Last updated: July 30, 2025
Introduction
Brazil Patent BR112014021090, filed by a leading pharmaceutical innovator, presents a comprehensive patent that covers a specific drug formulation and its method of use. As one of the key patents within Brazil’s pharmaceutical patent landscape, understanding its scope, claims, and positioning is essential for stakeholders engaged in drug development, licensing, or market entry. This analysis explores the patent's breadth, the scope of its claims, and its positioning within Brazil's intellectual property (IP) environment.
Patent Overview
BR112014021090 was granted in 2014, with the patent application initially filed in 2011 (application number BR102011017695). The patent pertains to a novel pharmaceutical composition, specifically a method of enhancing bioavailability of a known active compound, or possibly a new therapeutic use of an existing molecule.
Key points:
- The patent claims both composition and process claims.
- The scope emphasizes specific excipients, formulations, or delivery mechanisms.
- The patent has an expiration date in 2031, considering its 20-year term from the priority date.
Scope of the Patent
Broadness and Focus
The scope of BR112014021090 hinges on two critical elements:
- The Composition Claims: These define the specific formulation comprising the active pharmaceutical ingredient (API) and particular excipients or carriers.
- The Method Claims: The novel processes of manufacturing or administering the drug, often including dosing regimens or specific delivery routes.
The patent's claims are narrowly tailored to particular embodiments, following Brazil’s patentability criteria emphasizing novelty and inventive step[1].
Composition Claims
The composition claims focus on:
- The ratios and concentrations of APIs and excipients.
- The specific types of excipients used, such as those facilitating improved dissolution, stability, or bioavailability.
- The form of the drug, whether it is sustained-release, delayed-release, or immediate-release.
These claims aim to protect proprietary formulations that significantly differ from the prior art, often compared to existing patents or published data.
Method Claims
The method claims typically cover:
- The process of preparing the composition, including specific steps such as mixing, granulation, or coating.
- Administration protocols, targeting specific patient populations, or unique dosing schedules.
- Use of the drug for a particular therapeutic indication, which can extend patent scope via second medical use claims[2].
Limitations and Potential Challenges
Brazilian patent law emphasizes clarity and specific disclosure. Therefore, overly broad claims lacking detailed description may face challenges. The scope of BR112014021090 is expected to be focused around the specific formulation and methods disclosed, with narrow dependent claims that specify particular embodiments.
Patent Landscape in Brazil for Pharmaceuticals
Brazil’s Patent System and Pharmaceutical Patents
Brazil's patent framework, governed by the Brazil Patent Law (Law 9,279/1996), aligns broadly with TRIPS standards. Patentability criteria include novelty, inventive step, and industrial applicability[3].
The pharmaceutical patent landscape in Brazil is characterized by:
- Stringent Examination: Emphasis on the inventive step, often requiring detailed demonstrations of novelty over prior art.
- Flexibility in Patent Term: The 20-year term applies, but compulsory licensing and patent term extensions are possible under certain conditions.
- Data Exclusivity: Data exclusivity of five years for pharmaceuticals, which can impact market entry and generic competition.
Notable Patent Landscape Features
Brazil’s drug patent landscape has historically been conservative, balancing innovation incentives with access to medicines. Key observations include:
- A relatively low patent grant rate for pharmaceuticals compared to other jurisdictions.
- The prevalence of second medical use patents and formulation-specific patents to extend patent life.
- Increased patenting activity around biosimilars and biologic formulations in recent years[4].
Major Patent Families and Competitors
The landscape includes:
- International patent families from companies such as Pfizer, Novartis, and Roche.
- Domestic filings that focus on formulations adapted to local markets.
- Patent “evergreening” strategies, primarily through formulation or method claims.
BR112014021090 fits within this landscape as a formulation-specific patent aimed at establishing market exclusivity.
Legal Status and Enforcement
The patent enjoys enforceability within Brazil unless challenged via oppositions or nullity actions. It is critical for competitors to analyze grounds for invalidity, such as lack of novelty or inventive step, especially given Brazil’s rigorous examination history in pharmaceuticals.
Implications for Market and Licensing
The patent’s scope provides exclusivity over specific formulations and methods, impacting:
- Generic entry timelines.
- Licensing agreements and technology transfer opportunities.
- Strategic R&D investments by competitors seeking around-around innovations.
Comparative Analysis with International Patents
Compared to similar patents filed in the US or EU, BR112014021090 tends to be narrower, focusing on specific formulations or processes rather than broad molecule claims. Nonetheless, it positions the patent owner to safeguard key formulations essential for market differentiation in Brazil.
Key Takeaways
- Scope is Formulation-Focused: The patent primarily protects specific compositions and methods, limiting risk of broad invalidations but requiring precise drafting.
- Strategic Positioning: It extends control over specific formulations, potentially blocking generic versions or prompting licensing deals.
- Landscape Fit: Its narrow scope aligns with Brazil’s cautious patenting approach—protecting incremental innovations while fostering access.
- Challenges and Opportunities: Competitors can explore different delivery systems or therapeutic uses to circumvent existing patents, highlighting the importance of detailed patent analysis.
- Legal Vigilance: Continuous monitoring for potential nullity claims or patent challenges is crucial given Brazil’s active patent litigation environment.
FAQs
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What makes BR112014021090 distinctive within Brazil’s pharmaceutical patent landscape?
Its focus on specific formulations and methods of administration reflects Brazil’s trend toward protecting incremental innovations rather than overly broad patents, providing a strategic scope that balances innovation with access.
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Can other companies develop similar formulations without infringing this patent?
Potentially, yes—if they alter the formulation or delivery method sufficiently to avoid the specific claims. A detailed claim analysis and freedom-to-operate study are essential.
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How does Brazil’s patent law impact the enforceability of this patent?
Brazil’s strict examination and requirement for detailed disclosures enhance enforceability but also mean that prior art can challenge the patent’s validity if claims are overly broad or inadequately supported.
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When does patent protection for BR112014021090 expire?
Assuming standard patent term calculations from its filing date or priority date, expiration is expected in 2031, unless timely extensions or legal challenges alter this timeline.
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What strategic moves should licensees or competitors consider regarding this patent?
They should evaluate alternative formulations or delivery mechanisms, consider partnerships or licensing agreements with the patent holder, and monitor for legal challenges or potential invalidations.
Conclusion
Brazil Patent BR112014021090 exemplifies strategic formulation and process patenting within a cautious but incentivized pharmaceutical IP landscape. Its scope, centered on specific compositions and methods, provides robust protection for innovative drug formulations while embedding flexibility for subsequent developments. Stakeholders must tailor their R&D and legal strategies accordingly, leveraging detailed landscape understanding to sustain competitive advantage in Brazil’s evolving pharmaceutical sector.
Sources:
[1] Brazil Patent Law (Law 9,279/1996).
[2] World Intellectual Property Organization (WIPO) Patent Cooperation Treaty (PCT) Guidelines.
[3] Brazilian Patent Office (INPI) Examination Guidelines.
[4] Global Data on Pharmaceutical Patent Trends, WHO Reports.
Note: The above analysis is a generalized synthesis based on available patent and legal structures; for precise legal or patent counsel, refer to official patent documents and consult a patent attorney.
