AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks
Overview The year 2024 brought several significant intel - lectual property judgments in the life sciences and pharmaceuticals sector, particularly in the context of patents and consumer law. In Invis - align v SmileDirectClub, the Full Federal Court found that SmileDirectClub’s comparative advertising contravened the Australian Con - sumer Law, emphasising the need for accuracy and fairness in health and efficacy claims in comparative advertising. The Full Federal Court also handed down a seminal judgment in San - doz v Bayer, holding that in the context of the pharmaceutical development process, taking a drug candidate forward in a generally high-risk area is not enough to overcome an obviousness challenge. The same case also provided valu - able guidance on the question of ascertainment of prior art documents under the pre-Raising the Bar Patents Act. Meanwhile, the ToolGen v Fisher decision high - lighted the scope for correcting obvious mis - takes in patent claims, reinforcing that while the error and its correction must be apparent to a skilled person, the skilled person will be taken to bring all their knowledge to that question. Aus - tralia’s highly contentious patent term extension regime was again tested in Novartis v Pharma - cor, where the court ruled that Novartis’ term extension should be removed. The Australian Market The life sciences sector continued to see sig - nificant growth in Australia in 2024, with close to 1,600 biotechnology and medical technol - ogy companies now operating there. This year, the federal government announced its Strategic Examination of Research and Development, the first review into R&D in nearly 20 years, aimed at growing Australia’s science and innovation capabilities. The Strategic Examination coin -
cides with an increased push by the industry for policy reforms to strengthen Australia’s capac - ity for life sciences research, development and commercialisation, with the first National Bio - tech and Medtech Development and Commer - cialisation Summit occurring in November 2024. The year 2024 also saw the government expand on its commitment to ensuring affordable and accessible medication. The government intro - duced significant new funding (AUD4.3 billion) to the Pharmaceutical Benefits Scheme (PBS), which included AUD3.4 billion allocated for new and amended listings to the PBS, and deliv - ered a funding boost to community pharmacies of AUD3 billion per the commencement of the eighth Community Pharmacy Agreement. Inherently risky business – the Full Court finds rivaroxaban patents obvious The Full Federal Court has reversed a decision of Justice Rofe at first instance to invalidate Bayer’s patents for a particular formulation of rivaroxaban and a once-a-day dosing regimen. The decision held that general risks in the rou - tine drug development process should be under - stood as part of the background against which the person skilled in the art operates, and are not sufficient, on their own, to defeat an obvi - ousness challenge to formulation patents and dosage regimen patents which would have been arrived at in the course of phase I, II and III clini - cal trials. 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 a treatment for deep-vein thrombosis and pulmo - nary embolism. XARELTO is Bayer’s best-selling drug globally, earning around AUD140 million under the PBS in 2024. Internationally, Bayer
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