藥品的核准前專利爭端解決程序－－美國專利連結為借鏡

Pre-Approval Patent Resolution Process of Drug Product－ Lessons From U.S. Patent Linkage

系所名稱：法學院法律科際整合研究所
學位別：碩士
畢業學年：104年
指導教授：沈宗倫
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 process, fair, clear and meet the need of the public and domestic industry.