Les accords de report d’entrée sont des accords conclus dans le secteur pharmaceutique. Conçus par les laboratoires princeps, ils ont pour objet ou pour effet de retarder l’entrée de concurrents génériques sur le marché. Nés aux États-Unis à la fin des années 1990, ces accords continuent jusqu’à ce jour de générer de nombreux problèmes juridiques. Malgré plus de deux décennies de contentieux, les accords « pay- for-delay » produisent toujours un grand scepticisme outre-Atlantique et ne bénéficient pas d’un régime juridique clair. La difficulté tient à ce que ces accords cristallisent à la fois des problèmes de droit de la concurrence et de droit des brevets. De son côté, l’Union européenne a été récemment touchée par cette pratique. La Commission européenne s’est jusqu’alors saisie de trois cas. À chaque reprise, cette dernière a conclu que les accords restreignaient la concurrence en raison de leur objet. L’institution bruxelloise a ainsi fait preuve d’une grande intransigeance et d’une étonnante sévérité eu égard à sa faible expérience sur le sujet. Ce travail de recherche se propose de répondre aux problèmes posés par les accords de report d’entrée en mobilisant une approche comparatiste. Par ce biais, l’objectif de cette étude est double. D’une part, il s’agira de mieux comprendre le mécanisme qui se cache derrière ces accords. D’autre part, il s’agira de formuler des recommandations afin d’améliorer le contrôle actuel des « pay-for-delay » dans l’Union européenne / Pay-for-delay agreements are agreements concluded in the pharmaceutical sector. Designed by brand laboratories, they have for object or for effect to delay generic entry on the market. Born in the United States in the late 1990s, these agreements continue to generate many legal problems. Despite more than two decades of litigation, the pay-for-delay agreements still produce great skepticism across the Atlantic and do not have a clear legal regime. The difficulty is that these agreements crystallize both competition law and patent law issues. The European Union has recently been affected by this practice. The European Commission has prononced three decisions. In each of them, the commission concluded that the agreements restricted competition by their object. Thus, the commission showed a great intransigence and an astonishing severity in view of its weak experience on the subject. This research aims to address the problems posed by pay-for-delay agreements by mobilizing a comparative approach. In this way, the objective of this study is twofold. On the one hand, the purpose is to better understand the mechanism behind these agreements. On the other hand, the goal is to formulate recommendations to improve the current pay-for-delay control in the European Union

This dissertation is a historical evaluation of the movement of the English courts from the doctrine of pith and marrow to the Catnic test in the determination of non-textual infringement of patents. It considers how and why the doctrine was replaced with the Catnic test. It concludes that this movement occurred as a result of the adoption by a group of judges of literalism in the construction of patents while another group dissented and maintained the correct application of the doctrine. Although the Court of Appeal and the House of Lords initially approved the literalist approach, they, after realising its untennability, adopted the dissenters’ approach, but, ultimately, adopted the Catnic test in which features of the dissenters’ approach were included. The dissertation concludes that the doctrine of pith and marrow, correctly applied, should have been retained as the Catnic test creates uncertainty and confusion. / Mercantile Law / LL.M.

This dissertation is a historical evaluation of the movement of the English courts from the doctrine of pith and marrow to the Catnic test in the determination of non-textual infringement of patents. It considers how and why the doctrine was replaced with the Catnic test. It concludes that this movement occurred as a result of the adoption by a group of judges of literalism in the construction of patents while another group dissented and maintained the correct application of the doctrine. Although the Court of Appeal and the House of Lords initially approved the literalist approach, they, after realising its untennability, adopted the dissenters’ approach, but, ultimately, adopted the Catnic test in which features of the dissenters’ approach were included. The dissertation concludes that the doctrine of pith and marrow, correctly applied, should have been retained as the Catnic test creates uncertainty and confusion. / Mercantile Law / LL. M.

