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.

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。