| Summary: | 碩士 === 國立交通大學 === 科技法律研究所 === 107 === 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.
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