Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (No 3)

In the Federal Court of Australia, Sanofi-Aventis Deutschland GmbH filed an interlocutory injunction application against Alphapharm Pty Ltd, seeking to prevent the latter from manufacturing, selling, or advertising its insulin product, Semglee, which Sanofi claims infringes on its patent. Alphapharm contests the application, primarily arguing that the patent is invalid due to a lack of novelty over three prior art documents and that the Semglee product does not infringe the patent. Sanofi relies on the testimonies of six witnesses, including experts in biomedical engineering and insulin products, to support its case.

The primary legal issues the court needed to decide included whether the patent was novel and whether it was infringed by Alphapharm's product. The court evaluated the strength of Sanofi’s case based on the current state of the evidence, considering the construction of specific patent claims and comparing them to the prior art documents. The court held that it was not its role to determine the scope of the patent claims or their anticipation by prior art but to assess the strength of the case presented.

After evaluating the evidence and arguments presented, the court concluded that the balance of convenience and justice did not favour granting the interim relief sought by Sanofi. The court dismissed the interlocutory application, finding that Alphapharm had made out a prima facie case for the invalidity of the patent due to lack of novelty and that the burden of proof had not been met by Sanofi. The court also noted that Alphapharm had effectively argued that the Semglee product did not infringe the patent. The court restricted access to certain confidential information and ordered Sanofi to pay Alphapharm’s costs of the interlocutory application.