Interlocutory injunction granted in a pharmaceutical patent infringement case

Wayne Condon of Griffith Hack reports on the latest pharmaceutical patents to come under attack in court in Australia are two patents for Lilly’s Gemzar oncology drug. The active agent in Gemzar is gemcitabine hydrochloride. Gemzar is protected, in Australia, by two patents – one for the compound (the compound
patent) and one for a process relating to the manufacture of gemcitabine hydrochloride (the process patent).

According to Wayne Condon, the Court took into account the lack of clarity in the position (even assuming there were no other generic entrants into the market in the meantime) about whether the Department of Health and Ageing might restore the PBS price reductions that would have been implemented
in the meantime. The Court also held that the mere fact of competition in the market may well lead to quite substantial changes in the prescribing practices of medical practitioners, which would be unquantifiable. Wayne Condon also noted that Justice Jessup was much attracted by the approach taken by the Court in GenRx Pty Ltd v Sanofi-Aventis that temporary disturbance of the status quo was not justified. The judge did, however, draw a distinction between the compound patent and the process patent in considering whether damages would be an adequate remedy.

According to Wayne Condon, this is yet another example of the line of recent cases that suggest the Australian Federal Court is more likely to grant interlocutory injunction applications in pharmaceutical patent cases than not grant them. This, in turn, makes it even more important that generic pharmaceutical
companies wishing to gain early market entry into Australia take prompt steps to clear the path of any patent obstacles they have to negotiate.

Griffith Hack - Interlocutory injunction granted in a pharmaceutical patent infringement case