專利連結制度運作之基石──醫藥專利的本質及法院扮演的關鍵角色【本期企劃】 試閱
The Basis of Operating the Patent Linkage: Understanding the Nature of Pharmaceutical Patent and the Key Role of the IP Court
有鑑於醫藥產業之高風險、高投資與高不確定性等特殊本質，其所應受之專利保護應當更高、更強，美國視不同產業的保護需求而微調專利法適用標準之發展過程與經驗，足堪借鏡。在專利連結制度實施之際，臺灣將邁入藥品專利保護之新篇章，據目前專利案件審判數據之統計及分析，藥品專利保護在臺灣確實有再強化之空間，本文認為值得參酌之做法，即係仰賴法院因應醫藥產業之需求，而微調專利法之判斷尺度。
After the implementation of the patent linkage, over 400 marketing approvals have been listed with patents by the NDA holders. It demonstrates the successful effect in the first step of operating the patent linkage. In the second step with respect to dispute resolution, however, the court faces challenges from the new legal issues such as eligibility of patent listing and Paragraph IV litigation. This article suggest that the court should lower down the validity threshold and strengthen infringement assessment aimed at meeting the nature of pharma patents and providing adequate patent protection.
020-034
