Pharmaceutical drugs are often hailed as the poster child for the proposition that patents foster accelerated rates of innovation. This sentiment stems, in large part, from the significantly high research and development (R&D) costs endemic to the pharmaceutical sector. I argue that if the role of the patent regime is one of fostering higher amounts of investment in the R&D process, it is better served by a direct investment protection regime, where the protection does not depend upon whether or not the underlying idea behind the drug is 'new' and 'inventive', the two central tenets of patent law. Rather, any drug that successfully makes it past the regulatory filter ought to be entitled to protection, since its discovery and development entail significant investment and risk. Owing to the inadequacy of the current patent regime in appropriately protecting intensive pharmaceutical R&D investments from free-riders, I propose a comprehensive investment protection regime that protects all the investment costs incurred during the drug discovery and development process. Though similar to existing data protection regimes in some respects, it differs in others. Firstly, it enables a recovery of all R&D costs, and not only costs associated with clinical trials. Secondly, unlike patents and data exclusivity which offer uniform periods of protection, it rewards investments in a proportionate manner, wherein drug originators are entitled to protection against free-riders only until such time as they recoup their specific investments and earn a rate of return on investment that is dependent on the health value of the drug. Given that a pure market exclusivity based investment protection regime is likely to foster excessive pricing and subject the market to the dictates of a single firm, I advocate a compensatory liability model based on a novel cost sharing methodology, where follow-on entrants are free to manufacture the drug, but must pay a reasonable amount of compensation to the originator.

Die vorliegende Arbeit setzt sich mit der Bedeutung der Nationen aus Offb 21,24.26 auseinander. Wie ist es möglich, dort Nationen als Gegenüber des Gottesvolks zu finden? Die These erhärtet sich, dass das Alte Testament in Bezug auf die Beziehung des Gottesvolks zu den Nationen eine Vorschau auf die zukünftigen, himmlischen Zustände ist und dass die Zeit des Neuen Testaments eine Zeit des Übergangs darstellt, in der das Gottesvolk neu formiert wird. Der gegenseitigen Beziehung kommt eine enorme Bedeutung zu. Das Gottesvolk ist dazu eingesetzt, zusammen mit Gott über die Nationen zu herrschen. Die Nationen ihrerseits sollen durch diese göttliche Herrschaft zur Erkenntnis und zur Anbetung Gottes geführt werden. Es ist ein fester Bestandteil der Identität des Gottesvolks, dass es zwischen Gott und den Nationen steht und vermittelt. Somit begründet sich die Präsenz der himmlischen Nationen in ihrer Notwendigkeit als Gegenüber des Gottesvolks. / The following dissertation examines the meaning of the nations mentioned in Revelation 21:24.26. How is it possible that there will be nations as counterpart to God's people? In the course of the study, the thesis is confirmed that the relationship between God's people and the nations shown in the Old Testament is a preview to the future state in heaven and that the New Testament stands for a time of transition and new formation of God's people. An outstanding meaning is attributed to this mutual relationship. God's people is appointed to rule over the nations along with God. By divine rule the nations are to be led to recognition and adoration of God. It is an inherent part of the identity of God's people to stand and to intercede between God and the nations. Thus the presence of heavenly nations is justified by its necessity as counterpart of God's people. / Philosophy, Practical and Systematic Theology / M. Th. (Systematic Theology)

Les travaux présentés dans ce mémoire traitent de la synthèse d'algorithmes de diagnostic de défauts simples et multiples. L'objectif vise à proposer une stratégie de diagnostic à minimum de redondance analytique en exploitant au mieux les informations de redondance matérielle éventuellement disponibles sur le système. Les développements proposés s'inscrivent dans une démarche de coopération et d'agrégation des méthodes de diagnostic et la construction optimale d'un diagnostic global en fonction des diagnostiqueurs locaux. Les travaux réalisés se veulent génériques dans le sens où ils mêlent à la fois les concepts et outils de deux communautés : ceux de la communauté FDI (Fault Detection and Isolation) et ceux de la communauté DX (Diagnosis) dont les bases méthodologiques sont issues des domaines informatiques et intelligence artificielle. Ainsi, le problème de détection (ainsi que le problème de localisation lorsque les contraintes structurelles