Kevin E. Noonan is an attorney at McDonnell Boehnen Hulbert & Berghoff LLP.
Does patenting DNA – specifically isolated human DNA – spur innovation, improve health and contribute to a better future? Thirty years of medical biotechnology breakthroughs support a strongly affirmative "yes." But you wouldn't know it if you've been following the debate about patenting human genes in a lawsuit sponsored by the American Civil Liberties Union against Myriad Genetics, Inc.
There are three things that you are unlikely to hear in the human gene patenting debate: Patenting isolated human DNA doesn't inhibit basic genetic research on breast cancer, "gene" patents don't decrease patient access to such testing, and a victory by the ACLU in the case before the Supreme Court won't suddenly make screening tests available to women without some form of health insurance.
The first myth, that Myriad's patents on isolated human DNA encoding the BRCA proteins inhibits basic research, is the easiest to debunk. Since the patents were issued in 1997, more than 10,000 scientific research papers have been published. None of these basic researchers have been warned by Myriad not to perform this research. Why? Because the only "researchers" who risk a patent infringement lawsuit are those who charge patients for testing. That isn't research, it is commerce, which patents are intended to prevent.
The myth of patient access is a little more complicated. We live in a world Myriad made with regard to genetic testing for breast cancer. Fifteen years ago such testing was in its infancy, and most doctors were unaware of its predictive power. More importantly, most insurance companies were skeptical that the testing would enable them to avoid the costs of breast cancer treatment. Myriad established the validity and cost-effectiveness of the BRCA testing, a sine qua non for insurance reimbursement.
Then there are the logistics involved in performing these tests reliably. Testing must be done in a laboratory with established, rigorous procedures to prevent false positives (women without the genetic mutations testing positive) or false negatives (with the mutation testing negative). Women bearing a mutation must be counseled by a professional genetic counselor to understand their options. Someone has to pay for the tests, the assessment of the results and the genetic counseling.
In a world where testing is done by research hospitals in major urban centers, it is possible that there would be equal access for women living in the vicinity. But it is unrealistic to think that any research university or hospital would make testing available to poor women elsewhere – for example, in Appalachia. Are these university hospitals likely to do outreach to local gynecologists to make them aware of the testing? Or set up a network of genetic counselors throughout the country? Or to contact insurance regulators state by state to ensure reimbursement? No, but Myriad did all these things, thereby maximizing patient access. That there are still women who cannot get coverage is a reflection on the U.S. health care system.
Finally, testing will not become more available if the court rules against Myriad because the patent claims at issue are not infringed by BRCA genetic testing. Myriad's patents related to BRCA will expire over the next few years. For those who understand how such testing actually gets done, the likelihood is overwhelming that testing costs will not go down and patient access due to competition will not go up as much as the opposing side would have you believe.
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