生技專利進步性：美國與臺灣判斷標準之比較研究

Inventive Step in Biotechnology Patents: A Comparative Analysis of U.S. and Taiwanese Legal Standards

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。

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.