Two significant developments have emerged in the ongoing process for compulsory licensing (CL) of a patent covering the API Dolutegravir (DTG):
Firstly, the Colombia Patent Office (CPO) has already defined the methodology for determining the compensation fee to be paid to the patent holder for the CL. The chosen approach is that proposed by the Japan Patent Office, which establishes “normal royalties” at a range of 2% to 4% of the price of the generic (Gx) drug and offers the flexibility to adjust the price up or down to two percentage points, to suit the particularities of each product or country.
Secondly, two requests have been filed before the CPO for the granting of the potential CL: The Ministry of Health (the same entity that started ex-officio the process to declare the Public Interest for CL purposes) and a local Gx company. It’s important to highlight that the patent holder will have the opportunity to respond to these applications.
