「自然法則」運用與個人化醫療診斷方法專利適格性判斷－從美國Mayo v. Prometheus案判決談起

Application of ＂Laws of Nature＂ and the Patent Eligibility of Personalized Medicine Treatment Method-In the Wake of Mayo v. Prometheus Decision

陳龍昇(Lung-Sheng Chen)

《高大法學論叢》 11卷1期 (2015/09) Pp. 163-227+229-234

摘要

本文旨在研究美國聯邦最高法院Mayo v. Prometheus案判決及該案涉及的「自然法則」之運用與個人化醫療方法發明專利適格問題。製程或方法發明得否獲准專利，其判準為何，國內外司法實務迭有爭論。其中，個人化醫療診斷方法因多涉及「自然法則」的運用，其專利適格即常遭質疑。美國聯邦最高法院於Mayo案判決中，即以該案系爭診斷方法（依各病患實際反應以決定該病患施用特定針劑的適當劑量）僅係重申「自然法則」，認定該發明不具專利適格。然醫療診斷方法多與自然法則或自然現象（如人體生理反應）有關，應如何判斷該醫療診斷方法僅係自然法則而不具專利適格，即待思索。此外，關於方法或製程發明的專利適格，美國聯邦巡迴上訴法院雖曾提出「機器或轉換測試法」作為判準，但該標準於Mayo案判決後是否將繼續為司法實務採用，不無疑問，有待研究。又，醫療診斷方法發明得否予以專利，又常與病患權益及國民健康攸關，不論於個案判斷或整體政策決斷上，均應審慎考量。我國專利法現雖不許醫療診斷方法取得專利，惟未來應否開放以鼓勵生醫產業創新，亦值思索。美國實務及各界評論，即得供我國借鏡。

關鍵字

醫療診斷方法 ； 個人化醫療 ； 專利適格性 ； 自然法則 ； 機器或轉換測試法

並列摘要

This article addresses issues presented in the U.S. Supreme Court's Mayo v. Prometheus decision- whether an invention applying laws of nature and a personalized medical treatment process can be patented. The question whether a process/method invention is patentable has been long disputed. In particular, many have argued that personalized medical treatment process inventions should not be patented because those inventions claim laws of nature. In Mayo, the Supreme Court held that a personalized medicine dosing process invention is patent ineligible, finding that this invention is nothing more than an application of laws of nature. How to determine whether a medical treatment process is a patent ineligible application of laws of nature or a patentable subject matter remains controversial, however. In addition, to allow an inventor to patent a medical treatment process will inevitably implicates patients' rights and public health. How to set forth a standard to determine the patentability of medical treatment inventions becomes critical not only for the adjudicator in a single dispute but also for the policy maker. Taiwan's patent law currently prohibits a medical treatment process patent. Nonetheless, it deserves a careful consideration on whether to allow such patents in Taiwan in order to encourage the biotechnology industry's innovation. This article will look into the lessons from American experiences and figure out a feasible/possible approach to improving Taiwan's current patent law.

並列關鍵字

Diagnostic Process ； Personalized Medicine ； Mayo v. Prometheus ； Patent Eligibility ； Laws of Nature ； Machine or Transformation test

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