美國於西元2011年制定Leahy-Smith 美國發明法案(Leahy-Smith America Invents Act,AIA),規定於美國專利及商標局(United States Patent and Trademark Office,USPTO)的行政體系創設具準司法性質的多方複審程序(Inter Partes Review,IPR)等挑戰專利有效性的程序。其目的在於民事訴訟外另行創設具公眾審查色彩、能迅速淘汰品質不佳專利(weak patents)、且過程勞費較低廉的行政程序。不過,自2012 年制度創設以來,IPR被視為專利劊子手,對美國產業在專利權保護的攻防舉足輕重。生醫製藥領域更為深受影響的產業,但數據顯示生醫製藥的專利有效性卻在IPR的大刀下屹立不搖。 本文以美國IPR的制度之沿革及發展作為核心,分析不同技術領域在IPR制度下的有效性數據,並探究生醫製藥領域於IPR挑戰中一枝獨秀的表現得原因。本文亦介紹「專利連結制度」以及台灣專利舉發制度與美國複審程序的異同。對於台灣在未來導進複審程序提出建議。
The United States enacted the Leahy-Smith America Invents Act (AIA) in 2011, stipulating that the United States Patent and Trademark Office (USPTO) creates an administrative system with a quasi-judicial nature including Inter Partes Review (IPR) and other procedures that challenge the validity of patents. Its purpose is to create, in addition to civil litigation, administrative procedures that are characterized by public review, may quickly eliminate weak patents, and are relatively inexpensive. However, since the establishment of the system in 2012, IPR has been regarded as a patent executioner and has played an important role in the offensive and defensive protection of patent rights in the US industries. The biomedical and pharmaceutical industry is a particularly affected industry, but data shows that the patentability of biomedical and pharmaceutical patents has stood firm under the influence of IPR. This article takes the history and development of the IPR procedure in the United States as the core, analyzes the patentability of different technical fields under the IPR procedure, and explores the reasons for the outstanding performance of the biomedical and pharmaceutical fields in the IPR challenge. This article also introduces the "patent linkage system," and the similarities and differences between Taiwan's patent invalidation process and the US post-grant review process. In addition, the article also put forward suggestions for Taiwan’s introduction of review procedures in the future.