Argentina Eases Pharmaceutical Patent Rules

By Estudio Chaloupka

Argentina has introduced a significant shift in its pharmaceutical patent regime through a new joint resolution that repeals the restrictive 2012 examination guidelines and restores full discretion to the National Institute of Industrial Property (INPI) to assess applications on a case-by-case basis.

The measure was adopted jointly by the Ministries of Health and Economy together with INPI, formally eliminating criteria that had imposed additional limitations on what could be considered patentable in the pharmaceutical field. By removing these guidelines, the government effectively returns to a framework grounded directly in the Patent Law, without the interpretative restrictions that had shaped examination practices for more than a decade.

In practical terms, the change impacts how patent examiners evaluate key requirements such as novelty, inventive step, and industrial applicability. Under the previous regime, certain types of claims—particularly those related to incremental innovations—faced higher hurdles. The new approach does not guarantee broader protection, but it allows for a more flexible and individualized assessment of each application.

The resolution also clarifies its temporal scope, indicating that the new criteria will apply to both pending applications and future filings. This is particularly relevant for pharmaceutical companies with portfolios under examination, as it may alter the prospects of applications previously constrained by the 2012 framework.

At the same time, the reform introduces an important safeguard aimed at preserving legal certainty and access to medicines: patents granted under the new regime cannot be enforced against products that were already being commercially exploited before the resolution entered into force, nor can damages be claimed in relation to such uses.