Human gene at heart of patent fight
04/13/2013 12:00 AM
04/14/2013 9:24 AM
WASHINGTON – The building blocks of life are stacked up before the Supreme Court, as justices consider whether scientists can patent an isolated human gene.
In a case that combines deep thoughts and dollars galore, justices must evaluate a Utah-based company's patents on two human genes associated with cancer. The court's eventual answer will clarify a key unanswered question in intellectual property protection. It also could mean gobs of money for researchers, and it could definitely make history.
"This is the first lawsuit brought in the United States challenging the patenting of a human gene," noted American Civil Liberties Union attorney Sandra Park.
The ACLU is representing an alliance of scientists and others opposed to the human gene patents issued to a company called Myriad Genetics.
Underscoring the high stakes, the case to be heard Monday has attracted close attention from religious, legal and scientific interests. Conservative church leaders with the Southern Baptist Convention oppose the patenting of a human gene; so, for different reasons, does the American Medical Association.
From the other side, Silicon Valley venture capitalists support human gene patenting; so do giant pharmaceutical companies.
They note how costly research has led to the development of DNA-based medical advances such as genetically engineered synthetic insulin and human growth hormone and cancer screenings.
"It's extremely expensive to translate a patent into bedside medical tools," Myriad Genetics President Mark C. Capone said in a telephone interview, adding that "had we not had patent protection," the company could not have developed its widely used cancer screening tools.
Myriad spent many years and hundreds of millions of dollars on its genetic research, Capone said, with his company's legal brief elaborating that "countless companies and investors have risked billions of dollars to research and develop advances" because patents protect their work from infringement.
"As a result of our patents, we've been able to translate our discoveries into patient care," Capone said.
The case called Association for Molecular Pathology v. Myriad Genetics starts with the gene, a segment of DNA. Genes define physical traits such as eye color and sex and can influence whether an individual develops conditions such as obesity, diabetes and Alzheimer's disease.
All told, approximately 22,000 genes make up the human genome. Genes must be removed from the body and isolated in order to be studied and utilized.
Patents have been issued on about 4,000 of the human genes, according to a study by Science magazine.
Park of the ACLU said that "certainly, if the court rules in our favor," some of these other patents might become vulnerable to legal challenge as well. All told, 40,000 patents have been issued for genetic materials from a variety of sources.
"The vast majority of valuable patents in biotechnology are not of this kind and are not threatened in this case," said Dr. Robert Cook-Deegan, a research professor at Duke University's Institute for Genome Sciences and Policy. "However, the intellectual framework that comes out of the decision could have a significant impact on other patents."
Scientists with Myriad, a firm based in Salt Lake City with revenues of $496 million last year, used mapping tools to identify those genes associated with mutations predisposing a patient to breast and ovarian cancers. Scientists called these the BRCA1 and BRCA2 genes.
The average U.S. woman has a roughly 12 percent risk of developing breast cancer in her lifetime. Women with BRCA mutations, by contrast, face a cumulative risk of up to 85 percent of developing breast cancer.
Myriad obtained a number of patents relating to the isolated BRCA genes.
The patents enable the company to profit and control the shape of future research. Myriad can charge about $3,300 for its genetic-based tests for breast cancer, although the company notes insurance covers most patients. Other scientists, meanwhile, are limited in their own ability to work with the genes, and they say the research shackles extend even to variations on the patent-protected genes.
"Although Myriad has not exercised its authority to stop all research, Myriad's claims have had a proven chilling effect on research, as laboratories are dissuaded from pursuing scientific work that requires using the patented genes," the American Civil Liberties Union states in its main legal brief.
Certainly, patents provide powerful protection, which is why researchers want them. Inventors can obtain a patent for, as the law puts it, "any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof."
A gene falls under the category of "composition of matter."
There are limits, though. The Supreme Court has previously ruled that "laws of nature, natural phenomenon and abstract ideas" cannot be patented. Human invention must play a role.
"Myriad's patented molecules were never available to the world until Myriad's scientists applied their inventive faculties to a previously undistinguished mass of genetic matter," the company's chief legal brief states.
The company's opponents counter that Myriad's isolation of the genes in question did not fundamentally alter their character, meaning the patent improperly extended to what's naturally occurring. Beyond such legal restrictions, moreover, some critics claim a human gene patent violates ethical precepts.
"Permitting a corporation or person to own this fundamental component of a person corrupts the relationships between human beings and the Creator, and between human beings," members of the Southern Baptist Convention argued in a legal brief, adding that "patent law emphasizes that the human body is not subject to ownership."
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