Market Intelligence
Pharmaceuticals Uruguay

Uruguay Pharmaceutical Patents

An important Uruguayan law regarding pharmaceutical patent protection is amended. 

The Uruguayan Congress issued Article 325 of Law No. 19924 to modify Article 99 of Patent Law No. 17164 regarding patent infringement protection occurring between the time of patent publication and the granting of the patent. This change affects the protection of pharmaceutical products where the research occurred outside of Uruguay.

This modification establishes a difference between pharmaceutical products and other inventions. The modification also establishes a difference between pharmaceuticals whose research occurred in Uruguay or abroad. The new law states: “The owner of a patent may take the corresponding actions against anyone who infringes on the rights arising thereof and may even claim compensation for the acts carried out between the publication of the application and the granting of the patent. The possibility of claiming compensation for the acts carried out between the publication of the application and the granting of the patent shall not apply in the case of patenting of pharmaceutical products, except in the cases where it has been irrefutably proven that a substantial part of its development has actually taken place in the country (Uruguay)”.

There have been attempts to amend this regulation, but no consensus to amend the law has been reached in Parliament.  Some companies claim that this new regulation is against the TRIPS Agreement establishing that: “Each Member shall accord to the nationals of other Members treatment no less favorable than that it accords to its own nationals with regard to the protection of intellectual property, subject to the exceptions already provided in, respectively, the Paris Convention (1967), the Berne Convention (1971), the Rome Convention or the Treaty on Intellectual Property in Respect of Integrated Circuits.”

Unamended, this new law could have significant impact on foreign companies that have not carried out a “substantial part” of the pharmaceutical’s development in Uruguay.  The exact definition of “substantial part” has not yet been determined by local legal authorities. 

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