Executive Summary
Following publication in the Official Gazette today, Argentina has repealed the joint ministerial resolutions of 2012 that imposed restrictive examination criteria on chemical‑pharmaceutical patent applications.
This long‑awaited repeal marks a fundamental policy shift. Pharmaceutical and chemical inventions will now be examined under the general patent framework, without technology‑specific limitations, bringing Argentina meaningfully closer to international intellectual property standards.
Importantly, this measure should also be seen as the first concrete step within a broader commitment assumed by Argentina under the Argentina–United States Trade and Investment Agreement (ARTI), which contemplates further IP‑related reforms, including submission to Congress of a PCT accession bill by April 30.
Background: The 2012 Resolutions and Their Practical Effect
In 2012, joint resolutions from the then‑Ministry of Industry, the Ministry of Health, and INPI introduced sector‑specific criteria for chemical‑pharmaceutical inventions. Over time, this framework narrowed patent protection and reduced predictability for applicants, creating a persistent divergence from examination practice in other major jurisdictions.
The Repeal: What Has Changed
The new joint resolution fully repeals the 2012 resolutions and restores a technology‑neutral approach to examination. New applications and applications currently under prosecution will be handled under the general provisions of the Patent Law, without additional field‑specific restrictions. The resolution reaffirms INPI’s authority to conduct case‑by‑case examination.
Transitional Exception for Products Already on the Market
To avoid market disruption, the resolution establishes a transitional commercialization exception: for patents granted after the repeal takes effect, if the patented invention relates to a pharmaceutical product that was already being commercially marketed in Argentina by a third party on the effective date, the patent holder may not prevent the continuation of commercialization nor demand compensation for such continuation.
However, while Article 2 establishes an important transitional commercialization exception, its practical scope and application may be subject to differing interpretations
A Broader Context: ARTI and International Commitments
The repeal should be read as part of a broader international alignment. Under ARTI, Argentina committed to strengthen intellectual property protection and move toward international standards. Among the contemplated steps, the government has indicated that a PCT accession bill will be submitted to Congress by April 30, signaling potential structural change ahead.
Important Reminder: Argentina Is Still Not a PCT Member
Despite the reform momentum:
- Argentina is not yet a PCT member.
- Until formal accession and implementation occur, international protection in Argentina must continue via the Paris Convention route; PCT national phase entry is not available.
Practical Takeaways for Applicants (With Appropriate Caution)
- Review pending pharmaceutical cases for strategic opportunities.
- New filings may be planned with greater confidence in a technology‑neutral framework, yet applicants should monitor INPI’s forthcoming guidance and maintain flexibility in claim drafting and prosecution tactics.
- Enforcement and FTO assessments must account for the transitional exception where products were already marketed locally before patent grant; fact development on market status at grant will be key.
- International strategy: continue to use the Paris Convention route for Argentina while tracking ARTI‑linked reforms, particularly the PCT bill timeline and any interim administrative updates.
Conclusion
The repeal of the 2012 pharmaceutical resolutions is a turning point for Argentina’s patent landscape: it restores a technology‑neutral examination baseline and signals the start of a wider IP modernization agenda. The transitional commercialization exception balances innovation incentives with continuity of supply.
