“Everyone has genetic predispositions that put them at greater risks for some disease. If a patent limits access to that information, you are making a decision about someone’s life.”
No truer words were spoken on a complicated issue that is being taken up by the U.S. Supreme Court. The quote is from Kathleen Maxian of Pendleton, who suffers from the late stages of ovarian cancer and, as reported, wonders if that is because of the policy of Myriad Genetics, which controls the patents behind two genetic tests that can detect a family propensity for breast and ovarian cancer. She did not receive the second of those two tests but, if she had, she said she might have had her ovaries removed before they became cancerous.
As outlined by News medical reporter Henry L. Davis, the Supreme Court justices have been grappling with the question about the legitimacy of patenting genes. It is a 21st century question that has far-reaching implications.
The answer ought to be, no. While that position could have its own deleterious affect on the progress of medical science and commerce, the idea of patenting nature is unpalatable and carries its own unforeseen implications.
In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court is examining Myriad’s monopoly over human genes linked to a significant increase in the risk of breast and ovarian cancer for women. The Utah-based company obtained patents that give it the exclusive right to perform diagnostic tests for two genes that everyone carries: BRCA1 and BRCA2. The company charges a few thousand dollars for that test and, right or wrong, an individual would have to pay the price to have a peek at those genes.
The legal challenge says that the company’s monopoly on the BRCA genes allows it to dictate the terms of testing. Doing so bars other laboratories from testing the genes, which in turn makes it impossible to verify the accuracy of Myriad’s results.
But, the company and others contend, without patent protection it will be much harder for companies to bring innovation to market, which can take years and tens of millions of dollars. Basing a decision on the merits of commerce alone is bad public policy. Experts have written about the consequences of companies owning gene sequences, although there have been a long list of gene patents granted since the 1980s.
The Supreme Court’s ruling will resolve two conflicting court decisions. The U.S. District Court for the Southern District of New York ruled in 2010 that genes could not be patented. The following year, the Court of Appeals for the Federal Circuit reversed that ruling.
So far, the justices’ debate has ranged from comparisons to tree bark and baseball bats to chocolate chip cookies. This case has drawn analogies as to what in nature, if extracted or altered, can be patented. Is an isolated gene akin to an ingredient in a kitchen pantry, as Justice Sonia M. Sotomayor suggested, or like a baseball bat that doesn’t exist until being isolated from a tree, as a Myriad company lawyer suggested? Chief Justice John G. Roberts pointed out that baseball bats don’t just spring from a tree upon sight. “You have to invent it, if you will,” he said.
Allowing human genes to be patented by private companies is a slippery slope – one we’ve already begun to slide down. The continued downhill trajectory has too many pitfalls.