Resolution 197/2026 restores the Patent Examination Guidelines Applicable to Biotechnological Inventions

On June 19, 2026, the Argentine Patent Office (INPI) published Resolution No. 197/2026 (attached), which repeals Resolution No. 283/2015 and restores the Patent Examination Guidelines applicable to biotechnological inventions that were in force prior to the 2015 reform.

Specifically, the resolution amends Part C, Chapter IV of the Patent Examination Guidelines, which governs the examination of “Living Matter and Natural Substances”, as follows:

Section 2.1.7.2 has been replaced

Providing that the following shall not be regarded as inventions:

  • plants and plant parts or components capable of generating a complete individual;
  • animals and animal parts capable of generating a complete individual; and
  • essentially biological processes for the reproduction or production of plants or animals.

 Section 2.1.7.9 has been replaced

Maintaining that:

  • product claims directed to plants or animals are not patentable;
  • this exclusion applies even where such plants or animals have been obtained through microbiological processes; and
  • plants and animals containing genes introduced through recombinant DNA technology remain excluded from patentability.

Annex VIII has been entirely replaced

This annex replaces de definitions used in the interpretation of biotechnology-related subject matter for:

  • Animals
  • Plants
  • Living Matter
  • Cells
  • Organism
  • Microorganism
  • Fungi
  • Substances
  • Viruses
  • Genetic Material
  • Biological Material
  • Essentially Biological Processes

IMPORTANTLY: The resolution does not modify the general principles of the Argentine patent system: the requirements of novelty, inventive step, industrial applicability, sufficiency of disclosure, and unity of invention remain unchanged, as do the requirements concerning claim drafting and claim scope. Likewise, the reform does not amend Patent Law No. 24,481 or the statutory exclusions from patentability relating to plants, animals, and essentially biological processes.

Protection of Good-Faith Third Parties

The resolution includes a transitional provision aimed at protecting parties who, in good faith, were commercializing products in the Argentine market at the time the resolution entered into force.

Under this provision, if a patent application currently under examination is ultimately granted as a result of the repeal of Resolution No. 283/2015, the patent owner will not be entitled to seek monetary compensation or prevent the continued commercialization of such products by those good-faith third parties.

This safeguard is intended to preserve legal certainty and prevent the change in examination criteria from having retroactive effects on activities that were lawfully carried out under the previous framework.