WHAT A COMPULSORY LICENSE IS
A government authorizes a generic manufacturer to produce a patented drug without the patent holder's consent, paying a royalty set by the state rather than the market. The patent still exists; the monopoly does not.
THE DOHA DECLARATION
The 2001 WTO Doha Declaration on TRIPS and Public Health affirmed that member states have the right to grant compulsory licenses and to determine the grounds — explicitly including HIV/AIDS, tuberculosis, and malaria. It was the developing world's most significant trade-law victory of the post-Cold War era.
WHY DOLUTEGRAVIR
Dolutegravir is the WHO-recommended first-line HIV treatment — high efficacy, low resistance, once-daily dosing. ViiV Healthcare (a GSK subsidiary) holds the patent; branded prices in middle-income countries can run 10–20× the generic equivalent produced in India under voluntary licenses.
THE ANDEAN COMMUNITY
The Comunidad Andina (CAN) — Colombia, Ecuador, Peru, Bolivia — is a customs union with its own supranational court, the Tribunal de Justicia, whose rulings bind member states. Decision 486 governs industrial property across the bloc, which is why a Colombian patent move has to clear regional law, not just national law.
THE PRECEDENT THAT WORKED
Brazil compulsory-licensed Merck's efavirenz in 2007 after price negotiations failed. The price dropped from $1.59 to $0.45 per pill overnight; Merck's threatened US trade retaliation never materialized. The episode rewrote the playbook: credible threat plus actual issuance, not just the threat.
THE TEMPLATE EFFECT
A favorable ruling from a regional court does more than vindicate one country — it lowers the political cost for neighbors. Bolivia, Ecuador, and Peru can now point to binding Andean jurisprudence rather than fight the legal battle from scratch.