Hurdles In Compulsory Licensing Of Pharmaceutical Products In India: A Critical Analysis
- IJLLR Journal
- 1 hour ago
- 1 min read
Chhavi Jain, Research Scholar, ILSR, Mangalayatan University, Aligarh
Prof. (Dr.) Rekha Supervisor, ILSR, Mangalayatan University, Aligarh
ABSTRACT
Compulsory licensing is an useful legal mechanism that allows a government to permit a third party to use or manufacture a patented product without the permission of the patentee. In the pharmaceutical sector, compulsory licensing can help in reducing the price of life-saving medicines and improve their availability to patients. The TRIPS Agreement recognizes Compulsory licensing as a legal flexibility, Doha Declaration on TRIPS and Public Health confirmed that WTO Members can use this flexibility to protect public health.
India has incorporated compulsory licensing provisions mainly under Sections 84 to 92A of the Patents Act, 1970. Section 84 allows interested person to apply for a compulsory license when the reasonable requirements of the public are not satisfied, the patented product is not available at a reasonably affordable price or the invention is not worked in India. But the practical use of Compulsory licensing faces many difficulties. These include procedural requirements, the three year waiting period, negotiations with patent holders, lengthy litigation, financial and technical limitations, uncertainty about reasonable prices, international pressure and concerns about pharmaceutical innovation. This paper examines these hurdles and suggests measures to make Compulsory licensing more effective in ensuring access to life-saving medicines in India.
Keywords: Compulsory Licensing, Pharmaceutical Patents, Access to Medicines, Public Health, TRIPS Agreement, Patents Act 1970, India.
