Issues of Patent in Biopharmaceuticals

• Main Authors: Hung-Li Chen, 陳鴻利
• Other Authors: Kuo-Hua Chang
• Format: Others
• Language: zh-TW
• Published: 2011
• Online Access: http://ndltd.ncl.edu.tw/handle/58236967195059996533

碩士 === 國立雲林科技大學 === 科技法律研究所 === 99 === In the biopharmaceutical industry, especially for the drug produce by biotechnology, the patent system plays a crucial role. Not only the pharmaceutical companies’ competitiveness determined by the value of patents owned by pharmaceutical companies , but also relevant po licies of patent system directly affect guides of pharmaceutical comp anies. Since WTO (World Trade Organization) was established in 1995, all members who join are restricted to its multilateral trade agreem ent and have a direct impact on the domestic legal norms and policies of the members, especially by the trade agreement 「Agreement on Trade-related Intellectual Property Rights」（TRIPS）.However, No one had envisioned that the protection of pharmaceutical products under patent would incur global public health crises while formulating TRIPS. Although the main purpose of TRIPS is to protect the right of patent for patentee and provide limited exceptions to the exclusive rights at same time, but there are too many provisions of TRIPS in the fuzzy space. The fuzzy space leaving a number of internationalpatents for special provisions such as Article 31 of TRIPS （compulsory licensing）、article 39, paragraph 3（confidential obligations）、article 30（limited exceptions）, etc. Issue from the fuzzy space of these articles including experimental use exception、data exclusivity、compulsory license、parallel import、conscience clause as transitional provision, and the patent grant aystem.