Compulsory licensing is a flexibility built into international intellectual property law that lets a state override a patent holder's exclusive rights when the public interest demands it. The mechanism is most prominently codified in Article 31 of the TRIPS Agreement (1994), which permits WTO members to authorize "other use without authorization of the right holder," subject to conditions: prior negotiation with the patent owner (waivable in emergencies), adequate remuneration, non-exclusivity, and judicial review.
The 2001 Doha Declaration on the TRIPS Agreement and Public Health clarified that members have the right to grant compulsory licenses and to determine the grounds on which they are granted, explicitly affirming use in public health crises such as HIV/AIDS, tuberculosis, and malaria. A subsequent 2003 WTO decision, later incorporated as Article 31bis (entered into force 2017), created a pathway for countries lacking domestic manufacturing capacity to import generics produced under compulsory license abroad.
Compulsory licensing is most associated with pharmaceuticals but legally applies to any patented technology, including green tech and agricultural inputs. Typical triggers include:
- Public health emergencies (e.g., epidemic response)
- Anti-competitive practices by the patent holder
- Government use for non-commercial public purposes
- Failure to work the patent locally (in some jurisdictions)
Critics from the originator pharmaceutical industry argue that broad use erodes R&D incentives, while access-to-medicines advocates contend the tool is underused due to diplomatic and trade pressure. The United States has at times placed countries issuing compulsory licenses on its Special 301 Watch List, and bilateral free trade agreements (so-called "TRIPS-plus" provisions) frequently narrow the grounds available.
For MUN delegates and researchers, compulsory licensing sits at the intersection of WTO law, WHO health policy, and WIPO-administered IP norms, making it a recurring topic in committees on global health, development, and trade.
Example
In 2012, India's patent office issued a compulsory license to generic manufacturer Natco Pharma to produce a low-cost version of Bayer's cancer drug Nexavar (sorafenib), citing unaffordable pricing and insufficient local supply.
Frequently asked questions
Yes. Article 31 of the TRIPS Agreement explicitly permits it, subject to procedural conditions including adequate remuneration to the patent holder and, in most cases, prior attempts to negotiate a voluntary license.
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