Fernando Martínez Zuviría
Allende & Brea, Buenos Aires
fmartinez@allende.com

Octavio Mitelman
Allende & Brea, Buenos Aires
omitelman@allende.com

Pablo Palazzi
Allende & Brea, Buenos Aires
ppalazzi@allende.com

Mariano Peruzzotti
Allende & Brea, Buenos Aires
mperuzzotti@allende.com

Introduction

The pharmaceutical patent system constitutes one of the most sensitive areas of industrial property law, as it lies at the intersection between incentives for technological innovation and the protection of the public’s interest in access to medicines. In Argentina, this balance has historically been dynamic and, at times, conflictive.

From the enactment of Law No 111 in 1864 to the recent Joint Resolution No 1/2026 of March of this year, a regulatory trajectory can be identified that reflects changes in the conception of the role of pharmaceutical patents: from express exclusion, through adaptation to international commitments, to the contemporary redefinition of administrative patentability criteria.

The original regime: Law No 111 of 1864 and the exclusion of pharmaceutical compositions

Law No 111, the first comprehensive patent regime in Argentina, recognised the exclusive right of exploitation of inventors, in line with Article 17 of the National Constitution. However, its Article 4 expressly provided that ‘pharmaceutical compositions are not patentable’, establishing a categorical prohibition in this field.

This normative exclusion, in force for more than 130 years, shaped the development of the pharmaceutical sector under a system in which imitation and competition through lawful copying prevailed over exclusive protection.

This system could not be sustained given the particular characteristics of the chemical-pharmaceutical industry:

• its purpose is to improve public health;
• improving public health requires the development of new and effective medicines;
• obtaining new medicines requires complex and costly research;
• research funding is borne almost exclusively by the research company; and
• chemical-pharmaceutical inventions can be easily imitated.

Considering these features, it follows that in this field it is absolutely necessary to have a patent system that incentivises investment in research and fosters therapeutic progress, which can only function with a system that effectively protects innovations in this sector.¹ In Argentina, winds of change only began to blow as from 1995.

Incorporation of the TRIPS Agreement into Argentine law (Law No 24,425)

The turning point occurred with the approval of the Final Act of the Uruguay Round of Multilateral Trade Negotiations and the Marrakesh Agreement through Law No 24,425, which incorporated the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement into the Argentine legal system.

TRIPS imposed on Member States the obligation to grant patents for inventions of products and processes in all fields of technology, provided that they meet the requirements of novelty, inventive step, and industrial applicability, also enshrining the principle of non-discrimination by field of technology.

This mandate was hardly compatible with the absolute exclusion of pharmaceutical compositions that had prevailed in Argentine law until then. In light of Article 27 of TRIPS, the patentability of pharmaceutical products could no longer be disputed in Argentina.²

At the same time, TRIPS recognised regulatory margins for States, particularly regarding the determination of patentability standards and the possibility of establishing limited exceptions, aspects that would later be invoked to justify restrictive administrative policies in the pharmaceutical field.

Law No 24,481 and the modernisation of the patent system

The enactment in Argentina of the Patent and Utility Model Law No 24,481 represented the adaptation of domestic law to international commitments. The new legislation introduced significant changes, creating the Argentine Institute of Industrial Property as an autonomous body within the Ministry of Economy.

The essential change was the admission of patentability of pharmaceutical products. Article 4 established that inventions of products or processes that are new, involve an inventive step, and are industrially applicable are patentable, without sector-specific exclusions.

Another novelty was the regulation of limited exceptions to patent rights and the compulsory licensing regime, issues not provided for under the repealed Law No 111.³

Thus, the historical prohibition contained in Law No 111 was definitively overcome, shifting the debate to the interpretation and application of general patentability requirements.

Restrictive administrative guidelines: Joint Resolution Nos 118/2012, 546/2012 and 107/2012

In 2012, the Ministries of Industry and Health and the Argentine Institute of Industrial Property adopted guidelines for examining patentability of chemical-pharmaceutical inventions. These guidelines introduced specific criteria for claims typical of the sector, such as polymorphs, salts, esters, new dosages, and therapeutic uses.

They were justified by the need to protect public health and prevent the granting of patents for marginal developments, aligning with international discussions on evergreening. In practice, they established a stricter patentability standard for pharmaceuticals for over a decade.

