Argentina has introduced a major shift in pharmaceutical patent policy by eliminating the restrictive examination guidelines established in 2012. The change signals a move toward a more flexible and internationally aligned approach to patentability.

Under the new framework, categories that were previously excluded, can now be evaluated under standard legal criteria. This includes e.g. polymorphic forms, enantiomers, selection patents, Markush claims, salts, esters, formulations, and related processes. The update applies both to new filings and to applications currently under review, which will no longer be subject to the former limitations.

The reform also introduces a “safe harbor” provision to protect third parties who entered the market under the old rules. This may limit patent holders’ ability to block ongoing commercialization or seek damages in certain cases, though the scope and legal robustness of this mechanism remain uncertain.

Overall, the changes are expected to create a more supportive environment for pharmaceutical innovation in Argentina.