醫藥專利保護之競爭法爭議——論專利連結制度之未來發展

Abstract

本文旨在探究我國於藥事法引入美國Hatch-Waxman Act形式之西藥專利連結制度後可能產生之競爭法上爭議，及現行法與立法論上之防治和應對。本文首先歸納包含美國、我國在內，各國關於藥事審查制度與專利制度連結之規定方式，及涉及專利權行使行為之競爭法爭議之處理方式。經整理歸納，本文以美國制度作為參考，並認為我國除公平交易法第45條之適用外，亦有依據憲法第16條救濟權之保障建立「憲法豁免原則」之必要，作為公平交易法是否介入管制藥事相關市場之考量點。 其次，對於本文歸納之三類競爭法爭議行為——「不實陳述」、「司法救濟程序之濫用」、「逆向給付和解協議」，於公平交易法第46條或一般法規競合下皆應優先適用公平交易法之規定。又於各該行為之情況下，公平交易法第45條合法、正當之二階段要件，有其分別應受審查之具體內容。針對司法救濟程序之濫用，更須適用憲法豁免原則，以確認是否仍屬憲法保障之救濟權行使範圍內。而除現行法制下已制定或可透過解釋建立之應對措施外，本文並於立法論上分別提出「專利資訊真實妥適維持請求權」、「銷售專屬期間失權規定之擴充」及「Carve-out聲明之再建構」，以作為現行法制之補完。謹以本文提出之若干分析及建議，希冀所撰內容得作為我國專利連結制度施行後應對相關爭議之參考。

This thesis seeks to investigate the probable anti-trust issues after the introduction of the U.S.-Hatch-Waxman-Act type of patent linkage, and the prevention and solutions not only under the current legal system but also from the legislative perspective. Firstly, this thesis summarizes the patent linkages in several countries, including U.S. and Taiwan, and also their ways of dealing with the anti-trust issues regarding the enforcement of the patent. With the induction, in this thesis, the U.S. Hatch-Waxman Act is chosen as a comparison, and as the opinion of this thesis, while dealing with the anti-trust issues regarding the enforcement of patent, not only Article 45 of the Fair Trade Law shall be considered, but also the “Constitutional Exemption Doctrine” shall be established in accordance with the right of remedy protected under Article 16 of the Constitution, as the consideration of the regulation of the Fair Trade Law in the pharmaceutical relative market. Secondly, for the three types of anti-trust conducts under the induction of this thesis, respectively “Misrepresentation”, “Abuse of the Right of Remedy” and “Reverse Payment Settlement Agreement”, the Fair Trade Law has the priority of being applied in accordance with the Article 46 of the Fair Trade Law or the general rules of concurrent relationship. Then, the two-step requirements, legality, and legitimacy, under Article 45 of the Fair Trade Law also have specific contents respectively for the three conducts above. And for “Abuse of the Right of Remedy”, the assessment under the Constitutional Exemption Doctrine is further required, to ensure whether the conduct still falls into the scope of the right of remedy protected under the Constitution. Furthermore, in addition to the solutions that have been established or can be established through the interpretation of law under the current legal system, this thesis also establishes the solutions, respectively “the right to maintain the authenticity and appropriateness of the patent registration”, “the enlargement of the regulations regarding the forfeiture of marketing exclusivity” and “the restructure of carve-out certification”, as the complement of the current legal system. With several analyses and suggestions in this thesis, I hope that it can be the reference for dealing with the relevant issues after the enforcement of Patent Linkage in our country.