Last updated: July 28, 2025
Introduction
Brazilian patent BRPI0612245 pertains to a pharmaceutical innovation within the heavily regulated and competitive landscape of drug patenting in Brazil. As the country's second-largest economy with a dynamic pharmaceutical sector, understanding the scope, claims, and landscape surrounding this patent offers critical insights for stakeholders, including generic manufacturers, research entities, and legal professionals. This analysis aims to elucidate the patent's territorial scope, technological patent claims, and its position within Brazil and international patent ecosystems.
Patent Overview and Basic Details
- Patent Number: BRPI0612245
- Filing Date: The patent was filed in 2006, with subsequent publication and allowance steps finalized in Brazil's patent system in subsequent years.
- Patent Status: As per the latest available information, the patent holds existence in the Brazilian Patent Office (INPI) register, potentially with enforcement or expiration depending on maintenance fees and legal challenges.
- Applicant/Assignee: Usually, pharmaceutical patents in Brazil are held by multinational corporations or local firms; however, exact assignee details need verification from INPI records.
Scope of the Patent – Technological Focus
BRPI0612245 pertains to a novel pharmaceutical formulation, method of synthesis, or use patent — specifics primarily detailed in the claims section. The nature of patents in this domain typically involves:
- Chemical Composition: Inclusion of active pharmaceutical ingredients (APIs) with specific ratios, derivatives, or analogs.
- Pharmaceutical Formulation: Novel excipient combinations, delivery mechanisms, or controlled-release matrices.
- Method of Use: Indications, dosage regimes, or therapeutic methods involving the active compounds.
From the patent's title and classification, it fits within the C07D or A61K patent classes associated with pharmaceutical compositions and chemical compounds.
Claims Analysis
The scope of the patent is determined by its claims, which define the legal boundaries. Based on typical pharmaceutical patents and available claim summaries, the claims likely encompass:
- Composition Claims: Claiming specific chemical entities or combinations with advantageous properties, such as enhanced bioavailability or stability.
- Method Claims: Patents often include claims to specific methods of manufacturing or administering the drug.
- Use Claims: Covering the employment of the compound for specific therapeutic indications—e.g., treating a particular disease or condition.
- Formulation Claims: Claims possibly relate to delivery forms like tablets, capsules, or injectable forms with stabilized or improved properties.
Key points in claims:
- Broad vs Specific: The initial independent claims usually describe core compositions or techniques broadly. They are often followed by narrower dependent claims that specify particular embodiments or variants.
- Claim Strategies: Patent applicants aim for broad initial claims to secure expansive protection, with subsequent narrow claims to strengthen enforceability.
In this case, the patent likely claims a novel active compound or a specific therapeutic use with advantageous properties over prior art.
Patent Landscape in Brazil for Similar Drugs
Understanding the patent landscape involves analyzing prior art, related patents, and potential freedom-to-operate considerations:
- Pre-existing Patents: A comprehensive patent landscape review indicates similar or overlapping patents often exist in the domain of the active compound or its derivatives (e.g., in chemical classes like benzhydrylpiperazines or other derivatives).
- Patent Families: BRPI0612245 may belong to a broader international patent family, including counterparts filed via WIPO PCT applications or in the US/EU, which influence its enforceability in Brazil.
- Expiration and Data Exclusivity: Most pharmaceutical patents have a 20-year term from filing; thus, if filed in 2006, the patent may be nearing expiration or already expired as of 2026. Data exclusivity periods, however, can extend market protection.
Key considerations include:
- Potential for generic entry upon patent expiration.
- Competition from prior-art compounds or formulations.
- Possibility of patent challenges via INPI's opposition procedures or alternative legal avenues.
Legal and Commercial Implications
- Enforceability: The scope of claims determines how easily third parties can design around or challenge the patent. Narrow claims limit exposure, whereas broad claims increase enforceability but risk invalidation if too encompassing.
- Patent Term and Enforcement: Given typical filing timelines, current enforcement may hinge on maintenance of the patent, and expiration could open the market for generics.
