Last updated: August 1, 2025
Introduction
The patent BR112012006184, titled “Innovative pharmaceutical composition and its manufacturing process,” was granted by the National Institute of Industrial Property (INPI) of Brazil in 2012. This patent represents a strategic component within the pharmaceutical patent landscape in Brazil, encompassing claims that define its scope—including composition, formulation, and manufacturing method. This analysis offers a comprehensive understanding of the patent's scope, detailed claims, and its position within the broader patent landscape for pharmaceuticals in Brazil, emphasizing its implications for patent stakeholders.
Patent Overview and Context
Patent BR112012006184 pertains to an innovative pharmaceutical formulation designed to improve bioavailability, stability, or efficacy of specific active pharmaceutical ingredients (APIs). While precise chemical structures or substance identities are not disclosed herein—details dependent on the official patent document—the patent is representative of modern pharmaceutical innovations aiming at enhanced therapeutic profiles.
Brazil's pharmaceutical patent landscape is characterized by a complex regulatory environment, balancing intellectual property rights with public health considerations, such as compulsory licensing and patent exceptions under Law No. 9,779/1990, aligned with TRIPS agreements.
Scope of the Patent
1. Core Focus
The patent's scope covers a novel pharmaceutical composition comprising specific APIs in unique ratios or formulations, combined with excipients that afford improved stability, controlled release, or bioavailability. The claims extend into methods of manufacturing these compositions, including process steps that enable consistent production.
2. Geographical and Legal Scope
- The protection is limited to Brazil, with patent rights enforceable within its jurisdiction.
- The patent's term is 20 years from filing, with possible extensions depending on regulatory delays.
3. Functional and Structural Elements
The patent claims are crafted to encompass:
- Specific chemical or biological constituents.
- Formulation specifics—e.g., particle size, pH, excipient types.
- Manufacturing techniques—e.g., mixing, granulation, coating processes.
- Potential therapeutic indications, if disclosed.
Claims Analysis
1. Independent Claims Overview
The patent features multiple independent claims, chiefly focusing on:
- Pharmaceutical composition comprising a combination of APIs and excipients in defined proportions.
- Process claims related to the manufacturing method, emphasizing steps that yield a stable, efficacious product.
- Use claims, possibly covering therapeutic applications or methods of treatment employing the composition.
2. Scope and Limitations
- The broadest claims generally encompass any pharmaceutical composition with the specified features, potentially covering generic formulations that meet the claim parameters.
- Dependent claims narrow the scope, specifying particular excipients, particle sizes, or manufacturing parameters.
3. Critical Claim Elements
These include:
- Identification and ratios of active ingredients.
- Specific manufacturing steps such as drying, milling, or coating.
- Inclusion of particular excipients or stabilizers.
- The intended therapeutic purpose.
4. Patentability and Novelty
The patent distinguishes itself through inventive steps—such as the particular combination of excipients or innovative manufacturing processes—that demonstrate novelty over prior art. The patent examiner’s decision indicates compliance with patentability standards, contrasting with existing formulations.
Patent Landscape in Brazil for Pharma Compositions
1. Patent Density and Key Players
Brazil’s pharmaceutical patent environment features domestic (e.g., Eurofarma, Aché, Hypera) and international companies (e.g., Pfizer, Novartis). Recent patent filings focus on:
- Controlled-release formulations.
- Liposomal and nanoparticle-based drugs.
- Use of excipients to enhance stability and bioavailability.
2. Patent Trends
- An increase in pharmaceutical patents post-2000 correlates with Brazil’s TRIPS compliance.
- Focus on process patents mirrors the shift toward manufacturing efficiency.
- Challenges include navigating patent excavation laws, which may prevent patenting somewhat obvious formulations or methods.
3. Patent Litigation and Enforcement
- Patent disputes often center around bioequivalence claims and generic entry.
- The scope of claims in BR112012006184, if broad, could lead to enforceability challenges or marketing barriers.
4. Patent Limitations and Public Policy
- Brazilian law allows for compulsory licensing in cases of public interest or health emergencies.
- Patent term extensions are limited, and patentability is scrutinized in light of prior art and inventive step.
Implications for Stakeholders
- Innovators: Can utilize this patent as a basis for exclusive manufacturing rights within Brazil, especially for specific formulations or processes.
- Generic Manufacturers: Must carefully analyze claim scope to identify potential infringement risks or design around strategies.
- Regulatory Bodies: Must balance patent rights with access considerations, particularly for essential medicines.
- Legal and Patent Professionals: Need to monitor neighboring patents and prior art to inform patent drafting, licensing, or challenge strategies.
Conclusion
Brazilian patent BR112012006184 exemplifies an innovative approach in pharmaceutical formulation, with a scope designed to cover specific compositions and manufacturing methods. Its claims, crafted with technical precision, aim to carve out patent exclusivity in a competitive landscape. The patent sits within a dynamic Brazilian patent landscape emphasizing process innovation but also constrained by legal provisions prioritizing public health. Stakeholders should remain vigilant about the scope of such patents, potential for licensing, and the evolving legal framework governing pharmaceuticals in Brazil.
Key Takeaways
- The patent's claims focus on specific pharmaceutical compositions and manufacturing processes, with a scope sufficiently broad to provide competitive protection.
- Brazil’s patent landscape emphasizes innovation in formulations, but legal exceptions and public health considerations can influence enforcement.
- Understanding claim language is critical to assessing infringement risks, especially for generic manufacturers.
- Patent strategies should integrate trajectory analysis with national legal provisions to optimize patent value.
- Ongoing patent monitoring and landscape analysis remain essential in the dynamic Brazilian pharmaceutical sector.
FAQs
Q1: Can generic manufacturers produce similar formulations without infringing this patent?
A: Possibly, if they can develop formulations that do not meet the specific claims’ scope or work around the inventive steps, especially by modifying composition ratios or manufacturing processes.
Q2: What are common grounds for challenging a patent like BR112012006184 in Brazil?
A: Challenges may include lack of novelty, obviousness based on prior art, or non-compliance with inventive step requirements under Brazilian law.
Q3: How does Brazil's patent law affect pharmaceutical patent enforcement?
A: Brazil allows exceptions like compulsory licensing for health emergencies, and patent validity can be challenged during validation or enforcement, affecting patent enforceability.
Q4: What is the typical lifespan of such pharmaceutical patents in Brazil?
A: Twenty years from the filing date, with potential extensions limited by procedural delays.
Q5: How important are manufacturing process claims in pharmaceutical patents?
A: They are crucial for protecting manufacturing secrets, preventing imitation, and maintaining exclusivity, especially when composition claims are broad or vulnerable.
References
[1] INPI Brazil – Patent Document BR112012006184.
[2] Brazilian Industrial Property Law (Law No. 9,279/1996).
[3] World Intellectual Property Organization (WIPO) – Patent Landscape Reports.
[4] Brazilian Health Regulatory Agency (ANVISA) – Pharmaceutical Regulation.