le permettent) est résolu à l'aide des outils de la communauté FDI tandis que le problème de localisation est résolu à l'aide des concepts de la communauté DX, offrant ainsi une démarche méthodologique agrégée. La démarche méthodologique se décline en deux étapes principales. La première phase consiste en la construction d'une matrice de signatures mutuellement exclusive. Ainsi, le problème du nombre minimal de relations de redondance analytique (RRA), nécessaires pour établir un diagnostic sans ambiguïté, est abordé. Ce problème est formalisé comme un problème d'optimisation sous contraintes qui est efficacement résolu à l'aide d'un algorithme génétique. La deuxième étape concerne la génération des diagnostics. Ainsi, pour une situation observée, identifier les conflits revient à définir les RRAs non satisfaites par l'observation. Les diagnostics sont obtenus à l'aide d'un algorithme basé sur le concept de formules sous forme MNF (Maximal Normal Form). L'intérêt majeur dans cette approche est sa capacité à traiter le diagnostic des défauts simples et multiples ainsi que le diagnostic des plusieurs modes de fautes (i.e., le diagnostic des différents types de défauts) associés à chaque composant du système surveillé. De plus, il existe des preuves d'optimalité tant au niveau local (preuve de robustesse/sensibilité) qu'au niveau global (preuve de diagnostics minimaux). La méthodologie proposée est appliquée à la mission spatiale Mars Sample Return (MSR). Cette mission, entreprise conjointement entre l'administration nationale de l'aéronautique et de l'espace (NASA) et l'agence spatiale européenne (ESA), vise à ramener des échantillons martiens sur Terre pour des analyses. La phase critique de cette mission est la phase rendez-vous entre le conteneur d'échantillons et l'orbiteur. Les travaux de recherche traitent le problème de diagnostic des défauts capteurs présents sur la chaîne de mesure de l'orbiteur pendant la phase de rendez-vous de la mission. Les résultats, obtenus à l'aide du simulateur haute fidélité de Thalès Alenia Space, montrent la faisabilité et l'efficacité de la méthode. / The work presented in this thesis deals with the synthesis of algorithms for the diagnosis of simple and multiple faults. The main objective which is pursued is to design a fault diagnosis scheme by merging a minimum number of analytic redundancy with the available hardware redundancy. The main contribution of the proposed technique concerns the general architecture of the proposed diagnosis method. The originality of the research work is the combination of ideas and tools originated from two research communities : the FDI (Fault Detection and Isolation) community and the DX (Diagnosis) community whose foundations are derived from Computer Science and Artificial Intelligence fields. Hence, the fault detection problem (as well as the isolation task when structural constraints allow it) is solved by means of FDI techniques while the fault isolation problem is solved through the DX approaches, thus resulting in an aggregated methodology. The proposed method is divided in two steps. The first step deals with the construction of a mutually exclusive signature matrix. Hence, the problem of the minimal number of analytic redundancy relations (ARR), necessary for generating a diagnosis without any ambiguity, is treated. This problem is formalised as an optimized problem under constraints which is efficiently solved by means of a genetic algorithm. The second step concerns the generation of diagnoses. Thus, for an observed situation, the identification of conflicts results in the determination of the non satisfied ARRs for the given observation. The diagnoses are obtained by means an algorithm based on the concept of MNF (Maximal Normal Form) formulas. The main interest of this approach is its capacity to deal with the diagnosis of simple and multiple faults as well as the diagnosis of multi-modes faults (i.e., multiple types of faults) associated to each component of the system. Furthermore, it exists proofs on optimality both at a local level (proof of robustness/sensitivity) and at a global level (proof of minimal diagnoses). The proposed method is applied to the Mars Sample Return (MSR) mission. This spacecraft mission, undertaken jointly by the National Aeronautics and Space Administration (NASA) and the European Space Agency (ESA), aims at returning tangible samples from Mars atmosphere and ground to Earth for analysis. The critical phase of the mission is the rendezvous phase between the sample container vehicle and the orbiter spacecraft. The research work aims at realising sensor fault diagnosis on the orbiter during the rendezvous phase of the mission. Simulation results from the MSR high fidelity simulator, provided by Thalès Alenia Space, demonstrate the feasibility and the efficiency of the proposed approach.

