The United States Supreme Court ruled on June 13 that human genes cannot be patented.
This surprise decision is a victory for women who need genetic testing to detect whether they carry a genetic mutation that increases the risk of developing breast and ovarian cancers.
But the ruling has much broader implications. It puts in jeopardy thousands of patents already granted on human genes over the past 30 years.
All nine members of the US Supreme Court, in a rare unanimous decision, ruled against Myriad Genetics saying that isolated genetic material cannot be patented because it is a product of nature.
The case was brought by the Association for Molecular Pathology, although a number of organisations fighting for democratic and human rights, women groups and medical and research associations in the US were involved.
The court said that Myriad Genetics did not invent genomic sequencing, it only isolated the specific gene and did not change any of the content of the material. The ruling, which can be read in full here, said: “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
In previous cases, US biotechnical companies had argued that to isolate the gene, chemical bonds had been broken and this was sufficient to make the isolated DNA “markedly different” from that found in nature.
Actor Angelina Jolie brought attention to the issue of genetic testing after she announced in May she had undergone a double mastectomy. Jolie learnt she carried a mutated gene that gave her an increased risk of developing breast cancer.
However, Jolie would have paid more than $3000 for the test, a price out of reach for most women.
Until now, Myriad Genetics owned the exclusive rights to do testing on the BRCA1 and BRCA2 genes which show the risk for developing breast and ovarian cancer. The US court decision means that other companies can now offer the test, which will likely bring the cost down.
Patents on genes block health care in other areas. A patent prevents all medical research on that gene, preventing clinical care of patients, further investigations and important discoveries by any research group as they first must obtain permission from the patent holders to do the research. This request is usually refused.
The clinical laboratories of the University of Washington had stopped performing their own methods to test for mutations in two genes that were patented by Myriad after receiving an infringement warning.
These tests gave important information to the patient and their family on their risk of developing other cancers. Instead samples had to be sent to Myriad for testing at a cost in excess of $4000. This affected hundreds of patients a year whose family history put them at risk for breast or ovarian cancer.
In response to the ruling, biotechnical companies warned that innovations on new genetic testing would be stalled.
However, the ruling indicated that the court would welcome patents that applied to synthetic or artificial DNA.
Further, if a gene was manipulated to create something not found in nature, the invention would be eligible for patent protection.
The ruling also said companies can profit from methods of isolating genes. Companies may also obtain patents on new applications of knowledge gained from genetic research.
Many genetic tests use a form of DNA known as complementary (cDNA), which is not found in nature. The ruling has left the question of cDNA up in the air and this will surely lead to more court cases.
Although the Australian courts are not bound by decisions in the US, the US Supreme Court decision will impact on a recent Australian case.
Federal Court Judge John Nicholas ruled in May that Myriad Genetics had the right to patent genes. An Australian company, Genetic Technologies, has an exclusive licence from Myriad Genetics, to test for gene mutations in the BRCA1 and BRCA2 genes.
The Australian law firm Maurice Blackburn, which fought the case, was lodging an appeal on June 14, which now could include the US court decision. Rebecca Gilsenan, the principal lawyer from Blackburn, who will be in charge of the appeal to be heard in August, said: "It's a very significant development by a very significant court," the Sydney Morning Herald reported on June 14.
All genes, whether from human, plant or animal tissues, should be ruled out for any patent application. They are all derived from nature, and nothing new has been invented.
This also should apply to cDNA, the most common form of DNA used in medical tests. The commercial ownership of a gene prevents any further research on that gene for whatever purpose.
Further, private ownership means that the cost of having a medical test or examination for the inheritance of a disease due to a genetic mutation can exclude many people from essential information on the state of their health and that of their children.
The aim in a fair and equitable society should be free genetic testing for all who need it.