以合理原則檢視逆向給付和解協議案件之實證研究-以美國聯邦最高法院Actavis案後之判決為中心

有鑒於我國政府於台美貿易暨投資架構協定（Trade and Investment Framework Agreement, TIFA）中允諾修正藥事法，我國立法院於2017年12月29日三讀通過修正藥事法之規定，將美國藥價競爭及專利期間回復法（Drug Price Competition and Patent Term Restoration Act，又稱Hatch-Waxman法案）中，有關於學名藥簡化上市許可程序（Abbreviated New Drug Application, ANDA）的專利連結（Patent Linkage）相關制度，正式引進國內。惟該項制度自1984年發展至今約30餘年期間，存有不少爭議之處。其中一項最大的爭議之處，即屬原廠藥廠（Branded Drug Manufacturer）與學名藥廠（Generic Drug Manufacturer）間之逆向給付和解協議（Reverse Payment Settlement）。本文擬就美國實務處理逆向給付和解協議之爭議為討論出發點，於第貳章中介紹美國Hatch-Waxman法案之立法背景與規範概論，並解析潛在造成藥廠間行逆向給付和解協議之原因。於第參章中以逆向給付和解協議之發展沿革為始，論述該協議於學理上所引發之適法性爭議，以及美國實務判決中對於選擇各審查標準之討論，並以歐盟對逆向給付和解協議之管制方式作為比較法研究，再回歸我國法方面，整理目前學說上對藥事法修正三讀通過後，倘發生逆向給付和解協議之情事時，我國公平交易法應如何因應。於第肆章中以美國聯邦最高法院Actavis案為核心，論述聯邦最高法院審理該案之事實背景、訴訟歷程、法院之爭點及論理，最終決定以合理原則處理此類型案件，乃至後繼引發之問題，作一完整深入之討論。第伍章中則針對Actavis案判決後之下級審判決，進行實證判決分析與量化研究，分析現下美國實務如何操作合理原則以審理逆向給付和解協議類型案件，並歸納法院審理中具體參酌之重要審酌因素清單。最後，於第六章中統整本文之研究成果，並提出本文對於應如何操作合理原則之看法，同時就實證研究之成果反思給予我國藥廠、法院及公平交易委員會之啟示與建議。希冀本文之研究成果能作為Actavis案後處理逆向給付和解協議類型案件之參考，並對研究專利法與競爭法交錯互動關係之學者、實務工作者有所貢獻。

關鍵字

逆向給付和解協議；遲延給付協議；藥價競爭及專利期間回復法；專利連結；原廠藥廠；學名藥廠；合理原則；反托拉斯法

並列摘要

In light of the government’s commitment in the Trade and Investment Framework Agreement (TIFA) to amend the Pharmaceutical Affairs Act, the Legislative Yuan passed the amendment decision on December 29, 2017, which officially ushered the Patent Linkage and the Abbreviated New Drug Application (ANDA) system in the U.S. Drug Price Competition and Patent Term Restoration Act (also known as “the Hatch-Waman Act”) into Taiwan. Despite the fact that the Hatch-Waxman Act has been developed in the U.S. for more than 30 years, the system has long been denounced for many controversies, with one of the most conspicuous issue being the Reverse Payment Settlement Agreements among Branded Drug Manufacturers and Generic Drug Manufacturers. This thesis aims to set out by discussing the controversy over the US practice of dealing with Reverse Payment Settlement Agreements, introducing the legislative background and the norms of the Hatch-Waxman Act, also analyzing the cause of resulting in potential Reverse Payment Settlement Agreements between pharmaceutical manufacturers in Chapter II. Chapter III focuses on the developmental history of Reverse Payment Settlement Agreements by comparing the legal perspectives arosed from the agreement, as well as the discussion on selecting which proper standard to examine such cases in US court judgments, along with the EU approach to treat the issue as a comparative law study, and how should the Taiwan Fair Trade Act respond if similar cases were to occur after the amendment of the Pharmaceutical Affairs Act promulgates. Chapter IV will then discuss the U.S. Supreme Court’s decision in FTC v. Actavis, from the factual background, litigation history, court’s holding, court’s reasoning and eventually the final decision of applying the Rule of Reason analysis to Reverse Payment Settlement Agreement cases, which led to subsequent controversies. Chapter V conducts an empirical study centering on post-Actavis cases that involve potential Reverse Payment Settlement Agreement issues, and analyze how the current US practice manipulates the Rule of Reason to resolve the issue, thereby generating a list of important factors to consider when facing such cases. Last but not least, Chapter VI summarizes the aforementioned results, and propose a feasible way of applying the Rule of Reason, as well as reflections to the Taiwan courts, Fair Trade Commission and Drug Manufacturers.

並列關鍵字

Reverse Payment Settlement ； Pay-for-Delay Agreement ； Drug Price Competition and Patent Term Restoration Act ； Patent Linkage ； Branded Drug Manufacturer ； Generics Manufacturer ； Rule of Reason ； Antitrust Law