Should a private company be allowed to own the information in your genes? The Supreme Court today said no when it ruled unanimously that genes cannot be patented.
Medical researchers and patient groups are rejoicing. But they may be celebrating a bit too soon.
Genes are the chemical messengers that direct the functioning of every cell in your body. They are composed of DNA, a molecule that comes in long strands, known as chromosomes. Each one contains thousands of genes in a sequence.
Scientists have been working since the early 1990s to determine which segments of DNA represent individual genes and which cell functions they direct. Over the 20 years since then, thousands of genes have been identified along with variations between them in different individuals, known as mutations. Some of these can enhance susceptibility to cancer and other diseases.
The government has been issuing patents for genes since 1992. They give a single individual or company the exclusive right to conduct research on a gene or to administer a test for it. But just because the government grants a patent does not mean it will hold up in court. Judges routinely strike them down.
A group of plaintiffs including medical organizations, patients, and the American Civil Liberties Union filed suit in 2009 asking that patents on genes be declared invalid, as genes are products of nature, not human inventions. Their case involved two genes associated with susceptibility to breast and ovarian cancer, known as BRCA 1 and 2. A company called Myriad Genetics held patents for the genes and has been the sole provider of a test that spots cancer-causing mutations in them. (Actress Angelina Jolie took the test and found that she has a dangerous mutation in BRCA 1. See my blog post of May 17.)
The Supreme Court today agreed with the plaintiffs. Based on the ruling, the Myriad patents, along with all other gene patents, are no longer valid. (To read the full decision in the case, Association for Molecular Pathology v. Myriad, click here.)
For scientists, the ruling means freer access to genes for research. That may speed the pace of discovery and innovation. For patients, it may bring lower prices for tests through market competition. Myriad currently charges up to $4,000.
But the victory for gene patent opponents was incomplete. The Court ruled that a key step in the process of developing a genetic test can still be patented.
In that step, a lab creates stripped-down copy of a gene that contains the operative segments of DNA while omitting portions that are extraneous. The copy is known as complementary DNA (cDNA for short). The Court found that cDNA can be patented because it is created through chemical manipulation in a lab. That means Myriad's potential competitors will have to create their own cDNA versions of the BRCA genes.
So far, at least two companies seem to think they can. With the Supreme Court decision just hours old, GeneDx and Ambry Genetics announced plans to market their own BRCA tests. It remains to be seen whether others will join them.
But Myriad may have another ace in the hole. With over a decade of testing experience, it has amassed a huge database containing all of the results. That information holds the key to interpreting ambiguous test findings, of which there are many. Clinicians may be reluctant to use another lab that lacks this invaluable resource.
The ruling also says nothing about human genes that are deliberately altered, for example to enhance a cell's functioning. The Court suggested that these might merit patent protection.
So, where does today's decision leave the future of genomic medicine? It could bring a flood of new medical discoveries. And in the eyes of many, it is as an ethical triumph. No private interest can own the exclusive right to use the natural make-up of human beings.
However, the ultimate effect on the market for genetic tests and treatments remains unclear. The ruling may discourage investment in some biotech companies, but it could peak investor interest in others. Myriad's shareholders do not seem particularly concerned. The company's shares rose by more than 10% immediately after the decision was issued.
And the Court's Solomonic division of natural genes and cDNA could prove unworkable over time. This would create further market uncertainty.
However, one thing is clear. The field of genetic medicine will never be the same.