Did you know 20 percent of your genes have already been patented? While that may sound odd, it is true.
Soon after the relevant science allowed companies and universities to do so, the U.S. Patent and Trademark Office began granting patents for the isolation of genes. This biologic gold rush has led to speculative claims on over 50,000 total genes from all living things. Patenting of genes gave the exclusive rights to do things like develop diagnostic tests to detect for mutations that were associated mutations in a particular gene.
For example, patenting of the BRCA1 and BRCA2 genes allowed physicians to detect mutations associated with an increased risk of breast cancer. Myriad Genetics and the University of Utah own the rights to the gene and thus perform all of the BRCA 1 and 2 testing in the United States, which has recently been challenged in a case that may be decided by the Supreme Court.
Many voices have a stake in how this case is decided: from universities and biotech companies, to the slew of regulatory agencies that could be affected and, ultimately, everyone who could stand to benefit from genetic diagnostic testing.
But a company that owns the exclusive rights to interpret the sequence of an individual’s DNA, received from his or her parents and had by most accounts a significant impact on the creation of that individual’s body, seems wrong.
Legally, the group of breast cancer patients, genetic counselors, and medical associations that brought the case argue that the patents are a product of nature and thus un-patentable. Additionally, various government agencies do not hold the same opinion on the matter, with the Department of Justice last Friday saying it believes that patents should not be granted for isolation of a gene in obvious opposition to the historic practice of the U.S. Patent and Trademark Office to do so.
The present interests of universities and biotech companies are different from those of the individual patient. If their genetic monopolies are lost, universities and biotech companies stand to lose much of their intellectual property and potentially future financing. If the patent system is changed, the individual patient stands to gain from increased competition yet lose out on potential diagnostics that are not funded.
Although universities and biotech companies financing will suffer initially, individual patients will stand to benefit much more because of increased competition and cooperation. The elimination of gene patents will undercut the intellectual property holdings of many companies. Although the genetic diagnostic industry will initially suffer, the continued demand for valuable diagnostics will lead to corporate reformation and business models that work under the regulation change.
The shift away from companies holding stock of individual genes and to wider genetic analysis will benefit patients. The genetic basis for a disease is rarely determined by one gene. Rather, complex diseases like Alzheimer’s disease and autism have a complex genetic basis of many genes that, together, account for disease risk. By eliminating patents for genes, the researchers at universities and companies can more effectively create multi-gene diagnostic tests that give a more inclusive representation than a study of one gene.
With so many interests in addition to the individual patient, the outcome of this case is sure to be closely watched. Stay tuned.
Defend your gene pool at djgarry@asu.edu
