生物科技之專利對於生物科技產業之重要性更是不可言喻。由於生物科技發展之特性，例如：高度不確定性、研究週期長、投資成本高等因素，許多發明人在申請生物科技專利時，都試圖擬定較廣泛的申請專利範圍。「延展性申請專利範圍」（reach-through claims）為基於目前專利說明書揭露之內容來涵蓋所有「未來」可能衍生之產物；或是某特定化合物尚未被確認前，試圖藉由一個上游基礎研究「先驅型發明」之申請專利範圍擴大延展至下游後續發明之商業產品，這非但會箝制技術後續之發展，更可對已存在之先前技術主張侵權，影響範圍極廣。從2004年University of Rochester v. G.D. Searle案 和2010年Ariad v. Eli Lilly案 ，美國聯邦巡迴上訴法院皆認為「延展性申請專利範圍」無效，歸因於專利內容未清楚揭露而不符合美國專利法第112條第1段中所規定的「可據以實施性」和「書面說明要件」。2013年德國聯邦最高法院對同是屬於「延展性申請專利範圍」之Probiodrug案與前述兩件美國相關判例有分歧之見解和判決。有鑑於此，本文以比較法觀點分析國外相關判例及實踐標準，全面性針對生物科技領域「延展性申請專利範圍」問題進行探討，嘗試建立一最適的法律模式，並期許未來可作為我國對其相關法制與解決方案之參考依據。

論文內容著重在以下三個重點: 試驗免責、延展性授權與延展性專利範圍、書面描述要件。首先是35 U.S.C. § 271(e)(1)之Safe Harbor 緣由、案例、Integra v. Merck 一案之過程與後續影響以及271(e)(1)的試驗免責與研究工具的關係, 最後提出建議應限縮試驗免責範圍, 以強制授權或是明定專利法中的試驗免責範圍緩和基礎研究專利範圍過大現象(第二、三章)。 研究工具專利開發者多所採用之延展性授權與延展性專利範圍無非是想多獲得利益, 而研究工具專利對於生物科技發展是相當重要的, 第四章先以四方角色(大藥廠、大學與非營利機構、小藥廠與政府單位)討論研究工具對於本身的利益考量, 並且因試驗免責範圍不明, 延展性授權契約已是普遍存在, 詳細地討論其存在的意義, 並且分析已探討延展性授權金/契約議題文章, 另外對於延展性專利保護範圍, 明確指出哪一些核准專利是延展性保護範圍, 雖然2001年的三方會議已經明確地限制此類專利的核准, 由於Rochester v. G.D. Searle一案, 法院認為Rochester 專利包含延展性保護範圍, 歸因於未揭露出清楚的書面描述要件, 於是進行第五章書面描述要件的討論。 進而較詳細地探討生物機轉的途徑特性、功能性敘述必要性以及書面描述上的困難, 然後進行相關案件探討, 提出自己對於專利文件之書面描述要件的看法, 希望能在生物類研究工具專利保護範圍與書面描述要件中取平衡, 適切地保護研究工具發明。最後並提出總結與建議。 / Over the last twenty years, the biotechnology industry has grown very rapidly, and increased our understanding of incurable diseases. Research tools are playing important role to form the core of the pharmaceutical research, development, and testing. Because this industry is so research tool intensive, numerous problems have arisen stemming from the competing interests of the many players in this field. From the legislative history, the Hatch-Waxman Act embodies the legislative compromise balancing the competing interests of the pioneer pharmaceutical and allied research-based products industries with those of the generic drug industry. And the section 35 U.S.C. § 271(e)(1) statute provides a “safe harbor” from patent infringement based on activities that are reasonably related to obtaining FDA regulatory approval of drug products, but the plain language is fairly ambiguous. In Eli Lilly v. Medtronic, Supreme Court held the safe harbor extends to medical devices, despite the fact that § 271(e)(1) does not refer specifically to medical devices. Recently, for the case of Merck v. Integra, Federal Circuit announced that the term “solely” limits the safe harbor exemption from extending beyond uses of patented inventions that are reasonably related to those specified in § 271(e)(1). But Supreme Court rejected and held that § 271(e)(1) applies to uses of patented inventions that are reasonably related to the development and submission of any information to the FDA. The Court was silent on the potential applications and opened the questions of the safe harbor's application to patented research tools. These problems may be the reason that research tool providers attempt to request royalties such as reach-through royalties for covering the downstream compounds or products. They also try to file the patent application with the reach-through claim for claiming a future invention. However, the use of reach-through royalties is still controversial and causing a decrease in innovation. Patentees attempt to obtain reach-through claims for covering a future invention without actually describing in the written description. The Federal Circuit's holding in Rochester v. G.D. Searle that the Rochester's patents failed the written description requirement, and Rochester should curtail the use of reach-through claims. So far the USPTO has not been uniform in its application of written description requirement. We therefore propose a new test to determine whether, and under which circumstances, functional claiming may satisfy the written description requirement. One should not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. The approach would provide sufficient incentive for pioneering inventions, preserve room for the future, and thus expect to promote progress and to advance the purposes of patent law.