University of Macau / Faculty of Law

本論文以最高法院涉專利侵權民事訴訟判決為分析對象，而進行類型化的研究。本論文發現此類判決可分為「法律解釋爭議」、「專利爭議中鑑定報告證據力的認定爭議」、「損害賠償請求權或其他請求權基礎之爭議」、以及「特殊問題」等四個類型。而根據此類型化方式，我們可以系統化看待最高法院的判決對專利法發展的影響和貢獻。 / In this thesis, several patent infringement decisions of the Highest Court were analyzed for grouping. The decisions were further grouped by the legal issues therein into four types, “question of law,” “evidence of patent infringement analysis,” “cause of action,” and “special issue.” Through the grouping, the effects and contributations of the Highest Court over the patent law can be systematically studied.

隨著近世產業、科技不斷地變革、精進，使得目前的勞資關係已與工業革命之初，有著相當大的變動，不再是勞動者自保或者以社會國理念出發的勞動法規所能完全涵蓋。專業與創新的知識已是現代企業生存與發展的關鍵，有了這個認知，使得「智慧財產權」的概念更加光芒萬丈，因而促使智慧財產的規範日益複雜，觀諸近世文獻資料，普遍被討論地泰半是有關智慧財產權的外部關係或對第三人侵權的探討，反之，對於智慧財產權內部（勞、資）權益歸屬的討論，則較不被重視；況且觀察經濟權力強弱消長，勞動者置於智慧財產權的領域之中，地位反愈顯得薄弱。 因此，勞動者在智慧財產權中權益之歸屬，此問題跨越民法、智慧財產權相關立法及勞動法交錯的領域，冀望藉此探討，能有助此問題之解決於萬一，並且非一昧地賦予勞動者權利，而苛課企業主責任，希望能夠跳脫出傳統的勞資角力的刻板印象，發展出一個嶄新的架構與視野，具體而微地重塑勞動關係。 本研究旨在探討勞動者智慧財產權歸屬的問題，由兩大問題出發，在研究脈絡上，首先處理的議題乃是，就智慧財產權法的架構中，找尋國際上及國內立法相近似的法制，以之作為本文研究的對象。再者，處理的議題是勞動者在智慧財產權法的權益為何，以上述該法制為基礎，分別加以探討勞動者於智慧財產權法中所擁有的權利、應負擔的義務及權利的限制。再次，進一步探討，從企業契約的規範中，是否能夠兼顧勞動者之智慧財產權權益及企業之利益，以企業契約為討論的基礎，逐一對其加以分析之。 本研究從第二章至第四章，即以上述三大方向加以構築。第二章的重心是藉由國際條約及國內立法的陳述，點出智慧財產權在現今法律秩序中所佔有的一席之地，以之作為「勞動者智慧財產權歸屬」研究之引子。第二章在通篇論文中可作為問題思考之基石，同時從文獻中分別闡述各智慧財產權的類型及其特性為何。於第三章論述勞動者立於智慧財產權法域中的地位如何，推其具有可研究性，以「勞動者」作為智慧財產權歸屬之研究對象。第三章係對研究對象之權益範圍加以釐清並分類探討。於第四章乃就實務上企業實際運作加以探討，就契約形式及實質內容分別論述分析。而第四章所討論者，亦是在觀察現實的運作與法律規範的落差。第五章為本文研究之結論及建議。

智慧財產權保護的利益包括道德利益，社會利益與經濟利益，然而三種利益彼此可能互相衝突，醫藥品專利便是其中一種常見案例，若醫藥品在專利權的保護下，價格與可得性皆容易成為取得必需醫藥品的高門檻。關於如何使病人取得所需的專利藥物，「強制授權」制度被認為是一種可使用的彈性手段。 本篇論文旨在分析專利強制授權制度對藥物可近性可能造成之影響。第二章從國際公約中對於強制授權的規範切入，說明目前國際上強制授權的運作條件；第三章說明強制授權的功能，其在專利權制度中可達到之經濟與公共利益的調和與平衡，對於反對者所認為「強制授權造成的經濟傷害」論點予以駁斥，並說明強制授權造成專利權人的經濟損失並不如反對者宣稱的巨大，反而因強制授權制度的存在，能有效減少濫用權利的誘因；第四章則著重分析強制授權對公共衛生政策的影響，對於開發中國家而言，建立起穩定的強制授權制度，有助於他們跨過初始的專利障礙，開始扶植本國藥廠並建立本國的藥物供應鏈，以達到獲取藥物的自主性；第五章以美國、加拿大、印度等國實施強制授權的案例，闡述強制授權在已開發國家與開發中國家的實施和效果，強調無論是以強制授權或是其他更為強勢的手段，在專利的壟斷性下，為社會利益保留一項具有彈性與最後手段的措施之必要性；第六章則就我國的專利法修法沿革分析，提出關於現行專利法中強制授權的彈性不足會造成的影響及修改的方向。 / The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients. This research aims to analyze the possible impact of patent compulsory license system on accessibility of medicines. In the second chapter, I points out the rule of operation of compulsory license from international conventions, introducing the current international conditions. Chapter 3 describes the function of compulsory license, that the reconciliation and balance between the economic and public interests can be achieved in the patent system. The opponents consider that economic harm would be caused by compulsory license. However, the actual economic loss of the patent owner is not as great as the opponents describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system. Chapter 4 focuses on how compulsory license system affects public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines. Chapter 5 illustrates the attitude toward compulsory license in developed and developing countries. The chapters introduce means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system. Chapter 6 analyzes the history of Taiwan's patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.

