Update: Argentina Repeals Restrictive Pharmaceutical Patentability Guidelines — Joint Resolution 1/2026 Published on March 18, 2026
In our March 13 post, Argentina’s Seismic IP Shift: The U.S.–Argentina Agreement on Reciprocal Trade and Investment Reshapes Patent Strategy for Pharma, Biotech, and Beyond, we analyzed the sweeping intellectual property commitments embedded in the bilateral agreement signed on February 5, 2026, and identified the anticipated repeal of Argentina’s restrictive pharmaceutical patentability guidelines as one of the most consequential reforms on the horizon. That horizon has arrived faster than many expected.
On March 18, 2026, the Argentine Ministry of Economy, the Ministry of Health, and the National Institute of Industrial Property (INPI) published Joint Resolution 1/2026 in the Official Gazette, formally repealing Joint Ministerial Resolutions No. 118/2012, No. 546/2012, and No. 107/2012, the regulations that have severely constrained pharmaceutical patentability in Argentina for over a decade. The repeal is effective as from March 19, 2026.
This is a development of the first order for life sciences practitioners. Here is what you need to know.
What Has Changed
As we detailed in our prior post, the Pharmaceutical Guidelines issued in 2012 imposed examination criteria that went well beyond the standard novelty, inventive step, and industrial applicability requirements of Argentina’s Patent Law No. 24,481 and the TRIPS Agreement. They effectively declared many of the most common categories of pharmaceutical inventions non-patentable generally, making Argentina an outlier among major-market jurisdictions.
With Joint Resolution 1/2026, those restrictions have been lifted. The repeal restores Argentina to the more internationally aligned approach to pharmaceutical patentability that prevailed prior to 2012. Specifically, the patentability limitations on the following categories of inventions have been removed:
• Polymorphs and pseudo-polymorphs (hydrates and solvates)
• Enantiomers
• Markush-type formulas
• Selection patents
• Salts, esters, and other derivatives of known substances
• Active metabolites and prodrugs
• Formulations, compositions, and combinations
• Analogous processes
One area of continued uncertainty involves dosage claims and second medical use claims drafted in Swiss-type format. Argentina’s Patent Law continues to exclude methods of therapeutic treatment from patentable subject matter, and INPI may continue to apply this exclusion to dose-dependent and second medical use claims regardless of the repeal. Practitioners should monitor INPI’s examination practice in this area closely, as the boundary between permissible product or use claims and impermissible method-of-treatment claims will likely be tested in the near term.
Effective Date and Immediate Impact on Pending Applications
Joint Resolution 1/2026 took effect on March 19, 2026.
This means that INPI can no longer rely on the repealed Pharmaceutical Guidelines to support objections in pending office actions or to justify rejection decisions. For practitioners with applications currently in prosecution, this is an immediate and actionable change.
An Important Limitation for Newly Granted Patents
Article 2 of Joint Resolution 1/2026 introduces a noteworthy limitation. For patents granted as of today that are directed to or cover pharmaceutical products already being commercialized locally by third parties, the patent holder will not have the right to seek suspension of that commercialization or to claim compensation from those existing market participants. However, patent holders retain the right to seek compensation from new third parties that enter the market or begin commercializing covered products going forward. Practitioners and their clients should factor this transitional provision into enforcement and licensing strategy, particularly for inventions in therapeutic areas where generic or biosimilar competition may already be established in the Argentine market.
Strategic Guidance for Life Sciences Practitioners
The repeal of the Pharmaceutical Guidelines transforms the strategic calculus for Argentine patent protection. We recommend the following action items:
1. Audit pending Argentine applications immediately. Any application that was rejected, narrowed, or stalled under the Pharmaceutical Guidelines should be reassessed. Where claims were narrowed to satisfy the now-repealed restrictions, consider filing amendments to restore broader coverage consistent with the original filing. Applications that received office actions citing the Guidelines may be ripe for responsive arguments that the legal basis for the objection has been eliminated. Applications under appeal should be evaluated for whether the appeal posture should change in light of the repeal.
2. Leverage Resolution 056/2016 to accelerate grant. Argentina’s Resolution 056/2016, which functions as an internal patent prosecution highway (PPH), allows applicants to obtain early grant by paying a special fee and aligning the Argentine claim set with that of a granted foreign equivalent (typically from the USPTO, EPO, JPO, IP Australia, UKIPO, or CIPO). Combined with the now-broadened scope of patentable subject matter, this mechanism becomes a powerful tool for building robust patent portfolios in Argentina on an accelerated timeline. Practitioners should identify applications where a foreign equivalent has already been granted and evaluate whether Resolution 056/2016 can be used to fast-track the Argentine counterpart.
3. Realign Argentine claim drafting with global strategy. For years, applicants have been forced to prepare Argentina-specific claim sets that differed materially from those filed before other major offices. With the repeal of the restrictive guidelines, there is both an opportunity and a strategic incentive to bring Argentine claim drafting into closer alignment with global prosecution strategy. New filings should be drafted to pursue the full breadth of coverage available under internationally accepted examination standards, rather than preemptively narrowing claims to satisfy restrictions that no longer apply.
4. Reassess whether Argentina belongs in the portfolio. Clients who previously declined to seek Argentine patent protection due to the hostile examination environment should revisit that decision. Argentina’s position as Latin America’s third-largest economy, its growing pharmaceutical and biotech sectors, and the now-materially-improved patentability landscape make it a jurisdiction that warrants fresh consideration, particularly for innovators in small molecules, biologics, formulations, and combination therapies.
5. Monitor INPI’s post-repeal examination practice. While the legal basis for the restrictive guidelines has been removed, the transition from one examination framework to another is never instantaneous. Examiners who have applied the Pharmaceutical Guidelines for over a decade will need to adjust their approach. Practitioners should watch for any new examination guidance that INPI may issue, and should work with experienced Argentine counsel to navigate the transition period, particularly in areas where the repeal’s scope may be tested, such as dosage and second medical use claims.
6. Evaluate enforcement and licensing implications under Article 2. For patents that may now be grantable covering products already commercialized in Argentina by third parties, the Article 2 limitation on enforcement rights must be factored into any commercialization, licensing, or enforcement strategy. Clients with products in competitive therapeutic categories should discuss the implications of this transitional provision with both patent and commercial counsel.
Looking Ahead
The repeal of the Pharmaceutical Guidelines is the first major implementation milestone under the ARTI’s IP chapter, and it has arrived with remarkable speed — just six weeks after the agreement was signed. As we noted in our prior post, significant additional reforms remain on the horizon, including the submission of the Patent Cooperation Treaty (PCT) to the Argentine Congress by April 30, 2026, the anticipated repeal of Resolution No. 283/2015 (the Biotech Regulation), and accession to the Budapest Treaty, Patent Law Treaty, and other international instruments by the end of 2027.
Today’s development confirms that the Argentine government is moving with urgency to deliver on its ARTI commitments. For practitioners and portfolio managers, the message is clear: the time to act is now. Reassess pending applications, reconsider filing strategies, and prepare to integrate Argentina into global prosecution workflows as a jurisdiction where meaningful pharmaceutical patent protection is, for the first time in over a decade, realistically achievable.
We will continue to monitor and report on ARTI implementation developments as they unfold.
This post was written by Lisa Mueller and Maria Soledad Prado from Clarke Modet.