Generic Health Pty Ltd v Otsuka Pharmaceutical Co., Ltd

The Federal Court of Australia was asked to decide whether an interlocutory injunction should be granted in a patent infringement case between Otsuka Pharmaceutical Co., Ltd and Generic Health Pty Ltd. Otsuka, the patent holder, sought relief on the basis that Generic Health's intended sale of generic pharmaceutical products would infringe their patents for a carbostyril compound, aripiprazole, used in the treatment of schizophrenia and other disorders of the central nervous system. Generic Health cross-claimed for the revocation of Otsuka's patents. The primary judge found a prima facie case of infringement under section 117(2)(b) of the Patents Act 1990 (Cth) and granted an interlocutory injunction against Generic Health's supply of the products. Generic Health appealed the grant of this injunction, arguing that there was insufficient evidence to establish a prima facie case of infringement and that the balance of convenience did not favour the grant of the injunction.

The court considered the nature of the products supplied and the requisite knowledge for an infringement under section 117(2)(b) of the Act. It noted that the products were not staple commercial products and that the issue of whether they were such products was not necessary to decide. The court found that there was a prima facie case that Generic Health had reason to believe that the products would be put to an infringing use, based on the evidence of the use of aripiprazole to treat cognitive impairment associated with schizophrenia. The court also held that an assessment of the strength of the prima facie case was not required under Beecham Group Ltd v Bristol Laboratories Pty Ltd and that the balance of convenience and justice favoured the grant of interlocutory injunctive relief. The court concluded that the appeal against the interlocutory injunction should be refused, and the applicant should pay the respondent’s costs.