癌症基因治療發明之保護－以專利適格性為中心

Abstract

本文擬討論癌症基因治療相關的發明是否具有專利適格性，及應採取何種法律保護方式。我國主管機關就基因治療的相關方法專利與基因序列專利方面，與美國法院判決有不同的結果。如從專利適格性專利法之立法意旨在於促進創新來看，本文認為只要具有知識擴散的效果，便具有專利適格性。至於因科技發展所帶來關於道德倫理的考量，應由立法者另行立法規範，或由法院更加積極主動適用專利法第24條，輔以其他專利要件的把關，能比曖昧不明的適格性要件更能達到規範的效果。 專利和營業秘密可互相搭配，促進對發明人的保護。賦予癌症基因治療發明專利，除作為刺激研發的誘因外，並可透過授權和技術移轉機制，較能控制該技術的實施者的水準，降低社會承受的風險，故建議可修法放寬對癌症基因治療方法的專利適格，並增訂醫療行為豁免的規定，使醫療人員的醫療行為排除在專利權效力之外。 就癌症病患的權益而言，基因治療或基因檢測均重視諮商機制的落實，並保障患者尋求第二意見的機會。如專利權人以其專利限制了病患尋求第二意見的可能時，除由醫藥主管機關以行政規範禁止外，宜於專利法一併規範此種權利濫用，確保病患的權益。

This theis is about the patent eligibility and the proper protection method of cancer gene therapy. Since the authorities of Taiwan and the U.S. have different explanations of patent law with regard to method patents and gene sequences patents, the discution begins from the purpose of patent law to promote the innovation. Hence this thesis argues that when diffusion effect of knowledge exists, the subject in issue should be patent eligible. Concerns of moral and ethical aspects with the progress of technology should be considered by legislators who propose regulations or by the courts who can apply article 24 of Patent Law more actively. When compared with the vagueness of eligibility, it is better to solve these concerns by other patent requirements. Besides, not only patent but also trade secrets could protect inventions. When cancer gene therapy patents are conferred, economic incentives are produced. By technology authorization and transfer, the patent holder could ensure the skill and knowledge level of conductors of such method, which reduces social cost. So this thesis suggests that patent eligibility of cancer gene therapy and exemptions of medical use should be enacted. Finally, for patients’ rights and benefits, the consult system should be provided to ensure the access to second opinions. If the patent holders use their patents to prevent patients from second opinions, legal and administratine approach might also be taken.