Alors que sa disparition semble se profiler à l’horizon, du moins à l’intérieur de l’espace Européen, la notion juridique de frontière qui dessine les limites du territoire de l’Etat reste l’objet d’une imprécision surprenante. Aucune définition générale et intelligible ne semble encore lui avoir été consacrée, nonobstant la place centrale qui lui est attribuée par nombre d’analyses savantes sur les institutions de la modernité politique (Etat, souveraineté, territoire). Une tentative de définition (ou de théorisation) de la frontière est donc nécessaire. Théoriser la frontière n’implique pas de s’éloigner de la réalité : ce sont au contraire des données empiriques, sélectionnées à l’intérieur d’une foison d’informations disponibles sur le sujet, qui doivent guider un travail de systématisation. Au sein de celles-ci, la place privilégiée du droit fiscal (interne, communautaire et internationale) s’explique par les affinités personnelles de l’auteur. Ce dernier n’a toutefois pas omis de balayer d’autres disciplines, à l’instar du droit international public ou du droit international privé, aux fins de caractériser une substance irréductible et invariable de la frontière. Deux fonctions distinctes, bien que complémentaires, s’imposeront très rapidement comme les éléments constitutifs de la notion de frontière : la ligne réputée impénétrable en droit international qui sépare les territoires des Etats, d’un côté (ou « frontière internationale »), le filtre perméable qui régule les circulations entre les territoires des Etats (ou « frontière-obstacle »), de l’autre. Le temps et l’espace imposeront de limiter l’analyse au premier élément, à savoir la frontière internationale. À raison de ses fonctions pour commencer : quel est son rôle ? Mais aussi à raison de son objet : à quoi, ou à qui, s’applique-t-elle ? L’analyse des fonctions permettra d’abord de vérifier que la frontière internationale, en tant que cause et conséquence du principe de l’exclusivité territoriale, est étroitement liée à la notion d’Etat moderne. La naissance de la notion moderne de souveraineté, dans la mesure où elle est largement tributaire de la conquête du monopole de la violence légitime au profit des autorités centralisatrices de l’Etat, n’aurait pas été envisageable sans la constitution de frontières impénétrables aux limites du royaume. Plus largement, bien des notions fondamentales associées au droit étatique moderne (intégrité territoriale, centralisation de la contrainte, dualisme juridique,…) peuvent être reconsidérées à la lumière de la notion de frontière. L’analyse de l’objet de la frontière internationale permettra, ensuite, de surmonter bien des incertitudes. Celle qui touche, en particulier, au rapport entre la frontière impénétrable et le principe de territorialité des lois (ou des impôts) : la territorialité normative, sous toutes ses formes, ne peut-être assimilée à une manifestation (ou à une composante) de la frontière internationale. Celle qui touche, aussi, à la nature et à la portée de l’assistance administrative internationale entre les Etats dans le domaine fiscal. Le développement récent de celle-ci, sous toutes ses variantes (assiette et recouvrement), ne se traduit qu’exceptionnellement par des entorses à l’impénétrabilité des frontières. Toutes les activités de l’Etat n’ont pas, en effet, vocation à s’arrêter aux limites du territoire en application du droit international public. Seul l’imperium de l’Etat entendu stricto sensu, c’est-à-dire le pouvoir coercitif proprement dit, semble être soumis au respect de cette imperméabilité. En somme, à défaut de parvenir à dresser une théorie générale de la frontière en droit, certaines de ses caractéristiques majeures seront en l’espèce esquissées dans l’espoir de fournir au juriste une grille de lecture supplémentaire, et si possible originale, du droit positif. / Even though its disappearance seems to be predictable, at least within the European Union, the legal notion of “Border” remains subject to a high degree of uncertainty. No general definition which combines clarity and precision, has been formulated on this matter yet. Therefore, time has come to provide a rigorous “definition” of this limit which separates the territories of the states. In other words, an attempt to theorize the notion of “Border” will