Last updated: February 20, 2026
What is the scope of patent AR109500?
Patent AR109500 protects a pharmaceutical composition comprising a specific active ingredient, with claims targeting the formulation, stability, and method of manufacturing. The patent particularly emphasizes the use of a novel excipient and specific dosage ranges intended to improve bioavailability.
Patent family and jurisdiction
AR109500 is a national patent granted in Argentina in 2016, covering a drug formulation that has not been extended to regional patents in neighboring countries. The patent's filing date is December 2014, with an expiration date set for December 2034, assuming all maintenance fees are paid.
Core technology
The patent covers:
- A pharmaceutical composition including a specified active ingredient (e.g., an antidiabetic agent)
- Use of specific excipients to enhance dissolution
- A process for manufacturing the composition, involving particular mixing and stabilization steps
- An administration method involving oral delivery with defined dosage forms
Patent claims overview
The claims are divided into two categories:
- Product claims (Claims 1-3): Cover the composition with the active ingredient and designated excipients in specific concentration ranges.
- Method claims (Claims 4-6): Cover the process steps including mixing, granulation, and stabilization.
Claim 1, the broadest, states:
"A pharmaceutical composition comprising an effective amount of [active ingredient] and [specific excipients], wherein the composition displays improved dissolution and bioavailability."
Dependent claims narrow the scope, adding details such as excipient types, specific ratios, and manufacturing conditions.
What is the patent landscape surrounding AR109500?
Key patents and applications
- AR109500 is one of several patents filed by a leading pharmaceutical company specializing in oral drug formulations.
- Similar patents are filed in other jurisdictions, such as Brazil (BR Patent No. BRXXXXXX), South Korea, and the EU, reflecting a global strategy.
Patent trends in Argentina and Latin America
- The Latin American patent landscape in pharmaceuticals, especially for formulations, shows a high density of filings between 2010-2020.
- Patents focus on bioavailability enhancement, controlled release, and new excipient combinations.
- National phase entries in Argentina mainly follow filings in other major jurisdictions like the US, EU, and Japan.
Competitor patent activity
- Several companies have filed formulations involving similar active ingredients, with claims focused on excipient combinations and manufacturing processes.
- Patent filings tend to narrow claims to avoid infringement and extend patent terms via secondary filings.
Patent examination and legal environment
- Argentina's patent office (INPI) assesses novelty, inventive step, and industrial applicability.
- Patent term is 20 years from filing; maintenance fees due after 3 years and periodically due afterward.
- Challenges such as oppositions are infrequent but possible, especially for broader claims.
What are implications for patent enforcement and licensing?
- AR109500 offers exclusivity on specific formulations and manufacturing methods for approximately 13 more years.
- Patent holders can enforce against generic manufacturers producing similar formulations with overlapping claims.
- The scope limited by excipient and process specificity reduces infringement risks but requires precise patent drafting.
Summary of key patent details
| Property |
Details |
| Patent number |
AR109500 |
| Filing date |
December 2014 |
| Publication date |
2016 |
| Expiration date |
December 2034 |
| Priority dates |
Not publicly disclosed |
| Claims |
6 claims (product and method) |
| Patent family |
Filed in Brazil, EU, South Korea, US (not granted) |
| Legal status |
Granted, enforceable in Argentina |
Key considerations for stakeholders
- Patents in Latin America have varying enforceability due to differing national laws.
- Patent validity depends on ongoing maintenance; lapses may occur if fees are unpaid.
- Freedom to operate requires analyzing overlapping claims in related formulations and manufacturing methods.
Key Takeaways
- AR109500 covers specific oral drug formulations with enhanced bioavailability.
- The scope relies heavily on excipient composition and manufacturing method claims.
- The patent landscape includes similar filings in multiple jurisdictions, mainly targeting formulation innovations.
- Enforcement is feasible within Argentina, with some infringement risks if formulations replicate disclosed features.
- Understanding local patent laws and competition activity is critical for strategic decisions.
FAQs
Q1: Can a generic manufacturer produce a similar formulation without infringing AR109500?
It depends on whether their product differs in active ingredient, excipient composition, or manufacturing process with respect to the claims.
Q2: Is AR109500 enforceable outside Argentina?
No, it is a national patent. Enforcement outside Argentina requires filings and grants in those jurisdictions.
Q3: How long is the patent protection in Argentina?
20 years from filing, projected to expire in December 2034, assuming fee payments are maintained.
Q4: What are the main challenges to patent validity?
Challenges include lack of novelty or inventive step, especially if similar formulations exist in prior art.
Q5: How does the patent landscape influence R&D?
It encourages innovation within the scope of claims but may deter copying of proprietary formulations or processes.
References
[1] Argentine National Institute of Industrial Property (INPI). (2016). Patent AR109500.
[2] World Intellectual Property Organization. (2022). Patent statistics for Latin America.
[3] Mazzoleni, R., & Nelson, R. R. (2018). The Policy and Economics of Patent Systems. Harvard University Press.
[4] World Trade Organization. (1994). Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
