Judge rules against patenting human genes
By Deborah L. Shelton
http://www.JewishWorldReview.com | (MCT) Should a private company be allowed to patent a human gene?
That question lies at the heart of a landmark legal case that some are calling the Brown v.
A federal judge this week threw out a
The plaintiffs said the company's monopoly on the BRCA-1 and BRCA-2 genes prevents competition that could lower testing costs — now about
Scientists also say the patenting of human genes impedes research that could lead to better diagnostic tests and treatments.
"Many people are understandably disturbed by the idea that corporations are staking claim to the common heritage of humankind," said
Biotechnology companies say gene patents protect their investments in costly research and spur scientific innovations. About 20 percent of human genes, or about 2,000, already have been patented, including some associated with asthma, colon cancer, Alzheimer's disease and muscular dystrophy.
"Notwithstanding today's decision, we are extremely proud of what Myriad has been able to accomplish over the years in promoting women's health in the area of hereditary breast and ovarian cancer," company president and CEO
"It's about the whole principle of patenting parts of the human genome such that laboratory testing or information derived from those genes is of limited availability and limited use," Stoler said.
"How this plays out is uncertain," said
Women who carry mutations of the BRCA-1 and BRCA-2 genes are at greatly increased risk of developing breast cancer and ovarian cancer. Men who carry the mutation face a higher risk of prostate, pancreatic and other cancers.
Myriad holds patents not only on genetic tests but on the genes themselves and ideas about how they work. Other companies and scientists must receive permission to do research involving the genes. In some cases, they pay a royalty fee that critics said was often exorbitant.
Lawyers for Myriad had argued isolated DNA containing BRCA-1 and BRCA-2 gene sequences could be patented because it was different than that occurring naturally in the human body.
But in his ruling on Monday, Judge
"DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature," the judge ruled. "It is concluded that DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes."
"Similarly, because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter," he said.
"We think this ruling now decreases the barriers that people will have to their own genetic information," Ball said. "We think it's going to get them more opportunities for better patient care, second opinions or retesting, and eventually decrease costs as other companies are able to develop tests."
When Myriad's BRAC test was developed, technology to do the necessary gene sequencing was unavailable outside of the company, Ball said. But virtually all labs now offer molecular testing that makes it possible to develop tests, he said.
"Tests that cost
Several of the plaintiffs in the case were women who said they couldn't afford the expensive Myriad test.
Reynolds said financial issues related to patents have clouded medical research.
"We have cases where researchers are reluctant to publish data and share it with colleagues until their patent rights are secure," Reynolds said. "In some ways profit motives can spur innovation, but at the same time this has created some dangerous situations where public-funded research is leading to not only significant private profits but conflicts of interest and cutting of corners."
Banks had a lumpectomy in her left breast in 2002 and then a second lumpectomy when cancer was detected in her right breast last year. After learning last fall she was a carrier of BRCA-1, she decided to have both breasts removed to lower the chance of a recurrence.
She said she is perplexed about why any company would want exclusivity on any aspect of breast cancer research.
"There's so much money being raised for cancer research," she said. "Why would someone try to have a monopoly over trying to find out ways to keep people alive?"
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