be carried out in this book. The choice of a theoretical approach does not necessarily imply, however, to undertake a study remote from reality. To the contrary, an appropriate definition must be based on empirical data: selected matters among the huge amount of information available will be, as a result, the main source of this work. Among them, tax law (domestic, European and international) will play a key role due to the personal background of the author. The latter, however, did not forget to cover other disciplines. A wide-ranging scope is necessary where the objective is to reach the irreducible gist of a legal notion: International Public Law, Private International Law, Political Science as well as Sociology will be dealt with in this book. Two distinct functions (meanwhile complementary) will immediately be identified as the main components of the notion of “Border”: the dividing line, seen as impenetrable under International Public Law, that separates the territories of the States on one hand (so-called "international border"), and the permeable filter which regulates by way of discriminatory rules the movements (e.g. goods, persons, rights, values) between the states on the other hand (so-called “obstacle-border"). Due to limited time and space, however, this book will only focus on the first component, namely the international border. A study of its functions (i.e. what is the purpose for the impenetrability of the border?), will be followed by a study of its object (what is the scope of the impenetrability of the border?). The study of the functions will demonstrate that the international border, as a cause and a consequence of the principle of territorial exclusivity (i.e. monopoly of violence within the territorial borders), has strong ties with the concept of “Modern State”. Moreover, many fundamental notions generally attached to modern statute law (e.g. coercion, sovereignty, legal dualism) will be reconsidered in the light of this principle of impenetrability. Further, the analysis of the object of the international border will enable the author to eliminate certain jeopardizing uncertainties. Among others, the issue concerning the existence (or not) of a kinship between the “Border” and the territoriality of the law (including Power to Tax) will eventually be resolved: the territoriality principle, irrespective of its forms, is not an appearance (neither a component) of the international border. All activities undertaken by a state (i.e. legislative and executive powers), therefore, are not forced by law to be circumscribed to the territorial limits of that state. Only the core of the Imperium of a Modern State, that is to say the coercive power itself, seems to be subject to the impenetrability of the Border. In short, this book does not provide for (and is not aimed at) a general and all-comprehensive theory on “Borders”. Some of the major features of the latter are, however, clearly characterized herewith in order to provide the reader with another tool to scrutinize positive law.

1 and 2 Chronicles is a book that solicits many questions and on which neither research nor debate is complete. The reason for this is the discrepancies between the book compared to other books with similar content. The purpose of this dissertation is to: - -- identify the differences between Chronicles and source writings; -- determine which selections were made from the source material, what has been nuanced, omitted, added and emphasized; -- study these selections contextually and determine what its function or purpose would have been; -- determine the Chronicler’s ideology and against this background determine whether the text functioned as discourse of power. The book 1 and 2 Chronicles forms the study field of this dissertation. This book is mainly a narrative that pretends to be a narration of history and covers the period from Adam until after the Babylonian exile. The temple and cult in Jerusalem form the focal point of this narrative. A comparison of the book 1 and 2 Chronicles with the source documents the author(s) used (namely Genesis, Joshua, 1 and 2 Samuel and 1 and 2 Kings) clearly shows that the Chronicler worked extremely selectively when using the source documents and that he retells the history of Israel and Juda through