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.

毒品法庭自美國發展而逐漸影響世界各地，甚至成為台灣修法倡議，是晚近刑事政策的重要議題。為深入了解毒品法庭，除介紹制度的發展概況與具體內涵外，尚將進一步考掘歷史成因及改革困境，並從制度構造及程序法理的二方面剖析其所引發的爭議。最後，將問題帶回台灣，在透過實證數據理解實務現況的基礎上，將改革情勢與制度問題脈絡化進行比較研究，試圖從刑事政策的觀點提出評價性建議，以作為台灣毒品施用者處遇的策進方向。 毒品法庭於其權限範圍內，避免對於毒品施用者施加刑罰，而改採治療的態度與方法，促使其參與以治療為主、多元且細緻的處遇。在此同時，也視其表現給予懲罰或獎勵，進行嚴密監督以強化治療義務的要求，加深毒品施用者兼具病人與犯人身分的矛盾。另一方面，程序轉為合作、案主導向、問題解決，則與以往對抗、案件導向、真實發現有別。藉此反思台灣毒品施用者處遇，重要的毋寧是檢討制度的各種爭議，以及其背後所顯示的刑事政策的價值選擇。 / Drug Courts that have risen from development in the United States have had a gradual influence on the rest of the world, and have even been amended into Taiwanese law. This has been an important issue in recent discussions of criminal policy. In order to understand Drug Courts in detail, this article first introduces the background and the contents of the system, and then explores historical causes and reform dilemmas. It then analyzes the issue from the perspective of institutional structure and procedural legal principles. To then focus the issue back on Taiwan, on the basis of understanding the current state of practice through empirical data, a comparative study of the context of reform and institutional issues is conducted. Finally, this article will attempt to put forward a proposal for an evaluation from the perspective of criminal policy as a strategy for dealing with drug addicts in Taiwan. Within its jurisdiction, the Drug Court will avoid applying penalties to drug users, and instead adopt attitudes and methods that focus on meticulous and multi-faceted methods that promote participation in treatment. At the same time, they also punish or reward based on performance, carry out strict supervision aimed at strengthening requirements and treatment obligations, and deepen the contradiction between the identity of patients and prisoners among drug users. On the other hand, the transition of procedures to collaboration, case-director orientation, and problem solving is different from confrontation, case-orientation, and truth discovery. In this regard, it is important to reflect on the problems with the system and the choice of values of the criminal policy seen behind them.

2012年在金融風暴與連動債事件之影響下，我國設立金融消費者保護專法引入金融消費評議制度，並成立財團法人金融消費評議中心，為我國金融消費保護開啟濃墨重彩的全新篇章。在我國眾多現存的替代紛爭解決機制中，金融消費評議機制可謂是別具特色，特殊的組織、新穎的程序進行方式，有別於法院，亦有別於其他ADR組織。金融消費評議程序大致上仿自英國金融公評人制度，混合部分我國相關法令規則設計而成，而在這五年的運行當中，評議程序是否發生問題、是否完全合於我國法制、國情？此即本文所欲研究之方向。 對於現行評議制度之檢討，本文以評議實務上之重要問題出發，提出四大問題方向，分別是以評議「前端程序、受理程序、調查程序、糾紛解決效力」為核心。本文並以我國法釋義、立法歷程研究、案例研究、學者論述研究、比較法例研究，包括英國、新加坡、澳洲等國金融ADR制度為主要研究方法，對以上議題分析並提出個人的觀察與淺見。 研究結論上，本文得出幾點具體建議與觀察成果:1、應立法授權主管機關建立金融服務業標準化之內部申訴制度，以強化申訴制度之效率與明確性；2、對於小額評議案件改採強制調處制度，以加強前端程序糾紛解決能量；3、評議制度應明文採取強制管轄模式，揚棄現行曖昧不明之立法模式；4、修整現行評議案件不受理條文，刪除當事人不適格情形，將同時將並行評議與訴訟或其他ADR程序納入不受理事由，並新增彈性不受理條款供金評中心裁量運用；5、強化金評中心事證調查權限，將調查範圍擴大至申請人造，並使違反法律效果明確化；6、解釋上，成立後核定前評議決定應具有和解契約效力。此外，於申請人縮減請求額度成立評議決定情形，應允許其對於縮減後真實損害餘額繼續訴訟救濟。

