The Impact of the TRIPS Agreement on Bangladesh in the Fields of Patenting Medicine, Seed and Software

Abstract

This thesis aims to provide a clear legislative roadmap for implementing the TRIPS Agreement in Bangladesh to protect its national interest in the medicine, seed and software industries. Besides examining the need for changes in the existing patent regime of Bangladesh, this study seeks to identify changes necessary in the laws and policies relevant to the medicine, seed and software industries, and the technology transfer from developed countries within the scope of the TRIPS Agreement. This thesis argues that Bangladesh can successfully use the TRIPS Agreement’s flexibilities in implementing its provisions through patent law to protect the medicine and software industries, establish an effective sui generis system to protect the seed industry, harmonizing the legal regimes relevant to these sectors through changes in the patent regime. Using this argument, the thesis identifies the modes of incorporation of flexibilities such as compulsory license, research exception and Bolar provisions, exhaustion of rights and parallel import, and exhaustion of rights and parallel exports, and the provisions for implementing Article 27 of TRIPS through Bangladesh’s patent law in protecting its national interest on medicine. Similarly, this study explores an effective sui generis system for implementation of Article 27.3 (b) of the TRIPS agreement to protect the seed industry of Bangladesh and to preserve farmers’ rights by striking a balance with the commercial interests of multinational corporations (MNCs). The relevant legal and policy regimes of medicine and software have also been examined to identify the necessary changes for harmonizing with the TRIPS agreement. Finally, this thesis investigates the viability of software patenting for Bangladesh in the global context to protect its software industry, and to recommend the changes required in its relevant patent and legal regimes. Based on the argument developed in this thesis, the implementation mechanism of Article 66.2 of TRIPS for the transfer of technology in the fields of medicine, seed and software is delved into and legislative and policy options for adopting TRIPS flexibilities through the patent regime and relevant legal regimes are scrutinized with reference to important communications with the TRIPS Council. The world might undergo some seismic changes with the advent of mega-regional trade agreement like the Trans-Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (TTIP). Consequently, these may change the multilateral trading system and may have a potential to reduce the role of WTO as the mediator of commercial relations amongst nations. In the backdrop of these significant developments, this study highlights the flexibilities of the TRIPS to be exploited through legislative measures to protect the national interest of Bangladesh in the fields of medicine, seed and software. On the one hand, Bangladesh faces pressure from the US and EU to implement the TRIPS’ provisions through its national legislation during the transitional period or before the end of it; and on the other hand, at present Bangladesh is not in a position to decide its role in the negotiation process of the regional trade agreements due to its inadequate legal and policy framework and details of these agreements have been shrouded in secrecy. The TRIPS’ multilateralism allows least-developed countries (LDCs) to have a voice (however limited) over the rules that affect their collective destiny. In contrast, critics contend that a mega-regional agreement like TPP might breed global inconsistencies in standards, provide competitive advantages for certain countries, and increase trade distortions. The role of multilateral trading system cannot be replaced by Mega-regional Agreements (MRAs). This is since there are certain vital issues such as trade facilitation which can only be negotiated at the common platform of WTO. In the same way, WTO must negotiate sensitive issues like export subsidies in agriculture, fishing and support measures. While global trade rules must evolve, countries that are excluded will suffer because MRAs will damage their terms of trade and weaken their trade preference. This reality prompts an effective exploration of the TRIPS’ flexibilities through legislative measures of Bangladesh. Investor-state arbitration claim is a great challenge for an effective implementation of the TRIPS Agreement’s flexibilities through domestic legislation for an LDC like Bangladesh. Recent trend shows companies are increasingly challenging domestic decisions pursuant to bilateral and multilateral agreements that provide protection to foreign investors and permit them to bring the investor - state dispute. In these disputes companies, may not only challenge the patentability standards they disagree with but also exceptions to patent rights i.e. flexibilities even where these exceptions are permissible under TRIPS. This study explored that Bangladesh as an LDC should take sufficient legal measures in protecting its national interest in medicine, seed and software before entering any such bilateral or multilateral agreements. The legal and policy options explored in this thesis, for exploiting the TRIPS’ flexibilities to protect Bangladesh’s medicine, seed and software industries, would help to modify the country’s patent regime and to harmonize the relevant legal regimes within the transitional period. Additionally, LDCs with similar socioeconomic conditions would also benefit from this study.