A broad sector of legal doctrine criticised this regulation for excluding patentable subject matter in a manner inconsistent with the TRIPS Agreement, severing concepts such as ‘invention’, ‘novelty’ and ‘inventive step’ from verifiable and demonstrable factual circumstances, and reducing them to mere absolute prohibitions, thereby discriminating among technologies, since a series of restrictions are imposed on pharmaceutical inventions that are not applied to other technologies of a similar nature.⁴

Joint Resolution No 1/2026: repeal of the guidelines and a new approach

Joint Resolution No 1/2026, published in the Official Gazette on 18 March 2026, expressly repeals the 2012 guidelines and restores a framework under which the patentability of chemical‑pharmaceutical inventions must be assessed on a ‘case‑by‑case’ basis, in accordance with the general criteria set forth in Law No 24,481.

The regulation emphasises the need not to restrict the technical competence of the Argentine Patent Office and to align the Argentine system with international best practices, thereby promoting innovation and legal certainty. However, it introduces a transitional clause of particular relevance: patents granted as from its entry into force may not prevent the continued commercialisation of pharmaceutical products that were already present on the local market by third parties, nor give rise to any right to remuneration.

This exception is expressly justified within the framework of Article 41 of Law No 24,481 and Article 30 of the TRIPS Agreement, and is conceived as a balancing mechanism between strengthening patent protection and preserving access and competition in the pharmaceutical market.

Argentine commitment to adhere to the PCT within the framework of the Reciprocal Trade and Investment Treaty with the United States

Under the Reciprocal Trade and Investment Agreement entered into between the Argentine Republic and the US on 5 February 2026, Argentina assumed an express commitment in the field of intellectual property, aimed at aligning its patent regime with prevailing international standards. Among these commitments, particular emphasis is placed on the obligation to submit the Patent Cooperation Treaty (PCT) to the National Congress for its consideration and potential ratification by 30 April 2026.

The legal significance of this commitment lies in the fact that Argentina’s accession to the PCT is grounded in an international obligation undertaken within the framework of a bilateral instrument of an economic and investment-protection nature, the purpose of which is to strengthen legal certainty and regulatory predictability in sectors characterised by high levels of technological innovation.

It should be underscored that Argentina is not currently a party to the PCT, notwithstanding the fact that the treaty was approved by the Senate in 1998 but never completed the full constitutional legislative procedure. The recently assumed commitment reopens and updates this outstanding institutional matter, incorporating it into a framework of binding international obligations.

The accession to the PCT entails for Argentina:

• integration into the unified international patent application system;
• simplified access to the Argentine patent system for foreign applicants; and
• further alignment with the standards promoted under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), going beyond the minimum threshold currently required by the World Trade Organization (WTO).

Finally, it is important to note that the bilateral treaty does not produce self-executing effects on the patent regime, nor does it, by itself, amend AR Patent Law No 24,481. However, it does establish an international obligation of result, the implementation of which requires action by the Argentine Congress and potential administrative adjustments within the Argentine Institute of Industrial Property (INPI). In this sense, the commitment to adhere to the PCT constitutes one of the most significant pillars of the agreement in the field of industrial property and one of those with the greatest potential structural impact on the Argentine patent system.

Conclusions

The evolution of the pharmaceutical patent regime in Argentina demonstrates a transition from absolute normative exclusion toward a system legally integrated with international intellectual property law. The recent repeal of the restrictive 2012 guidelines and the reinstatement of a generalised patentability examination mark a new chapter, albeit tempered by a transitional exception aimed at avoiding disruptive effects on the market.

The future challenge will lie in the jurisprudential and administrative development of clear and consistent standards that, without disregarding public health objectives, provide predictability to system stakeholders and consolidate an environment conducive to responsible pharmaceutical innovation.

Notes

1. Mitelman, Carlos Octavio y Zuccherino, Daniel: ‘Derecho de patentes: aislamiento o armonización’, Ad-Hoc, Buenos Aires, 1994.
2. Mitelman, Carlos Octavio y Zuccherino, Daniel: “Marcas y patentes en el TRIPS”, Abeledo-Perrot, Buenos Aires, 1997.
3. Zuccherino, Daniel: ‘Patentes de invención’, Ad-Hoc, Buenos Aires, 1998.
4. Bensadón, Martín: ‘Derecho de patentes’, Abeledo-Perrot, Buenos Aires, 2012 y Aulmann, Miguel Ángel. ‘Invenciones farmacéuticas en la República Argentina. La Resolución Conjunta 546/2012, 107/2012 and 118/2012. Pautas para el examen de patentabilidad de las solicitudes de patentes sobre invenciones químico farmacéuticas’, Dialnet, Buenos Aires, 2013.