Argentina relaxes biotech patent criteria: repeal of INPI Resolution 283/2015
Regulatory background and context
Over the past months, Ojam IP has been closely tracking and reporting on the series of regulatory reforms in intellectual property law unfolding in Argentina since the signature of the Reciprocal Trade and Investment Agreement (ARTI) between Argentina and the United States on February 5, 2026. Among its key commitments, the agreement called for the repeal of a series of resolutions that since 2012 and 2015 had imposed restrictive patentability criteria in the pharmaceutical and biotechnological sectors.
The first concrete step was Joint Resolution 1/2026 (Ministry of Health, Ministry of Economy and INPI), dated March 17, 2026, which repealed Joint Resolutions 118/2012, 546/2012 and 107/2012, eliminating the restrictive guidelines for pharmaceutical patent examination. We alerted our clients and correspondent network at that time.
On June 18, 2026, INPI took the next step in the same direction.
The new regulation: INPI Resolution 197/2026
On June 19, 2026, INPI Resolution 197/2026, signed by INPI President Carlos María Gallo, was published in the Official Gazette and entered into force on that same date.
Its main provisions are:
- Repeal of INPI Resolution 283/2015, which had introduced restrictive criteria for the patenting of living matter and natural substances in the field of biotechnology.
- Substitution of paragraphs 2.1.7.2 and 2.1.7.9 of Chapter IV, Part C of the Patent Examination Guidelines, reverting to the original wording of INPI Resolution 243/2003.
- Update of Annex VIII (Definitions), including technical definitions of animals, plants, living matter, microorganisms, fungi, substances, viruses and genetic material.
- A transitional safe harbor for good-faith third parties who, as of the effective date, were already commercializing products covered by pending patent applications that are subsequently granted as a result of this repeal.
What changes in practice?
Resolution 283/2015 had required that parts and components of plants and animals be claimed in their “isolated state” in order to potentially qualify for patent protection. INPI acknowledges in the recitals of the new resolution that this requirement was unworkable: such elements only have meaning and functionality when inserted into a living organism, and their isolation effectively deprived them of industrial applicability, making biotechnology patent protection practically unattainable in Argentina.
In line with the underlying legislation (Law 24.481) and the original 2003 guidelines, the following remain excluded from patentability:
- Plants, animals, and their parts or components capable of giving rise to a complete individual, whether or not modified (including species, plant varieties and animal breeds).
- Essentially biological processes for the reproduction or production of plants or animals.
- Plants and animals containing genes introduced through recombinant DNA technology.
What the resolution enables, on the other hand, is the protection of biotechnological inventions that do not involve claiming complete organisms or parts capable of reconstituting them: gene sequences with specific technical functionality, recombinant proteins, microbiological processes, compositions and industrial applications derived from biological material, among other categories that may now be evaluated under criteria more aligned with international standards.
Who is affected?
This resolution has direct impact on:
- Agribiotech companies with patent applications pending in Argentina that were denied or narrowed under the criteria of Resolution 283/2015.
- Owners of technologies related to genetically modified organisms, plant and animal breeding, bioinputs and biotechnological agrochemicals.
- Pharmaceutical and medical biotechnology companies with inventions involving biological material (monoclonal antibodies, recombinant proteins, viral vectors, among others).
- Investors and licensors with portfolios including biotechnological technology who had discarded or deferred protection in Argentina due to the previous regulatory environment.
Scope and implications of the reforms
This resolution confirms that Argentina is systematically implementing the IP commitments made under the ARTI. The roadmap further includes, before the end of 2027, submission to Congress for ratification of the Patent Cooperation Treaty (PCT), the Budapest Treaty, the Hague Agreement on industrial designs, the Madrid Protocol for international trademarks, and the UPOV Convention 1991 on plant varieties, the latter carrying particularly significant implications for the agricultural sector.
The Argentine regulatory landscape in intellectual property is changing at an unusual pace. Ojam IP continues to monitor every development and is available to assess the specific impact of these changes on our clients’ portfolios.
For any inqueries, please do not hesitate to contact us at ip@ojamip.com
This Legal Alert is for informational purposes only and does not constitute legal advice.
