New regulations on pharmaceutical patents in Argentina: repeal of the restrictive regime of 2012
Report of the Departments of Health Law – Life Sciences, Intellectual Property, and Administrative Law | New regulations on pharmaceutical patents in Argentina: repeal of the restrictive regime of 2012
We are writing to inform you about a regulatory change of great relevance for the pharmaceutical and health sector in Argentina. On March 18, 2026, Joint Resolution No. 1/2026 of the Ministry of Health of the Nation, the Ministry of Economy of the Nation and the National Institute of Industrial Property (INPI) was published in the Official Gazette.
What’s changing
The new resolution repealed Joint Resolution 118/546/107 of the same Ministries, which had approved the “Guidelines for the Examination of Patentability of Patent Applications on Chemical-Pharmaceutical Inventions”, in force since 2012. Those guidelines imposed highly restrictive criteria for granting patents in the pharmaceutical sector. In practice, under the previous regime it was very difficult to obtain a pharmaceutical patent in Argentina, since it excluded developments that in other jurisdictions of the world are patentable.
From now on, the INPI will analyze each patent application individually, on a case-by-case basis, applying only the requirements established in the Patent Law (Law 24,481): novelty, inventive step and industrial application. This change aligns Argentina with international standards on the matter.
Why this decision was made
The resolution explains its rationale clearly. Among the main arguments indicated in the recitals are:
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), incorporated into Argentine legislation by Law 24.425, establishes that the essential requirements for patentability are novelty, inventive step and industrial applicability, and promotes the principle of non-discrimination by technological field. The 2012 guidelines departed from these principles by imposing additional restrictions specific to the pharmaceutical sector.
The resolution also recognizes that strengthening intellectual property rights is important to promote innovation and increase the availability of new chemical-pharmaceutical products. In the words of the regulation itself, “the introduction of patenting regimes, especially patents on pharmaceutical products, increases the speed at which new drugs are launched on the markets of different countries, a result that is still maintained for developing countries.”
In addition, it was argued that adequate and effective protection of inventions at the local level generates conditions of predictability and legal certainty that facilitate the introduction of innovations and timely access to new medicines and treatments for the benefit of public health and general welfare.
Finally, the government considered that the repeal is the most appropriate measure to give rise to the effective exercise of the INPI of its exclusive competence in the study of patent applications, promoting efficiency and ensuring consistency with international best practices.
Protection for those who already market pharmaceutical products
The resolution includes an important transitional mechanism. In the case of patents granted as of the entry into force of this regulation and that are linked to pharmaceutical products that were already being marketed by third parties in the local market, the holders of such patents may not prevent the continuation of such commercialization or demand the payment of royalties or any remuneration.
This exception is understood in a broad sense: it covers not only the finished pharmaceutical product, but also its active ingredient or ingredients, manufacturing methods, and everything related to the marketing of the product (including production, processing, storage, import and export).
Practical implications
This measure has concrete consequences for different market players:
For innovative pharmaceutical companies (national and international), the repeal opens the possibility of obtaining effective protection of their developments in Argentina, under conditions similar to those that exist in other countries. This includes incremental inventions—such as new formulations, salts, or metabolites—that could not be patented under the previous regime.
For companies in other chemical sectors, such as agrochemicals, the derogation is also significant. In practice, many of the restrictions arising from the implementation of the 2012 resolution were applied by analogy by the INPI in the examination of patent applications related to other areas of chemistry. The elimination of these restrictive guidelines should result in a more favourable examination criterion for these industries as well.
For companies that already market pharmaceutical products in Argentina, the regulation offers peace of mind: they will be able to continue with the commercialization of their products without the risk of being affected by new patents that are granted from this resolution.
For the Argentine industrial property system, the change represents a modernization and alignment with international practices, which can contribute to attracting investment and development to the country.
For access to medicines, according to the resolution itself, the adequate protection of inventions facilitates the introduction of innovations and timely access to new medicines and treatments.
Validity
The Joint Resolution entered into force on March 18, 2026, the date of its publication in the Official Gazette.
We remain available to discuss how this new regulation may impact your particular situation and to assist you with any related queries.
Sincerely,
Ana Andrés, Florencia Rosati y Juan Antonio Stupenengo