As a physician and researcher interested in public policy, I follow closely issues that have medical, scientific and legal implications. This practice requires different mindsets given that science and law have different foundations and often speak different languages.
In science, we seek to identify the absolute truth as determined by natural law. In the legal system, “truth” may not be possible to identify, and conflict resolution often rules the day.
An example is the Supreme Court’s recent case of “Association for Molecular Pathology versus Myriad Genetics.” The legal issue in question is a vital one for cancer researchers and physicians.
Myriad is a company that owns patents on BRCA1 and BRCA2, two genes that signal a predisposition to breast cancer and ovarian cancer. If we recommend a patient have these genes tested to help us assess her chances of getting breast cancer, she would have to have Myriad do the testing and pay a steep fee for the test.
Many other human genes have been patented. In fact, it is estimated that 20 percent of all human genes are “owned” by patent holders.
The Association for Molecular Pathology, with many other groups in support, did not agree with the idea that natural human genes should be patented. It argued that no one should be able to “own” human genes or control testing for those genes.
There was no question about the absolute truth that information on cancer genes is important for the care of cancer patients. What was in question was the legal issue of whether human genes can be “owned” by patent holders, thereby allowing companies to control access to testing of those genes.
Irrespective of the legal arguments, there are many reasons scientists and physicians, including myself, feel Myriad’s approach to patenting human genes is bad for science and bad for patients.
- The prohibitive cost of gene tests charged by Myriad limits access to those tests for patients who need the information but cannot afford the cost.
- Perhaps more importantly, we are moving toward an era when determining what is best for a given patient does not involve testing a single or even a small number of genes. Instead, we now have the ability to test hundreds or even thousands of genes at the same time and look at the resulting pattern to determine what is best for each individual person. While we have overcome the technical challenges of testing for multiple genes at the same time, it would be practically impossible for us to put them together into a single affordable test if each gene had a different “owner.”
I therefore was greatly relieved when the Supreme Court ruled unanimously that natural genes cannot be patented. This ruling opens up our ability to utilize genetic testing for multiple genes in both research and in the care of patients.
In this case, the best legal and scientific minds reached the same conclusion, and settled the legal question in a manner that allows us to use the information revealed by scientific research to the benefit of our patients.
George Weiner, MD
Holden Comprehensive Cancer Center Director