Do Clinical Drug Trials Trigger Imminent Infringement?

By Landy Jiang and Xiao Li

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Imminent infringement is a new concept for China and has recently been introduced into Chinese Law. It brings China into line with the relevant provisions of the WTO agreement of Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 2001. Article 61 of the Patent Law allows a patent holder to seek an order requiring an apparent infringer to suspend its activities and preserve the relevant property in cases where there is reasonable evidence of ¡¥imminent infringement¡¦ that will cause ¡¥irreparable harm¡¦. Although Article 63 does provide exemptions for scientific research and experimental use, drug companies insist that ¡¥experimental use¡¦ must be construed narrowly. They argue that ¡¥imminent infringement¡¦ occurs as soon as experiments are directed towards a clear commercial purpose. This includes the production or use of a patented drug for clinical experiments in order to obtain regulatory approval. In this article we examine the reasons as to why clinical trials are exempted from liability for patent infringement.