醫藥產業的專利法（二）：專利要件—適格標的【醫法教室】 試閱
Patent Law for the Pharmaceutical Profession (II): Patentability Requirements—Patent-Eligible Subject Matter
本系列文章旨在從醫藥產業的角度切入，探討專利法的各項基本概念，是為「醫藥產業的專利法」。第二篇將著重在專利必須具備的前提要件「適格標的」，亦即希望申請發明專利的標的本身，是否具有獲得保護的資格，這可說是專利要件的第一道，也是最棘手的一道門檻。在適格標的篩選之下，並不是所有創新的事物都能夠獲得專利保護，而哪些技術成果能夠受到保護，背後其實是政策的權衡與選擇。本文將先介紹適格標的兩項主要限制之一，即「發明」的定義，說明我國專利法以及審查基準的規定後，再借鏡美國法案例的發展，進一步釐清醫藥產業的研發成果何時可能非屬發明。接著，本文將介紹適格標的的另一項限制，即「法定不予專利標的」，也將著重在其與醫藥產業的關聯。透過本文的分析，希望能凸顯「專利適格標的」之議題與醫藥產業的發展與運作息息相關。
“Patent Law for the Pharmaceutical Profession” is a series introducing key doctrinal concepts of patent law, with particular focus on the context of the pharmaceutical industry. This second entry delves into one of the patentability requirements known as “eligible subject matter,” namely whether the subject matter of a patent application in and of itself qualifies for patent protection. Establishing eligible subject matter is often the first and trickiest threshold for potential patent owners to clear. As it turns out, not all technical advances or improvements are eligible; what does and does not count as eligible subject matter depends on policy choices about the objectives of patent law and what it should really protect. This article starts by discussing one of the sub-doctrines of eligibility, the definition of “invention” in Taiwanese patent law. Upon establishing the boundaries of that term’s meaning as prescribed in statutory language and administrative guidance, this article will further illustrate how this might apply to the pharmaceutical industry by means of referring to foundational U.S. cases. After that, the focus will shift to the other eligibility sub-doctrine, statutory ineligible subject matter, also with particular concern towards the pharmaceutical industry. This article hopes to show that eligible subject matter is a crucial issue for the pharmaceutical sector to navigate.
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