In a recent decision, the Federal Court of Australia dismissed an application for an interlocutory injunction. This has allowed two pharmaceutical companies to launch their generic drugs as planned pending the outcome of the trial. The decision is interesting because in recent years most applications for an interlocutory injunction in pharmaceutical and medical device patent cases have been granted.
In October and November 2010, two generic companies, Interpharma and Hospira, had each sought revocation of patents owned by the sanofi-aventis group relating to the anti-cancer drug docetaxel. sanofi-aventis then cross-claimed for infringement and applied for an interlocutory injunction to restrain the generic companies from launching their generic products.
In dismissing the application for an interlocutory injunction, Jagot J based her decision on “two bases each of which, of itself, would be sufficient to deny [sanofi-aventis] such relief”:
The first base is a requirement for the grant of an interlocutory injunction. sanofi-aventis had to establish that it would suffer irreparable harm if the generic companies were allowed to launch their products - that is, damage that could not be compensated by monetary relief. In considering this requirement, Her Honour focused on the nature of docetaxel, being an anti-cancer drug, and its market. Further, Her Honour determined that “the classes of unquantifiable losses on which [sanofi -aventis] relied appear neither likely to occur nor as serious as suggested (if they do occur) given the nature of the product. Otherwise, the suggested consequences appear to be largely within the control of [sanofi-aventis], in circumstances where the very same issues would need to be confronted by reason of expiry of the patent on 3 July 2012 in any event”. Jagot J concluded that the evidence supported the conclusion that damages will be an adequate remedy for sanofi-aventis.
The second base reflects the fact that an interlocutory injunction is an equitable remedy. This means that sanofi-aventis had to demonstrate that there was no undue delay in seeking the interlocutory injunction. sanofi-aventis submitted that it could not bring earlier proceedings as it was not until it had notice of the imminent registration of the generic by the regulatory authorities that time began to run. Based on the correspondence between sanofi-aventis and each of the generic companies wherein the generic companies positively asserted an intention to launch a generic version after expiry of the API patent on 6 February 2011, Jagot J concluded that sanofi-aventis was in a position to begin an action on a quia timet basis as early as April 2010. As such, Her Honour held that the delay had been lengthy and inadequately explained by sanofi-aventis.
Whilst this case demonstrates that each application for an interlocutory injunction will be considered on its own particular facts, it establishes that once a patentee is placed on notice of an intended event, it needs to proceed expeditiously if it is to be given the benefit of equitable relief such as an interlocutory injunction.