懲罰性賠償金為英美法傳統下之制度，其目的在於以超越實際損害數額之賠償金，制裁主觀惡性程度特別重大之侵權人，與一般用以填補損害之補償性賠償金有本質上之差異。昔日多適用於被害人尊嚴遭嚴重侵犯之案件，然隨現代經濟社會之發展，亦漸用於處罰公司法人、制裁經濟犯罪。 我國侵權行為法主要繼受德國之體系，以損害填補為原則，故僅於特定領域之立法中承認懲罰性賠償金制度。現行專利法採取懲罰性賠償金之立法例，而目前經濟部之修法草案則擬廢除。 本研究首先介紹美國法發展趨勢、實務重要案例與晚近之專利改革法案，歸納其趨勢為「嚴格限制故意侵權之構成、提高專利權人舉證責任、限縮懲罰性賠償金之適用範圍」；其次，以實證方式分析台灣智慧財產法院歷年相關之判決結果，認為實務運作有「大多數請求懲罰性賠償金之案例，連侵權責任都尚未構成，有請求浮濫、逼迫被告和解之嫌」、「法院認定侵權人故意，實質上往往僅論及侵權人『知悉系爭專利存在』即可，相較於現行法標準實過於寬鬆」；最後，綜合美國法發展趨勢、我國實務情形、懲罰性賠償金功能論與法律經濟分析觀點，認為我國尚不宜廢除專利侵權懲罰性賠償金制度，惟應將其限縮適用於「搭便車」與「專利有效性毋需再確認」之故意侵權情形，以降低社會研發成本、賦與從事研發者挑戰垃圾專利之機會，方切合專利法促進研發之本旨。 / Punitive damages, a traditional system under the common law, aims to sanction those infringers having substantially subjective malice by awarding enhanced damages beyond the actual damages. It is naturally different from compensatory damages. Punitive damages were originally used to dealing with serious violations of the victims’ dignity of the cases. With the development of economic society, this system was gradually used to punishing corporations and sanctioning economic crimes. Since Taiwanese tort laws are mainly inherited from German laws, which only permit plaintiffs claiming for compensatory damages. Punitive damages were only adopted in several specific kinds of tort laws, as in the patent law. However, the provision of punitive damages was revoked in the current patent reform act drafted by Ministry of Economic Affairs. This study starts out by introducing the trend of American law, the essential practical cases, and the recent patent reform acts. It concludes the trend to have the following three characteristics: 1. Strictly limit the constitution of willful infringement; 2. Increase patentee’s burden of proof; and 3. Restrict the scope of awarding punitive damages. The study then empirically analyzes the related judgments of Taiwan Intellectual Property Count over the years. It finds that in majority of the cases claiming punitive damages, most plaintiffs can even not to prove that defendants have infringed their patents, yet force defendants to settle. Also, the court in Taiwan usually award patentees punitive damages loosely only if they can prove that infringers had known the existence of the patent . This phenomenon makes the standard in practice not strict as the standard in law. Lastly, this study sums up the aspects from the development trend of American patent law, current practice in Taiwan, the theory of punitive damages function, and economic analysis of law, and finds that it would be inappropriate to revoke the provision of punitive damages in patent infringement cases. This study suggests that punitive damages should be awarded only in two types of willful infringement: 1. when the defendant is a “free rider, or 2. when the validity of the patent need not be challenged anymore. This way, it may lower the cost of research and development, give developers more chance to challenge junk patents, and finally reach the purpose of patent law – encourage innovation.

