12 years ago, the government of Argentina issued “Guidelines for Patentability Examination of Patent Applications on Chemical and Pharmaceutical Inventions.” These guidelines set the standard for patent examiners evaluating applications for pharmaceutical products. Today, the negative impact of these guidelines is clear and underscores the importance of promoting strong intellectual property (IP) protections. 

Here’s why it’s time Argentina revokes the Guidelines for the benefit of its people:

The Guidelines are based on a false premise and don’t fit within existing international standards. Argentina’s guidelines are based on the false presumption that World Trade Organization Members can define the three substantive patentability criteria used in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as they wish. In actuality, any such guidelines must conform to the well-accepted and ordinary meanings of the patentability criteria, which Argentina fails to do. For example, some of the provisions in the guidelines declare outright that certain types of pharmaceutical inventions are not novel, arbitrarily changing the definition of what’s patentable. As a result, only 11% of biopharmaceutical patents have been granted since 2012, compared with 46% in other sectors.

The Guidelines have failed to improve access to medicines. By hindering IP protections and innovation, the Argentinean people lose out with restricted access to medicines. Of the 460 new medicines launched from 2012 to 2021, only 2% of medicines were available in Argentina within one year of global first launch. New medicines launch later in Argentina than in other countries in the region, including as Brazil, Chile and Mexico, where the regional average is 10% of medicines available within a year of launch.

The Guidelines ignore the importance of continued and follow-on innovation for patients. Argentina’s patentability guidelines preclude patenting improvements to existing medicines. Such development is essential for new treatment options, including new formulations that are easier to deliver to patients or more personalized to their needs and new uses of existing compounds. Follow-on innovations have clear value:

• In supporting patients: an analysis of the World Health Organization’s Model List of Essential Medicines shows more than 60% of the medicines on the list are improvements of existing medicines. Argentina’s patentability guidelines preclude and disincentivize the development of these medicines.
• In driving economic growth: the guidelines appear to have had a significant chilling effect on efforts by several Argentine entities to patent innovative medicines in the largest five patent offices in the world, since patenting such innovations are not supported by their home country. This is a loss to patients and the Argentinean economy.

Enabling biopharmaceutical innovation is essential to satisfy the health care needs of a population. Yet Argentina’s patent regime disincentives the development of novel medicines and follow-on innovation. To improve the health of its economy and people, Argentina needs to eliminate the restrictive patentability guidelines and seek reforms that promote innovation and support a strong IP ecosystem.