By means of Resolution No. 0453 dated 16 March, 2026, the Colombian Ministry of Health and Social Protection (the “Ministry”) declared the existence of public interest grounds to submit three patents owned by Gilead Pharmasset LLC and Gilead Sciences, Inc. to compulsory licensing. These patents are related to sofosbuvir, velpatasvir, voxilaprevir, and the combination sofosbuvir + velpatasvir, which are used for the treatment of Hepatitis C.
This proceeding was initiated by Resolution No. 5246 dated 20 December, 2017, and included the Recommendations of the Interinstitutional Technical Committee, which, in its session of 6 April, 2021, unanimously recommended not declaring the existence of public interest grounds. The Committee’s Recommendations, published on 5 July, 2022, were based on the following: (i) access to treatment has been ensured, such that “in Colombia, there is no evidence of unmet demand among patients suffering from the disease”; (ii) savings estimated at more than COP 400 billion have been generated for the General Social Security Health System (GSSHS) through alternative and less burdensome mechanisms than a compulsory license; and (iii) a compulsory license entails legal risks, potential loss of legitimacy of the State in light of its international obligations, and possible negative effects on the investment climate.
Considering that the Committee’s Recommendations are advisory and not binding, the Ministry decided, through Resolution No. 0453, to depart from such recommendation and declare the existence of public interest grounds. The Resolution argues that: (i) the State has a duty to guarantee access to healthcare under the principles of universality, efficiency, and solidarity; (ii) compulsory licenses do not discourage innovation; (iii) as this is a case of public non-commercial use, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows waiving prior negotiations with the patent holder; (iv) there are no relevant voluntary licenses for the products; (v) there has been an increase in the number of diagnosed cases, rising from 314 in 2020 to 1,255 in 2024, and a 46.6% increase for 2025 compared to the same epidemiological period in 2024; (vi) although access has improved in recent years, such improvement may not be sustainable given the increase in demand for treatment; and (vii) a compulsory license could result in an approximate 90% price reduction.
The Resolution opens the door for the Superintendence of Industry and Commerce to initiate proceedings to grant a compulsory license. However, the decision may be challenged through a reconsideration action, within ten (10) business days from notification, by the patent holders or interested third parties.
