Argentina and U.S. Advance Trade Framework: a possible new IP scenario for our country
Argentina and the United States announced a framework on November 13, 2025, to deepen bilateral trade and investment ties, signaling a potential reset of Argentina’s intellectual property regime after more than a decade of restrictive pharmaceutical patent practice. The joint statement, issued under the countries’ Trade and Investment Framework Agreement, commits both sides to foster a “transparent and rules-based environment for commerce and innovation” and singles out intellectual property as a priority area for reform.
In the statement, the United States noted Argentina’s recent enforcement actions against a major regional market for counterfeit goods and highlighted commitments by Argentina to tackle structural concerns cited in the 2025 Special 301 report. Those include patentability criteria, patent backlog, and geographical indications, alongside broader alignment of Argentina’s IP framework with international standards. The Milei administration would be forced to modify certain regulations and ratify intellectual property treaties, putting Intellectual Property at the center of ongoing talks, focusing on two headline measures: repealing a 2012 Joint Resolution that tightened the examination of pharmaceutical patents, and advancing ratification of key international IP treaties including the Patent Cooperation Treaty (PCT), the Madrid Protocol, and the Hague Agreement, among others.
At the heart of the policy debate is the 2012 Joint Resolution (MI 118/12, MS 546/12, INPI 107/12), adopted during the administration of Cristina Fernández de Kirchner. That measure introduced restrictive examination guidelines for chemical-pharmaceutical inventions at the National Institute of Industrial Property (INPI), curbing what innovators describe as routine avenues of protection for follow-on improvements. The guidelines have sharply limited patentability for new forms of known substances, dosing regimens, combinations lacking demonstrated synergy, and second medical use claims, among others, driving lower allowance rates, lengthier prosecution, and narrower claim scopes. Research-based pharmaceutical companies have long argued that the framework deters investment in high-risk R&D and places Argentina at a disadvantage relative to jurisdictions applying standards closer to the European Patent Convention or the United States.
Domestic generic manufacturers, represented by industry groups such as CILFA, have historically supported the tighter criteria, framing them as necessary to prevent “evergreening” and protect public health. Litigation brought by the Argentine Chamber of Medical Specialties (CAEME) and the Biotechnology Chamber (CAB) to overturn the 2012 regime has thus far failed to dislodge it. In a recent first-instance ruling on October 9, 2025, Federal Civil and Commercial Court No. 1 upheld the validity of the 2012 guidelines and related administrative measures, finding them consistent with Argentina’s Patent Law and flexibilities under the TRIPS Agreement. The court emphasized the guidelines’ status as internal instructions to examiners rather than new legal requirements, while noting that the executive retains authority to repeal the resolution. Appeals remain possible to higher courts.
Parallel to domestic policy shifts, Argentina is moving to integrate with multilateral IP systems long favored by its trading partners. While the Senate approved the PCT in 1998, final ratification still requires approval by the Chamber of Deputies. The Argentine government shall have to complete PCT ratification soon and apparently before the end of 2025. Then, adopt the Madrid Protocol for trademarks and the Hague Agreement for industrial designs as well as other international treaties before the end of the Milei mandate in 2027. If enacted, these steps would streamline cross-border protection for patents, brands, and designs and bring Argentina into closer alignment with the practices of major markets.
Industry observers say the combined effect of repealing the 2012 pharmaceutical guidelines and adopting international registration systems could materially alter Argentina’s innovation landscape. Although details of any revised patentability criteria have not been released, practitioners expect either a full repeal of the 2012 resolution or a negotiated replacement that eases current restrictions while addressing domestic stakeholders’ concerns. Procedurally, faster pathways may also gain traction. INPI’s existing accelerated examination mechanism under Resolution P-56/2016 allows applicants to leverage a granted foreign patent—subject to constraints on claim scope, prior art, and patentable subject matter—with a 60-day decision window once conditions are met. In a reformed environment, companies could see patent grant timelines fall from the current eight to ten years to as few as four years in straightforward cases.
Any shift is likely to reverberate across Argentina’s pharmaceutical sector. Strengthened protection for incremental innovations could extend exclusivities around core compounds, alter lifecycle management strategies, and influence the timing of generic entry. Generic manufacturers may face a tighter window to launch variants and follow-on formulations, even as data requirements and evidentiary standards continue to frame examination outcomes. For global rights holders, alignment with the PCT, Madrid, and Hague systems would reduce administrative friction and facilitate coordinated filing strategies across markets.
The path ahead remains tied to political and legislative calendars. With a new composition in Congress after December 10, 2025, government officials and industry stakeholders are preparing for consequential debates over the contours of Argentina’s IP policy. While further court proceedings may continue in parallel, the executive branch retains latitude to unwind or replace the 2012 guidelines. For now, the joint U.S.-Argentina framework marks the clearest signal yet that Buenos Aires intends to recalibrate its IP rules toward international norms, setting the stage for a new chapter in trade, investment, and innovation policy.
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