Samsung Bioepis Au Pty Ltd v Pfizer Ireland Pharmaceuticals & Ors

Samsung Bioepis Au Pty Ltd sought special leave to appeal from a decision of the Full Federal Court of Australia. The dispute concerned preliminary discovery applications made by Pfizer Ireland Pharmaceuticals and Pfizer Australia Pty Ltd. Samsung Bioepis argued that the Full Federal Court had erred in its construction and application of rule 7.23 of the Federal Court Rules, which governs preliminary discovery, and also in its approach to sections 76 and 79 of the Evidence Act concerning opinion evidence in interlocutory proceedings.

The primary legal issues before the High Court were whether the Full Federal Court had correctly interpreted and applied rule 7.23 of the Federal Court Rules, particularly concerning the preconditions for granting preliminary discovery. This involved determining whether the court had properly assessed the requirement for a "reasonable belief" that the applicant may have the right to obtain relief, and whether this assessment should focus on objective facts or the subjective state of mind of the deponents. A further issue was the correct approach to applying sections 76 and 79 of the Evidence Act to opinion evidence in interlocutory proceedings, with Samsung Bioepis contending the Full Federal Court adopted a novel and incorrect approach.

Samsung Bioepis submitted that the Full Federal Court had departed from established authorities, such as *George v Rockett* and *Sandhurst*, which emphasised an objective assessment of facts to determine if a reasonable belief was held. It was argued that the Full Federal Court, particularly the Chief Justice, had shifted the focus to the subjective state of mind of the deponents, thereby excusing the need for an objectively established nexus between the asserted belief and the patent claims in question. Samsung Bioepis contended that the Full Court erred by dismissing the need to demonstrate a connection between the alleged similarity of glycosylation profiles and the specific patented methods, and by focusing on whether expert opinions were untenable rather than on whether they established a reasonable basis for believing in patent infringement. The applicant argued that the primary judge's approach, which involved an objective assessment of the evidence and the claims, was the correct one.