Argentina Makes Strides in Pharmaceutical IP Protection

By Estudio Chaloupka

CILFA, the Argentine Chamber of Pharmaceutical Laboratories, it's an industry association representing Argentinian manufacturers of generic and biosimilar medications.

In a press release, the association highlighted that the Office of the United States Trade Representative (USTR) "no longer includes criticism regarding the existence of undue limitations on the patentability of pharmaceutical and biotechnological products in Argentina, nor questions to the patentability guidelines in force since 2012.

In April 2024 the USTR released its 2024 Special 301 Report on the adequacy and effectiveness of U.S. trading partners’ protection and enforcement of intellectual property (IP) rights. This annual report details USTR’s findings in a review of more than 100 trading partners after significant research and enhanced engagement with stakeholders.

The report positions Argentina in its Priority Watch List. "The country continues to present long-standing and well-known challenges to intellectual property-intensive industries, including those from the United States. Enforcement of IP rights in Argentina remains a challenge, and stakeholders report widespread unfair competition from Sellers of counterfeit and pirated goods and services," it states.

However, the USTR did not warned on deficiencies on patent-eligible subject matters, including patent examination guidelines that automatically reject patent applications for categories of pharmaceutical inventions that are eligible for patentability in other jurisdictions and requirements that processes for the manufacture of active compounds disclosed in a specification be reproducible and applicable on an industrial scale.

According to the USTR, up until 2023 stakeholders remained concerned about the limits on patentability for biotechnological innovations based on living matter and natural substances, which differed in Argentina from the standard in many other countries.