Merck Sharp & Dohme Corp v Apotex Pty Ltd

Merck Sharp & Dohme Corp and Merck Sharp & Dohme (Australia) Pty Ltd have brought an action against Apotex Pty Ltd for the alleged infringement of patent No. 691880, which relates to the once-daily intra-nasal use of mometasone furoate (MF), a corticosteroid, to treat allergic rhinitis. Apotex denies that it is infringing the patent and argues that the patent is invalid on the ground of lack of inventive step. Merck has applied for interlocutory orders to restrain Apotex from infringing the patent pending the final hearing of the action. The court must determine whether Merck has established a serious question to be tried, that damages will not be an adequate remedy, and that the balance of convenience favours the granting of the interlocutory relief.

The court considered the evidence of the parties on the question of inventive step. Apotex argued that the patent lacked inventive step because it was obvious to try MF as an intra-nasal once-daily treatment of allergic rhinitis with the substantial absence of systemic levels of MF in the bloodstream. Merck argued that Apotex had not established a prima facie case of invalidity because there were real arguments to counter those of Apotex as to invalidity on the basis of common general knowledge in the art. The court found that although Apotex had a real case for invalidity, it was not of sufficient strength to deny the existence of a prima facie case of infringement on Merck's part. Merck has established a prima facie case of infringement.

The court also considered the balance of convenience. Merck argued that if Apotex was not restrained it was likely that Nasonex would become a significantly less profitable product for Merck with the consequence that marketing expenditure on Nasonex would have to be reduced including the termination of the experienced sales representatives presently employed to market Nasonex. Apotex argued that damages would be an adequate remedy for Merck but not an adequate remedy for Apotex. The court found that Merck had established that it will suffer harm for which damages will not be an adequate remedy and that the balance of convenience favours protecting the status quo pending the outcome of the hearing.

Accordingly, the court made the interlocutory orders which Merck seeks. The respondent, whether by itself, its servants, agents or otherwise howsoever, is restrained from infringing Letters Patent No. 691880, including by supplying, offering to supply, selling or offering to sell: (a)APO-MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(b)APOTEX-MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(c)CHEMMART MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(d)GENRX MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(e)TERRY WHITE CHEMISTS MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle. The applicants must undertake to the Court to submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the operation of the interlocutory order or any continuation (with or without variation) thereof, and to pay the compensation referred to in (a) to the person there referred to.