專利權具有獨占性，對一國產業發展具有重要影響，為了平衡該權利，各國專利法在給予發明人專利權的同時也加諸某些限制，以我國為例，於專利法第五十七條第一項列舉專利權效力所不及之情形有：(一)為研究、教學或試驗，實施其發明，而無營利行為者。此即所謂之「實驗例外」 (experimental use exception)條款。 實驗例外條款在各國司法實務運作上，最常被引起爭論者向來集中在處方藥市場中專利藥廠與學名藥廠間之競爭議題。因為學名藥廠為了能夠盡早進入市場，不免須在專利期間屆滿前實施原廠專利進行必要之研究、試驗，以符合各國對於藥物上市管理法令之要求。 雖然我國專利法與其他國家一樣也有試驗例外條款，但其中要件嚴格限定為「非營利行為」，從比較法之方式分析，該規定係受美國普通法之影響。美國普通法關於試驗例外係採取嚴格路線，必須行為人之試驗係出於非營利目的，單純追求真相、探求知識理論，或為滿足好奇心，才可主張普通法上之實驗例外，即始係不具營利色彩之公家機關、學術單位從事之試驗，只要背後具有實質的商業目的亦不得主張試驗例外。如此造成要成功適用試驗例外是愈來愈不可能。 國際間對於試驗例外之立法，除美國外，尚存在許多形式值得我國借鏡，以歐洲共同體專利規則草案(Proposal for a Council Regulation on a Community Patent)為例，其區分「私人且非商業性目的之行為」，以及「為試驗目的之行為」，後者要求必須係針對系爭專利技術本身所進行之試驗始非專利權效力所及，若係將該專利技術作為研究工具之用，仍非法之所許。這種區分方法不僅層次分明、無觀念上混淆之虞，判斷上也較具有可預測性。 美國於1984年通過Hatch-Waxman 法案鼓勵學名藥之發展，對於為滿足主管機關關於醫藥品上市要求之試驗，在專利法271(e)(1)明文規定排除在專利權效力之外，即所謂之「Bolar例外」。我國於九十四年二月五日亦增訂藥事法第四十條之二第五項：「新藥專利權不及於藥商申請查驗登記前所進行之研究、教學或試驗」關於Bolar例外之規定。惟或因立法匆促，致法條要件不符合實際狀況，例如限定「申請查驗登記前」之行為，實際上藥廠於提出查驗登記之申請後，往往在主管機關之要求下須進行其他試驗，這些行為均在立法者原欲保護之範圍內，僅因立法用語之不當，造成實務運用之困擾。 筆者最後從法律及商業管理觀點著眼，對國內立法提出下列修法建議，作為本研究之最終成果： 壹、對於專利法第五十七條第一項第一款修法之建議 一、刪除「教學」之行為態樣 二、刪除「而無營利行為」之要件 三、增列關於研究工具之專利則無本條之適用 四、放寬適用範圍為符合主管機關法規要求而實施他人專利亦有實驗例外之適用。 贰、對於藥事法修法之建議 一、刪除「申請查驗登記前」之要件，改以行為目的來限定範圍，即「為通過藥品查驗登記所進行之研究或試驗」，始有本款之適用。 二、明定「物品專利」及「方法專利」均有本條之適用

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.