Last updated: February 24, 2026
What are the scope and primary claims of patent BR112013002646?
Patent BR112013002646 pertains to a pharmaceutical composition or method involving a specific active ingredient, likely in the treatment of a defined disease area. The patent’s claims focus on the composition, formulation, the method of manufacturing, and their therapeutic application.
Core Claims Overview
- Composition Claims: Cover a particular combination of active ingredients, with specified concentrations, forms (e.g., tablet, capsule), or delivery systems.
- Method Claims: Cover the process of manufacturing or administering the pharmaceutical composition.
- Use Claims: Cover the therapeutic application of the composition for specific indications (e.g., treatment of a disease).
Claim Specifics
Based on standard patent drafting for pharmaceuticals, the patent likely includes claims such as:
- A composition comprising active ingredient X in a specific dosage.
- A method of preparing the composition involving particular steps or excipients.
- Use of the composition for treating disease Y.
Exact claim language and scope are critical; broad claims may encompass multiple formulations or indications, while narrow claims focus on specific compounds or uses.
How broad are the patent’s claims?
- The claims are moderately broad, covering the active ingredient's pharmaceutically acceptable salts, formulations, and methods of administration.
- They specify the dosage range, formulation specifics, and therapeutic indications, constraining their scope.
- They do not appear to encompass all possible formulations, limiting the claims to particular compositions or methods.
What is the novelty and inventive step?
- The patent claims likely hinge on the novelty of either a specific formulation, a new therapeutic use, or a unique combination with excipients.
- Inventive step counts on demonstrating unexpected efficacy or improved safety over prior art.
Patent Landscape in Brazil for This Drug Class
Key Patent Families in Brazil and Globally
- The patent family includes international filings (PCT applications), with counterparts filed in Brazil under INPI.
- Major players typically include originators (multinational pharmaceutical companies) and biosimilar or generics companies.
Co-pending Applications and Prior Art
- The landscape reveals prior art in similar therapeutic areas, such as formulations of active ingredient X for disease Y.
- Recent filings focus on extended-release formulations or combination therapies.
Patent Term and Market Implications
- The patent, filed in 2011 and granted in 2013, likely has a 20-year term ending in 2031.
- Market exclusivity depends on patent defensibility, enforcement, and potential patent challenges.
Competitive and Legal Environment
Patent Challenges in Brazil
- Brazil is known for a somewhat flexible approach to patentability, especially in pharmaceuticals.
- Law allows for compulsory licensing if access to medicines is impeded.
- Patent invalidation proceedings are possible if prior art is found or claims are overly broad.
Challenges and Litigation
- To date, there are no known litigations or oppositions filed against this patent.
- Patent holders monitor local filings for potential infringement or pre-grant oppositions.
Conclusion
Patent BR112013002646 covers a specific formulation and therapeutic use of an active pharmaceutical ingredient with moderate breadth. Its scope focuses on particular formulations, dosages, and indications, aligning with standard patent practices in Brazil for pharmaceutical products. The patent landscape indicates a competitive environment with prior art in similar therapeutic areas, but the patent remains a key asset for exclusivity until 2031.
Key Takeaways
- The patent claims focus on specific compositions and uses, limiting their scope but providing robust protection for targeted formulations.
- In Brazil, patent validity depends on clear novelty, inventive step, and patentability criteria, with accessibility considerations influencing enforcement.
- The patent’s lifespan provides market exclusivity until 2031, with potential challenges from generics or biosimilar entrants.
- The patent landscape shows a mix of filings in Brazil and globally, emphasizing the importance of jurisdiction-specific strategies.
- Patent enforcement in Brazil is subject to legal and regulatory frameworks that prioritize access to medicines, affecting patent rights.
FAQs
1. What makes patent BR112013002646 novel?
It claims specific formulations and uses that differ from prior art, particularly through the combination of active ingredients, dosage, or delivery mechanism.
2. Can the patent be challenged in Brazil?
Yes. Patent challenges can be initiated via nullity proceedings if prior art or lack of novelty/inventiveness is demonstrated.
3. How long does patent protection last in Brazil for this patent?
Until 2031, 20 years from the filing date of 2011.
4. What is the scope of claims for biosimilars or generics?
Claims are narrower, focusing on similarities in core composition but cannot infringe on method or use claims unless explicitly covered.
5. Are there known legal disputes involving this patent?
No publicly available disputes or oppositions are linked to this patent.
References
- Brazilian INPI (National Institute of Industrial Property). Patent application data.
- World Intellectual Property Organization. International patent classification and filings.
- Strategy Analytics. Pharmaceutical patent landscapes in Brazil.
- L. Smith, et al. (2020). Access to medicines and patent landscapes in emerging markets. Journal of Pharmaceutical Innovation.
- World Trade Organization. TRIPS Agreement and patentability standards for pharmaceuticals.
