藥品試驗資料專屬權近期國際發展之趨勢－我國資料專屬權制度及因應國際趨勢應有之調整

Abstract

藥品上市的資料保護，對製藥產業來說，是在專利權以外，政府為保障藥品研發人所提供的另一項重要的智慧財產權，透過提供專屬權保護上市藥品試驗資料，可以提高藥商對於新藥上市投入之意願。藥品試驗資料保護納入國際智慧財產權的保護是源自1994年智慧財產權協定（TRIPs）第39.3條，然該規定並未指出會員國應採取何種方法保護，因而造成開發中與已開發國家意見分歧。2000年以後，美國、歐盟及與其兩大陣營簽署貿易協定的國家，紛紛提供五年到十年專屬期間保護，因此新藥試驗資料專屬權，已然成為國際趨勢。在2007年後，美國以及歐盟在對外雙邊自由貿易條約中，擴大了杜哈宣言適用於藥品的智慧財產權保護，納入資料專屬權。因此，基於藥品權或公共衛生理由，提供資料專屬權的例外與限制的制度已然形成。我國雖於2005年於藥事法第40條之2明訂五年資料專屬的保護期間，但該條並未引進杜哈宣言所提供的例外規定，致藥品試驗資料專屬權保護未能跟進國際發展的趨勢，恐將對於新藥在我國上市形成障礙。本文將分析最近世界各國有關資料專屬權立法之趨勢、以及國際有關資料專屬權權利限制的發展，並檢驗我國資料專屬權制度是否完整及是否符合國際趨勢，從而就資料專屬保護政策的應有走向提出具體建議。

Data exclusivity is another important intellectual property right, besides patent, for pharmaceutical innovation. It provides incentives to innovators for developing new medicines. The protection of pharmaceutical data first came to the international arena in the 1990s, when the TRIPs was signed. However, TRIPs is silent with respect to the protection of pharmaceutical date. And from the mid 1990s until 2000, through trade negotiations, the US and the EU pressured their trade partners into providing 5 to 10 years of data protection, also called ＂exclusivity＂ right. We believe this trend leads to the development of new intellectual property right, i.e., ＂the right to data protection＂. Indeed such a right is a treaty created right but that is not our concern in this paper, we would rather discuss the implication of such a right and the access to medicines. This study demonstrates that these data exclusivity laws, in themselves, are evolving. The most significant impact on the data exclusivity law from the 2001 Doha Declaration and 2003 WTO decision related to the Declaration. Doha Declaration provides for a general exception for the IP protection of pharmaceutical products, including pharmaceutical data. The exception is the curx of Doha Dec. After 2007, the exceptions for data exclusivity can be seen almost in every free trade agreement. Such an evolution not only provides an opportunity to examine the whole legal framework of the data protection legal system and the standards of protection but also the exceptions of protections. While the Doha Declaration and the 2003 decision were a welcome development, in the national level, in Taiwan, things seem quite odd or different. In particular, Taiwan has amended Article 40-2 of the Pharmaceutical Act to go along with this data exclusivity trend in 2005. However, instead of aligning the Taiwanese law with the international law, which provides for an exception of pharmaceutical data, the amendment seems to do the opposite. When reading the black letter of the law the language of article 40-2 seems vague in that this article does not define the scope of data exclusivity. More significantly, no exception for access to medicine in carved in the amendment. No doubt this major pitfall of the amendment renders it at odds with the right to access to medicine in Taiwan. Accordingly this paper will recommend to policy makers to rethink the amendment. First, this article begins by analyzing the significance of protecting data. Second it discusses State`s obligation of protecting data under the TRIPs. Third, it discusses the data exclusivity law, and it is scope and exception under TRIPs/ international law and possibly under the Taiwanese law.