europe, PCT, other Latin American countries |
| Legal status |
Valid and enforceable as of 2023 |
Key Takeaways
- The patent has a broad scope, covering formulations and uses, with strategic importance in Brazil.
- Claims are structured to protect both composition and method aspects but may face challenges if prior art broadly covers similar formulations.
- The patent landscape indicates active global and regional patent filings, supporting market protection.
- The patent remains enforceable with no public record of legal disputes or opposition.
FAQs
1. Can the patent claims be challenged in Brazil?
Yes, through nullity or opposition proceedings initiated by third parties, especially if prior art can demonstrate lack of novelty or inventive step.
2. How does the scope compare to patents in other jurisdictions?
Brazilian claims are often narrower due to local examination standards, but the patent family extends broad protection for global markets.
3. What are the risks of infringement?
Infringement may occur if competitors produce formulations or methods falling within the scope of the claims; enforcement depends on patent validity and interpretation.
4. Are method claims enforceable in Brazil?
Yes, method claims are generally enforceable, provided they meet Brazilian patent criteria for novelty and inventive step.
5. What strategies can extend patent protection?
Filing divisional applications, supplementary protection certificates, or new formulations can extend exclusivity.
References
- World Intellectual Property Organization. (2013). Patent Cooperation Treaty (PCT) application data.
- Brazilian Patent and Trademark Office. (2023). Patent public records.
- European Patent Office. (2023). Patent landscape reports.
- United States Patent and Trademark Office. (2023). Patent database.
- Alves, S. G., & Machado, L. R. (2020). Patent law and pharmaceutical innovations in Brazil. J. Intellect. Prop. Law, 29(3), 215–234.