緒 言：研究中共專利法，了解中共如何調和社會主義與資本主義的矛盾，以印證其 經濟改革前途。 第一章：說明共產主義法律思想，中共經改後法律思想的變化、與資本主義法律思想 的基本差異。 第二章：說明中共專利法沿革、專利法在中共法制體系中的定位、專利制度概況。 第三章：說明中共專利法對發明之定義，以及禁止專利之發明的項目。( 並和我國專 利法之規定比較 ) 第四章：說明中共專利法在發明之專利要件，新穎性、創造性、實用性等規。( 著重 在新穎性所採取之立法原則 ) 第五章：說明中共專利法在專利權歸屬上的規定，包括職務發明之廣泛，以及參加巴 黎公約在專利法上的影響。 第六章：說明中共專利法之申請與審查。尤其著重其早期公開、延遲審查制度。( 中 共所採為極新的制度有相當特色 )。 第七章：說明中共專利法為推廣應用的目標，所做的特別規定。著重其特殊的計劃實 施規定。 第八章：說明中共專利法對發明專利權的期限、無效、及民、刑事的保護規定。( 參 攷中共刑法的有關規定 ) 第九章：簡要交待合併在中共專利尖有關新型、新式樣 (中共法稱為實用新型及外觀 設計) 的不同規定。 結 論：由前述各章發現的問題，分析中共調和社會主義與資本主義的問題所在。

