AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks
evidence was not before the court. As a result, her Honour assigned little weight to the video evidence and the evidence given by Dr Pizzari by reference to the demonstrations in the video. In this case Vald had characterised the video evidence as “demonstrations”, rather than “experiments”, presumably with rule 34.50 of the Federal Court Rules 2011 (Cth) in mind. Under rule 34.50, a party cannot tender experimental proof as evidence in the Federal Court of Aus- tralia (without leave of the Court) unless it has applied for orders for the experiment to be con- ducted, including in the presence of the oppos- ing party’s representatives. The purpose of the rule is to ensure that an opposing party has an adequate opportunity to challenge the validity of an experiment, and avoid wasteful duplication by the opposing party of an experiment that can be seen to be valid. While compliance with rule 34.50 would not have saved Vald’s infringement case, the strictness of those requirements is indicative of the level of disclosure required by parties when seeking to rely on video demonstration evidence. • All relevant facts on which expert evidence is based should be disclosed to the Court. For demonstrations, this may include details regarding the test subject, information given to the test subject, and details regarding testing in advance of and the design of the demonstrations. • Parties should consider using the regime under rule 34.50 of the Federal Court Rules if they are contemplating evidence in the form of a demonstration. By engaging with the other party beforehand, agreeing a protocol for the demonstration to be carried out which will allow the other party’s solicitors and experts to be present, early attention tends to
be given to the inclusion of all of the facts the Court will find relevant in its assessment of the evidence. Term extensions remain in the firing line As the authors reported on in the 2024 Trends & Developments chapter in this guide, the patent term extension (PTE) regime continues to be a contentious issue in Australian litigation. A patentee is permitted, under the Patents Act, to apply for a PTE if certain conditions are met, including that a “pharmaceutical substance per se” is “in substance disclosed” in the specifica- tion and “in substance fall[s] within the scope” of the claims. In Novartis AG v Pharmacor Pty Limited (No 3) [2024] FCA 1307, Novartis sought a PTE in rela- tion to goods containing, or consisting of, the pharmaceutical substance included in the ARTG as: “ENTRESTO sacubitril/valsartan (combined as a sodium salt hydrate complex)”. Novartis obtained the PTE in relation to its patent titled “Pharmaceutical compositions comprising vals- artan and NEP inhibitors”, of which claim 1 is to pharmaceutical compositions comprising a NEP inhibitor, such as sacubitril, and an AT 1-antago- nist, such as valsartan, and salts thereof. Pharmacor challenged the validity of the PTE on the basis that Entreso contains TSVH, a sin- gle crystalline complex of the anionic forms of sacubitril and valsartan. Pharmacor argued that because the claims were to two separate salts of sacubitril and valsartan, TSVH was not disclosed and claimed in the patent. Novartis responded that the two distinct mol- ecules had not lost their identities in forming the complex, pointing to the ARTG certificate which
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