Colombia wins favorable ruling at the Andean Tribunal on the dolutegravir compulsory license — but the domestic legal battle continues

The Andean Community Court of Justice dismissed as unfounded the complaint filed by two multinational pharmaceutical companies against the compulsory license for the first-line HIV medication, in a historic decision for access to medicines in the region. However, three legal proceedings before Colombian courts remain pending.

Bogotá D.C., Colombia — In a decision of regional significance, the Andean Community Court of Justice ruled in favor of Colombia on April 27, 2026, dismissing as unfounded the complaint filed by ViiV Healthcare and Shionogi & Co., which alleged that Colombia had violated its obligations under the public interest declaration for dolutegravir.

The ruling sets clear and concrete precedents for the Latin American Region:

1. TRIPS flexibilities are defensible. Governments that use compulsory licenses to protect public health now have solid supranational jurisprudential backing against potential litigation by the pharmaceutical industry.
2. Patent rights have limits when public health is at stake. The ruling confirms that no patent is absolute when access to essential treatments for vulnerable populations is at stake.
3. Non-commercial government use is a valid modality. The Colombian license was granted exclusively for State use, which the Court validated as a proportionate and legitimate tool.
4. The duration of a license must be conditioned on epidemiological reality. It is not necessary to set a rigid end date if the public health reasons persist — an interpretation that opens space for more flexible health policies adapted to changing contexts.

The Court concluded that Colombia did not breach Andean regulations or its obligations under the Andean Community, finding that the compulsory license was consistent with applicable rules. It further noted that Colombia had incorporated both the conditions and the duration limits of the measure, including a defined term, and that the pharmaceutical companies’ arguments did not undermine the legality of the process.

A compulsory license: the origin of the dispute

A compulsory license allows a government to authorize the production or importation of generic versions of a patented medicine, without the consent of the patent holder, for reasons of public interest. This tool is recognized under international law and forms part of the flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization. Its use can significantly reduce drug costs and expand access for the populations that need them most.

In October 2023, the Colombian government initiated the process of public interest declaration for dolutegravir, a first-line HIV treatment drug recommended by the World Health Organization for its efficacy and lower rate of side effects. This measure allows the State to authorize the purchase or production of generic versions without the patent holder’s exclusivity, thereby reducing the cost of the medication.

In April 2024, the Superintendency of Industry and Commerce granted the first compulsory license for the medication, and in June confirmed that measure when resolving the challenges filed by ViiV Healthcare and Shionogi & Co., affirming that the State may authorize the production or importation of generic versions even where a patent is in force. The implementation process of the license subsequently took place.

Prior to reaching the Court, the General Secretariat of the Andean Community had already issued in October 2024 Dictamen N° 004-2024, concluding that Colombia had not violated Andean regulations. The pharmaceutical companies persisted and escalated the case before the Andean Community Court of Justice in January 2025, challenging the legality of the license. Among their arguments, they contended that the measure did not clearly define its duration, that it was granted without sufficient temporal criteria, and that it blurred the exceptional nature of such licenses.

Colombia argued that the compulsory license complies with Andean regulations and that its duration may depend on the conditions that gave rise to the public interest declaration, maintaining that it is a legitimate health tool aimed at ensuring access to essential treatments.

The domestic legal battle continues:

Notwithstanding the significance of this ruling, it is important to note that the victory before the Andean Tribunal does not fully close the legal docket — three judicial proceedings before Colombian courts remain active:

1. Before the Council of State, under case number 11001032400020240006100, there is a nullity action against Resolutions No. 1579 of October 2, 2023 and No. 2024 of 2023 issued by the Ministry of Health and Social Protection. The case is currently pending before the chamber.
2. Before the Administrative Court of Bogotá, case number 25000234100020240123400, a nullity and rights-restoration action has been filed against those same ministerial resolutions. This case is also pending before the chamber.
3. A third proceeding, case number 250002341000202500159 00, challenges before the Administrative Court of Bogotá Resolutions No. 20049 of April 23, 2024 and No. 34716 of 2024, issued by the Superintendency of Industry and Commerce. In all three cases, several civil society organizations — including PMA LAC and GHP Corp. — are participating as intervening parties in defense of the license.

The ongoing judicial proceedings represent an opportunity for national authorities to continue strengthening the institutional framework that underpins this public policy. Whatever decision is reached will contribute to reinforcing legal certainty, coherence across branches of government, and confidence in the mechanisms provided by the legal order.

A timely resolution will allow the State to reaffirm its commitment to protecting the right to health and to the responsible use of tools available under international law to promote equitable access to essential medicines.

Although the patent on the active ingredient dolutegravir related to the compulsory license has just expired (April 28, 2026), other patents related to this medication remain in force in Colombia and in other countries in the region, particularly in therapeutic combinations used in HIV programs. Therefore, this matter is not closed by the expiration of the base patent. The precedent set by the Andean Tribunal is relevant and should serve as a guide for Colombia and for other countries in the region when evaluating the use of TRIPS flexibilities where barriers arising from exclusive rights persist. The decision reaffirms that, when tensions arise between commercial interests and the protection of public health, States retain the authority — and the responsibility — to prioritize timely and affordable access to essential medicines.