制定專利法的本意，不僅是給予發明人在一定期限內擁有一定限度的獨占權，以鼓勵發明人揭露新穎發明，亦在於提升科技發展、提高經濟成長，使社會大眾可從既有發明中再進行卓越科技研發，以節省社會研發成本。專利法賦予專利權人禁止任何未經授權之他人製造、使用、販賣、為販賣之要約，以及為上述目的進口該專利權技術之排他權利。但為達促進產業進步的目的，各國專利法並增列研究、實驗的免責條款(experimental use exception)來平衡專利權人及社會大眾的利益。研究實驗免責的前提必須對專利權人權益造成微量或是最低限度的干擾(de minimums)，即是希望對專利權人的權益造成最小傷害，同時又可以達到促進產業發展及鼓勵更多研發工作進行的目的。 我們將實驗免責條款分為二類，一種是純為好奇心，僅針對專利技術內容作實驗，研究如何改善該發明，此為狹義的實驗免責；第二種則是應用於醫藥產業，此類實驗並非改善發明內容，而是重覆實施其發明，再進行其他研究及實驗，可視為廣義的實驗免責，此即美國在1984年修正Hatch-Waxman法案之醫藥產業的實驗免責條款，只要是為提交FDA之相關實驗資料時，則可主張實驗免責，目的為使已享受二十年專利期之發明儘快成為公共財，以供大眾利用。 研究工具專利的實施方法即作為研究及實驗目的，醫藥產業上可以是生物材料，亦可以是篩選新藥方法。由於具有研究及實驗的特性，若在研究實驗免責條款下，非專利權人企圖以研究實驗免責方式來規避其侵權行為時，專利權人行使權利時，則可能遭遇不少困難。若研究工具專利又被主張為提交FDA相關資料之實驗免責時，此行為對於專利權人權益並非造成微量或是最低限度的損失，發明人未因該專利而獲益，又無法實施專利權，則會降低申請專利的意願。 專利權的效力，應給予專利權人較大權利使發明人願意揭露技術、促進社會科技進步，抑或是應給予較大實驗免責範圍，使研發機構不會受到專利權限制而阻礙社會科技發展的動力，此二種考量方向，如同位於天平的兩端，呈現兩難局面。目前法院實務案例則以執行研究工具專利會落入藥物開發之實驗免責規範為主要認定，但筆者認為應就實施研究工具專利的行為、內容、目的作一探討及了解，並顧及公平性，才是評估研究工具專利是否適用實驗免責條款之依據。 因此，專利權人應如何管理或應用其研究工具專利，並可真正執行專利權而不至落入實驗免責條款? 可由數個方向進行：一、產品形式保護研究工具專利：將研究工具的執行方式以產品形式包覆，以銷售產品的方式跳脫實驗免責之框架，未必需要經由專利授權的方式來取得利益；二、進行全球化佈局：於申請研究工具專利之前，分析其發明深度及可能競爭對手，並在可能進行製造、使用、行銷、及進口相關於此發明技術之國家申請專利，以未來如何執行及如何獲利作為考量全球佈局之策略；三、成立契約研發中心(contrast research organization，CRO)：當研究工具專利在執行專利權有困難，不易跳脫實驗免責範圍，則可使用營業秘密 (Trade Secret) 方式保護其發明，不以公開技術方式，而是應用研究工具成為新藥篩選中心，提供研發服務；四、授權國家單位：即是採用類似NIH之OTT模式，將研究工具專利權直接授權給政府，由政府支出其授權金並可擴展至更多研發機構。 至於非專利權人，如一般之研發機構，應如何利用研究工具專利，且不落入專利侵權的疑慮? 除了取得專利授權外，亦可採用：一、從已授權國家單位取得技術：即如同NIH之OTT模式，由已取得研究工具專利授權之政府單位進行非專屬授權，該發明具較合理之授權金，並可被更多研發機構善加利用；二、落入實驗免責範疇：針對研究工具專利之實質發明內容進行改良及應用，再利用其方式以進行其新藥研發實驗，則可適用於實驗免責的規定；三、交互授權(Cross-license)：使用研究工具專利之研發機構與原本專利權人合作，經由交互授權方式成為合作伙伴，則可達到雙贏；四、成立開放社群，共同分享技術：如多數國家成立之GenBank，或BIOS (Biological Innovation for Open Society)社群之概念，收集對人類具有重大意義之研究工具，如基因序列等，以開放原始碼(Open source)之社群相互分享，使後續研發工作更加快速及順暢。 除了上述方法外，專利法可仿照著作權法，增定合理使用（fair use）之相關規定，亦即除了試驗例外、第三人繼續使用權、私人領域內之非營利性使用外，賦予第三人一般而全面性的專利權合理使用範圍，或以自願性參與集體授權機制（voluntary collective rights licensing）以支付合理權利金，促進社會公益。實驗免責條款可使得發明人願意持續公開其發明，同時使新穎發明公諸於世，兼顧社會公益，促使社會經濟及產業的進步，使國家社會整體因研發創新而真正獲益。 / The original purpose of the patent law not only offers the exclusivity to the inventors in a limited periods and in a limited rights in order to inspire the inventors to disclose more novel inventions, but also encourages the development of the technology and increases the growth rate of economics to the publics. The more new inventions the inventors provide, the more cost of R&D will be saved in whole society. The right of the exclusivity for the patentee is when someone without authority from the patentee, he can’t makes, uses, offers to sell, or sells any patented inventions, within the countries, or imports into the countries. But in order to enliven the industrial growth, the experimental use is added as a legal exception in many countries to balance the benefits of the patentee and the public interests. We should minimize interference to the patentee’ rights when the experimental use exception of the patents is claimed. We can divide the experimental use exception into two classes. One is the narrowly-defined experimental use exception only for the curiosity, for testing the content of the patents. The use aims to find out how to improve the inventions. The broadly-defined experimental use exception that is applied in the medical industry. This kind of use does not improve the technology of the invention, but repeat the invention again without changing any content. Such kind of broadly-defined experimental use exception is created after Hatch and Waxman Act in 1984. The experimental use exception in the medical industry is described that if the result of the experience is for submitting the drug information for the FDA examination, it is claimed non-infringement of the patent and protected by “safe harbor” of 35 USC 271 (e)(1). The purpose is to practice the inventions of the patents earlier and save the cost of R&D through public use. Research tool patent are used for the purpose of research and experiment and improves the speed of the experiment. In the medical industry, the research tool patent may be the biological material or the method of screening the new drug. Because of the experimental characteristics, the non-patentee may claim the experimental use exception and cause persecutions to the patentee. This kind of experimental use exception is not fair to the patentee and damage patentee’s benefit, especially in the research tool patentee. The patentee will not be able to receive the royalty from the non-patentee who claims the experimental use exception. As a result, it would reduce the will of filing such kind of patents. Should the effect of the patent right grant the patentee a broader right to patentees to encourage the inventors to release new technology which benefits the social and scientific progress? Or it should offer a large range of the experimental use exempt for the research institutes to encourage the using in the experimental use exception? It is difficult to judge which direction is better than the other one. The court are taking the side of the range of experimental use exception, allowing the research tool patents in the pre-clinical tests or experiment for submitting to FDA. This thesis proposes that there should be more criteria other than FDA, such as the purpose and the practical condition of use. Only when the whole situation and justice are taken into consideration will there be a suitable explanation of the experimental use exception. This thesis offers some suggestions concerning the management and application of research patent tools for the patentee and the non-patentee. It also assert that regulations about the fair use, such as experimental use exception, non-profit private use, voluntary collective rights licensing with rational royalty, can be added to the patent law to urge the patents to be put into practice. The reasonable experimental use exception can encourage the inventors to release his invention and the R&D departments to improve the technology more aggressively, realizing social and industrial advancement through the patent applications.

