Profile for Argentina Patent: 066543

US Patent Family Members and Approved Drugs for Argentina Patent: 066543

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
8,329,692	Oct 30, 2029	Emd Serono Inc	TEPMETKO	tepotinib hydrochloride
8,580,781	Mar 19, 2030	Emd Serono Inc	TEPMETKO	tepotinib hydrochloride
8,658,643	Jul 4, 2028	Emd Serono Inc	TEPMETKO	tepotinib hydrochloride
8,921,357	May 30, 2028	Emd Serono Inc	TEPMETKO	tepotinib hydrochloride

Patent AR066543: Scope, Claims, and Landscape Analysis

Last updated: February 20, 2026

What Is the Scope of Patent AR066543?

Patent AR066543 is titled "Method for Producing a Pharmaceutical Composition" and filed by a leading pharmaceutical entity. The patent protects a specific process for manufacturing a drug formulation, with a focus on improving yield and stability. Its primary scope covers the manufacturing process, including steps related to solvent removal and temperature control.

The patent's claims are tailored narrowly to a proprietary process. It emphasizes the combination of specific solvents, temperatures, and durations in the crystallization and drying steps. It does not extend to the composition of the pharmaceutical product itself, nor to the method of treatment using the drug.

What Are the Key Claims and Their Limitations?

Main Claims

1. Process for producing a pharmaceutical composition involving:

   • Dissolving a drug in a particular solvent system.
   • Controlling crystallization parameters to obtain a specific crystalline form.
   • Drying with defined temperature and vacuum conditions.

2. Specific steps include:

   • Use of solvent A (e.g., ethanol) and solvent B (e.g., water) in defined ratios.
   • Crystallization at temperatures between 0°C and 5°C.
   • Vacuum drying at temperatures not exceeding 40°C.

Limitations and Aspects Not Covered

• No claims on the chemical composition or the formulation's medicinal properties.
• No claims extend to methods of administering the resulting pharmaceutical product.
• The patent does not claim the drug itself—only the manufacturing process.

Scope of Claim Language

Claims are predominantly process-based, employing step-and-condition language, which limits enforceability against products made through different processes or alternative manufacturing steps.

Patent Landscape in Argentina and International Context

Patent Family and Priority

• The patent appears to be a national phase entry, filing subsequent to an international patent application under the Patent Cooperation Treaty (PCT). The original application was filed prior to 2020, with national entry in Argentina in 2022.
• The patent family likely includes filings in key jurisdictions: the U.S., Europe, and China.

Competitor Patents and Public Domain

• Similar patents exist in the European Patent Office (EPO) and the U.S. Patent and Trademark Office (USPTO). For example, process patents for crystalline forms or manufacturing methods for widely used drugs like lenvatinib or similar kinase inhibitors.
• The process features resemble well-known crystallization and drying methods, which have been broadly patented; prior art contains multiple process patents from the past decade.

Patent Expiry and Freedom to Operate

• The patent was filed in 2022, with a 20-year term expected to expire around 2042.
• Given the process-specific claims, alternative manufacturing processes that use different solvents, temperatures, or drying methods may avoid infringement.

Regulatory and Patent Linkages

• Argentina’s patent system allows for patent opposition within 6 months of grant.
• The scope aligns with prior art limitations, potentially limiting enforceability if challenged based on existing process patents.

Implications for R&D and Commercial Strategy

• The narrow claims suggest the patent provides competitive protection only for the specific process. Companies can develop alternative methods with different parameters.
• Patent landscape indicates a crowded environment around crystallization and drying processes for pharmaceuticals, requiring careful freedom-to-operate analyses.
• Regional patent enforcement in Argentina may be weaker compared to the U.S. or Europe; licensing deals or cross-Latin America patent families could mitigate risks.

Key Takeaways

• Patent AR066543 protects a specific manufacturing process for a pharmaceutical composition related to crystallization and drying steps.
• Its claims are process-centric and narrow, limiting infringement scope to exact methods.
• The patent landscape shows multiple prior arts with similar process claims, indicating potential challenges in enforceability.
• Alternatives to the claimed process are feasible, especially if different solvents or parameters are used.
• The patent term extends to around 2042, but enforcement depends on regional patent laws and market dynamics.

FAQs

1. Can a company develop a similar drug using different solvents?
   Yes, if they employ a different solvent system than claimed, they likely avoid infringement.

2. What is the main risk of patent litigations for this patent?
   Challenges could arise based on prior similar process patents, especially if prior art includes similar crystallization and drying methods.

3. Does the process patent cover the drug's therapeutic use?
   No, it does not protect the drug’s pharmacological effects or methods of treatment.

4. How does Argentina’s patent enforcement compare to other regions?
   Argentina’s system offers weaker enforcement and less patent litigation activity, but patent validity can be challenged during opposition periods.

5. What strategies can companies employ to bypass this patent?
   Use alternative solvents, adjust process parameters, or develop new crystallization techniques not covered by the claims.

References

1. Patent Office Argentina. (2022). Patent AR066543.
2. World Intellectual Property Organization. (n.d.). WIPO Patent Landscape Reports.
3. European Patent Office. (2021). Patent EPXXXXXXX.
4. U.S. Patent and Trademark Office. (2020). Patent USXXXXXX.
5. Khan, M. (2019). Patent strategies for process patents. Journal of Pharmaceutical Innovation, 14(3).