藥品專利權期間延長之立法目的及其落實──從新近實務爭議談起

Patent Term Extension in the Pharmaceutical Sector and the Recent Development in the Judicial Practice in Taiwan

新藥研發依賴鉅額資金投入，智慧財產權因而乃不可或缺的政策工具。若無智慧財產權保護，藥廠即無意願投入新藥研發，專利權尤其扮演關鍵角色。新近臺灣於醫藥及專利領域之重要議題，乃專利權期間延長規定之要件闡釋，最高法院及最高行政法院先後表示意見並廢棄智慧財產及商業法院判決後，逐漸釐清及確定制度本旨及其條文之具體適用。本文從專利權期間延長制度之立法目的及形塑歷史、藥品研發及查驗登記審查實務觀點，歸納智慧局、經濟部訴願會與各級法院之見解歧異處及提出本文見解，兼而檢視我國現行規定與實務運作中，尚可研議及檢討者。

There is no doubt that research and development (R&D) of a new drug is costly and time-consuming. Without any legal protection, pharmaceutical companies would not have sufficient incentive to develop innovative drugs. In this regard, patent protection is essential. One of the important and debatable issues related to pharmaceutical patent in recent years in Taiwan is the patent term extension (PTE). PTE permits patent holders to enjoy an additional period of exclusivity. The rationale behind establishing the PTE is that before being marketed, pharmaceutical products are required to undergo a series of lengthy safety and efficacy approval process under governmental administration. Thus, the effective patent term of pharmaceutical products is shorter than that of other inventions. This article summarizes the differences of opinions among the TIPO, Petitions and Appeals Committee (MOEA), Intellectual Property and Commercial Court, Supreme Court and Supreme Administrative Courts. A proper solution from the viewpoints of R&D on drugs and the process of new drug application (NDA) will be proposed too.