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Comment: compulsory licensing of patented pharmaceutical inventions: evaluating the options
1Duke University School of Law, Durham, NC, USA.
Summary
Developing countries can collaborate on compulsory licensing for essential medicines, balancing access with innovation incentives. Recent public health measures are legal under WTO law, and retaliation is unlawful.
Area of Science:
- Intellectual Property Law
- International Trade Law
- Global Health Policy
Background:
- The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) governs pharmaceutical patents.
- The 2003 waiver and subsequent amendments to Article 31 facilitate compulsory licensing for public health needs in developing nations.
- Access to essential medicines remains a critical global health challenge, particularly for low-income countries.
Purpose of the Study:
- To trace the legislative history of compulsory licensing for pharmaceuticals under the TRIPS Agreement.
- To critically evaluate recent controversial applications of compulsory licensing mechanisms.
- To explore collaborative strategies for developing countries to access medicines while preserving innovation incentives.
Main Methods:
- Legislative history analysis of the TRIPS Agreement and related protocols.
- Review and critical assessment of recent compulsory licensing cases.
- Examination of World Trade Organization (WTO) law and jurisprudence.
Main Results:
- Recent compulsory licensing measures for public health in developing countries are legally defensible under international trade law.
- Collaborative approaches can mitigate negative social costs associated with compulsory licensing, such as reduced innovation.
- Unilateral trade retaliation by developed countries against such measures is illegal under WTO foundational law.
Conclusions:
- Compulsory licensing, when used judiciously, is a legitimate tool for enhancing access to essential medicines.
- International cooperation and adherence to WTO principles are crucial for balancing intellectual property rights with public health.
- Developing countries have legal recourse against protectionist trade measures that impede access to medicines.
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