IMPLEMENTASI LISENSI WAJIB TRIPs AGREEMENT DALAM PRODUK FARMASI DI AMERIKA SERIKAT

Abstract

ABSTRACT
The TRIPS Agreement provides a comprehensive legal framework to protect and
regulate intellectual property rights in the pharmaceutical sector, including in the
United States, which has implemented this agreement into its national law. One
important aspect of implementing the TRIPS Agreement in the pharmaceutical sector is patent protection. The agreement establishes minimum standards regarding the
duration and patent requirements. In this study, a qualitative research method is used
to systematically analyze literature in order to gather and analyze relevant information
regarding compulsory licensing in the TRIPS Agreement. The implementation of the
TRIPS Agreement in the US involves various aspects, including the legal system and
pharmaceutical regulations, the process of implementation in national laws, and the
role of the Food and Drug Administration (FDA) in granting marketing authorization
for drugs while considering patent protection. Article 31 of the TRIPS Agreement, which pertains to compulsory licensing, plays a crucial role in protecting IPRs in the
pharmaceutical sector. This article provides flexibility for TRIPS member countries to
grant the use of patents without the patent holder's consent in certain situations that
protect the public interest.
Keywords: Amerika Serikat, Compulsory License, TRIPs Agreement