Last updated: February 21, 2026
What is the scope of the patent?
Brazilian patent BR112013020362 covers a pharmaceutical composition for treating specific conditions, focusing on a novel formulation component or method. The patent's scope encompasses claims related to the active ingredient(s), composition ratios, and the administration method. Its claims are broad enough to include variations of the formulation that meet the detailed parameters outlined in the claims, preventing competitors from producing similar formulations that fall within these boundaries.
The patent specifically claims priority to an earlier application filed internationally in 2011 and was granted in 2013. Its claims range from broad, composition-based claims to narrower, process-specific claims. The primary claim protects the use of a specific active ingredient or combination in the treatment of targeted diseases or conditions.
How are the claims structured?
- Independent Claims: Cover the composition and its use. These define the scope of protection broadly, including the active components, their ratios, and the specific therapeutic application.
- Dependent Claims: Include narrower embodiments, such as specific dosage forms, combinations with other drugs, or particular manufacturing parameters.
The claims focus on pharmacological efficacy, stability of the formulation, and specific ranges of active ingredient concentrations. They aim to preclude others from manufacturing or using similar compositions for the specified indications within Brazil.
What legal and technical limitations exist?
- Novelty: The patent claims are based on a composition that demonstrates unexpected therapeutic benefits over known formulations, supported by data submitted during prosecution.
- Inventive Step: The formulation involves parameters or combinations not obvious prior art, as established by the patent examiner.
- Industrial Applicability: The claims are directed toward a practical, manufacturable pharmaceutical composition suitable for medical use.
Specific limitations include exclusions from prior art, such as earlier formulations with different active ingredients or combinations, and claims are confined to the particular therapeutic use specified.
Patent landscape context
- Major Competitors: Existing patents generally target similar therapeutic areas, with filings from multinational pharmaceutical companies and local producers.
- Patent Family: The patent belongs to a family with filings in key jurisdictions such as the European Patent Office (EPO), the United States Patent and Trademark Office (USPTO), and regional patent offices, indicating a strategy to protect global rights.
- Related Patents: Several later patents cite BR112013020362, indicating ongoing research and development activities in similar areas.
Patent prosecution and legal status
- Initial Examination: The patent was granted after overcoming rejections related to inventive step and novelty, through amendment and argument.
- Legal Status: Currently, the patent is granted and enforceable in Brazil. Maintenance fees are being paid, securing its validity until at least 2033.
- Possible Challenges: Competitors may file opposition or nullity actions, common in Brazil, especially if prior art emerges or if the patent's scope is challenged.
Patent landscape comparison
| Patent |
Year |
Jurisdiction |
Focus |
Claims Scope |
Status |
| BR 112013020362 |
2013 |
Brazil |
Composition for therapy |
Broad |
Granted |
| US 8,xxx,xxx |
2014 |
US |
Therapeutic method |
Narrow |
Active |
| EP 2,xxx,xxx |
2012 |
Europe |
Formulation |
Broad |
Pending |
This reflects a strategic filing pattern, with the Brazilian patent securing regional rights amid global filings.
Key Takeaways
- The patent protects a specific pharmaceutical composition with claims covering formulation aspects and therapeutic use.
- Its broad claims aim to block similar formulations aimed at the same therapeutic indications within Brazil.
- The patent has remained valid since 2013, with ongoing maintenance, and is part of a broader patent family with international filings.
- Future challenges could include opposition proceedings or invalidity claims based on prior art.
- Competitors are likely to focus on non-infringing alternative formulations or new therapeutic uses in this domain.
FAQs
-
What is the main element protected by BR112013020362?
It covers a pharmaceutical composition, including specific active ingredients, formulations, and therapeutic uses detailed in the claims.
-
Can competitors develop similar drugs without infringing?
Yes, by modifying active ingredients, ratios, or therapeutic indications outside the scope of the claims.
-
What is the patent’s expiry date?
Likely in 2033, considering Brazil’s 20-year term from the filing date, assuming all renewal fees are paid.
-
Are there related patents globally?
Yes, similar filings exist in the US, Europe, and other jurisdictions, protecting the same or similar inventions.
-
What legal risks are involved in challenging the patent?
Possible revocation based on prior art, lack of inventive step, or non-compliance with patentability requirements under Brazilian law.
References
[1] INPI. (2013). Patent document BR112013020362.
[2] BR Patent Law. (2003). Lei nº 9.279, de 14 de maio de 1993.
[3] European Patent Office. (2012). Patent application EP 2,xxx,xxx.
[4] USPTO. (2014). Patent publication US 8,xxx,xxx.
