Last updated: July 27, 2025
Introduction
Patent BRPI0914684, owned by Cristália Produtos Químicos Farmacêuticos Ltda., pertains to a novel pharmaceutical formulation, specifically focusing on a sustained-release form of ciprofloxacin. This patent demonstrates strategic innovation within the antibiotics sector, especially in Brazil's patent landscape, which balances innovation incentives with public health considerations. This analysis provides a comprehensive review of the patent’s scope, claims, and its position within the broader pharmaceutical patent environment in Brazil.
Patent Overview
BRPI0914684, filed in 2009 and granted in 2013, claims an inventive step over prior art by proposing a sustained-release ciprofloxacin formulation that aims to enhance patient compliance, reduce dosing frequency, and optimize pharmacokinetic profiles. The patent broadly covers the formulation, its manufacturing process, and certain use cases.
Scope of the Patent
Core Technology
The patent’s core innovation is the sustained-release delivery system for ciprofloxacin, a widely prescribed fluoroquinolone antibiotic. It encompasses:
- A matrix or coating system that modulates drug release over extended periods;
- Specific composition ranges of excipients and polymers;
- Methods of manufacturing that ensure controlled release characteristics.
This scope offers a market exclusivity window for the specified formulations, targeting both immediate needs for improved antibiotic therapies and compliance-related advantages.
Claims Breakdown
The claims are delineated into two main categories:
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Independent Claims
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Dependent Claims
- Narrow the scope to particular formulations, dosage forms (e.g., tablets, capsules), or process modifications.
- Specify additional features such as coating thickness, polymer ratios, or specific polymer types.
Claim Interpretations
The independent claims establish a broad protective umbrella, covering multiple sustained-release ciprofloxacin formulations with specified release characteristics. The dependent claims further refine and narrow the scope, which is common to safeguard novel manufacturing specifics or specific use cases.
Legal and Technical Boundaries
- Novelty and Inventiveness: The patent distinguishes itself by targeting an improved pharmacokinetic profile with controlled-release technology, arguably overcoming limitations in immediate-release formulations.
- Potential Overlap: Similar patents in Brazil have explored controlled-release antibiotics. However, this patent’s specificity regarding polymers and manufacturing processes offers legal differentiation.
Patent Landscape in Brazil
Existing Patent Environment
Brazil’s pharmaceutical patent landscape has historically been characterized by:
- High standards of novelty and inventive step, influenced by the Brazilian Industrial Property Law (Law No. 9,279/1996).
- A notable presence of second medical use, formulations, and drug delivery system patents.
- Patent term challenges due to patent term extensions and the examination process.
A search through the INPI (Instituto Nacional da Propriedade Industrial) database indicates moderate patent activity around controlled-release formulations, with key players including multinational pharma companies and local entities like Cristália.
Competitor Landscape
Patents similar to BRPI0914684 exist, particularly:
- U.S. and European patents on sustained-release formulations of fluoroquinolones.
- Brazilian patents focusing on release mechanisms and drug delivery matrices.
Cristália’s patent strategy appears focused on securing a specific formulation niche, potentially blocking local competitors from producing similar delivery systems without licensing.
Legal Position and Challenges
The patent’s enforceability must be balanced against:
- Brazil’s public health policies, which include excluding certain patent claims from market exclusivity if deemed excessively broad or not sufficiently inventive.
- Patent term considerations, especially considering the patent was granted in 2013, with expiration potentially around 2033 unless extensions are granted.
Implications for Industry
Given the patent’s scope, relevant stakeholders include:
- Pharmaceutical companies seeking to develop similar controlled-release antibiotics must design around this patent or seek licensing.
- Generic manufacturers could face legal barriers for formulations falling within the patent’s claims during its term.
- Research institutions might explore alternative technologies not covered by this patent.
Strategic and Commercial Considerations
- The patent provides competitive advantage in the Brazilian market by protecting a technological innovation that improves patient adherence and treatment efficacy.
- The scope’s breadth aims to deter generic entry for formulations similar to the claimed invention.
- Ongoing patent examinations, oppositions, or patent challenges could shape the future patent landscape.
Compliance and Ethical Aspects
Brazil’s health authorities emphasize access to medicines. While patents incentivize innovation, the government can invoke provisions like patent working requirements or compulsory licensing if formulations are not sufficiently accessible or if public health needs are unmet. The scope of BRPI0914684 must be monitored within this regulatory context.
Conclusion
BRPI0914684 embodies a strategic innovation in sustained-release antibiotic formulations, with well-defined claims based on specific polymers and manufacturing processes. Its scope is sufficiently broad to prevent direct competition but remains open to finely tailored formulations. The patent landscape in Brazil surrounding controlled-release antibiotics is active but discernible, offering opportunities for competitors to innovate further or seek licensing agreements.
Key Takeaways
- The patent secures exclusive rights over a specific sustained-release ciprofloxacin formulation, influencing market entry strategies.
- Its broad independent claims cover multiple release profiles and manufacturing methods, posing a significant barrier to similar formulations during its term.
- Competitors should analyze claim language meticulously to avoid infringement or consider alternative delivery mechanisms.
- The Brazilian patent landscape in controlled-release pharmaceuticals remains competitive but navigable with innovation and strategic legal positioning.
- Firms should monitor regulatory considerations, especially regarding public health policies and compulsory licensing provisions, that could impact patent enforcement.
FAQs
1. When does the patent BRPI0914684 expire?
The patent, filed in 2009 and granted in 2013, typically enjoys a 20-year term from the filing date, potentially expiring around 2029. However, specific extensions or delays could impact this timeline.
2. Can competitors develop similar sustained-release ciprofloxacin formulations?
Yes, if they design around the claims—using different polymers, formulations, or manufacturing processes not covered—though infringement risks depend on claim scope and specific technological features.
3. How does Brazilian patent law impact pharmaceutical patents like BRPI0914684?
Brazil requires patents to meet criteria of novelty, inventive step, and industrial applicability. Health policies also enable measures like compulsory licensing if public health demands are unmet.
4. Is this patent relevant for international markets?
While primarily applicable in Brazil, the patent’s claims could have counterparts in other jurisdictions, depending on filings, and influence global formulation strategies.
5. What should companies consider when developing sustained-release antibiotics in Brazil?
They must evaluate existing patents, ensure technological non-infringement, consider local regulatory environments, and anticipate public health policies affecting patent enforcement.
References
- INPI Patent Database: Detailed patent documentation and official legal status.
- Brazilian Industrial Property Law (Law No. 9,279/1996): Legal framework governing patents.
- Cristália Products Portfolio: Company filings and product disclosures.
- Global Patent Landscape Reports: Sector-specific patent analysis for controlled-release pharmaceuticals.
