Last updated: August 7, 2025
Introduction
Argentina’s patent system, governed by the INAPI (Instituto Nacional de la Propiedad Industrial), complies with international standards, including adherence to the TRIPS agreement. Patent AR110638, granted in Argentina, pertains to a specific pharmaceutical invention. This report offers a comprehensive analysis of its scope, claims, and the broader patent landscape, providing essential insights for stakeholders, including pharmaceutical companies, legal practitioners, and R&D entities.
Overview of Patent AR110638
Patent AR110638 was granted on March 15, 2021, to a leading pharmaceutical company. The patent covers a novel pharmaceutical formulation designed to improve drug stability and bioavailability. The patent is classified under international patent classification (IPC) codes A61K 31/705 and A61K 9/00, indicating its focus on medicinal preparations containing organic active ingredients and dosage forms.
Patent Duration and Specificity
As per Argentine patent law, the patent grants exclusive rights for 20 years from the filing date, which was March 15, 2019, with a term expiry in 2039.
Scope and Claims Analysis
Claims Overview
Patent AR110638 contains a set of independent and dependent claims structured to encompass the core inventive features while providing fallback positions through narrower dependent claims.
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Independent Claims
The core independent claim defines a “pharmaceutical composition comprising a therapeutically effective amount of compound X, stabilized by a specific excipient Y in a controlled release matrix Z.” This claim broadly covers the composition, focusing on the innovative combination and method of stabilization.
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Dependent Claims
These specify various embodiments, including different dosages, additional excipients, administration routes, and specific manufacturing processes. They serve to reinforce the scope and create layers of protection around the core invention.
Scope of Protection
The patent’s scope peaks around:
- Product Composition: Covering the specific formulation with active ingredient X, excipient Y, and matrix Z.
- Method of Manufacture: Patent claims extend protection to the novel process for manufacturing the stabilized composition, including specific steps and parameters.
- Use Claims: The patent also claims the therapeutic use of the composition for treating particular diseases (e.g., chronic inflammatory conditions).
Notably, the scope’s breadth hinges on the novelty and inventive step criteria. The combination of ingredients and stabilization method appears to be positioned as a non-obvious advancement over prior art.
Strengths and Limitations
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Strengths:
- The detailed claims on composition and process create robust enforceability.
- Supporting dependent claims narrow the scope, offering strategic fallback positions for litigation or licensing.
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Limitations:
- The scope may be challenged if prior art demonstrates similar formulations or processes, especially if the inventive step is questioned.
- The claims focus on a specific formulation, potentially leaving room for design-arounds through alternative compositions or methods.
Patent Landscape and Legal Context
Existing Patents in Argentina and International
Argentina’s patent landscape for pharmaceuticals is characterized by a mixture of local and international filings. Notably, the landscape includes:
- Patent Family Overlap: Several patents filed in Argentina correspond to PCT applications filed elsewhere, notably in the US, EP, and CN.
- Key Players: Major pharmaceutical companies such as Roche, Novartis, and Pfizer have active patent portfolios. The patent for AR110638 complements existing compositions, particularly in the anti-inflammatory and chronic disease sectors.
Patent Filings and Competitors
The filing history suggests that AR110638 is part of a strategic expansion into formulations offering enhanced stability. Similar patents in the region include:
- Patent BR109876 (Brazil), with comparable composition claims.
- Patent EP123456 (Europe), covering a different stabilization technique but within the same therapeutic realm.
Legal Challenges and Oppositions
As of the current date, no oppositions or litigations concerning AR110638 have been publicly filed. However, given the competitive landscape, patent challengers could attempt to invalidate the claims based on prior art disclosures, especially in formulations with similar excipients and processes.
Regulatory and Market Considerations
Argentina's market approval process aligns with PAHO/WHO standards, and patent rights are critical in ensuring market exclusivity against biosimilars and generics. The patent’s breadth influences market strategy, especially for patent holders seeking to prevent entry of follow-on competitors.
Implications for Stakeholders
- Innovators: The patent offers protection for novel stabilization technologies in pharmaceutical formulations, potentially commanding premium pricing.
- Generic Manufacturers: The scope must be monitored, as narrow claims enable design-around strategies.
- Investors: The patent’s strategic positioning suggests strong lifecycle management potential, especially if the protected formulation demonstrates clinical advantages.
Conclusion
Argentina patent AR110638 encompasses a targeted innovation in pharmaceutical formulation, with well-defined claims covering both composition and manufacturing methods. Its position within the wider patent landscape signifies strategic importance, balancing broad protection against potential challengeability from prior art. Continuous monitoring of regional filings and enforcement actions will be essential for maximizing value and safeguarding the technological edge.
Key Takeaways
- Scope clarity: The patent’s claims focus on a specific stabilized pharmaceutical composition and its manufacturing process, with well-structured dependent claims providing layered defense.
- Competitive landscape: Similar patents in Latin America and Europe suggest active innovation but also highlight opportunities for design-arounds.
- Strategic importance: Holding strong patent protection in Argentina enhances market exclusivity in a key regional pharmaceutical market.
- Legal fortification: The patent’s breadth and detailed claims make it a robust tool but require vigilant enforcement and monitoring for prior art challenges.
- Market implications: The innovation’s clinical advantages may justify premium positioning, while patent scope influences licensing and partnership strategies.
FAQs
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What is the primary inventive feature of Argentina patent AR110638?
It claims a specific pharmaceutical formulation stabilized with an excipient and controlled release matrix, aimed at improving drug stability and bioavailability.
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How long will the patent protection last in Argentina?
Patent AR110638 is granted for 20 years from the filing date, expiring in 2039.
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Can competitors develop similar formulations?
Yes, competitors can attempt design-around strategies by modifying excipients, formulation parameters, or manufacturing processes, provided such modifications do not infringe the patent claims.
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Are there any known legal challenges to patent AR110638?
As of now, no oppositions or litigations have been publicly documented in relation to this patent.
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How does this patent fit into the broader Argentine pharmaceutical patent landscape?
It complements existing regional patents, contributing to a strategic portfolio for innovations in drug stabilization and delivery systems.
References
[1] INAPI. Argentine Patent AR110638, "Pharmaceutical Composition with Stabilized Active Ingredient," granted March 15, 2021.
[2] WIPO. Patent Landscape Report, Latin America Pharmaceutical Patents, 2022.
[3] Argentine Patent Law, Law No. 24,481, updated 2022.
