The impact of international legal framework - The recognition of second medical use

• Main Authors: Shanmugaiah, Kamini, Zainol, Zinatul Ashiqin
• Format: Conference or Workshop Item
• Language: English
• Published: 2014
• Subjects: RS Pharmacy and materia medica
• Online Access: http://repo.uum.edu.my/13166/1/83.pdf; http://repo.uum.edu.my/13166/; http://www.uumicg2014.com/

This paper analyses the impact of international legal framework on the pharmaceutical patent and second medical use.The provisions under the Trade Related Aspects of Intellectual Property Rights(“TRIPS”) Agreement generally focuses on the pharmaceutical patent in relation to the access to medicines and not specifically addressing issues on the medical innovation involving first and second medical use.Although Doha Declaration on the “TRIPS” Agreement and Public Health equally recognizes on the importance of medical innovation, the issue on medical innovation is not further analysed in relation to the second medical use. The provisions of the “TRIPS” Agreement open a flexible option to the member countries to exclude method of medical treatment from patentability. Although excluding method of medical treatment seems to be as a flexible option to countries to prevent evergreening patents, it further adds to the challenge of overlooking the importance of the second medical use type of patents.The author will also analyse another important international legal framework on the European Patent Convention (EPC) which emphasizes on the new uses of known substances.However, the Article 54(5) of the EPC only impliedly recognizes first medical uses.The question on whether EPC recognizes second medical use is still ambiguous in the international legal framework not with standing its importance in the pharmaceutical and medical field.