Major radiopharmaceutical patent case exits Australia's Federal Court

Latest NewsBioPharma

The patent court case involving Novartis' radioligand therapy PLUVICTO (Lutetium (177Lu) vipivotide tetraxetan) has exited the Federal Court.

According to an order issued by Justice Stephen Burley last week, the proceeding was dismissed ahead of a case management hearing listed for 31 July.

Novartis joined the action filed against GenesisCare earlier this year.

Novartis gained rights to PLUVICTO through its 2018 acquisition of US company Endocyte, which was spun out of Purdue Research Park in 1996. Endocyte filed an action against GenesisCare in federal court in January, joined by Purdue Research Park and Novartis. 

Novartis would not comment on the dismissal. While the reason is unclear, the dispute could be the subject of a non-judicial negotiation.

The action was filed following the Albanese Government's unprecedented move in the 2024-25 Mid-Year Economic and Fiscal Outlook, to fund the unapproved PLUVICTO copy recommended by the Medical Services Advisory Committee.

The copy has no supporting clinical trials. It is not manufactured to the Good Manufacturing Practice standard, meaning it is effectively unapprovable. It is manufactured according to the Good Laboratory Practice standard, which is commonly used to produce candidates in pre-clinical studies.

PLUVICTO is among the first radioligand therapies to emerge from company pipelines. It is TGA approved, with several other candidates currently in development, including by Australian companies.