本論文從IBM在軟體的策略，尤其是軟體的產業解決方案作為研究的核心。2008年的金融海嘯造成全球經濟大衰退，IBM適時提出了智慧的地球的計劃與願景，並積極推動從客戶實際需求與價值思考出發的產業解決方案(Industrial Solution)，結果IBM驗證了其營運與業績不但沒有受到影響並且在營收與獲利上繼續穩健成長。本論文首先依時間軸對IBM自1993年葛士納總裁接任後針對服務與創新的轉型；到2003年帕米沙諾接班後的併購計劃與智慧的地球創新策略；乃至於2012年羅美蒂繼任後推動之商業分析，軟體產業解決方案以及最重要的2015年成長計劃等各項重要改革與執行策略做一詳細的整理與分析，個案研究針對IBM公司所面臨的挑戰與企業經營策略及轉型架構進行分析與探討並延伸至軟體產業解決方案，以Michael Porter的五力分析架構對IBM公司在軟體產業與產業解決方案的產業競爭態勢予以深入探討分析，並針對IBM與其主要競爭對手的軟體產業解決方案以SWOT做一完整的分析，此外也從IBM的軟體事業群的成長與轉型策略，來驗證IBM對軟體的產業解決方案的重視與策略意涵，並針對軟體之產業架構(Industry Framework)的發展與導入的「客戶導向與客製化產業解決方案開發策略(client focused & tailored execution strategy)」與成功要素予以分析並歸納。 最後結論中對國內軟體產業以Michael Porter的鑽石模型做一分析，並對未來台灣軟體產業可能的發展方向提出建議以提供產業與政策制定者參考，如何面對與開發國際市場以及如何從人才面發展並建立台灣的軟體產業競爭優勢將是值得我們仔細深入思考的方向，希望未來台灣的軟體產業也能創造出典範移轉，發展出如同IC設計與製造產業的規模與競爭優勢。 / The development of this paper is focused on IBM`s software strategy，especially on the strategy of IBM`s software industrial solution as the research focuses。When the financial tsunami caused the serious economic recession around the world during 2008 year end，IBM raised the「smarter planet 」initiative and vision to drive the execution of series of industrial solution centric projects according to the client real requirements and values。IBM proved that its operation and business performance were not affected by this crisis，moreover IBM continued to grow steadily in the areas of both income and margin。In the context of this paper，I will first analyze the IBM`s transformation history in the three key stages under three CEOs，including Lou Gerstner`s service & innovation transformation since 1993；Sam Palmisano`s Merge & Acquisition plan & smarter Planet initiative；and Ginni Rometty`s 2015 roadmap plan to shoot for at least US$ 20 EPS by year 2015。 In the case study we will analyze the challenges which IBM was facing from corporate operation and transformation standpoints. For IBM`s software & software industrial solution strategy，Michael Porter’s five forces framework will be used to do an analysis to have a clear view on IBM`s competitiveness in the software & software industrial solution industry. SWOT analysis will also be applied to gain an in-depth view on IBM and its major software industrial solution competitors。From IBM software group’s growth and transformation strategy，we can also verify the strategic imperatives on IBM`s focuses on industrial solutions。Finally we use the example of how IBM successfully developed the various Industry Frameworks through client focused & tailored execution strategy to illustrate IBM`s asset-based solution development concept。From the recent organizational transformation of IBM software group in 2012，we can also prove that the transformation direction is toward solution centric。 In the summary of this paper I will analyze Taiwan`s software industry using Michael Porter’s Diamond model to come out several suggestions for the reference of software development vendors and government policy makers in Taiwan。How to develop the international market and build the talent resources to increase Taiwan`s competitiveness advantage will be the key focuses which we need to think deeply。Hopefully the software industry in Taiwan will have a paradigm shift and grow to the scale of the IC design and manufacturing industry with competitiveness。