omissions and additions with his own particular emphasis. The narrative offers a negative judgment of the Northern Kingdom (Israel) and all the tribes that lived in that area. On the other hand the Southern Kingdom and the tribes Juda, Levi and Benjamin are described extensively and are judged positively. David is presented as the ideal king. Bar one, all his wayward deeds that are comprehensively reported in the source documents are concealed. The purpose is evidently to create an extremely positive image of him. He is inter alia depicted as the founder of the cult in Jerusalem. In this manner the cult is also legitimized and given the stamp as the only true place of worship of the living God. To have a close connection with the cult in Jerusalem or not thus becomes the criterion to judge all kings after David. The study clearly reveals that 1 and 2 Chronicles functioned as a discourse of power that was aimed at promoting the interests of the post-exilic temple personnel in Jerusalem and legitimizing their control over the cult. As a discourse of power it sets boundaries and excludes different groups that were traditionally part of the people of YHWH. The destruction of the temple in 70 AD and the ending of the cult also meant the end of the purpose of this text as a discourse of power and created the possibility that it could become part of the collection of sacred writings known as the Old Testament. / Thesis (PhD (Old Testament Studies))--University of Pretoria, 2007. / Old Testament Studies / unrestricted

美國作為醫藥技術的領導者，為了確保其利益，並維持其領導地位，不斷在各種貿易談判場合，向世界各國施加壓力，要求提供醫藥品更強力的智慧財產保護。台灣當然也不例外，在加入跨太平洋戰略經濟夥伴關係協議 (Trans-Pacific Partnership Agreement, TPP)、簽訂臺美貿易暨投資架構協定 (Trade and Investment Framework Agreement, TIFA) 的壓力下，我國政府從2014年開始積極推動專利連結，雖然獲得美國商會肯定，但卻在國內業界卻引起十分強力的反彈。 專利連結，本質上只是核准前專利爭端解決程序 (Pre-Approval Patent Resolution Process) 的其中一個類型而已。核准前專利爭端解決程序，就是在特定產品上市核准的准駁中，把專利侵權問題作為准駁的考量。國際上類似的制度主要出現在人用藥品、動物藥品中，通常是在允許引據他人安全性、有效性資料的藥品中 (類新藥、學名藥)。 我國目前對類似制度的了解並不深，尤其缺乏對制度原生國－美國的全面性研究。本研究選擇以發展最早的藥品專利連結作為研究標的，並全面、深入分析其中每個機制的目的、立法/修法歷史 (含行政法規)、法院判決，探求其爭議的發展過程。在這個基礎上，本研究就引進的必要性、各種立法手段的選擇與優劣，提出「修正版柔性專利連結」，主要特徵在排除了自動停止核准期、重定核准日條款，使藥品審查和專利爭端大致維持獨立，並符合TPP的要求。希望本研究能夠幫助台灣建立一套明確、合理，且符合我國國情的核准前專利爭端解決程序。 / As the phamaceutical industry’s market leader, the United States continues to call for strengthening patent protection for pharmaceutical products during every trade negotiation, to preserve its national profit and leadership. Taiwan, being highly interested in joining “Trans-Pacific Partnership Agreement” (TPP) and signing “Trade and Investment Framework Agreement” (TIFA) with the United States, Taiwan's government is actively promoting the “patent linkage” since 2014. Althougn the effort done by Taiwan's government is extremely welcomed by American Chamber of Commerce, the domestic industry, which is mainly organized with generic drug manufactors, has expressed their opposition resolutely. Patent linkage, as a kind of “pre-approval patent resolution process”, considers the possibility of patent infringement as a factor when issuing market approval. Such process are normally found in those countries that are trade partners of the United States, and espetially during the approval prosses of human-use drug products, animal drug products, which permits persons to rely on evidence or information concerning the safety and efficacy of a product that was previously approved. Our current knowledge of pre-approval patent resolution process is limited, especially on how it was oranginally created in the United States. This research will focus on the purpose, enactment, amendment, court decisions, development, and issues of patent linkage, the first-of-its-kind which is established in 1984. On this basis, the reseach will then look back to what Taiwan has faced now, and provides recommendations on whether there is necessity of introdution, how to adjust the prosses, and how to enforce it, without serious abuse. This research propose “revised soft patent linkage”, which excludes automatic stay and re-date remedy, generally keeps the independence between drug approval and patent infringement, and at the same time meets TPP requirement. The research hopes to help Taiwan establishing its own pre-approval patent resolution, fair, clear and meet the need of domestic and public the industry.

