京都大学 / 0048 / 新制・課程博士 / 博士(エネルギー科学) / 甲第21473号 / エネ博第378号 / 新制||エネ||74(附属図書館) / 京都大学大学院エネルギー科学研究科エネルギー応用科学専攻 / (主査)教授 平藤 哲司, 教授 馬渕 守, 教授 土井 俊哉 / 学位規則第4条第1項該当 / Doctor of Energy Science / Kyoto University / DGAM

本文以2003到2006年美國上市之不動產投資信託（REITs）的資產稅賦遞延交換做研究，並用資產出售交易作為比較，觀察稅賦遞延交換對股票報酬和股利的影響，研究結果發現稅賦遞延交換對於股票報酬有負的宣告效果，然而出售資產的交易有正的且顯著的宣告效果，由於美國REITs基於稅法規定，作為免稅體，每年要以股利的形式分配百分之九十的盈餘給股東，稅賦遞延交換並不能像資產出售交易一樣帶來現金流入，因此對於未來股東的股利所得有所影響，股東對於股票報酬沒有正向的反應，但是股東會考慮稅賦遞延交換會帶來資產重配置的效率，再加上REITs通常會支付比規定還要多的股利，因此稅賦遞延交換的對於股票報酬的負影響會因此而減弱，進一步針對交易方式還有REITs股利分配進行研究，研究的結果支持稅賦遞延交換後的股利比起直接出售交易後所發放的股利還要少。本文除了研究股東對於交易宣告的反應之外，也綜觀不同資產交易方式的現金流量和REITs股利的關連性，藉此瞭解影響REITs選擇交易方式的內涵因素，以及對股票報酬和股利的影響。 / This research examines the tax deferred exchanges made by public U.S. Real Estate Investment Trusts (REITs) over 2003-2006 as well as the transactions of sell-off. The purpose of this study attempts to explore the effects of tax deferred exchange on stock returns and dividend distribution. Result of this study shows that announcement effect of tax deferred exchange is negative in stock value. On the contrary, the relationship between sell-offs and stock value is significantly positive. The reason to explain the difference on announcement effect between two types of property transaction is the specific taxable earning distribution restriction on REITs. U.S REITs have to pay out 90 % of taxable earnings in the form of dividends to their shareholders to exempt from tax. As a result, tax deferred exchange doesn’t bring cash inflow contributing to dividend increase and then shareholders react a lower stock return on tax deferred exchange than on sell-offs. However, the negative effect is weakened by the efficiency of asset reallocation and the regular dividend distribution over tax law restriction. In the analysis of dividend payment, the result of dividend examination supports the hypothesis that tax deferred exchange without cash inflow make dividend fewer than sell-offs. This study may be of importance in explaining the reaction of shareholders on tax deferred exchange of REITs’ property, as well as in providing shareholders with a better understanding of the relationship between cash flow and dividend distribution in order to clarify the cause that affect REITs to utilize different types of transaction and the factors that affect stock return and dividend.

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.

本論文主要是探討在二維度空間上二母體分佈是否一致。我們利用排列 (permutation)檢定方法來做比較, 並藉由費雪(Fisher)正確檢定方法的想法而提出重標記 (relabel)排列檢定方法或稱為費雪排列檢定法。 我們透過可交換性的特質證明它是正確 (exact) 的並且比 Syrjala (1996)所建議的排列檢定方法有更高的檢定力 (power)。 本論文另提出二個空間模型: spatial multinomial-relative-log-normal 模型 與 spatial Poisson-relative-log-normal 模型 來配適一般在漁業中常有的右斜長尾次數分佈並包含很多0 的空間資料。另外一般物種可能因天性或自然環境因素像食物、溫度等影響而有群聚行為發生, 這二個模型亦可描述出空間資料的群聚現象以做適當的推論。 / This thesis proposes the relabel (Fisher's) permutation test inspired by Fisher's exact test to compare between distributions of two (fishery) data sets locating on a two-dimensional lattice. We show that the permutation test given by Syrjala (1996} is not exact, but our relabel permutation test is exact and, additionally, more powerful. This thesis also studies two spatial models: the spatial multinomial-relative-log-normal model and the spatial Poisson-relative-log-normal model. Both models not only exhibit characteristics of skewness with a long right-hand tail and of high proportion of zero catches which usually appear in fishery data, but also have the ability to describe various types of aggregative behaviors.

