Patents and Diagnostics

Intellectual property claims may hinder using genomic tools for the betterment of public health, particularly for combating non-communicable diseases like type 2 diabetes, writes Anna George, an adjunct professor at Murdoch University in Australia and a Chatham House associate fellow, at the Guardian Professional. She estimates that about 20 percent of the human genome "is subject to patents that can impose complex legal and cost constraints on medicines and diagnostics."

Current — though not universal — practices allow the patenting of unmodified, though isolated, bits of genomic DNA, George says, noting that there are legal challenges, especially focused on Myriad Genetics' BRCA1 and BRCA2 gene patents, underway in the US and Australia. Two reports, one from the US National Academy of Sciences and the other from the Department of Health and Human Services, indicate that patent restrictions could hinder the development of diagnostics, George adds.

"Ensuring open access to such basic scientific genomic data is a necessary step to enable the scientific collaboration and inventive solutions to evolve," she says. "The so-called 'genome divide' is not just between developed and developing countries but also between closed and open access to these unique produces of nature that no one invented."


I wonder if Anna George or

I wonder if Anna George or Czarina Sebellius would invest 2- 4 million dollars of their own money for discovery of a new marker and establishing its utility in principle, and another 10 million to develop and qualify a highly accurate, high predictive value assay of proven clinical untility and safety when the very next day someone could take all your work, plagiarize it and practice it themselves for a few thousand dollars investment. If one is satisfied to say, "who needs expensive, clinically developed diagnostics any more? We have translation," then we are facing a future of hodgepodges of unregulated, lowest common denominator, unreliably calibrated and qualified assays of poor stability and shot in the dark clinical utility. Essentially taking us back to the middle ages where barbers guessed what was wrong with us, asked the seer next door to confirm with whatever auspices they were disposed to favor and then applied whatever treatement they were most familiar with anyway.

This is a fabulously argument

This is a fabulously argument by Biotreker. It cuts right to the chest. Yes, innovations cost money and hard work. And the game-changing and high-impact ones are even more expensive, as they often requires several large-scale prospective validation clinical trials. These trials can easily cost much more than $10 million, let alone the tremendous human efforts involved. We have not even count the cost of those failed to reach the clinical stage. So if you do not protect the hard work of innovators and reward those willing to invest the risk capital, you will have nothing to have open access to. If I am a biomarker researcher, as soon as the court struck down patents on genetic variants or other biomarkers with diagnostic values, I will change my field.