人體生物資料庫之合理近用及其專利政策－－以我國之商業運用利益回饋為核心

ON THE FAIR ACCESS AND PATENT POLICY OF HUMAN TISSUE BIOBANKS－FOCUSING ON THE BENEFITSHARING CLAUSE IN TAIWAN

人體生物資料庫是當代生醫研究領域重要之公共資源，基於其所擔負之公益性與社會信任，各國皆強調人體生物資料庫之倫理治理重要性，我國甚至以特別立法詳細規範人體生物資料庫之管理與使用原則。本文特別關注其中生物資料應如何提供研究者之合理近用，以及提供研究者使用後，如何規範研究者將研究成果申請專利及行使專利權之問題，比較英國、日本與我國之制度模式後可發現，我國採行之制度模式與英、日兩國明顯不同，我國所創設之商業運用利益回饋制度，在運作上面臨許多實務問題，終究需要透過跨國制度原理比較，才可能找出適切之解決方法。本文最後對我國之制度運作提出具體建議。

Human tissue biobank has become an important resource for biomedical research. Because of the major public interest concerned, most countries have developed their own ethical governance frameworks. In this study, I focus on the norm of data release in different biobanks. How to adhere to fair access principle? What are the duties for researchers after they use the tissue and data from biobank? Can they apply patent of their research results? Whether the biobank has any power to limit the patent implementation? I compare the principles of UK. Biobank, Biobank Japan, and the law in Taiwan. My findings suggest that Taiwan should ponder the consequences of the benefit-sharing obligation, if Taiwan wants to keep in collaboration with international research community.