On 24 April 2024, the Superintendence of Industry and Commerce granted the Ministry of Health a compulsory license (CL) for reasons of public interest (“Governmental use”), under the modality of governmental use, over a Patent covering the active ingredient Dolutegravir, used for the treatment and prevention of HIV.
The license permits the importation and production of Dolutegravir exclusively for governmental use, and the SIC expressly indicated that the Ministry can utilize available mechanisms such as centralized purchases to meet the demand for the product.
According to the Superintendence, the CL will come into effect on 27 May 2024. However, there are administrative and judicial mechanisms available that can be exercised against the compulsory license and judicial mechanisms against the Declaration of Public Interest.
This is the first case in which a compulsory license has been granted in the country, and it is worth mentioning that the modality of governmental use is not regulated in the applicable legislation.
