Life Sciences and Pharma IP Litigation 2025

AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

Sandoz’s evidence on ascertainment involved a “short cut” because: • it involved a hypothetical literature search that was limited to one search term (factor Xa inhibitors) and one database; and • Professor Roberts had been provided with a spreadsheet of search results from which he selected WO 919 as a top priority, but had not been provided with copies of the other documents. Justice Rofe was critical of the form of this evi - dence, and found that Professor Roberts had not been provided with “the full suite of results from searches undertaken across all his sug - gested databases”. Her Honour therefore held that the evidence did not establish that it would be reasonable for the person skilled in the art undertaking a search of the kind described by Professor Roberts, but not restricted to factor Xa inhibitors, to have found WO 919. On appeal, the Full Court found that, once Jus - tice Rofe accepted that the search results were a subset of the searches that a skilled person would have done, it was not to the point that additional searches might have been performed, or that the skilled person would have been required to review these additional documents or information. It was not, therefore, necessary for evidence to be adduced that the skilled per - son would select WO 919 over all other informa - tion that they would reasonably be expected to have discovered or found out. Invisalign appeal against SmileDirectClub In 2024, the Full Court of the Federal Court also weighed in on comparative advertising in pro - ceedings brought by Invisalign against SmileDi - rectClub.

Invisalign Australia Pty Ltd (“Invisalign”) and SmileDirectClub LLC (SDC) are competitors in the market of clear aligner teeth-straightening products in Australia. Invisalign alleged that SDC made false, misleading or deceptive rep - resentations in contravention of ss 18 and 29 of the Australian Consumer Law (ACL) in rela - tion to certain material promoting its clear align - ers, which are a type of orthodontic appliance that induces mechanical movement of the teeth (“SDC Aligner Treatment”). On appeal in Invisalign Australia Pty Ltd v Smil - eDirectClub LLC [2024] FCAFC 46, the Full Court reversed the first-instance decision of Justice Anderson, finding that SDC had engaged in con - duct which contravened the ACL. Invisalign relied on five groups of representations made by SDC, each of which was considered by the Full Court. These representations and the Full Court’s holdings are summarised below: 1. The comparable treatment representations – the SDC Aligner Treatment was of compara - ble efficacy to, and would achieve the same or similar clinical outcomes to, traditional braces or Invisalign aligners. The Full Court did not agree with the primary judge and held that by making the comparable treatment representations, SDC had contra - vened the ACL, as the dominant impression cre - ated by the promotional material was to convey to a consumer that they would end up with the same smile, irrespective of whether they chose braces or SDC Aligner Treatment; that consum - ers would achieve the same or a similar clinical outcome from SDC Aligner Treatment as they would achieve with Invisalign treatment; and that SDC Aligner Treatment was of comparable

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