醫藥資料專屬權制度之法律經濟分析

The Legal and Economic Dimensions of Data Exclusivity in Pharmaceutical Regulation

生技製藥產業是一種研究密集、高風險、高投資的活動，醫藥界在從事新藥研發時，為確保其投資能有效回收，往往必須取得專利權，以確保其成本回收。跨太平洋夥伴全面進步協定（Comprehensive and Progressive Agreement for Trans-Pacific Partnership, CPTPP）採取較WTO之《與貿易有關之智慧財產權協定（Agreement on Trade-related Intellectual Property Rights，TRIPS）》更為嚴格保護制度（通稱為TRIPS-plus）。我國政府在以加入CPTPP為政策目標之前提下，已於2018年增訂藥事法第40條之3新適應症資料專屬權與藥事法第48條之3至第48條之22（（第四章之一「西藥之專利連結制度」）（，立藥藥專專利資揭露、、名藥藥明、、發發可延遲與與售專專屬間等機制，以符合入會之標準。目前關於專利連結制度之研究已累積相當文獻，對其法制內涵與實務運作已有較為充分之探討，相關議題亦多涉及藥專專利訴訟、侵權抗辯與程序設計領域，屬另藥主題之研究重點。相對而言，資料專屬權制度儘管已實質影響我國藥政法規與製藥產業實務，但其法律定位與經濟功能之整體理解，仍有待進一步釐清。本文擬討論醫藥資料專屬權性質與擴大資料專屬保護適用範圍（，透過經濟分析與制度回顧，指出此一制度兼具創新誘因與市場限制兩面向，若未適度平衡，延能導致仿製藥長間無法上市，影響藥專延近性與健保支出。除了因應世界醫藥法規潮流，醫療政策藥法設計應以公平、透、及利益平衡為原則，提升整體法規體系之合理性與延行性，實現公共健康與產業競爭力的雙贏。

The biopharmaceutical industry is characterized by its research-intensive, high-risk, and capital-intensive nature. To secure returns on investment, pharmaceutical innovators typically rely on patent protection. The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) adopts a more stringent intellectual property protection framework than the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), commonly referred to as“TRIPS-plus.”In anticipation of CPTPP accession, Taiwan amended its Pharmaceutical Affairs Act in 2018 to introduce data exclusivity for new indications (Article 40-3) and establish a patent linkage system (Articles 48-3 to 48-22), including provisions for patent disclosure, generic applicant declarations, regulatory approval stays, and periods of market exclusivity. While existing literature has extensively addressed the patent linkage system—focusing on legal mechanisms, infringement disputes, and procedural design—scholarly attention to the legal nature and economic implications of data exclusivity remains relatively limited. This article aims to analyze the institutional function and legal character of pharmaceutical data exclusivity, particularly in light of its expanded scope under the CPTPP. Through a combined legal-economic analysis and institutional review, the study identifies a dual character in the data exclusivity regime: it simultaneously serves as an innovation incentive and a market entry barrier. Without appropriate balancing mechanisms, this system may delay the entry of generic drugs, reducing accessibility and increasing public healthcare expenditures. Beyond aligning with global pharmaceutical regulatory trends, legislative design in healthcare policy should emphasize fairness, transparency, and benefit-sharing to enhance regulatory coherence and achieve a balance between public health objectives and pharmaceutical innovation.