材料移轉契約相關問題之研究

The Study of Issues Concerning Material Transfer Agreement

施汝憬(Ju-Ching Shih)

指導教授 ： 黃銘傑

國立臺灣大學/法律學院/法律學研究所/碩士(2009年)

https://doi.org/10.6342/NTU.2009.01385

摘要

在生命科學領域中，研究者為了進行研究發展，經常必須使用其他研究者最新的研發成果，因此，機構之間經常進行研發成果之移轉。研發成果包含有體物及無體物，其中有體物的「材料」(material)係屬研究工具(research tool)，為泛用性高、替代性低之上游技術，而與下游研發具有緊密關聯，因此，「材料移轉」 (material transfer)為研究者進行研發所不可或缺。近年來在美國大學間或大學與私人企業間為了取得材料以進行研發經常使用「材料移轉契約」(MTA)，雖然許多機構有效利用材料移轉契約以合理條件提供材料，然而，材料移轉契約之條款阻礙材料在研究者間廣泛散布之情況似乎變得越來越普遍。基於材料或材料相關專利權對於研發之進行所具有的重要性，並鑑於研究者之間就材料移轉或專利授權無法達成協議或施加不合理的條件之情況逐漸增加，經濟合作暨發展組織(OECD)及各國政府分別發布相關準則，促進材料或材料相關專利權為研究目的以合理條件及時提供。由於材料或材料相關專利權係屬研究工具，故材料所有人或材料相關專利權人一旦拒絕提供材料或拒絕授權，可能阻礙研究者進行後續研發，甚至危害相關市場之競爭秩序。此時，如何兼顧材料所有人或材料相關專利權人權益之保護與研發自由、競爭秩序等公共利益之維護即為一重要課題。
本文首先於第一章提出本文之研究動機及目的，並就研究方法與結構加以說明。第二章探討研發成果中有體物的材料及無體物的發明，在研究者創作或完成時應如何歸屬，先就材料與發明在僱傭關係下之歸屬加以說明，並特別針對大學中研發成果之歸屬進行探討。第三章探討目前在研究者之間移轉材料時廣泛使用的材料移轉契約所造成的問題，並介紹由美國國家衛生院(NIH)所發布供公共及非營利機構使用之「標準生物材料移轉契約」(UBMTA)。第四章介紹OECD及各國政府為促進材料及材料相關專利權之流通所發布之準則。第五章首先說明我國生物科技產業之發展情況，以及材料所有人或材料相關專利權人雖然原則上享有拒絕交易或拒絕授權之自由，但在例外情況下仍得加以限制，並試圖從專利法上的強制授權制度、促進受政府資助的研發成果之流通與競爭法等不同角度，探討何時得例外加以限制，甚至於必要時對其課予強制交易或強制授權之義務。第六章則總結本文藉由比較法方式所得之觀察，以及將其與我國法比較分析後所得之看法，而重申本文各章之結論。

關鍵字

研發成果 ； 材料 ； 研究工具 ； 材料移轉契約 ； 強制授權 ； 介入權 ； 關鍵設施

並列摘要

In the field of biotechnology, it is often necessary for researchers to use the newest research results from other researchers in order to conduct research and development, which leads to the transfer of research results between institutions. Research results include tangible and intangible products. The “material” of tangible product is considered research tool, an upstream technology with high application and low substitution, having a close connection with downstream research and development. Therefore, “material transfer” is indispensible to researchers. In recent years, universities and firms in the U.S. usually use Material Transfer Agreement (MTA) to obtain materials in order to conduct research and development. Many institutions use the MTA effectively to offer materials in reasonable terms and conditions, however, the clauses in MTA preclude the widespread of materials between researchers has become more prevalent.In terms of the significance of materials or material-related patent in conducting research and development, as researchers often can not reach an agreement or impose unreasonable terms and conditions on material transfer and patent license, OECD and the government of several countries have issued guidelines to encourage the timely offer of materials or material-related patent in reasonable terms and conditions for research purposes. Since material or material-related patent is considered research tool, once the owner of material or holder of material-related patent refuses to offer or license, the downstream research and development may be precluded, and the competition in the relevant markets may be endangered. Thus how to protect the right of the owner of material or holder of material-related patent and the public interest of the freedom to conduct research and competition at the same time has become an important issue.
In Chapter 1, I address the motivation and purposes of this study and illustrate the research methods and the organization of this study. In Chapter 2, I discuss as a researcher makes a material or complete an invention, whom the material and the invention should belong to. I illustrate the ownership of material and invention of the employee, and specifically focus on the ownership of result results in university. In Chapter 3, I focus on the problems caused by MTA widely used by researchers to transfer materials, and further introduce the “Uniform Biological Material Transfer Agreement” (UBMTA) issued by NIH for public and nonprofit institutions.In Chapter 4, I introduce the guidelines issued by OECD and the government of several countries to encourage the distribution of material and material-related patent. In Chapter 5, I elaborate on the condition of biotechnological industry in Taiwan. Although the owner of material or holder of material-related patent principally is free to refuse to deal or license, their freedom should be restricted in exceptional conditions. Furthermore, I discuss when their freedom should be restricted and when it is necessary to impose the obligation of compulsory deal or license on the owner of material or the holder of material-related patent from the perspectives of compulsory license system in patent law, the encouragement of the distribution of government-sponsored research result, and competition law. In Chapter 6, I summarize the conclusions of each Chapter.

並列關鍵字

research result ； material ； research tool ； material transfer agreement ； compulsory license ； march-in right ； essential facility

參考文獻

謝銘洋，智慧財產權之基礎理論(第三版)，2001年。

李素華，從公共衛生之觀點論醫藥專利權之保護與限制，國立台灣大學法律學研究所博士論文，2006年。

陳郁信，不同技術移轉類型對契約條款影響之研究，私立中原大學企業管理研究所碩士學位論文，2002年。

鍾詩敏，生物科技研究工具之專利法及競爭法交錯，國立臺灣大學法律學院法律學系碩士論文，2008年。

李素華，智財權人拒絕授權構成優勢地位濫用─歐洲法院確立判斷標準，科技法律透析第16卷第7期，2004年7月。