"The issue of whether insurance or Medicaid wants to cover a test for a genetic disposition for a disease is a healthcare issue, and you would have that issue whether or not you have patents covering the test. One of my colleagues at work decided he wanted to have a genetic test done because his mother died of ovarian cancer and he's an Ashkenazi Jew, so he was concerned that he might be a carrier and pass the gene on to his daughter. Even though he met his insurance company's criteria, they denied him coverage. These tests are being denied because of coverage problems with insurance companies and reimbursement by Medicaid, not the maker of the diagnostic test. Additionally, some universities and hospitals that have discovered and patented genes and license them to private companies are beginning to require that the company makes commercial tests available to the poor.
"Some people argue that it doesn't take much effort to develop a diagnostic test today. That's not really true. The fact that you find a correlation between a gene and a disease in an academic laboratory doesn't mean that it has been validated in the clinic and is sufficient to make medical and insurance coverage decisions. Increasingly, diagnosis is based on correlations with a large number of genes. You need a company like Myriad to spend money to show that it is accurate. The U.S. government is not paying for that. How much money would any company put into validation if anyone could come along and run the test without paying for it? Instead of having more tests available in the absence of patent protection, we are going to have fewer tests.
"My own view is that people in the diagnostic industry have not done a good job explaining to the public why they need patents. Most of the public gets alarmed by these patents, but we've seen tremendous development in this field in the last 30 years through now-criticized patent protection. The patent system is not a perfect system — it certainly has its flaws — but critics have yet to present a feasible alternative system, such as government subsidies for diagnostic test validation.
"Given the current government budget deficits, looking to the government to pay for the additional work is not going to happen. Without the economic incentive provided by the patent system, no one else is going to step up to do the work."