摘要 自2008年金融風暴後，長期的經濟動盪造成顧客喪失對於傳統投資產業之信心。在這樣的環境下，從自動化投資管理、社群交易平台到零售演算法交易的興起，提供低成本與先進的替代方案取代傳統的投資管理產業。這種方式獲得廣大消費者的信賴，並使得顧客擁有更多投資管理之控制權。 本研究欲探討賦權投資者於金融科技的浪潮下，競爭者加入後所面臨之挑戰進行情境分析，了解投資者如何以自動化管理及報告、社群交易平台和零售演算法交易改變投資管理業之發展，並使得傳統以顧問諮詢為主的投資管理興起全自動化或財務顧問協助之新商業模式；再者，透過個案分析，分別探討自動化管理及報告為代表之機器人理財公司以及零售演算法交易平台Quantopian，並建議投資產業應善用金融科技結合兩者，因此，未來顧問所扮演的角色將轉型為從旁協助財務規劃之服務，不僅能夠降低成本，亦可大幅提升理專的效率，為更廣大的客群提供高價值之金融服務。 / Abstract The 2008 financial crisis was the worst economic disaster since it has caused public losing confidence in traditional investement management industry. As a result, the three key innovation clusters are booming─automated management and advice, retail algorithmic trading and social trading platform─that offer lower-cost and advanced alternatives to replace the traditional investement management industry. Additionally, those innovation clusters gain more trust to the masses and allow customers to control in their own investment portfolio. This study analyzes three scenarios how the empowered investors face the challenges under the new waves of Fintech. In particular, we consider the investment management industry transfer the traditional model to the new business models of fully automation or advisor-assistant. In the case studies, we compare six typical robo-advisor firms and retail algorithmic trading platform like Quantopian. Furthermore, we suggest that the investment industry should make good use of Fintech that combines both advantage of automated management and retail algorithmic trading;therefore, it can not only reduce costs but also improve the efficiency of financial services.

京都大学 / 0048 / 新制・課程博士 / 博士(法学) / 甲第18026号 / 法博第159号 / 新制||法||147(附属図書館) / 30884 / 京都大学大学院法学研究科法政理論専攻 / (主査)教授 中西 康, 教授 山本 克己, 教授 笠井 正俊 / 学位規則第4条第1項該当 / Doctor of Laws / Kyoto University / DGAM

熱可塑性エポキシ樹脂を母材とするCFRTPの母材を高分子量化することにより静的および疲労特性の改善を行えることを示し，重量平均分子量の違いによりそれらの特性が大きく変化する変曲点が存在することを明らかにした．さらに，CFRTPの実用化のためにミシンステッチを利用したCFRTPテープ積層法を提案し，その試作機を作成することで，CFRTPテープ自動積層装置の実用性を明らかにした． / 博士(工学) / Doctor of Philosophy in Engineering / 同志社大学 / Doshisha University

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.

本研究以Stroop中文叫色作業，測驗兒童和成人在Stroop作業之練習和刺激向度分離等情形下，其干擾效果的變化情形。共執行兩個實驗，實驗一中的受試者先接受中性刺激和不和諧刺激的測驗，然後對兩類作業練習8日，其後再測驗一次，探討受試者在練習前、後之干擾效果的變化情形。另一組受試接受實驗二中，中性刺激、整合性不和諧刺激和分離性不和諧刺激等作業的測驗，藉以比較整合性干擾和分離性干擾的差異。兩組受試者皆接受文字閱讀的速度測驗。 結果發現，小學二年級兒童的Stroop干擾效果最大，六年級兒童次之，成人最小，這與之前文獻上所載的研究一致，同時也證實，練習確能降低干擾效果，但仍不能使其完全消失，且練習後，三組受試間的干擾效果已無顯著差異。在實驗二的結果顯著，刺激向度分離的干擾效果仍然存在，但比整合性干擾效果小，且受試者間的分離性干擾也沒有顯著差異。而所有受試的閱讀速度均快於叫色速度。 / The study was used the Stroop Chinese task to examine the course of the Stroop interference among second, sixth grade children and adults. Two experiments were conducted. In experiment I, participants were tested with neutral and incongruent tasks and practiced with the same tasks for the following 8 days. They were tested neutral and incongruent tasks again. Then examined the course of the Stroop interference among children of second, sixth grade children and adults, they were test with neutral and incongruent tasks again. Then examine the course of the Stroop interference in between children and adult during before and after practice. The other group of participants took part in experiment II. They were presented with three tasks consist of neutral, integrated and separated incongruent tasks. Then examine the difference of the interference among children of second, sixth grade and adult during integrated and separated incongruent tasks. Two groups of participants were presented word reading speed of task. The finding of the study was Stroop interference increased from the adults through the sixth grade children and finally to the second grade children is in line with previous finding. We have confirmed that although interference decreases with practice, it is very resistant to eradication. After practice, the interference between children and adults is not significant difference. In the experiment II, it was that separated Stroop stimulus showed interference, and the amount was relatively small. The interference of separated Stroop task among children of second, sixth grade and adults were not significant difference. All participants took longer to name color than to read words.