| A law suit filed last May in the U.S. District Court for the Southern District of New York could change the face of genetic research, as groups representing thousands of doctors, scientists and patients went to court in order to prevent any form of gene patenting.
A hearing was held last week, during which the plaintiffs asked to be declared victorious without a trial. They argued before federal district court Judge Robert Sweet, that patents on genes are unconstitutional. A decision is expected to take several months.
The suit was initiated by a coalition of civil rights, research and women’s health groups: American Civil Liberties Union and the Public Patent Foundation. A not-for-profit organization affiliated with Cardozo School of Law in New York, have filed it. These two are supported by groups such as the American Medical Association, the March of Dimes, the American Society for Human Genetics and others. Roughly 150,000 researchers are represented by associations that have filed court briefs supporting the plaintiffs.
The case hinges around the claims of Myriad Genetics on BRCA1 and BRCA2, a pair of genes closely linked to breast and ovarian cancer. Myriad has the genes written under its name since 1994, together with the University of Utah Research Foundation, and the company sells a test kit for the genes.
Myriad’s patents stifle innovation, the plaintiffs claim, and in addition the company’s monopoly limits women’s health choices.
The suit also argues that because every human has these genes, the patents infringe on First Amendment rights of freedom of scientific inquiry and the free exchange of ideas, as well as undermining bodily integrity and a person's right to know about his or her genetic makeup.
It also argues that gene patents make research into tests and cures for cancer more difficult because it requires researchers to obtain licenses from the patent holder.
Myriad argues that if you remove the patents, the tests will not be profitable any more. "Without the patents, there wouldn't have been the financial incentive" to create the tests, says company general counsel Rick Marsh.
The public debate concerning gene patenting has long been intensive in scientific and social circles. However, the claims set a precedent for other gene patents. The results could greatly affect medical research and health care based on genetics.
Nowadays, the U.S. Patent Office allows genes to be patented as soon as the DNA is isolated by removing it from the cell. ACLU attorney Sandra Park said: "We're arguing that isolating it does not make it patentable. It's a natural phenomenon, and the Supreme Court has always said natural phenomena are not patentable."
In May, the court rejected Myriad’s request that the case be thrown out without a trial. If the court rules against Myriad, patents involving genes and other biological products won’t be eliminated altogether. Instead, claims will need to be made on specific types of tests or modifications, rather than the discovery of something that exists in nature.
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