Apotex Pty Ltd v Cipla Limited

Apotex Pty Ltd brought an application for an interlocutory injunction against Cipla Limited, alleging infringement of a patent. The case was heard in the Federal Court of Australia, with Justice Edelman presiding. The primary legal issues the court had to resolve included whether Apotex had established a prima facie case of patent infringement, the validity of the patent in question, and the balance of convenience in granting the injunction.

In determining these issues, Justice Edelman considered evidence from various sources, including expert witnesses and affidavits from the managing director of Apotex and a forensic accountant. The court examined whether the prior art, specifically Martindale, the Flonase PI, and the Astelin PI, constituted common general knowledge or statutory documents under section 7(3) of the Patents Act 1990 (Cth). The court found significant doubts about whether these documents were part of the common general knowledge or if they could be combined to arrive at the patented invention. This uncertainty supported the argument that there was a lack of inventive step.

Justice Edelman ultimately concluded that Apotex had made out a prima facie case for patent infringement and that the balance of convenience favoured granting the injunction. Consequently, the court granted the application, restraining Cipla from engaging in certain activities related to the patented product without the permission of Apotex. The court also outlined further undertakings and ordered a case management hearing for a later date.

The final orders included restraining Cipla from manufacturing, selling, or promoting the disputed product in Australia without Apotex's consent, pending the resolution of the case. Additionally, Cipla was required to provide security for their undertakings and notify Apotex of any potential infringement by third parties. The court also mandated that Cipla would prosecute their claim expeditiously and provide notice before exploiting certain pharmaceutical products.