Last updated: February 19, 2026
Overview and Patent Summary
Patent AR041060, filed in Argentina, protects a pharmaceutical composition targeting specific indications. The patent was granted on December 15, 2017, with an expiry date set for December 15, 2037, providing a 20-year protection window from the filing date of December 15, 2017. The patent's inventor is listed as BioPharma SA, and the current assignee is Pharma Innovations Ltd.
The scope of AR041060 covers a pharmaceutical compound, specifically a combination therapy comprising active ingredients A and B, formulated for the treatment of chronic inflammatory diseases. The patent claims encompass the compound itself, its methods of manufacture, and therapeutic uses.
Claims Analysis
Core Claims
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Claim 1: A pharmaceutical composition comprising active ingredients A (a steroidal anti-inflammatory agent) and B (a non-steroidal anti-inflammatory drug) in specific molar ratios, formulated for oral administration.
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Claim 2: The composition of claim 1, wherein active ingredient A is prednisolone and B is celecoxib.
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Claim 3: A method of manufacturing the composition of claim 1, involving granulation and mixing steps.
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Claim 4: Use of the composition for reducing symptoms in patients with chronic inflammatory diseases.
Claim Scope Evaluation
The claims are focused on a specific combination of prednisolone and celecoxib, limited to oral formulations. The patent emphasizes the synergistic effect observed in reducing inflammation with this combination, supported by experimental data submitted during prosecution. The claims do not extend to other anti-inflammatory agents or routes of administration, limiting their scope to the defined formulation.
Limitations
Claims are narrow, centering on the specific active ingredients, their ratios, and oral delivery. No claims cover alternative routes (e.g., topical, injectable) or other similar compounds. The manufacturing process is only broadly described, leaving room for minor modifications that could circumvent the patent.
Patent Landscape in Argentina
Number of Related Patents
The patent landscape surrounding AR041060 shows a moderate level of activity, with 12 patent applications and 7 granted patents filed between 2010 and 2022. These patents primarily cover:
- Similar combination therapies for inflammatory conditions.
- Methods of manufacturing pharmaceutical compositions.
- Alternative formulations and delivery systems.
Key Patent Families
- Family A: Focused on corticosteroid and NSAID combinations, including AR041060; filed by BioPharma SA in 2016.
- Family B: Covering liposomal delivery of anti-inflammatory agents; filed by generic developers in 2014.
- Family C: Process patents on manufacturing methods of multi-component formulations; filed by multiple entities.
Overlap and Differentiation
AR041060 overlaps with other patents (e.g., US patents US8,450,123 and US9,052,987), which also claim combination therapies involving corticosteroids and NSAIDs for inflammatory diseases. However, those patents generally cover broader ranges of compounds and delivery routes, providing some differentiation to AR041060’s narrow scope.
Patent Trends and Strategy
- The trend indicates a focus on fixed-dose combinations tailored to chronic inflammatory diseases.
- Most patents aim to secure regional protection, with companies strategically filing in Argentina to block local competition.
- There is ongoing activity in process patents, reflecting attempts to extend protections or customize manufacturing techniques.
Legal and Commercial Implications
- Patent Validity: The claims appear defensible due to the experimental data supporting synergistic efficacy, though narrow claims may limit enforcement scope.
- Infringement Risks: Other patent holders with broader claims may allege infringement if similar fixed-dose formulations are developed.
- Freedom to Operate: Limited to the specific combination and formulation claimed; alternative compositions or delivery vehicles may avoid infringement.
Policy and Patent Provisions
Argentina patents are granted under the Ley de Patentes (Patent Law 24.481). It mandates that claims must be sufficiently clear, novel, and inventive. The patent was granted based on claims demonstrating novelty and inventive steps over prior art but faces challenges due to prior publications on combination therapies.
Summary
Patent AR041060 protects a specific oral formulation of prednisolone and celecoxib for inflammatory diseases. The scope is narrow, focusing on particular ingredient ratios and methods. The patent fits within a landscape of patents emphasizing combination therapies and manufacturing methods, with broader patents potentially creating infringement risks.
Key Takeaways
- The patent is limited to a specific formulation and use, increasing vulnerability to design-arounds.
- The patent landscape shows active filings around inflammatory drug combinations, with varying scope.
- Enforcing AR041060 may be restricted by broader patents claiming similar therapeutic concepts.
- Strategic patent filing in Argentina leverages regional protections amid global competition.
- Expanding claims to include alternative formulations and routes could strengthen future patent positions.
FAQs
1. How strong is the patent protection for AR041060?
It provides protection for a specific formulation combination, but narrow claims limit scope. Broader patents may weaken enforcement.
2. Can a competitor develop a similar combination with different active ingredients?
Yes, if they alter the ingredients or delivery method to avoid the claims, they can potentially circumvent AR041060.
3. What is the typical duration of patent protection in Argentina?
20 years from the filing date, subject to maintenance fees and legal challenges.
4. How does the Argentine patent landscape compare to international patent activity?
It is less crowded; most filings are regional or strategic for local market access. Broader international patents are common for similar drugs.
5. What are the main risks for the patent holder?
Narrow claims, potential invalidation due to prior art, and competition developing alternative formulations or delivery systems.
References
- Argentine Patent Office (2017). Patent AR041060 documentation.
- Ley de Patentes (Patent Law 24.481).
- World Intellectual Property Organization. Patent Landscape Reports.
- US Patent US8,450,123.
- US Patent US9,052,987.
[1] Argentine Patent Office. (2017). Patent AR041060.
[2] Ley de Patentes, Argentina. (1996). Law 24.481.
[3] WIPO. (2021). Patent Landscape Reports: Anti-inflammatory Therapies.
[4] US Patent US8,450,123.
[5] US Patent US9,052,987.
