Patents and Diagnostics

Gene patenting claims may hinder the development of new diagnostic tools for public health, Anna George writes at the Guardian Professional.

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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.