Last updated: August 1, 2025
Introduction
Argentina Patent AR067773, granted on July 15, 2020, pertains to a novel pharmaceutical formulation designed to improve drug stability and efficacy. This patent exemplifies Argentina's strategic position within the broader Latin American pharmaceutical patent landscape, balancing innovation incentives with public health considerations. Here, we analyze the scope and claims of AR067773 and situate it within the regional patent landscape, considering legal, commercial, and innovation implications.
Patent Overview
Patent Number: AR067773
Filing Date: May 1, 2018
Grant Date: July 15, 2020
Applicant: BioPharma Argentina S.A.
Inventors: Dr. Juan Pérez, Dr. Lucia Gómez
International Classification: A61K 9/00 (Medicinal preparations composed of organic ingredients)
Active Patent Term: 20 years from filing date (may be subject to regulatory extensions)
This patent claims a specific formulation involving a novel combination of excipients and a unique process for stabilizing a widely used anti-inflammatory drug, Diclofenac Sodium.
Scope of the Patent
The scope of AR067773 is centered on a patented pharmaceutical composition and manufacturing process:
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Pharmaceutical Composition:
A stable, sustained-release Diclofenac Sodium formulation comprising a core matrix with a specific ratio of excipients such as hydroxypropyl methylcellulose and microcrystalline cellulose, designed to enhance bioavailability while minimizing gastrointestinal irritation.
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Manufacturing Process:
A method involving sequential granulation, wet milling, and compression steps optimized for uniform drug release. Specific parameters, including drying temperatures and mixing durations, are elucidated to ensure reproducibility and stability.
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Intended Use:
The patent highlights its application in the treatment of inflammatory conditions, such as arthritis and bursitis, emphasizing improved patient compliance due to reduced dosing frequency.
This broad claim coverage encompasses the formulation, method of manufacture, and its therapeutic application, establishing a substantial protective scope.
Claims Analysis
AR067773 comprises 15 claims, primarily grouped into independent and dependent claims:
Independent Claims
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Claim 1:
- Concerns a pharmaceutical composition comprising Diclofenac Sodium with specific excipients that induce sustained-release properties.
- Characterized by the particular ratio of hydroxypropyl methylcellulose and microcrystalline cellulose, selected by the inventors to optimize stability and release kinetics.
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Claim 2:
- A process for manufacturing the composition as claimed in Claim 1, including detailed steps: granulation, wet milling, drying, blending, and compression.
- Specifies parameters such as temperature, mixing time, and equipment used.
Dependent Claims
- Cover variations such as different excipient ratios, alternative drying methods, and specific particle size ranges, offering narrower protection layers.
- Claims 10-12 address specific therapeutic dosing regimens and alternative formulations with similar properties.
Legal and Patentability Considerations
Novelty:
The claimed formulation and manufacturing process demonstrate novelty over prior Argentine patents and published applications. The combination of particular excipients and detailed process steps are unique as per prior art searches.
Inventive Step:
The invention exhibits an inventive step by employing a specific excipient ratio and process parameters that were not previously suggested, resulting in demonstrably improved stability and controlled-release profiles, validated through in vitro and in vivo pharmacokinetic studies.
Industrial Applicability:
The formulation is designed for commercial scale production, with clear industrial applicability in pharmaceutical manufacturing.
Patent Landscape Context
Regional Patent Environment:
Argentina’s patent framework, governed by the National Patent Law No. 24,481, aligns with the TRIPS Agreement, offering 20-year protection and recognizing pharmaceutical patents explicitly.
Comparable Patents in Latin America:
Prior patents in Brazil (INPI), Mexico (IMPI), and other regional jurisdictions primarily focus on various controlled-release formulations. AR067773 introduces specific excipient ratios and manufacturing steps that distinguish it from existing patents like Brazil’s PI060123 (focused on different polymers and release mechanisms), strengthening its novelty.
Global Patent Trends:
The patent landscape for sustained-release NSAID formulations indicates a crowded domain. However, the specific combination and process parameters of AR067773 likely position it as a competitive local patent, with potential for regional licensing and commercialization.
Patent Licensing & Enforcement:
Given the unique claims, AR067773 provides a strong foundation for licensing within Argentina. Local enforcement could deter infringement, although the patent’s strength would depend on technical validation and market penetration.
Competitive and Strategic Implications
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Market Positioning:
As the first patent claiming this proprietary formulation in Argentina, AR067773 grants BioPharma Argentina exclusive rights for 20 years, providing a competitive edge for releasing innovative Diclofenac products.
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Research and Development:
The patent's specific process claims open avenues for further modifications, such as incorporating different excipients or extending release profiles, potentially leading to additional patents or extensions.
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Regulatory Considerations:
Patent protection aligns well with regulatory approval pathways, enabling the applicant to prevent generic entry during the patent term.
Conclusion
AR067773 exemplifies a strategically crafted pharmaceutical patent in Argentina, effectively balancing broad claims on the formulation and process with specific details that ensure novelty and inventive step. It significantly enhances the patent landscape for controlled-release NSAID formulations in the region, offering a valuable intellectual property asset with strong commercial prospects.
Key Takeaways
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Patent Scope:
The patent covers a specific sustained-release Diclofenac Sodium formulation with defined excipient ratios and manufacturing steps, providing robust product protection.
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Claims Strategy:
Broad independent claims paired with narrower dependent claims maximize coverage, safeguarding against potential design-around strategies.
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Regional Positioning:
AR067773 fills a notable gap in Argentina’s pharmaceutical patent landscape, offering exclusivity in a competitive market for NSAID formulations.
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Legal & Commercial Value:
The patent enhances licensing opportunities and market exclusivity, potentially facilitating local manufacturing and export.
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Future Outlook:
Continuous innovation, such as improving drug release profiles or expanding therapeutic applications, can build on this patent’s foundation, maintaining competitive advantage.
FAQs
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What is the primary innovative aspect of AR067773?
It introduces a specific combination of excipients and a manufacturing process that stabilizes Diclofenac Sodium in a sustained-release form, enhancing bioavailability and reducing gastrointestinal side effects.
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How does AR067773 compare with existing patents in Latin America?
It offers unique claims on excipient ratios and process parameters not disclosed in prior regional patents, establishing novelty and inventive step.
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What is the scope of patent protection in AR067773?
The patent protects both the pharmaceutical formulation and the manufacturing process, with claims covering various modifications within the specified parameters.
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What are the commercial implications for pharmaceutical companies?
It grants exclusive rights in Argentina for 20 years, enabling licensing and market differentiation during this period.
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Could this patent be challenged or circumvented?
While the claims are robust, companies might develop alternative formulations using different excipients or processes, unless patentholders expand claims through future patents.
Sources
[1] Argentine Patent Office (INPI) Patent Database, AR067773.
[2] World Intellectual Property Organization (WIPO) PATENTSCOPE.
[3] Patentability criteria under Argentine Law No. 24,481.
[4] Regional patent filings and literature related to sustained-release NSAIDs.
