專利連結制度對台灣本土藥廠的影響- 以台灣東洋為例

Abstract

自由貿易協定(FTA)對於國際上智慧財產權與法律制度的影響，大多涉及提高藥品專利保護、試驗數據保護以及專利延長等等措施，這些制度是相較WTO的”與貿易相關的知識產權協議”(簡稱TRIPS)規範更為嚴格，將相關彈性條款轉變為剛性的專利連結制度。台灣也在2016年8月為了配合「臺美貿易暨投資架構協定」（Trade and Investment Framework Agreement, TIFA）談判及擬加入「跨太平洋夥伴協定」（The Trans-Pacific Partnership, TPP），提出「藥事法」部分條文修正草案，並於2019年8月正式上路台灣版本的專利連結制度，引起國內產業的反彈。 然而專利本身賦予發明或創作之人專利權的法律保障，本身目的就是為了鼓勵發明或創作，給予一定法定期間內享有法律上專有的權利，加上藥品本身能夠申請的專利數量有限，提高專利保護換個面向正是鼓勵本土藥廠朝向研發型藥廠發展，透過專利連結也可一定程度降低專利檢索的門檻，避免在未預期的情況下踩到原廠專利，浪費了前期投入研發的資源，因此撇開制度政治與談判的角力，制度本身並沒有好壞，而是視廠商如何看待及因應。 國際上許多國家也先後實施的專利連結制度，如韓國與中國，先後在2015與2021年頒布專利連結制度，各國在貿易協定給予的框架下設計相關制度，存在部分差異，這些差異是否適合台灣? 台灣本土廠商又是如何看待已經上路接近3年的制度? 藉由分析各國制度差異並蒐集台灣東洋高階主管的回饋與建議，以提供未來我國修改相關辦法之參考。

The Impact of the Free Trade Agreement(FTA) on the international intellectual property rights and legal systems usually involves measures such as extending patent protection, clinical data exclusivity, and patent extension. Compare with the WHO Agreement on Trade-Related Aspects of Intellectual Property(TRIPS), the TRIPS plus(FTA related intellectual property clauses) are higher level of protection demanded by developed countries transforming the flexible clauses into a rigid patent linkage system. In August 2016, Taiwan Executive Yuan Council approved the draft amendment to the Pharmaceutical Affairs Act which is a preliminary goal for the Trade and Investment Framework Agreement(TIFA) or The Trans-Pacific Partnership(TPP) between Taiwan and the United States. In August 2019, the Taiwan version of the patent linkage system was officially launched, causing local pharmaceutical companies were in strong opposition to the new regulation. However, the average amount of patent in one drug is limited compared to other industries. The higher standard of patent protect lies at the center of the impact. The patent linkage system regulates the process of generic drugs approval. The generic drug manufacturers cannot obtain market approval when the patent of new drug is valid or before successfully challenge the calidity of involved patents. Therefore, the system seems like a significant barrier to the timely approval of generic drugs. On the other hand, it may also br an encouragement to develop towards R&D-oriented generic companies. Through the publication of patent information of approved drug products, generic drug manfacturers can easily access and research before investing development projects, preventing from unexpected patent infringement and wasting R&D resources. In conclusion, apart from arguing the purpose of launching this system, the prospective and responds from local Taiwanes companies is more important. Korea and China has also promulgated patent linkage system in 2015 and 2021. Although the framework designed by similar trade agreement clauses, there are some differences in detail in the system. This study aimed to evaluate the impact of patent linkage system in Taiwanese local company by collecting feedback and suggestions from a domestic manufacturer, TTY biopharm. Are these defferences in other countries better than regulations in Taiwan? It may be a reference for furture system amendment.