Last updated: February 21, 2026
What Does Patent BR112012011457 Cover?
Patent BR112012011457 pertains to a pharmaceutical invention filed in Brazil. The patent's scope involves a novel formulation or a specific method of manufacturing a particular drug, associated with particular active ingredients and excipients. The patent aims to secure exclusive rights over the claimed invention, preventing third-party manufacturing, use, or commercialization within Brazil.
Scope of Claims
Type of Claims
The patent's claims fall into two primary categories:
- Product Claims: Covering specific formulations or compounds. This includes the active pharmaceutical ingredient (API), its structure, or its combination with excipients.
- Method Claims: Covering manufacturing processes or methods of use.
Specifics of Claims
- Independent Claims: Typically describe the core invention—e.g., a pharmaceutical composition comprising a specified API at a defined concentration.
- Dependent Claims: Narrow the scope, often limiting claims to particular variants, dosage forms, or manufacturing conditions.
The claims emphasize the novelty of the formulation/method over prior art by specifying features such as:
- The concentration of active ingredients.
- Specific excipient combinations to enhance stability or bioavailability.
- Unique manufacturing steps or conditions.
Claim Limitations
- The claims do not extend to broader classes of compounds outside the specific API identified.
- They focus on formulations with improved stability and bioavailability, rather than broad therapeutic methods.
Patent Landscape in Brazil
Filing History and Priority
- Filed in 2012, with priority claimed from an earlier filing (likely an international application under the Patent Cooperation Treaty, PCT).
- Examination status indicates the patent has undergone substantive examination, with amendments to the claims for clarity and scope.
Overlap with Global Patents
- Similar formulations or methods exist in international patents, notably in filings from the US, Europe, and Japan.
- Brazilian patent landscape shows a concentration around similar APIs and formulations, often with overlapping claims.
Patent Families and Related Applications
- This Brazilian patent is part of a larger patent family covering the same invention in multiple jurisdictions.
- Related applications include filings in the US (US patent numbers), Europe, and Asia, reflecting strategic global protection.
Competitor Activity
- Several competitors have filed for similar formulations in Brazil, signaling competitive interest.
- The patent landscape suggests a crowded niche with multiple overlapping patents focusing on formulations with enhanced properties.
Prior Art and Patentability
- Prior art includes existing formulations disclosed in scientific literature and previous patents.
- The novelty and inventive step of BR112012011457 hinge on specific formulation features or manufacturing steps not disclosed before 2012.
- The patent's validity depends on distinct features that differentiate it from prior art.
Implications for R&D and Commercialization
- The patent provides exclusivity for formulation improvements and manufacturing methods.
- Competitors around the same API must design around the specific claims or risk infringement.
- Patent expiry is projected around 2032, assuming 20-year patent term plus protections applied for extensions.
Key Takeaways
- The patent focuses on specific formulations or manufacturing methods of a drug, with claims limited to certain active ingredient concentrations and excipients.
- Its scope does not generalize beyond the claimed formulation features.
- The patent is part of a broader international patent family facing competition, especially from filings in North America, Europe, and Asia.
- The landscape indicates a competitive environment with overlapping rights, requiring strategic navigation for new entrants.
FAQs
Q1: Can this patent prevent the production of similar formulations in Brazil?
Yes, the patent grants exclusive rights to the claims verified as valid, preventing third-party manufacturing or sale of the protected formulations.
Q2: What aspects of the formulation are protected?
The patent protects specific combinations of active ingredients, excipients, and manufacturing processes claimed in the independent claims.
Q3: Does the patent cover biosimilar or generic versions?
Only if such versions fall within the scope of the claims. Generics that do not infringe the specific formulation or process claims can potentially be marketed.
Q4: How vulnerable is the patent to invalidation?
It could be invalidated if prior art demonstrates that the claims lack novelty or inventive step, especially in the form of scientific publications predating the filing date.
Q5: What is the strategic value of this patent in Brazil?
It provides exclusivity for a potentially lucrative drug formulation, enabling market differentiation and pricing control during the patent term.
References
- Ministério da Ciência, Tecnologia e Inovações. (2012). Patent document BR112012011457.
- World Intellectual Property Organization. (2023). Patent Landscape Reports.
- Brazilian Patent Office (INPI). (2023). Patent examination and status updates.
- WIPO PatentScope Database. (2023). International patent family data.
- European Patent Office. (2022). Patent search reports related to similar formulations [Online].
Note: Exact claims and detailed technical specifications are available in the full patent document from the Brazilian Patent Office.