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

知識經濟時代，智慧財產權已經成為公司經營的策略重點，不再只是著重於法律與科技等構面，觸角更擴張為經營管理、商業競爭、企業併購、財務規劃與驅策新事業的重要工具。新的專利侵權原告（The New Breed of Patent Infringement Plaintiffs）便趁此一熱潮悄然誕生，美國稱之為「Patent Troll」，其不為營運研發、純粹在全球購買專利，以創造利潤與策略佈局考量為主，挾著專利持有人的地位大張旗鼓尋找「交易」對象，以訴訟為手段作為談判的籌碼，到處發警告函以獲取權利金。「Patent Troll」不僅在法律制度上引發爭議，更提高企業在智財管理方面的困難度，其對專利體系上的影響是全面性的。 本文第一章主要說明本論文之研究動機，包含專利訴訟新趨勢、新的商業營運模式，以及順應而生的「Patent Troll」之情形，闡述其所造成與被授權人間議價能力失衡之現象，接著闡述其對交易關係的影響以及美國法上相應適用的法律原則之變化，最後針對台灣的現況做一說明並向企業提出策略上之建議。 第二章蒐集並整理國內外與「Patent Troll」相關問題的爭議及探討。首先針對智慧財產服務業(IP Service Corporation)及智財控股公司(IP Holding Company)等名詞作一基本介紹。次對「Patent Troll」之名詞、定義、由來及分類做一整理介紹，接著說明「Patent Troll」之特徵、功能及商業模式。最後則針對各方文獻對於專利管理流程以及企業營運策略等建議做一整理分析。 第三章針對「Patent Troll」此一名詞做全面性的介紹與探討。首先對「Patent Troll」的定義、名詞爭議、發展歷史及與類似名詞的區辨為一概括式的介紹，本文將「Patent Troll」定名為「專利地痞」，並認為分析特徵可歸納為下列七項，只有當七項特徵都符合時才是本文所指涉之專利地痞：（一）為專利權人的個人、獨立發明人或公司；（二）藉由購買專利（如MercExchange）或進行技術創新(如Lemelson)；（三）不製造生產產品；（四）非提供專利服務；（五）鎖定目標公司（Target Company）：該目標公司必須是獨立發明製造技術，真正使用該專利，欠缺專利授權，在商業上成功，並且出現且已投入不可回復的損害；（六）以訴訟與禁制令作為要脅；（七）以達和解授權以獲取權利金等創造利潤及策略布局。接著說明「Patent Troll」的分類，以掌握其可能存在的不同態樣，本文將專利地痞分類為「發明型」專利地痞」，以及「購買型」專利地痞。然後就其特徵、優勢及商業模式加以闡述，歸納出一些共通的特徵，本文認為專利地痞的商業模式可以分成下列幾個步驟，第一階段為累積專利期，第二階段為授權協商期，第三階段則為專利訴訟期。各階段之間有其前後順序，並且環環相扣，除了第一階段需投入成本外，另外兩個階段均以創造利益為最終目的。最後再就全球各主要國家關於「Patent Troll」的現況進行討論並提出結論，以此部分的撰寫與結論作為第四張及第五章關於法律面與管理面相關議題批評檢討的基礎。 第四章探討「Patent Troll」在美國法上涉及的相關法律爭議問題，期以此觀察緣起環境變遷的方式了解國內外法制環境的差異，並定位台灣在此一進程中所處之發展位置，以解析台灣關於「Patent Troll」此議題重視之必要與否以及應該採取的態度與方法。首先以美國法上針對「Patent Troll」此一議題在行政、立法和司法的變革為引，帶出此一議題影響層面的全面性。次專注於美國法上關於立法上「專利改革法案」對於解決「Patent Troll」問題所做的努力，如前已提及之專利先申請原則、專利侵權損害賠償計算基礎、惡意侵權損害賠償、專利核可後非經訴訟程序的異議制度（Post-Grant Opposition）和專利侵權訴訟管轄權等。接著以法院判決的變化演進，如前述主要提及之2006年eBay v. MercExchange一案中對於禁制令核發原則的確立、2007年KSR v. Teleflex一案中對於可專利性原則（Patentability）的解釋運用，2007年MedImmune,Inc. v. Genentech一案對於確認判決（Declaratory Judgment）行使範圍的解釋。2007年Microsoft v. AT&T 針對域外效力（Extraterritorial Impact）的確立，以及2007年In re Seagate一案對於惡意侵權(Willful Infringement)的認定等。最後針對個別修正法案或法院判決的變遷對專利地痞的影響做一說明。 第五章提出企業面對「Patent Troll」此一威脅時所能採取的因應策略。將以第三章所分析之專利地痞商業模式三步驟為本，針對專利地痞行使各該步驟時，企業可能採取的因應策略。第一階段的累積專利期，包含有專利資訊管理、專利購買與公司併購、延攬IP專業人才、保險分擔機制與提撥準備金、技術創新設計、專利交叉授權、專利策略聯盟、契約條款規劃和其他新型態的因應策略等；第二階段的授權協商期，包含有專利評估、和解授權，確認訴訟；第三階段的侵權訴訟期，則有專利訴訟程序、侵權認定程序、善用迴避設計、提出異議制度、提出專利再審查、慎選繫屬法院，以及採取團體訴訟以資因應等。期以一相關流程使企業得以瞭解其現階段落在何種情況時應採取何策略始得降低風險並妥善因應。 第六章為本論文之結論建議，結論部份，將前述第三章、第四章和第五章所提出之觀點作一概括性的總結。建議部分，即就我國產官學各界及現行法制面對「Patent Troll」問題可能適用之解決方式加以檢討並提出建議。 / In the knowledge-based economy era, intellectual property has become the focus of business management strategy. The concerns of intellectual property management extend from law and technology to management, market competitions, mergers and acquisitions, financial plans, and start-ups. The trends also bring forth a new breed of patent infringement plaintiffs, Patent Troll, who do not undertake R&D and purchase patents worldwide as their main profit and business strategy. Those patentees utilize litigation as measures to bargain with their “clients” to obtain loyalties. The issue of Patent Troll is influential in the Patent system. It rouses controversy in legal system and increase difficulty for industry in intellectual property management. Chapter I describes the main concern of this thesis, including new trends of patent litigation, new business model, and “Patent Troll.” The chapter will elaborate an imbalance of bargaining power between licensors and licensees cause by patent troll, the influences of patent troll to IP transactions, and the changes of legal principles under U.S. patent law and judicial decisions. The chapter will outline the current situation in Taiwan and propose some strategy to industries. Chapter II involves relating issues on "Patent Troll" in Taiwan and abroad. First, the chapter will introduce the definition of IP Service Corporation and IP Holding Company. Then the chapter will elaborates and discuss patent troll from the