A company in Utah owns my genes, or at least they owned bits of them until recently when the United States District Court for the Southern District of New York invalidated patents issued to Myriad Genetics for the breast cancer genes, known as BRCA1 and BRCA2. I have a BRCA2 mutation and have long wondered how it was that Myriad could own two small slices of the chromosomes that reside in every cell in my body. After all, Myriad didn’t “invent” my DNA; that was the exclusive job of my parents, who created the unique DNA sequence that is mine.
My mother had breast cancer when she was 43 and her grandmother also had breast cancer. When I wanted to test for the breast cancer genes my only option was to send my blood and my money to Myriad because their exclusive patent precludes other companies from testing for these genes.
The District Court’s decision is only the opening skirmish in what is likely to be a protracted battle over gene patents. Myriad has promised to appeal, and experts believe this is an issue that will be decided by the U.S. Supreme Court. But the decision is nonetheless a watershed moment with implications that reach far beyond the BRCA genes, because approximately 20 percent of the human genome has been patented. Several thousand companies own different slices of my DNA.
Myriad and others argue that without the promise of patent protection companies will not invest the money needed to make new genetic discoveries. While this argument has some merit it ignores the fact that millions of public dollars also went into the discovery of the BRCA genes. The fruit of this public investment in gene research should be publicly available.
In contrast to the BRCA genes and other privately patented genes, the vast majority of gene sequences were discovered through the Human Genome Research Project and are publicly available through a database on the Internet, which facilitates collaboration and research to find cures for complex diseases like cancer. Multitudes of companies as well as public institutions do fund and collaborate on research on these non-patented genes.
The era of truly personalized medicine is at hand, when genetic information can be used to customize medical recommendations for both prevention of and treatment of diseases. But first we need to know the genetic code stored in our DNA. The National Human Genome Research Project is speeding toward its goal of a commercially available analysis of an individual’s entire genome for less than $1,000. Yet even when technologically feasible, no company will be able to actually provide a full genome sequence. All of the DNA slices covered by patents will be excluded. Although I paid Myriad to find out that I have a BRCA2 mutation, as a practical matter neither I or anyone else will pay several thousand different companies for the information stored in the various other slices of DNA that are subject to patents. A full genome sequence for $1,000 would be useful to me and to my doctor, especially if it could shed light on my risk for the heart disease in my family. The future of personalized medicine could be strangled by the patent system. What an absurdity.
But this is an absurdity that can and should be avoided. By law, products of nature cannot be patented. Judge Sweet was right that the “essential characteristic” of DNA — its nucleotide sequence — does not change in any way as a result of the scientific manipulation necessary to decode the sequence for scientific or clinical use. The nucleotide sequence is defined by nature, not by any technology applied to it. Indeed, if the DNA code were changed as part of the chemical manipulations applied to it, then it would no longer be a blueprint of our genetic instructions and would lose its usefulness to both science and the individual. DNA, whether inside our bodies or out, whether whole or chemically manipulated for decoding, retains its native sequence as given to us by the egg and the sperm that created our first cell.
Myriad has vigorously enforced its patents, preventing research labs from performing certain types of research related to the BRCA genes and in some instances stopping research altogether. Other companies are unwilling to invest research dollars into BRCA-related research because of Myriad’s patents. Myriad’s patent not only limits research, it forces researchers to withhold critical information that would change the patient’s future healthcare.
Any woman who wants to know if she is carrying a BRCA mutation must shell out more than $3,000 to Myriad to perform the test (in fact, Myriad raised the price of its test three days after the court’s ruling in the patent case). But not all women can afford this. Even those with health insurance may find that the insurance company will not pay for the test, leaving them to fund the test themselves. The result is that each year women go untested and without the benefit of knowledge that could save their lives by changing a chemotherapy regimen or by early cancer detection through an intensive screening program. Myriad’s monopoly has prevented access to what can be lifesaving information.
The goal of decoding and understanding human DNA should be to improve the lives of individuals affected by hereditary disorders, not just to improve the quarterly profits of the companies who perform genetic tests.
Joi Morris is co-author of “Positive Results: Making the Best Decisions When You’re at High Risk for Breast or Ovarian Cancer.” September is National Ovarian Cancer Awareness Month.