台灣資訊服務業的興起，係源自於企業需要資訊服務以解決重複性作業及複雜的管理面問題，以及過去外商進入台灣市場促成產業的競爭發展。台灣資訊服務業者普遍存在有營運資本小、資源有限、產業鏈分工界線不明確的先天體質問題，又同時面臨內需市場小、進入障礙低、競爭者眾之環境面挑戰，在對外開拓國際市場時，又得面對瞬息萬變的環境競爭因素。 資通訊科技服務係為國家基礎建設，資通訊服務是伴隨著商業應用需求而來。繼電子、資訊及通訊產品發展成為占有台灣高達3成外銷比重之後，政府已將資訊服務業列入重點推動產業，期許能在既有的硬體產業優勢下，結合資訊服務業者於軟體質量的提升，打造台灣核心競爭優勢。尤其是資訊服務產業中占比重最高之系統整合業者，應如何建立核心競爭優勢，推出具競爭力的產品服務，建立與產業客戶的長期合作關係，並確保在利基市場上的交易競爭優勢，以求獲利與永續經營發展，是值得關切的議題。 本論文分析架構係以交易成本理論和策略行銷4C理論為基礎，以A公司個案分析為主軸。透過探討A公司發展歷程中如何建立4C行銷策略優勢，包括如何降低客戶之C1：外顯單位效益成本、C2：資訊搜尋成本、C3：道德危機成本，以及運用C4：專屬陷入成本等，以建立市場行銷優勢，並運用4C優勢，建立良性之4C循環，以求長期經營發展。A公司之行銷策略將可提供類似規模與背景的資訊服務業者參考之用。 研究分析A公司個案後，發現其4C循環策略為，建立C1優勢加強競爭力，藉由與C3優勢強者合作拓展通路以降低C2，在客戶端建立有利的C3和C4，並為符合客戶之C1需求，再強化C1之產品效用，建立更強的C3和C4；但其中最為注重C1，因為C1是競爭力的來源，是構成其他3個C的支撐點。 朝聚焦策略發展，並做好基礎技術研發和國際品質認證等基本功；對產品有明確之STP（Segmentation, Target, Positioning），並掌握市場動向之洞察力（street-smart insight），以對的產品切入對的市場（do it right），形成有利的4C循環，才能夠維持優於同業之表現。並在穩健創新經營原則下，掌握利基市場，因時因地制宜的運用4C行銷策略，才能確保4C競爭優勢。 / The advancement of Taiwan IT services is derived from the business needs for information service to solve duplicate activities and complicate management problems, and also contributed by the industrial competitions from foreign IT service companies’ entering Taiwan market. In Taiwan IT service industry there widely exist endowment problems like small operation capital, limited resources, vague supply chains, etc., and environmental challenges, such as the small domestic market, low industrial barrier, furious competitions, etc., and furthermore, there are changeable competition factors in exploring international markets. ICT services are the fundamental national infrastructure, and are accompanied by business application needs. As we know, electronic, information and communication products account for more than 30% of Taiwan exports. After this, with the expectation to create the core competitive strength for Taiwan, IT service industry is one of the key promotion targets chosen by the government, to combine the current hardware industrial strength with the upgrade of software quality and volume. Especially for system integration services, the majority type of IT service industry, it is always worthy to study how to build up its core competence, launch competitive product services, and establish long-term relationship with customers to ensure transaction strength in the niche market, gain profits and sustain for long. The research is based on the analysis framework of transaction cost theory, and strategic marketing 4C theory. The case study：Company A is the axis. By researching the development of Company A, to find how it can accumulate 4C strength, including how to lower customers’ external cost on utility, cost of information searches, cost of moral hazards, and better use cost of assets specificity to enter positive 4C cycles in the long run. Its marketing strategy can be used as a reference for the similar IT service companies. The finding of Company A’s 4C cycles is that, build up C1 power to strengthen its competitiveness, by alliance with C3 power enabled partners to lower C2, and establish customers positive C3 and C4. In the meantime, in accordance with the customer’s C1 needs to enforce the utility of C1, there is C3 and C4 competitiveness strengthened furthermore. Above all, it is suggested to focus on C1, and be aware that C1 is the source of competitiveness, and the leverage of other 3Cs. Deploy focus strategy, and elaborate the basic techniques of fundamental technology research and international quality assurance, with specific product STP（Segmentation, Target, Positioning）, street-smart insight and do-it-right, will form positive 4C cycles, which can result in better performance in the industry. Under the stable, innovative operation principles, catch niche markets and use strategic marketing 4C deliberately to ensure 4C competitive strength.