name, definition, classification, origin, features, functions and business models. At last, this chapter will analyze the patent managerial process and operating strategies for the industries. Chapter III focuses on a comprehensive introduction towards patent troll. First, the article elaborates the disputes on the definition, the term, the history and the differences between similar terms of patent troll. A Patent troll should meet all the following seven characteristics, (a) patent owner/independent inventor/company; (b) Compare purchase of rights (MercExchange for example) vs. invention (Lemelson for example); (c) Does not Make, Use, Sell, Offer to Sell, Or Import Patented Article/ Does not Use/Practice Patented Method; (d) no IP Service; (e) Target company (infringer): The target company must be an independent inventor of the technology, has real use of the patent, lacks of patent license, has successful business and devotes substantial investments; (f)Threat of litigation & Injunction; (g) Demand for licensing fee. Then the article describes the classification of patent troll in order to grasp the potential types of it. Patent troll in this chapter will be classified as "inventor" one and "purchaser" one. The business model of patent troll can be divided into three stages: (a) cumulative period ;(b) licensing and consolation period and (c) patent litigation period. The three stages are of time sequence and closely linked together. The “Patent Troll” needs to invest money only in the first stage and take profit creation as the ultimate goal in the other two stages. Finally, the chapter describes and discusses the developments and current status of patent troll in some major countries in the world. The observation and discussion will be served as the foundation for further discussion in the following chapters. Chapter IV focuses on the legal principle changes under U.S. patent system in three dimensions: administration, legislation and jurisdiction and illustrates the effects that occur to patent troll. The changes of administration focus on three parts: the limitation of continuation application, the limitation of divisional application and the limitation of claims. In legislation, the changes focus on “Patent Law Reform Act”, including the first-to-invent to first-to-file principle, the calculation basis of damages, enhanced damages, post grant review procedure, and venue and jurisdiction. The changes of jurisdiction focus on five verdicts and cases, eBay v. MercExchange, KSR v. Teleflex, MedImmune, Inc. V. Genentech, Microsoft v. AT & T, and In re Seagate. The chapter will elaborate the influences of those changes and decisions on the business model of patent troll. Chapter V proposes some possible solutions and strategies to industries when they are confronted with the threats of patent troll. This thesis takes the three stages of patent troll’s business model as a foundation and proposes the strategies for industries against patent troll during different stages. The strategies for first stage are IP information management, patent purchase, mergers and acquisitions of companies, IP professionals recruitment, insurance mechanism, technology R&D, patent cross-licensing, patent alliances, contract planning and other new types of strategies and so on. The strategies for the second stage include patent evaluation, authorization of reconciliation and declaratory judgment. The strategies in the third stage are patent litigation, infringement procedures, patent design around, patent re-examination, choose of venue and jurisdiction and group litigation. The thesis expect to enable industries to understand what stage they fall on and what strategies they can adopt, with the proposal of management procedure. Chapter VI will be the conclusions of this thesis and will include suggestions on the issue of patent troll to industries, government and academia.