Le présent mémoire est consacré à l'étude des chevauchements entre revendications territoriales autochtones. On s'y interroge sur l’origine et l’évolution de ces chevauchements ainsi que sur les mécanismes qui pourraient être employés pour trouver des solutions acceptables pour toutes les parties. Notre étude retrace d'abord l'évolution du critère d’exclusivité élaboré par les politiques et décisions judiciaires canadiennes relativement à l’octroi du titre autochtone, concluant que ce critère d’exclusivité est devenu un enjeu déterminant dans l’élaboration d’une solution relative aux chevauchements entre revendications territoriales. En observant la manière dont les différents paliers de gouvernement ont échoué dans leurs tentatives de solutionner les enjeux de chevauchement, nous constatons que les traditions juridiques autochtones doivent être intégrées à la résolution des conflits et à l’interprétation du critère d’exclusivité. Ceci exige de percevoir l’institution juridique de la résolution de conflits selon une certaine vision du droit. Nous utilisons ici celle de Lon Fuller, qui présente une approche permettant de réconcilier plusieurs traditions juridiques. Notre étude nous conduit à proposer le système du Indigenous Legal Lodge comme mécanisme de résolution de conflit permettant aux autochtones de faire appel à leurs traditions juridiques dans la résolution des chevauchements, permettant ainsi de réconcilier ces traditions diverses. / This thesis is dedicated to the study of overlapping aboriginal land claims. We question the origin and evolution of these overlaps and study the mechanisms which could be used in order to determine a solution acceptable to all parties. Our study first discusses the evolution of the exclusivity criterion developed in Canadian policy and case law relating to the granting of an aboriginal title, concluding that the criterion of exclusivity has become a defining issue in the development of a solution to overlaps between land claims. By observing the failures of the various levels of government in their attempts to develop solutions to overlapping claims, we find that Aboriginal legal traditions must be integrated into conflict resolution and be used when interpreting the exclusivity criterion. This requires us to perceive conflict resolution, as a legal institution, according to a certain understanding of the law. We use Lon Fuller’s vision, who presents an approach for reconciling various legal traditions. Our study brings us to propose the Indigenous Legal Lodge as a conflict resolution mechanism enabling Aboriginal groups to call upon their own legal traditions in resolving overlaps and to reconcile their differing traditions.

Bibliography: leaves 235-261 / Queer studies have not adequately considered gay men seeking sexual exclusivity within longterm relationships. In contrast, the emphasis has been on understanding evolving queer norms. Homonormativity has been informing sexual permissiveness. In accordance, and contrasting gay men seeking sexual exclusivity, gay, male couples tended to use relationship agreements to stipulate guidelines for extradyadic sex. This study was inspired by my inability—as a counsellor of gay men seeking sexual exclusivity—to provide them with credible insights to better understand their goals. Representing an initial step in generating practical knowledge, it was anticipated that my counselling clients could benefit from an exploration of lived experiences rather than having to rely on theoretical inferences and opinions. “How” and “why” participants maintained sexual exclusivity were the main targets of discovery. Eleven gay, Canadian men aged thirty-three and older, in relationships of five years or longer, participated in semistructured interviews in-person or via video chat. Using Kleiman’s (2004) protocol for phenomenological analysis, common units of meaning were coded, from interview responses, so that distinct subthemes, contributing to six themes, were identified. These findings included content concerning “seeking positive affects,” “avoiding negative affects,” “factors supporting sexual exclusivity,” “threats to sexual exclusivity,” “rigidity in beliefs,” and “decision-making toward sexual exclusivity.” The first two themes integrated innately to form a meta-theme, “emotional optimization.” An essential insight into how participants maintained sexual exclusivity was their awareness of, and restraint in using, sexually tantalizing, visual stimuli, which was the primary risk to sexual exclusivity. Suggestions for gay men desiring sexual exclusivity included discontinued utility of pornography and cybersex. Varied implications for prospective research, clinical practice and support groups were delineated. / Psychology / D. Phil. (Psychology)