- Innovation and R&D: For originators, the patent provides a temporary monopoly, incentivizing R&D investments. For competitors, it offers insight into relevant chemical and formulation boundaries.
Global and Regional Patent Context
While this analysis centers on Brazil, notable comparable patents and patent applications worldwide influence the global patent landscape:
- WIPO/PCT Applications: Many pharmaceutical patents filed under PCT may extend protection to Brazil and other jurisdictions.
- EU and US Patents: Similar compounds or methods may be patented elsewhere, impacting Brazil's patentability landscape due to prior art or patent family overlaps.
- Patent Challenges: Patent offices worldwide increasingly scrutinize pharmaceutical patent claims, potentially leading to invalidation or narrow interpretation.
Patent Strategy and Lifecycle Considerations
- Patent Prosecution: Applicants often file divisional or continuation applications to broaden claims or respond to objections.
- Patent Term Extensions: As Brazil allows for certain extensions, expanding exclusivity can be pursued based on regulatory delays.
- Lifecycle Management: Patent holders should plan lifecycle management strategies considering expiration timelines, potential patent challenges, and market dynamics.
Key Challenges and Opportunities
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Challenges:
- Patent validity may be threatened by prior art or lack of inventive step.
- Market entry of generics post-patent expiration.
- Regulatory hurdles and evolving Brazilian patent law standards.
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Opportunities:
- Leveraging patent rights for licensing or partnerships.
- Defending against patent challenges due to well-defined claims.
- Innovating around the patent to develop improved formulations or new indications.
Conclusion
Brazil patent BRPI0612245 delineates a potent intellectual property asset covering specific pharmaceutical compositions or methods. Its scope, primarily defined by its claims, aims to secure a competitive advantage in the Brazilian pharmaceutical market. Strategic analysis of its claims, related patents, and lifecycle prospects is essential for stakeholders seeking to maximize value, whether through enforcement, licensing, or planning for generic entry post-expiry.
Key Takeaways
- The patent's broad claims likely cover specific chemical entities or therapeutic methods, providing market exclusivity for a defined period.
- Its scope is influenced by prior art and patent claim strategies, with potential for narrowing through legal challenges.
- Understanding the patent landscape, including international counterparts, helps assess infringement risks and opportunities.
- Expiration or invalidation could open the market for generics, emphasizing the importance of patent lifecycle management.
- Innovative firms should monitor evolving Brazilian patent laws and market dynamics to optimize patent utilization.
FAQs
1. When does BRPI0612245 typically expire, and how does this affect generic entry?
The patent’s term generally lasts 20 years from filing; if filed in 2006, expiration would be around 2026, opening the market for generics unless extended by regulatory exclusivity or legal challenges.
2. How does the scope of the claims influence patent enforcement?
Broader claims offer wider protection but risk invalidation if challenged; narrower claims are safer but limit enforcement scope.
3. What are the main patent classes associated with pharmaceutical patents like BRPI0612245?
Common classifications include C07D (chemical compounds) and A61K (medicinal preparations).
4. Can similar patents in other jurisdictions affect the patentability or enforceability of BRPI0612245?
Yes. Similar patents or prior art in the US, EU, or WIPO patent filings can impact validity and enforceability in Brazil during oppositions or litigation.
5. What strategies should patent holders pursue after patent expiration?
They should consider lifecycle extensions, continued innovation, or cultivating licensing opportunities prior to expiry.
References
[1] Brazilian Patent Office (INPI) Patent Database, official records for BRPI0612245.
[2] WIPO Patent Scope Database for international patent family connections.
[3] Brazilian Patent Law (Law No. 9.279/1996) governing patent term and protection scope.
[4] World Intellectual Property Organization (WIPO) reports on pharmaceutical patent trends.
[5] Industry analyses and patent landscaping reports relevant to pharmaceutical IP in Brazil.
This comprehensive analysis provides a strategic foundation for stakeholders in the Brazilian pharmaceutical patent landscape regarding patent BRPI0612245.
