人類醫療方法專利之全球規範趨勢與理論基礎分析暨對我國生醫專利政策發展之建議

Abstract

醫療方法是否應准予專利，是專利法上爭議已久的議題，全球至今未有定論。過 去百年來，隨著醫療科技的進步與醫療產業型態的改變，世界各國頻有企圖調整其對 醫療方法專利的態度，且多在促進本國醫療科技發展與保護人民醫藥可接近性的兩種 公共利益間左右為難。針對各國與文獻中所臚列可能支持或反對的理由，亟需有力之 學理基礎加以檢驗。例如：許多文獻多以醫學倫理為理由，反對醫療方法專利；又許 多國家以「醫藥產品可以專利」為理由，支持對醫療方法發明應有同樣的保護，其等 說法均有值得深入探討之處。而於 Mayo Collaborative Services v. Prometheus Laboratories, INC.一案中，美國聯邦最高法院以其不足以轉換自然法則成為可專利 之應用方法，否定該類診斷方法之可專利性，也擴張了准否醫療方法可專利性之論證 層面。

百年來各國立法例與文獻實累積眾多支持與反對醫療方法專利之論點，本研究將 從醫療專業主義，健康權與人類智慧資產可接近性三種理論基礎，分析醫療方法專利 規範之全球趨勢，並深入針砭探討各種論點之真偽，提出對醫療方法專利政策之建議。 台灣專利法禁止醫療方法發明取得專利保護。台灣近年來對於生醫科技的研發，亦投 注大量資源，尤其我國臨床醫療社群具有超群國際之研究水準，在世界各國頻繁反省 醫療方法發明之可專利性的同時，本研究將追蹤 Mayo Collaborative Services v. Prometheus Laboratories, INC.與 the Association for Molecular Pathology v. U.S. Patent & Trademark Office (Myriad) 判決對美國生醫專利政策之影響，並實際訪 談台灣醫療社群對醫療方法專利之看法與評估，提供台灣在生醫專利政策發展的建議。

The patentability of methods of medical treatment is a complex issue in patent law that leads to a lack of consensus among jurisdictions. Due to the advancement of medical technology and the changing forms of medical industry, many countries have been adjusting their position on patenting methods of medical treatment in the past hundred years. For a long time, many countries face conflicting interests of promoting medical science and ensuring the public’s access to medical technology when they evaluate the medical patent policy. As countries around the world are adjusting their attitudes towards the patentability of methods of medical treatment and listing their rationales for and against patenting such methods, it is necessary to examine the reliability and validity of those reasons from solid theoretical base. While some literatures are against patenting such methods due to medical ethics, some support it from the perspective of giving equal patent protection to both medical products and methods. However, both arguments are worth being rethought. In the Mayo Collaborative Services v. Prometheus Laboratories, INC., the U.S. Supreme Court expanded the issue of patenting medical methods to whether some methods are inventive enough to transform laws of nature into an application of laws of nature. As the U.S Supreme Court and the United States Patent and Trademark Office’s (USPTO) are modifying its attitude to the patentability of methods of medical treatment, this research organizes the rationales for and against such patentability and approach the theories of medical professionalism, right to health and the accessibility of human intellectual achievement to examine the reliability and validity of those rationales. Taiwan’s Patent Act has limited the patentability of methods of medical treatment for a long time. Taiwan government has increased its investment to promote biomedical science in recent years. In addition, Taiwanese medical profession is famous for its world- leading clinical skill. As countries frequently modify their positions on patents on methods of medical treatment, this research will provide proposal to Taiwan’s patent policy of methods of medical treatment.