A mixed outcome. Argentina repeals restrictions on pharmaceutical patentability

The Argentine government has recently (March 17, effective March 18, 2026) issued Joint Resolution RESFC20261APNINPI#MEC, which repeals the joint resolution adopted in 2012 by the former Ministry of Industry, the Ministry of Health, and the National Institute of Industrial Property (INPI). That earlier regulation had introduced restrictive examination criteria for chemical and pharmaceutical patents and had long been the subject of criticism from patent holders and the international intellectual property community.

Background: the controversial 2012 patentability guidelines

The 2012 joint resolution established examination guidelines for chemical and pharmaceutical inventions that significantly limited the possibility of obtaining patent protection for certain types of subject matter, including:

• polymorphs and crystalline forms,
• salts, esters and formulations,
• second medical uses,
• pharmaceutical compositions,
• synthesis methods,
• selection patents, and
• other variants of known compounds.

Many commentators argued that these guidelines went beyond the scope of Argentine Patent Law No. 24,481, effectively introducing additional patentability restrictions not contemplated in the statute or in the Agreement on TradeRelated Aspects of Intellectual Property Rights. In practice, however, these criteria were applied by INPI examiners for more than a decade in the examination of pharmaceutical patent applications.

The new resolution: repeal of the prior framework

The new resolution expressly repeals the 2012 regulation, marking a significant shift in Argentina’s patent policy. From a formal standpoint, the repeal removes one of the most criticized administrative instruments affecting the country’s patent system.

For patent applicants and rights holders, particularly in the pharmaceutical sector, this development may be seen as a step toward greater alignment with the statutory framework of Argentine patent law and with international patentability standards.

Nevertheless, the practical implications of the reform require closer scrutiny.

“A mixed outcome”: new regulatory exceptions to patent rights

Article 2 of the new resolution introduces a provision that has already generated debate within the IP community. It establishes certain exceptions to the exercise of patent rights, particularly in connection with pharmaceutical inventions.

Article 2 states: “For patents granted as from the entry into force of this resolution relating to pharmaceutical products that, as of that date, are being commercially marketed locally by third parties, patent holders shall not have the right to prevent the continuation of such commercialization nor to claim remuneration”.

This applies to patent applications filed before the date of the aforementioned repeal and that are pending, even if they are granted.

The legal concern arises from the fact that these exceptions are not expressly provided for in the Patent Law but instead are introduced through a regulatory instrument. From the perspective of the principle of legality, this raises questions regarding:

• the regulatory authority of the executive branch to create limitations on patent rights;
• the consistency of these exceptions with the framework established by Patent Law No. 24,481, which enumerates the permissible limitations to patent rights; and
• their compatibility with the standards set forth in the TRIPS Agreement, which requires that exceptions to patent rights comply with specific criteria.

In other words, while the resolution removes a long-standing administrative mechanism that restricted the patentability of certain pharmaceutical inventions, it simultaneously introduces regulatory limitations on the exercise of patent rights.

Practical implications for patent applicants and right holders

The combined effect of these changes creates a mixed landscape for the pharmaceutical sector.

Positive developments

• Elimination of restrictive administrative guidelines applied for more than a decade.
• Potentially greater flexibility in the examination of chemical and pharmaceutical patent applications.

Areas of uncertainty

• Introduction of regulatory exceptions whose legal basis may be open to challenge.
• Possible administrative or judicial disputes regarding the validity of such limitations.
• Continued regulatory uncertainty in a sector that relies heavily on predictable patent protection.

Outlook

The repeal of the 2012 guidelines represents a significant development in Argentina’s patent policy. At the same time, the introduction of new regulatory exceptions suggests that the broader debate over the balance between pharmaceutical innovation and access to medicines remains unresolved.

It will be essential to observe how the National Institute of Industrial Property applies this new framework in the examination of applications, and whether the provisions introduced by the resolution give rise to administrative or judicial disputes any time soon.