AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks
Current Australian Patent Litigation The year 2024 gave rise to a number of signifi- cant decisions shaping key aspects of Australian patent law, from the approach to obviousness to procedural rules and patent term extensions. The Full Federal Court handed down a semi- nal judgment in Sandoz v Bayer, clarifying the approach to inventive step in the context of the drug development process and providing valu- able guidance on the question of ascertainment of prior art under the pre-Raising the Bar Patents Act. In other decisions, the long-running dispute between Aristocrat Technologies and the Com- missioner of Patents is set to be back before the High Court following the grant of special leave in August. In Vald v KangaTech, the Fed- eral Court highlighted the pitfalls of relying on video demonstration evidence, emphasising the need for transparency with the opposing party and for adherence to procedural rules for experimental evidence. Lastly, in one of several patent term extension challenges commenced in 2024, Novartis v Pharmacor underscored the complexities of the Australian patent term exten- sion regime. Inherently risky business – full court finds rivaroxaban patents obvious The Full Federal Court has weighed in on appeal to reverse a decision of Justice Rofe at first instance, and to invalidate Bayer’s patents for a formulation and dosing regimen of rivaroxaban. The decision confirms that inherent general risks in the routine drug development process are not sufficient, on their own, to render follow-on pat- ents inventive. Rivaroxaban is in a class of factor Xa inhibitors, and is the active ingredient in Bayer’s block-
buster drug XARELTO. XARELTO is used as treatment for deep vein thrombosis and pulmo- nary embolism. XARELTO is Bayer’s best-selling drug globally, earning around AUD140 million under the Pharmaceutical Benefits Scheme in 2024. Internationally, Bayer and Sandoz have been involved in a number of disputes regard- ing rivaroxaban, including in the UK where the UK High Court revoked Bayer’s patents. At issue were Australian Patent No 2004305226 (the 226 Patent) for a formulation and Austral- ian Patent No 2006208613 (the 613 Patent) for a once-a-day dosing regimen. At first instance Justice Rofe found that each was not obvious in the light of the common general knowledge (CGK) together with WO 919, the compound patent which disclosed rivaroxaban as a par- ticularly promising candidate. In her reasoning, Justice Rofe accepted that WO 919 would be of interest to a drug development team seeking to develop a new antithrombotic drug, and that the skilled reader would likely focus on rivaroxaban when selecting lead can- didates to take into further drug development work. Justice Rofe then went on to apply the “reformulated Cripps question”, finding that: • the well-known standard series of steps of drug development were not routine steps; and • Bayer’s drug development journey was more akin to a “voyage of discovery” than the “working towards the invention with an expectation of success”. On appeal, the Full Court found that Justice Rofe had placed too much emphasis on “the risk of failure to gain regulatory approval which is inherent in any drug development project”, and what would have been undertaken as a matter
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