生物藥品是很多先前具致命性和難以治療的疾病領域，像是癌症、自體免疫疾病及神經系統疾病內最被看好的現行新穎療法。近年來，隨著探索出突破性小分子藥物愈趨困難，加上生物藥品在新藥研發過程中有較低的折損率與較高的成功產出率，使得越來越多藥廠紛紛轉向開發利潤豐厚的大分子生物產品。此外許多暢銷生物藥品專利期即將屆至，從而帶來對相對價廉、通常被稱為原廠生物藥品仿製版本之「生物相似性藥品」的龐大治療需求。然而，由於生物藥品和小分子藥物在分子大小及結構複雜程度方面存在截然不同的特性與本質差異，因此建立一套專屬於生物相似性藥品的上市許可規範勢在必行。 作為於2010年3月23日正式簽署公告之「患者保護及可負擔照護法案」中的一部分，美國國會通過了「生物藥品價格競爭與創新法」(BPCIA)。BPCIA的生效被視為製藥產業最重要的變革之一，旨在藉由競爭達到維護公眾健康、促進生物技術創新和控制醫療支出之目的，同時取得適當之三方利益平衡。BPCIA即以Hatch-Waxman法案下的化學學名藥核准途徑為模版，創建生物藥品簡易上市申請程序。 本論文的結構主要區分為兩大部分進行研究，其一提供了製藥產業概觀與全球生物藥品市場的發展趨勢，其二則聚焦在BPCIA新建立的核准前專利爭端解決程序下，生物相似性藥品面臨「專利舞蹈」時的法律評估及智慧財產權管理。 論文的第一部分係根據從各種市場研究報告收集、整理而成的統計數據，以系統性的方式深入介紹全球製藥產業，並分析生物相似性藥品的市場機會和潛在隱憂。另外此部分亦詳細說明了生物相似性藥品的生理活性、知識斷層與製程依賴性之間的關係、分析技術對生物產品做完整定性的不足以及生物相似性藥品的開發流程。 論文的第二部分則以討論BPCIA的重要條文規定為主，包括專利舞蹈制度和上市審查要求，諸如生物相似性之證明、可互換性之認定與適應症外推。其他相關議題，包含參考藥品的法定專屬權保護期長度、生物相似性藥品自動替換之立法化、專利資訊交換機制的可能濫用及原廠與生物相似藥廠達成反競爭協議之風險皆會予以進一步探討。除此之外，本部分也介紹了歐盟和台灣生物相似性藥品上市法規的沿革與現況。 本文試圖透過對生物相似性藥品的全方位綜合研究成果，提出可行的市場進入方案及善用專利和營業祕密優勢之智慧財產權保護佈局策略。 / Biologics represent many of the most promising novel therapies for previously deadly and intractable disease areas like cancer, autoimmune disease and neurological disorders. As discovery of breakthrough small-molecule drugs becomes more difficult, together with lower attrition rate and higher productivity of biologics in the new drug research and development (R＆D) process, pharmaceutical companies are increasingly turning to develop lucrative large-molecule biological products in recent years. In addition, the patents on numerous blockbuster biologics treatments will soon expire, bringing soaring demand for relatively inexpensive generic versions of originator biologics, generally known as “biosimilars.” However, due to contrasting characteristics and natural differences in terms of size and structural complexity between biologics and small-molecule drugs, it is necessary to create a regulatory pathway solely for biosimilars. As part of the Patient Protection and Affordable Care Act which was officially signed into law on March 23, 2010, the U.S. Congress passed the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is considered one of the more significant overhauls to the pharmaceutical industry, aiming to strike a proper balance among securing public interests, stimulating biotechnology innovation and controlling healthcare expenditure through competition. It established an abbreviated approval pathway for biosimilars modeled closely after the Hatch-Waxman Act’s approval process for generic chemical drugs. The structure of this thesis is divided into two major parts, of which the first part provides an overview of pharmaceutical industry and trends in the global biologics market, whereas the second part focuses on the legal assessment and intellectual property management of biosimilars under BPCIA’s new pre-approval patent dispute resolution process, the “patent dance”. The first part starts from the in-depth systematic introduction of global pharmaceutical industry based on statistics collected from various market research reports, then analyzes the market opportunities and potential concerns for biosimilars. Moreover, this part illustrates the physiological properties, the relationship between “knowledge gap”and manufacturing path-dependence, the insufficieny of analytical techniques in fully characterizing biological products, and the development process of biosimilars in details. The second part discusses key provisions of the BPCIA, including the patent dance procedures and regulatory requirements, such as demonstrating biosimilarity, interchangeability and extrapolation. Other relevant issues include the length of statutory exclusivities granted to reference products, legislations on biosimilar automatic substitution, potential abuses of patent information exchange mechanism and risks of reaching anti-competitive agreements between pioneers and biosimilar manufacturers will be further discussed. Besides, this part describes the timeline and status quo of EU and Taiwan’s biosimilar approval regulations. With comprehensive study on multiple aspects of biosimilars, this article tries to propose feasible market access plans and robust intellectual property protection strategies capitalizing upon patents and trade secrets.