When Lisbeth Ceriani, a 43-year-old Massachusetts woman, was diagnosed with breast cancer last year, her doctors recommended that she undergo genetic testing to see if she carried mutations in the BRCA1 and BRCA2 genes that increase risk of breast and ovarian cancers...
When Ceriani’s doctors submitted her blood to Myriad Genetics—the only company that offers a sequencing test for BRCA mutations—the company refused to process it, saying that Myriad did not accept Ceriani’s health insurance. She could not afford to pay for the test herself (it costs nearly $4,000), so she did not have it done. If there had been a cheaper test or a company that took her insurance, she would have known quickly what her best treatment options were....
This year Myriad’s patent was challenged in court by the American Civil Liberties Union on behalf of 20 plaintiffs, including the American College of Medical Genetics, the Association for Molecular Pathology, and various individuals, including Ceriani. The lawsuit charges that the BRCA patents—and gene patents in general—violate established laws that prohibit the patenting of products and laws of nature. According to the ACLU, “Human genes, even when removed from the body, are still products of nature."
Myriad has argued that the law has long granted patents for products of nature isolated or purified away from their natural setting, and that gene patents promote research.
Many in the academic scientific community consider that second claim dubious; breast cancer researchers have frequently run up patent barriers when pursuing their efforts to understand the mutations that predispose a person to breast cancer. In this case, Myriad owns patents on some, but not all BRCA mutations in breast cancer patients, so if you wanted to get a comprehensive test for your risk for breast cancer, you would need to get testing done by various companies - each one owning a patents on a few mutations. And some companies will have done the research to quantify the risk
posed by a given mutation, while others will have just sat on their patents, and prevented others from further exploring effects of those mutations.
According to the ACLU (who is arguing the case for the plaintiffs):
There are actually many things that everyone involved in this case agrees on. Everyone agrees that researchers are free to patent new drugs, new therapeutic methods, devices, or specific DNA sequencing methods. Everyone agrees that patent law prohibits the patenting of natural phenomena and laws of nature, as these are not human inventions and no person should be able to own exclusive rights to something that occurs in nature.
Everyone also agrees that DNA in the body is a product of nature and therefore not patentable. But the defendants claim that the "isolation" of the BRCA genes — or the separation of the gene from the rest of the DNA— that is necessary to test and study them somehow makes them patentable. Chris Hansen and Sandra Park, arguing for our side, refuted this claim, explaining that isolating a gene, no matter how difficult and ingenious, does not alter the structure of the DNA itself, and so what has been patented is indeed a product of nature. Chris made an elegant point:
"Isolated DNA" must not be markedly different from DNA in the body because when a woman sends a blood sample to Myriad to find out if she has a mutation that puts her at increased risk for cancer, Myriad gives her results about the DNA in her body; they don't say, "We found a mutation in the DNA we isolated from your blood, but that's different from the DNA in your body, so we don't know what it means for your risk for cancer."
The plaintiffs also contend that Myriad's patent claims over the correlations between mutations and cancer are invalid because mutations are created by nature and the fact that some mutations lead to cancer is a phenomenon of nature
I don't know who has the better legal argument, but gene patenting has long made me extremely uncomfortable. It's one thing to patent a purified product from your body (like estrogen purified from urine); it's another to patent your DNA. It's your DNA - what matters is the information encoded in it, and not the atoms your DNA is comprised of. If those atoms have been generated in a Myriad lab by a PCR reaction, that's still your DNA sequence.
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