We stand to lose billions in blockbuster drug patent challenge

Australia stands to lose billions in a patent challenge to a key, more cost-effective cancer drug.

One of the reasons rare earths brought Presidents Trump and Zelinsky together is the looming boom in nuclear medicine, which is emerging as the best hope to locate and cure a wide variety of cancers.

Australia and Australians are in a wonderful position to benefit from the linked rare earths and nuclear medicine booms. But in medicine, we are under legal attack by the Swiss.

We stand to lose countless billions if the Swiss legal challenge is successful.

We will also lose our unique global position among the world leaders in both rare earths and nuclear medicine.

Australia can thank the foresight of many people for its unique position in nuclear medicine. But, in the political arena, two of the greatest contributors have been former Prime Minister Robert Menzies and current Health Minister Mark Butler.

Menzies, 67 years ago, launched the Lucas Heights nuclear reactor to enable Australia to enter the nuclear medicine industry. Butler last year took a risk in backing our nuclear cancer technology advances and won for the nation, subject to the Swiss counterattack.

This is a time in our nation’s history when it is really important for both political parties to put aside their differences and act together in Australia’s vital interests.

The timing of the Swiss attack means that they may gain a powerful legal beachhead when we are in caretaker mode preparing for the election.

Australia’s involvement in nuclear medicine is one of our great national achievements.

Currently it’s prostate cancer that is on the frontline of cures, but that’s just the start.

As is their right, the Swiss are now prepared to spend vast sums on patent-based court challenges trying to spike our long-established position in nuclear medicine. The initial challenge is to our major oncology service provider, GenesisCare, which sells Australian medicine.

The Swiss are writing to our hospitals asking about their use of Australian technology and appear to be considering legal attacks on those hospitals using Australian medicine.

One major hospital has already caved in and refuses to use Australian technology because of the danger of potentially huge damages payouts. Others may follow.

The development of nuclear medicine goes back to the 1930s with iodine. We have come a long way.

The Australian medical team being challenged by the Swiss will need government assistance to help fight in the courts. Picture: Tom Roschi

One of Australia’s current major initiatives is the prostate cancer drug PSMA i&t.

Its development started in a German university in 2015 and in 2016 at the Peter MacCallum Cancer Centre in Melbourne.

The Germans and Australians, including St Vincent’s Hospital research in Sydney, have worked closely together for the last decade in this area of nuclear medicine, which covers both imaging and treatment.

On the treatment side, the rare earth Lutetium 177 is required and is normally obtained from the Russian/Ukraine deposits. It is converted to a medical building block at Australia’s nuclear reactor at Lucas Heights.

Around 2023 it was clear Australian advances in the use of Lutetium required further trials and $300,000 was contributed by Morgan Research (the major shareholder in Haoma Mining, which has large Lutetium and other rare earth deposits in the Pilbara) and $200,000 from Genesis.

The federal government via Mark Butler contributed around $10m. The trials succeeded and the research was so successful Butler last December put Australia’s PSMA i&t on the subsidised list for medicines, starting July 1.

The current PSMA i&t cost is $8000 per dose and six doses are normally required. This cost to patients will be slashed from July 1. Neither the Germans nor Australians took out patents on their ­developments.

During the decade of German-Australian development, another German group developed a treatment and, like the first group, went to Australia to access world-class expertise to help. But this time patents were taken out. The Germans sold their technology to the Swiss company Novartis.

The Australians saw the Swiss as “copycats” but Novartis say it’s the Australians who are “copycats” and are claiming PSMA i&t breaches their patents.

The initial hearings will start in Federal Court next month. Naturally, the Swiss will bring to the court case some of the best patent legal minds.

On the Australian side, the defendants simply don’t have the money to fight the Swiss. Both political parties need to urgently get behind both the oncology provider and our hospitals and guarantee them against losses so the Australian side has the money to fight the court battles here, and possibly in world courts.

The Australians are very optimistic they can win, but clearly the Swiss believe the opposite.

I think that unless the Australian government backs up its investment in research with investment in a legal defence, we will certainly lose.

If the Swiss were to win it would be a major precedent in global patent law.

While Australia’s PSMA i&t costs $8000 a dose, the Swiss product costs $66,000 if you’re in the US, and they will fight very hard to avoid being forced into a price cut. I do not know which product is the best, but the global boom will get a huge boost if nuclear medicine is available at Australian prices.