UPDATED June, 13 2013: The Supreme Court has ruled unanimously that human genes cannot be patented. Justice Clarence Thomas, writing on behalf of the court, said, “Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes . . . patent eligible.” Though human genes cannot be patented, the Supreme Court stated the Myriad’s synthetic form of DNA, cDNA, does deserve patent protection. Myriad officials were happy with the decision about cDNA. “We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” said Peter D. Meldrum, company president and chief executive.
Can you patent a human gene? That’s the question being asked in the Supreme Court as Myriad Genetics defends its right to patent the genes that it isolates. Myriad Genetics states that patenting genes helps with their research, diagnostics and treatment of diseases. The genes being debated in the Supreme Court, BRCA-1 and BRCA-2, are associated with increased risk in breast and ovarian cancers.
If Myriad Genetics wins the Supreme Court case, they would gain exclusive access to those genes for 20 years. This monopoly on the genes would allow them to continue to be the only company to sell a BRCA gene test. That test is used to indicate any mutations in the breast cancer predisposition gene, BRCA. Women with such a mutation are at a considerably higher risk of developing both breast and ovarian cancer.
Concerns about this monopoly are being raised by groups such as the ACLU, AARP and the American Medical Association. They are wondering about the ability of patients who have taken the Myriad test to receive a second opinion about their results if they feel the test missed a marker for cancer. Opponents also question if this kind of patent could prevent patients from accessing information about their own genes.
As both sides argued their points, justices and lawyers alike struggled to find an appropriate analogy for the situation when the case was heard Monday, April 15.
Justice Sonia Sotomayor likened the patenting of genes to trying to patent individual ingredients in cookies. “I can’t imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I’ve created a new use or a new product from those ingredients,” she said.
Lawyer for Myriad, Gregory A. Castanias, countered by saying the justices should think of their invention like a baseball bat. “A baseball bat doesn’t exist until it’s isolated from a tree. But that’s still the product of human invention to decide where to begin the bat and where to end the bat,” he said.
Chief Justice John Roberts disagreed. “The baseball bat is quite different. You don’t look at a tree and say, ‘well, I’ve cut the branch here and cut it here and all of a sudden I’ve got a baseball bat,” he said. “You have to invent it, if you will. You don’t have to invent the particular segment of the [DNA] strand. You just have to cut it off.”
The Supreme Court is expected to rule on this case by the end of summer.