人體基因是否可為專利保護標的: 由Myriad案為起點

Abstract

專利制度藉由賦予研發者或投資者排他權，以達鼓勵研發之目的。此排他權可使投資者與發明者回收研究資金成本，甚至得到額外的報酬。過去三十年來，基因相關專利急速的增加，代表基因關聯發明的重要性日益增加，但也因基因專利排他的特性而對現有的科學研究產生了不良影響。例如有些基因研究因他方的專利之阻礙，無法順利進行研究。這通常涉及支付相關專利授權費用而導致基因研究的時間延長與成本提高。再從病人的角度言，當僅有專利權人可實施該技術時，可能剝奪病人獲得第二意見(second opinion)的權利。所謂的第二意見係指為了確定先前診斷報告準確性而去尋求其他意見。這些問題與專利制度鼓勵創新的本質產生了衝突，也是近期Myriad案之所以受到廣泛關注的原因之一。本案的主要爭點為人體基因是否可為專利保護標的，原告主要為受到基因研究專利所帶來的負面影響的研究機構與正接受臨床治療的病人，他們透過主張人體基因係非專利適格標的而使基因專利無效。本案判決代表了美國聯邦上訴法院對基因專利的最新見解，突顯出Myriad案的重要性。本論文之研究重點是分析美國以往專利適格標的之重要案件，並與最新Myriad案比較，希望藉此了解法院判斷專利適格標的之標準，哪些是一致的，而哪些是有改變的。最後，針對此判決對研究機構、病人、發明人與投資者所造成的影響，本論文將提出可行的解決方案。

The drastic increase of patent filing and applications on genes for past thirty years has shown the increased importance gene related inventions. One primary motivation of setting up the patent system is to provide an incentive to invent by insuring the investors and prospect inventors a possible return or gain of the research cost. But this exclusivity offered by gene patents has produced some adverse consequences such as the inaccessibility to genes for research, increase cost in diagnostic cost or deprive the opportunity for second opinion for patients. These are some reasons why the issue on the patentability of human genes has attracted more concern since the instigation of the Myriad case. The plaintiffs of this case are mainly research groups and patients that have “negatively” affected by the gene patent and therefore, hope to invalidate the patent by challenging the gene sequence not a patentable subject matter. The uniqueness and the complexity of gene patents are related to the unidentified functions in genes or broad wordings used in claims. As a result, granting gene patents may stifle the future genetic research and development of diagnostic test such as parallel sequencing and whole genome sequencing. In addition, lack of clear standards when determining patentable subject matter is also another sophisticated issue that needs to be solved when granting gene patents. Thus, the major focus of this thesis is to analyze different standards used in the precedent cases in U.S. and compare these standards with the standards used in the Myriad case. Thus, hope to understand Federal Court’s recent view on this issue. Furthermore, discuss the implications of these new holdings on the public, investors and prospect inventors. Lastly, with different problems arise from the granting of gene patents and propose some possible solutions to help solving the current and future situation on gene patents.