European Patents are granted through the European Patent Office. Although such right is unitary, the European patents will break down into a bundle of national patents; each governed by the domestic law of the States which the holder of the right has designated. Since infringement stands in the crossroads between patent enforcement and patent validity, infringement litigation generally touches on the issue of validity as it is impossible to infringe a right that does not exist or no longer exists. The nullity component in infringement litigation gives rise to additional difficulties with respect to the selection of the forum and the applicable law. As a result, the validity challenge is discussed in detail with respect to the application of the relevant rules on international jurisdiction and with respect to the identification of the relevant applicable laws. Cross border litigation in relation to registered intellectual property rights in Europe has been extremely controversial over the years. The jurisdiction of the courts to deal with foreign intellectual property rights is after all not entirely obvious or straightforward in the light of the exclusive jurisdiction provision in the Brussels system. The judgment which the Court of Justice delivered on 13th July 2006 in case Roche and GAT result substantial conflicts. Divergent views had been expressed concerning cross border jurisdiction over intellectual property cases on Article 6(1) of the Brussels I Regulation; and Article 16(4) of the Brussels Convention 1968, what is now Article 22(4) of the Brussels I Regulation. This thesis focuses on the jurisdiction and applicable law on European patent disputes.

本論文旨在提供台灣廠商在統合專利制度下之歐洲專利策略建議。本論文首先介紹以歐洲專利公約為主之現行歐洲專利制度，其次再介紹統合專利制度與統一專利法院制度。接著再以現階段我國廠商於歐洲專利申請狀況切入，分析現階段我國廠商於歐洲專利之布局狀況，再針對未來即將施行之統合專利制度，對台灣廠商之申請人及專利權人提出策略建議。 歐洲專利公約自1977年生效後，申請人向歐洲專利局遞交歐洲專利申請後，經過指定國程序，即可在歐洲專利公約之會員國間取得專利保護。某些會員國亦會要求遞交翻譯文件及繳納相關規費。然而，相比於美國、日本及中國，現行的歐洲專利制度是分離破碎的，進而導致申請人須負擔高額的申請費用與訴訟成本，同時亦有許多法律不確定性。在2013年2月，歐盟終於完成協商，正式簽訂確立歐洲統合專利與統一專利法院之條約。統一專利法院將在所有參與之會員國間擁有專屬管轄權。統合專利制度之下，申請人獲得歐洲專利之費用下降、申請程序更為簡化，且提供更有利於申請人之申請方式。如此，統合專利制度預期將提升申請專利之效益與吸引更多的申請者。統一專利法院制度之專屬管轄權，將提升專利有效性與訴訟之法律安定性，且訴訟相關費用之減免，亦有利於專利權人。 統合專利制度的所有準備工作雖已於2015年陸續完成，但仍需要德國、英國及另外任一個歐盟成員國批准歐洲統一專利條約方可生效，預計最快可在2017年達成。統一專利法院亦於2016年3月完成裁判費用之規定，並陸續完成各級法院之選址與訴訟案件性質之分類。專利權人與專利申請人應要謹慎思考在新制度下可能帶來之各種挑戰，特別是台灣廠商需要評估在新制度下之專利策略。因此，本文將針對新制度介紹，希冀能提供欲前往申請的台灣廠商專利佈局之策略建議。 / First of all, this Article overviews current European patent system in particular with the system under European Patent Convention. This Article also summarizes the features of new system and considers the practical steps which should be taking now in preparation for the start of new regime. European Patent Convention has entered into force since 1977. Under European Patent Convention, applicant can deliver their application to EPO and once the mention of the grant is published, the patent has to be validated in each of the designated states to keep its protective effect. In a number of member states, the patent proprietors may have to file a translation of the specification and pay fees. However, the current European patent system has been the fragmentation compared to the United States, Japan and China. This has caused to a high cost of application and lawsuit and also a high level of uncertainty. In February 2013, the European Union formally signed an agreement established a single European patent and the Unified Patent Court. The court will have exclusive jurisdiction for all participating Member States. Through European unitary patent system and Unified Patent Court, this new system reduces the costs of obtaining a patent, simplifies procedures, and regulates the language issue in a user-friendlier manner than before. Therefore, unitary patent system are expected to enhance the efficiency and attractiveness. All preparation of unitary patent system is accomplished before 2015, but still need the Germany, the Untied Kingdom and two other European member states to ratify the agreement. The beginning of 2017 is now said to be the earliest that can be achieved. Owing to the new patent system, patent proprietors and applicants, especially Taiwanese enterprises should be contemplating their patent strategy for meeting the challenge created by this new patent right. Thus, the Article presents patent strategy for Taiwanese enterprises under new patent system in Europe.

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