出刊年月/Date of Publishing

2026.03

所屬卷期/Vol. & No.   第56卷第1期 Vol. 56, No. 1

類型/Type                研究論文 Research Article

篇名/Title
Inventive Step in Biotechnology Patents: A Comparative Analysis of U.S. and Taiwanese Legal Standards
生技專利進步性：美國與臺灣判斷標準之比較研究

作者/Author
陳龍昇 Lung-Sheng Chen

頁碼/Pagination
pp. 1-68

摘要
本文比較美國與臺灣專利進步性 (非顯而易見性) 判斷標準，探討對生技發明可專利性的影響。美國於2007年KSR案後，採以「合理預期成功」為基礎的「顯而易試」彈性標準，臺灣則強調「組合動機」與「非預期結果」之舉證。美國彈性判準有助促進生技醫藥創新，臺灣嚴格標準雖可維護專利品質，但卻提高專利保護難度。本文借鏡美國與比較臺灣運作，分析兩國進步性要件判準異同，觀察其對研發之影響，思考提出折衷判斷標準──調整「合理成功預期」適用範圍，納入更廣泛的輔助因素供我國參酌，以達在鼓勵生技創新之際，亦可兼顧專利品質維持之目的。

Abstract
This article examines evolving frameworks for assessing the inventive step (nonobviousness) patentability requirement in the United States and Taiwan, with a focus on the biotech sector. In the U.S., the 2007 KSR v. Teleflex decision shifted the grounds to a flexible “obvious to try” standard, grounded in a “reasonable expectation of success.” Conversely, Taiwan’s approach prioritizes a “motivation to combine” and “unexpected effects,” requiring robust technical evidence. The U.S.’s dynamic framework fosters biopharma innovation, while Taiwan’s rigorous standard ensures patent integrity, though it raises the bar to patentability. Through a detailed comparison of U.S. case law and Taiwanese practices, this analysis highlights the tension between promoting pioneering research and upholding stringent patent criteria. It proposes a harmonized global approach, blending the U.S.’s adaptability with Taiwan’s precision, refining the “reasonable expectation” standard and incorporating broader secondary considerations to spur biotechnology advancements while preserving patent quality.

關鍵字/Key Word
KSR、教示、建議與動機、顯而易試、非顯而易見性／進步性、輔助因素／次要考量
KSR, teaching suggestion and motivation (TSM), obvious to try, nonobviousness/inventive step, secondary consideration

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DOI
https://doi.org/10.7015/JEAS.202603_56(1).0001

學門分類/Subject
法學 Law