Argentina has significantly altered its approach to pharmaceutical patentability with the recent repeal of a 2012 resolution, a move expected to streamline the process for evaluating patent applications and potentially increase access to medications. The change, formalized through Resolución Conjunta 1/2026, published on March 18, 2026, revokes a previous joint resolution (MINISTERIO DE INDUSTRIA Nº 118, MINISTERIO DE SALUD Nº 546, and INSTITUTO NACIONAL DE LA PROPIEDAD INDUSTRIAL Nº 107) that had delegated the initial assessment of patentability to the National Institute of Industrial Property (INPI) on a case-by-case basis.
This shift returns the authority for determining whether pharmaceutical inventions meet the criteria for patent protection – novelty, inventive step, and industrial applicability – directly to the INPI. The move aligns with Argentina’s commitments under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), part of the World Trade Organization (WTO) agreements, which emphasize non-discrimination in patent granting across technological fields. The original TRIPS agreement was approved in Argentina through Law N° 24.425.
A Balancing Act: Innovation and Access to Medicines
The decision comes with a key provision designed to protect existing market dynamics. For patents granted after the resolution’s effective date concerning pharmaceutical products already being commercially sold by other companies in Argentina, patent holders will not be able to prevent continued sales or demand compensation. This aims to prevent disruption to the supply of essential medicines and acknowledges the investments already made by generic manufacturers. This provision is outlined in Article 2° of the new resolution.
The previous framework, established in 2012, had been criticized for potentially creating bottlenecks in the patent approval process. Advocates for a more streamlined system argued that it hindered innovation and delayed the introduction of new drugs to the Argentine market. The Ministry of Health, the Ministry of Economy, and the INPI jointly reasoned that restoring the INPI’s full authority would promote efficiency and align with international best practices. They similarly emphasized the importance of strong intellectual property rights in fostering innovation and increasing the availability of new pharmaceutical products.
The Role of Law 24.481 and International Agreements
Argentina’s patent law, Law N° 24.481 (as amended by Decree N° 260/96), already establishes the criteria for patentability – novelty, inventive step, and industrial applicability. Article 4° of this law specifically states that inventions, whether products or processes, are patentable if they meet these criteria. The new resolution seeks to ensure that the INPI’s evaluation process is fully consistent with both this law and Argentina’s international obligations under the TRIPS agreement.
Article 41 of Law N° 24.481 also allows the INPI to establish limited exceptions to patent rights, provided these exceptions do not unduly harm the legitimate interests of the patent holder or the normal exploitation of the invention. This provision provides a legal basis for the transitional measure protecting existing generic drug manufacturers.
What This Means for Pharmaceutical Companies and Consumers
The change is expected to have a multifaceted impact. For pharmaceutical companies, it could lead to a more predictable and efficient patent examination process, potentially accelerating the introduction of innovative medicines to the Argentine market. However, the provision protecting existing generic competition introduces a degree of uncertainty for companies holding patents on products already widely available. The INPI will now assess patent applications on a case-by-case basis, considering the requirements of Law N° 24.481.
For consumers, the resolution aims to balance the need to incentivize pharmaceutical innovation with the importance of ensuring access to affordable medicines. The transitional measure is intended to prevent price increases or supply disruptions for drugs already on the market. The long-term effect on drug prices and availability will depend on how the INPI applies the patentability criteria and how companies respond to the new regulatory landscape.
Looking Ahead: Implementation and Potential Challenges
The INPI now faces the task of implementing the new resolution and establishing clear guidelines for evaluating patent applications. The agency will need to ensure that its examiners have the expertise and resources to assess the novelty and inventive step of complex pharmaceutical inventions. The resolution’s success will also depend on effective coordination between the Ministry of Health, the Ministry of Economy, and the INPI.
The resolution acknowledges that the repeal of the 2012 resolution could lead to the granting of patents for applications currently in progress that relate to products already marketed by third parties. The transitional measure is designed to address this potential issue, but its effectiveness will be tested in practice. The INPI will likely face legal challenges as it implements the new framework, and its decisions will be closely watched by both pharmaceutical companies and consumer advocacy groups.
The next key step will be observing how the INPI handles the first wave of patent applications under the new guidelines. Further clarity on the agency’s interpretation of the patentability criteria is expected in the coming months. The INPI has not yet announced a specific timeline for issuing these guidelines, but stakeholders are encouraged to monitor the agency’s website for updates.
This regulatory shift represents a significant development in Argentina’s pharmaceutical landscape. The coming months will be crucial in determining whether it achieves its intended goals of fostering innovation while ensuring access to essential medicines. Share your thoughts on this evolving situation in the comments below.
