Intellectual property (IP) protection is a crucial component of success for all diagnostic tools. A great example of this is a bowel cancer blood test the Commonwealth Scientific and Industrial Research Organisation (CSIRO) developed in conjunction with Clinical Genomics, explains CSIRO Project lead Dr Trevor Lockett.
This test is believed to be the first commercially available blood test for bowel cancer. It has the potential to increase the rate of bowel cancer screening in Australia and effectively save thousands of lives.
A result of over ten years of research, the blood test (ColoVantage Plasma) uses ‘biomarkers’ to allow early detection of 65 per cent of bowel cancer cases. The rate of detection increases to 73 per cent for more advanced cancers (stage two or higher). The ‘biomarkers’ are essentially two genes that become methylated during the development of cancer. The use of blood as a sample overcomes the obstacle of unpleasant sample collection for stool-based examinations.
Clinical Genomics and CSIRO have signed an exclusive license agreement based on their jointly discovered and patented biomarkers for bowel cancer.
This agreement will allow Clinical Genomics to develop, deliver and promote its ColoVantage Plasma blood test for bowel cancer as an international innovation.
The benefits of IP
‘If we want to have impact from discoveries like this, then patenting is crucial,’ said Dr Lockett.
‘Benefits for society from diagnostic tests such as ours can only be realised if the tests are made available in the marketplace. It is critical to realise that at the time of patenting, a test is highly unlikely to be in its final format.’
Dr Lockett says that even when a company decides it wants to market the test, it still has significant costs ahead before sales proceed to flow.
He said the company needs to develop the test into a robust product format that can be reproduced in a wide variety of diagnostic laboratories in different parts of the world. The company also needs to test the product in large and expensive clinical trials, gain regulatory approvals for the use and finally, if the test is to meet its market potential, gain approval for the test to be subsidised through the Pharmaceutical Benefits Scheme (PBS).
‘For the company to spend these large sums of money upfront, it needs assurance that another company is not going to come along a short time later with a lookalike product that rides to market on the coat tails of their upfront commercialisation and validation expenditure,’ he said.
This is particularly the case when competing in a limited market (such as the diagnostic one).
‘This is where the patent comes in, because it is the patent that provides that all important assurance. For the life of that patent, no other company is able to market a lookalike product that will cut into its profitability.
In the cut-throat world of diagnostics, this assured window of profitability is the difference between the product becoming available on the market and saving lives, or remaining a good idea that never has impact.”