基因有關研究工具授予專利之探討：以基因專利之審查為中心

Research on Patents Grant of Gene Related Research Tools: Focus on Review Procedure and Criteria of Gene Patents

陳昭華(Jau-Hwa Chen) ； 鍾鏡湖(Ching-Hu Chung) ； 張乃文(Nei-Wen Chang) ； 林芬瑜(Fen-Yu Lin) ； 鄭耀誠(Yao-Cheng Cheng)

《臺大法學論叢》 39卷1期 (2010/03) Pp. 403-447

https://doi.org/10.6199/NTULJ.2010.39.01.08

摘要

研究工具是科學家於實驗過程中必須使用之工具，尤其是基因有關研究工具，往往在基因治療、基因藥理學、基因診斷技術及其他有關基因之研發扮演極其重要的角色。尤其基因相關材料及技術通常具有「替代性低、泛用性高」之特色，因此基因有關研究工具更經常是後續研發上必備之工具，若研究工具已授與專利，專利權人是否提供他人利用，對該技術之後續研發將有極大的影響。為避免後續研發受到影響可由基因專利之審查基準及基因專利之利用加以探討，前者目的在避免基因專利之授予過於浮濫；後者則使已取得專利者不致因提供他人使用或提供之要求過高，而造成後續研發之障礙。惟因二者涉及之問題層面均很廣，因此在此擬先就前者加以探討，後者將另文探討之。在專利審查方面，本文將特別著重在新穎性、進步性之審查基準及專利申請範圍之探討，由於研究工具常有後續之研發，專利申請人是否可將申請專利範圍擴及將來可能衍生之發明？乃衍生出「延展型申請專利範圍」之問題，就此在專利審查上應採何基準，亦為本文將探討之問題。

關鍵字

基因專利 ； 研究工具 ； 延展權型專利請求範圍 ； 新穎性 ； 進步性 ； 產業利用性

並列摘要

Research tools are necessities for scientists in researches. Especially gene related research tools, which always play important roles in gene treatment, gene diagnosis, pharmacogenomics, and other gene related researches. Gene materials and technologies, which are usually lack of substitution and are widely used in researches, are bases of following innovations. Once these research tools are patented, patent holders can affect following researches by licensing their patents or not. To avoid such influence to innovations, we discuss on the side of review guides of gene patents and on the side of utilization of gene patents. A proper review guide can avoid grant of improper gene patents; and utilization of patents focus on strict license terms that may substantially block further innovations. However there are many issues on both sides, we will discuss criteria of patent and review guides of gene related patents in this article only; utilization of gene patents will be discussed in another paper. On the side of patent review process, we focus on examination guidelines of novelty and non-obviousness, and scope of patent claims. There are usually further research on research tools, where rises a problem that if a applicant can broaden his patent claim to possible future inventions, which is known as reach-through claim? We discuss what criteria we may apply in patent review process.

並列關鍵字

gene patents ； research tools ； reach-through claim ； novelty ； non-obviousness ； utility

參考文獻

Harvard oncomouse-the EPO's latest word

Dastgheib-Vinarov, Sara(2000).A higher nonobviousness standard for gene patents: Protecting biomedical research from the big chill.(Marquette Intellectual Property Law Review).

Grubb, Philip W.(2004).Pharmaceuticals and Biotechnology.Oxford University Press.

"Reach-Through" Patent Claims and Research Tool Patents

What is patent-worthy? 2001 European Molecular Biology Organization Report