THE COMPARATIVE STUDIES OF COMPULSORY LICENSE REGULATION FOR PHARMACEUTICAL PRODUCT BETWEEN INDONESIA AND INDIA

Abstract

invention. The protection given by the state is the exclusive right. However, the exlusive right leads the patent holder to the monopoly right which means that not all people can utilize the invention because it needs the patent holder consent. For that reason, Indonesia and India which are the states member of the WTO and also the developing countries used the flexibility of the patent. The flexibility of patent is the kind of option to except and limit the right granted by the patent protection (exclusive right). In the practice, Indonesia and India are commonly used flexibility of patent through the compulsory license to avoid monopoly right. Compulsory license is the kind of license to use the invention without patent holder consent which is granted with a certain procedure. However, there is an exception to give the compulsory license directly such as for the pharmaceutical product because it is related to the public interest. Furthermore, the TRIPs Agreement has already permitted the provision. The problems of this research are focused on (1) the similarities and differences between Indonesia and India’s regulation regarding the compulsory license of pharmaceutical product especially in the matter HIV/AIDS medicines; and (2) legal implication of regulation regarding compulsory license in Indonesia and India especially in the matter HIV/AIDS medicine. The results of the study show that there are similarities between Indonesia and India as the WTO members. In this matter, they must adopt the same legal basis to implement the compulsory license based on TRIPs Agreement. In addition, they require the requirement to ask to compulsory license are based on the request during the 3 years after granting patent protection. Another similarities are related to the purpose of the compulsory license based on the public interest. In addition, both countries adopted same legal certainty for the pharmaceutical product granted directly without any requirement procedure. However, there are still differences among the members especially Indonesia and India. The differences regarding compulsory license for pharmaceutical product on patent are related to the subject grants the compulsory license. In Indonesia, Ministry through Minister Decision is one of the subjects who has an ability to grant the compulsory license. In another side, India has regulated the subject who is able to grant the compulsory license which is the Controller. In the practice, the compulsory license for pharmaceutical product in Indonesia has not yet been implemented. However, India has already implemented the compulsory license for generic production. Furthermore, the regulation on compulsory license for pharmaceutical product in patent protection gives the legal implication for Indonesia and India. The first legal implication is in the form of legal certainty for compulsory license in Indonesia and India. The second legal implication is related to the protection for the parties involved in compulsory license. The last implication is regarding the form of utilization of compulsory license in Indonesia and India.