Legal clash threatens access to prostate cancer treatment

From 1 July 2025, Medicare is set to fund radioligand therapy 177-Lutetium prostate-specific membrane antigen (LuPSMA) in the treatment of metastatic castrate-resistant prostate cancer (mCRPC). Yet, the milestone is overshadowed by a patent dispute in the Federal Court of Australia.

Novartis subsidiary Endocyte is pursuing legal action against the nation’s largest private cancer care provider, GenesisCare. The lawsuit, filed in January, alleges that GenesisCare’s use of a generic 177Lu-PSMA I&T treatment infringes on Novartis’ patent for Pluvicto. A court hearing has been set for 31 July before Justice Stephen Burley.

The dispute follows a draft proposal submitted by Novartis to the Department of Health (DoH) in November, seeking interim “bridging” access to its patented therapy, Pluvicto, while simultaneously requesting a delay in the MBS listing of the locally compounded alternative. The DoH rejected the request, stating that MBS funding “applies universally to all forms of Lutetium,” including both I&T and Pluvicto, from July 2025.

GenesisCare, while acknowledging the current legal proceedings, maintains that the technology was pioneered in Australia and was in clinical use before Novartis patented it. The 77Lu-PSMA I&T has been locally manufactured and compounded for over a decade using non-TGA approved radiopharmaceuticals under clinical trial conditions, the TGA Special Access Scheme (SAS), and Authorised Prescriber (AP) pathways.

Novartis’ Pluvicto was approved by the TGA, in July 2024, for the treatment of metastatic prostate cancer. Subsequently, Novartis updated its patents in Australia, effectively banning the manufacture and supply of any generic Lutetium equivalent. The move reignited criticism over the current intellectual property frameworks which fail to acknowledge the substantial financial investments of billions of dollars made by pharmaceutical companies in developing innovative treatments.

Correspondence between the DoH and Australian Diagnostic Imaging Association (ADIA) reveals that back in August 2024 the peak body was seeking assurance that providers would have a legal right to continue using 177Lu-PSMA I&T once it was added to the MBS. That assurance now hangs in legal limbo.

While the patent battle escalates, the approved Medical Services Advisory Committee (MSAC) funding for LuPSMA presents another challenge.

The MBS schedule fee of $8,000 per cycle (up to six cycles) offers a rebate of $7,901 – but stakeholders, including the ADIA and the Royal Australian and New Zealand College of Radiologists (RANZCR), argue that it is “insufficient” to meet the real-world costs of delivering the therapy outside public tertiary hospitals. The result? Patients will be forced to pay out-of-pocket to access treatment.

With Novartis represented by Clayton Utz and GenesisCare by Thomson Geer, the outcome of the July hearing could determine just how close, or how far, Australian patients with metastatic prostate cancer truly are from achieving equitable access to LuPSMA therapy.

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