If there's a medical test that could save your life, should one company have the power to set its cost so high that few people could afford it? And what if the thing that makes the company's test exclusive is a government-issued patent on a part of the human body?
That's what is at stake in a case the U.S. Supreme Court heard April 15 that could determine whether some biotech companies, by patenting particular human genes, can completely control certain gene therapies and tests.
The specific case concerns a Salt Lake City company, Myriad Genetics, which discovered and then patented genes that, if damaged, increase the likelihood of breast cancer and ovarian cancer in women and the risk of other cancers in men as well. Because the government granted Myriad patents on the genes, Myriad also controls testing. Even if another company developed a new, cheap, efficient test for the damaged genes, it couldn't bring the test to market.
That's why a coalition of scientists, professors, genetic counselors, individuals at high risk and nonprofit organizations (including AARP) filed friend of the court briefs in support of a lawsuit claiming that Myriad's patents on genes violate the Constitution and patent laws. In its brief, AARP and six other organizations argue that human genes and DNA molecules are natural phenomena that are not the kind of 'discovery' covered by patent laws.
Genes, after all, are the fundamental stuff of life. No scientist has invented them. Should researchers seeking to corner the market on lifesaving tests or therapies be able to patent genes?
The judges of the Supreme Court have a way of bringing complex issues like this down to earth; instead of talking about genes and cancer, Justice Sonia Sotomayor was bringing up chocolate chip cookies. She was willing to admit that a new process or recipe for cookies could be patented, but not the flour, salt and butter. Sort of like genes.
Then the lawyer for Myriad said he preferred comparing his company's patent to the design for a baseball bat. It was after all, just a piece of wood, but you probably couldn't slam a home run with a branch.
Far beyond the baseball bat discussion, Myriad's argument echoes that of drug companies fighting cheap and easily available generics. If companies like Myriad are not protected by patent law, they say, then there will be no incentive to spend the many millions of dollars on research that makes life-saving gene therapies and tests possible. Further, they say, their discoveries and the way they use genes are patentable because a freestanding BRCA gene, for example, doesn't exist in nature.
But the people suing Myriad don't want a world where a company can gain an exclusive right to use the human genome, or other bits of stuff that make up our bodies, and then sell them back to us, or determine the costs of tests or procedures that could save our lives based on those rights.
And if a company's exclusive right to a part of the human body gives it a monopoly on medical procedures, could the company patent our own blood, or our organs, and extract whatever price they decided was fair to fix them or sell them back to us? That's the specter raised by the groups banding together to fight this case.
Photo: National Human Genome Research Institute
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