Posted by Michael Wonder on 26 Mar 2017
Federal Court of Australia dismisses preliminary discovery application regarding biosimilar suspected of infringing manufacturing process patents
26 March 2017 - In the recent decision of Pfizer Ireland Pharmaceuticals v Samsung Bioepis, Justice Stephen Burley of the Federal Court of Australia has delivered an important decision dismissing an application for preliminary discovery of documents relevant to determining whether a registered biosimilar product might infringe one or more patents claiming manufacturing processes.
Pfizer parties (collectively, Pfizer) were concerned that Samsung Bioepis Co Ltd Korea (SBK) and Samsung Bioepis (SBA) were infringing one or more of their registered patents claiming a process for making a biological medicine, etanercept. Pfizer therefore sought orders pursuant to r 7.23 of the Federal Court Rules 2011 for preliminary discovery of confidential documents lodged with the TGA in order to determine whether to commence proceedings against SBK and SBA for patent infringement.
