美國專利法上書面說明要件之探討——由產業及技術領域區別適用觀點切入

Abstract

書面說明要件於Regents Of The University of California v. Eli Lilly & Co案中，由於在生技領域適用較嚴格之揭露要求，而引發關於書面說明要件可否作為一獨立於可據以實施以外之實質揭露要件、其功能和範圍，以及其要求之揭露程度之爭議。鑒於書面揭露是否充分於美國專利申請以及美國專利訴訟中為重視之課題，並且於Ariad Pharms., Inc. v. Eli Lilly & Co., Inc.全院聯席審理案後，仍有評論認為未提供明確之判斷標準。 本文擬由書面說明要件於產業以及技術領域間區別適用之觀點切入，並且進一步分析書面說明要件與顯而易知性之間的關聯；此外，輔以Ariad Pharms., Inc. v. Eli Lilly & Co., Inc.全院聯席審理案之後續美國相關案例發展，以及我國實務界人士對於書面說明要件之見解，以為檢視、探討書面說明要件之揭露程度。 本文認為，於書面說明要件於產業以及技術領域間區別其要求之揭露程度，法院實著眼於技術本質之可預測性，以及所屬技術領域具有通常知識者之知識程度以及技術水準。再者，案例發展趨勢顯示可隨產業技術發展而適度調整書面揭露之程度，因此，本文建議應區分系爭發明涉及所屬技術領域內習知技術與否，以為類型化書面揭露之要求強度，提供一可行且明確之判斷邏輯。

The Federal Circuit’s written description decision in Regents of the University of California v. Eli Lilly & Co. established uniquely rigorous doctrine for the description of biotechnological subject matter. This description doctrine gave rise to disputes over whether a written description requirement separate from an enablement, the function and scope of the written description, and the level of this requirement. Due to patent application and some cases are concerning about whether the specification provide adequate support or not; in addition, after an en banc decision of Ariad Pharms., Inc. v. Eli Lilly & Co., Inc., some have argue that majority fail to tether written description requirement to a workable legal standard. This study in view of the Federal Circuit has treat written description requirement from different industry and technology fields differently, and analyze the relationship between written description and non-obvious. Furthermore, by providing discussion regarding cases follow-up the en banc decision, and domestic practitioners’ understanding in order to examine the level of disclosure. On the basis of varying level of predictability, and the knowledge and abilities of the ordinary skill in the art, the Federal Circuit is applying industry-specific and technology-specific results. Besides, in more recent decisions, the Federal Circuit adjusts the level of requirement depending on the maturity of the technology. Thus, this study suggests categorize the level of requirement considering whether the technology were known in the art or not, so as to offering an explicit and feasible standard.