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.

No description available.

Dans les pays en développement (PED), les problèmes engendrés par le VIH/SIDA et l’inaccessibilité des antirétroviraux (ARV) s’avèrent être la cause de ravages extrêmement préoccupants à tous les niveaux (démographique, politique, social et économique). Dans le cadre de l’Organisation mondiale du commerce (OMC), et notamment de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (« Accord sur les ADPIC »), un nombre croissant de PED ont ou sont en train d’intégrer un standard international de protection des brevets de produits et de procédés pharmaceutiques à leur législation nationale. Cette intégration a eu et continue de jouer un rôle majeur dans la problématique de l’accès aux médicaments dans les PED. Les conditions et les effets du régime de protection des innovations suscitent de vifs débats entre les partisans d’une protection accrue des brevets et les défenseurs de l’accès aux médicaments essentiels. Une des principales motivations de notre travail de recherche est de fournir une étude permettant de trouver des solutions à la fois favorables à l’amélioration de l’accès aux médicaments et à la préservation de l’innovation. Le problème complexe de l’accès aux médicaments ARV dans les PED est influencé par la pluridisciplinarité et l’interdépendance de nombreux facteurs. Le système des brevets ne constitue pas « l’unique » solution au problème. Toutefois, il doit être plus sérieusement considéré dans sa fonction d’équilibrage entre l’intérêt privé et l’intérêt collectif. C’est un outil juridique précieux pour le développement économique et technologique des PED et la réalisation de l’intérêt commun contre la pandémie. / In developing countries, problems brought about by HIV/AIDS and inaccessibility of antiretrovirals (ARVs) are proving to be the cause of serious damages at all levels (demographic, political, social and economic). Within the context of the World Trade Organization, and in particular the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), a growing number of developing countries have integrated or are in the process of integrating into their national law an international standard of patent protection for pharmaceutical products and processes. Such integration continues to play a major role in the issue of access to medicines in developing countries. The conditions and effects of the protection regime respecting innovations give rise to heated debates between supporters of an increased patent protection and defenders of the access to essential medicines. One of the main motivations for our research is to provide a study that helps to find solutions that are both in favour of improving access to medicines and protecting innovation. The complex problem of access to ARV drugs in developing countries is influenced by the multidisciplinarity and interdependence of many factors. The patent system does not solve the problem on its own. However, it should be seriously considered in its function of balancing the private and collective interests. It is a valuable legal tool for the economic and technological development of the developing countries and to achieve the common interest against the pandemic.