Telix patent fight over Novartis’ Pluvicto heads toward 2027 trial

The Federal Court of Australia has mapped out the next phase of a closely watched patent dispute between Melbourne-based Telix Pharmaceuticals and the Purdue Research Foundation, as Telix continues its bid to clear the legal path for its small molecule radioligand therapy candidate TLX597.

The Purdue Research Foundation is the legal owner of the intellectual property (IP) patents behind prostate cancer radiopharmaceutical Pluvicto (lutetium Lu 177 vipivotide tetraxetan), while Novartis holds the exclusive commercialisation license.

The litigation stems from proceedings filed in February 2026 by Telix, represented by Herbert Smith Freehills Kramer, seeking to invalidate an Australian patent held by the Purdue Research Foundation that protects Pluvicto. Purdue, represented by Clayton Utz, has filed a cross-claim alleging patent infringement.

Justice Stephen Burley has issued a case management timetable extending to August 2027, following recent Federal Court orders made on 24 July. The latest orders mark a procedural milestone in the litigation where Purdue has discontinued its interlocutory application to amend its case, prompting the Court to vacate earlier orders relating to that application.

A comprehensive pre-trial timetable has also been established where experts from both parties will participate in Court-supervised conferences in August 2027 aimed at narrowing the disputed technical issues before producing a joint expert report.

The proceedings unfold as Telix advances development of TLX591, its radio antibody-drug conjugate (rADC) designed to compete with Novartis’ Pluvicto in metastatic castration-resistant prostate cancer (mCRPC).

Telix senior executives attended the recent American Society of Clinical Oncology (ASCO) meeting, where the company presented data from the first part of its phase III ProstACT trial. Patients enrolled in the study have previously received other therapies, and investigators are free to pair TLX591 with either Astellas’ Xtandi (enzalutamide), docetaxel or abiraterone during the study.

Like Pluvicto, TLX591 uses an isotope of lutetium to deliver targeted radiation to cancer cells. However, while Pluvicto uses a small molecule to guide the lutetium to its target, TLX591 employs an antibody-based approach. The company believes this could allow treatment with just two doses, compared with Pluvicto’s regimen of up to six doses, while potentially delivering a more favourable safety profile.

Telix expects to report data from the second part of the ProstACT trial by the end of this year or early 2027. The study is enrolling patients across Australia, New Zealand, Canada, Türkiye, the United Kingdom, Singapore, South Korea and the United States. Should TLX591 secure regulatory approval, it would become Telix’s first therapeutic product for commercialisation.

The patent dispute also comes as Novartis seeks to broaden the commercial reach of Pluvicto in Australia. The Medical Oncology Group of Australia (MOGA) is backing Novartis’ application to the Medical Services Advisory Committee (MSAC) to expand access to Pluvicto earlier in the treatment pathway for men with mCRPC.

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