Argentina: Developments for Biotech Patentability Guidelines

Today, June 11, 2026, the Argentine Government repealed Joint Regulation 810/2001 and 99/2001 from the year 2001, which had imposed constraints on the revision of patentability guidelines for biotechnological inventions. That regulation had established a Permanent Task Group (composed of representatives from various government bodies) to oversee patentability guidelines concerning living matter and natural substances. It also required that any amendment to such guidelines had to be approved by the Secretary of Agriculture.

The decision to repeal this regulation expressly acknowledges that the involvement of multiple governmental bodies, together with the requirement of an administrative review external to the competent technical authority, had rendered the revision process overly complex and bureaucratic, ultimately limiting the AR PTO’s ability to adapt its patentability guidelines in a dynamic and efficient manner.

Argentina still maintains restrictive patentability guidelines in the biotechnology field, which exclude specific categories of subject matter from protection in a manner that has long been considered inconsistent with the TRIPS Agreement. In this context, the repeal of said regulation is a welcome development, as it removes procedural constraints and allows for a more agile and technically-driven review of the existing guidelines.

It should also be noted that, under the bilateral agreement entered into earlier this year between Argentina and the United States, Argentina undertook to repeal its restrictive patentability guidelines applicable to both pharmaceutical and biotechnological inventions. The guidelines applicable to pharmaceutical inventions have already been repealed, and this new measure opens the door for the AR PTO to also revise and adjust its patentability criteria for biotechnological inventions.

While no specific amendments to the biotech guidelines have yet been issued, this is a noteworthy and positive step toward their potential revision and signals a shift toward a framework that may become more aligned with international standards and be more favorable to innovation in the life sciences sector.

We will continue to closely monitor further developments and will keep you informed of any changes that may impact patent prosecution strategies in Argentina.