According to one Australian columnist, the Commonwealth should fund and effectively indemnify one side of an intellectual property dispute or legislate to retrospectively revoke lawfully granted patents.
In a week of strange claims propagated by PBS conspiracy theorists, these have added to what is now a motherload of bad ideas currently infecting the public discussion on medicines and health technologies.
Novartis has launched Federal Court action to defend the intellectual property covering its radioligand therapy PLUVICTO (Lutetium (177Lu) vipivotide tetraxetan) against copies prescribed and administered by GenesisCare.
PLUVICTO is TGA-approved based on extensive clinical trial data and the gold standard of Good Manufacturing Practice.
The copies are unapproved and unapprovable. Public hospitals have been producing them according to the Good Laboratory Practice standard, which is commonly used to produce candidates in pre-clinical studies.
The users of these copies assert their safety without any widely accepted level of evidence. Why didn't they patent the copies when they started using them? Why didn't they launch proper clinical trials? Why did they wait to seek government funding until PLUVICTO's arrival?
The Medical Services Advisory Committee recommended the copies based on published PLUVICTO data, and the Albanese Government bizarrely decided to fund them.
Funding approval involved an unfortunate workaround of Australia's established regulatory regime based on some clinicians asserting the safety of the copies based on their experience. Is that the new standard? If so, we can abolish the TGA.
This funding decision has hit an unsurprising snag. Public hospital administrators may have been hit by a reality bomb of legal exposure to federal court action and the apparent risk of adverse events associated with using an unapproved product.
Yet, according to a columnist in The Australian, the Albanese Government should indemnify the hospitals against the risks, including side effects from using an unapproved product, fund GenesisCare's legal costs, or legislate to revoke the PLUVICTO patents ahead of the court case.
Sorry, but this is kooky.
Patents are granted under a legislated framework that is independent of ministerial intervention. People and organisations are free to dispute those patents in Australia's court system, which is precisely what's happening, and patent holders are free to defend them and seek to block the use of unlawful copies.
In this case, Novartis is defending its intellectual property granted under Australian law. Australian courts will determine the validity of these rights, free of political intervention.
The parliament cannot simply revoke a patent without broader implications for Australian intellectual property protection and obligations under any number of trade agreements. Any move to proactively revoke patents covering one product would certainly necessitate a wider change in the law, which would risk a shuddering effect on Australia's life sciences sector and international reputation, including the range of emerging nuclear medicine companies.
The Commonwealth could join the court action, as it has in many cases, but funding the respondent's court case against lawfully granted patents while indemnifying them against a negative outcome and the risk of side effects involving the use of an unapproved product? Seems unlikely, not least because it's a terrible idea.
