論我國專利期間的調整與延長、資料專屬權與專利連結制度之發展現況－－藥品智慧財產權保護相關修正草案評析

Development of Patent Term Adjustment and Extension, Data Exclusivity and Patent Linkage in Taiwan－Analysis on the Latest Draft Amendment Related to Pharmaceutical Intel-lectual Property Protection

跨太平洋夥伴協定（The Trans-Pacific Partnership Agreement，以下簡稱TPP協定）歷經數年談判，12個締約國於2015年10月6日正式達成協議，並於2016年2月4日簽署。我國政府原本擬加入TPP協定，以參與多邊貿易協定爭取我國較有利的貿易地位。惟2016年11月8日，唐納川普當選美國總統，TPP協定的未來發展充滿變數。然TPP協定中智慧財產權章，特別是與藥品相關部份，係對美國最有利的部分之一；而美國提案立場與各國談判結果，對我國未來與美經貿談判亦有重要參考價值，我國目前針對藥品智財相關之專利法與藥事法修正草案，政府實有繼續推動之誘因。是此，本文將介紹TPP協定智慧財產權專章中，專利權期間的調整與延長、資料專屬權與專利連結部分之美國提案、最終談判結果與台灣政府目前相關的修法計畫，最後並就我國專利法制、藥政管理與製藥產業可能發生之衝擊提出評論。

After negotiating for several years, 12 members reached the Trans-Pacific Partnership Agreement (TPP Agreement) on October 6th 2015 and singed on February 4th 2016. Taiwan’s government made the policy to join the TPP Agreement. Unfortunately, Donald J. Trump’s victory of the presidency creates uncertainty of TPP’s future. However, The Intellectual Property Chapter in the TPP, especially the part related to pharmaceuticals is beneficial to the U.S.; therefore, the U.S.’s proposal and final version of the TPP are still an important reference to us for our future trade negotiation with the U.S.. Because of this fact, Taiwan’s government still has incentive to promote the proposal of revising Patent Act and Pharmaceutical Affair Act in Taiwan.
This article introduces the U.S’s proposal and the provisions of TPP Agreement about patent term adjustment and extention, data exclusivity and patent linkage of pharmaceutical patents. In addition, it explores Taiwan’s related proposal of revising Patent Act and Pharmaceutical Affair Act. Eventually, this article discusses the possible impact to Taiwan’s pharmaceutical industry, patent law and patent litigation.