The Supreme Court is poised to take up the highly charged question of whether human genes can be patented. But another question could trump it: Has the field of genetics moved so far so fast that whatever the court decides, it has come too late to the issue?
The case, which will come before the court on Monday, involves patents held by Myriad Genetics on two human genes, which, when mutated, give a woman a high risk of getting breast or ovarian cancer. The patents give Myriad a monopoly on testing for these mutations, a highly lucrative business.
The hearing comes as rapid scientific advances are producing an explosion of new information about human genes, as well as those of animals, plants and microbes, yielding new approaches to detecting and combating diseases.
Opponents of gene patents say no company should have rights to what is essentially part of the human body. They contend that Myriad's monopoly has impeded medical progress and access to testing — in some cases denying patients their own genetic information.
Myriad and its allies in the biotechnology industry counter that a ruling that invalidates gene patents would upend three decades of patenting practice and undermine billions of dollars of investments to develop not only genetic tests but also biotech drugs, DNA-based vaccines and genetically modified crops.
"It would chill a wide range of important activities that benefit society," the Biotechnology Industry Organization said in a friend of the court brief, one of about 50 such briefs filed in a sign of the case's potentially far-reaching consequences.
But while the debate continues, some experts say patents on human genes are actually fading in importance.
"Events on the ground have overtaken the law," said Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina. He said the impact of the Supreme Court's decision "will be much more ideological than it will be practical."
For one thing, the Myriad patents at issue are due to expire over the next two years. And experts say a relatively small number of other diagnostic tests or drugs are protected by patents on single genes.
"I don't think this affects many patents that really matter to companies," said Robert Cook-Deegan, a professor at Duke University's Institute for Genome Sciences and Policy.
It is often said that one-fifth of the roughly 20,000 human genes are patented. But in a study, Christopher Holman, a professor of law at the University of Missouri, Kansas City, found that many of those patents merely mentioned genes but would not block genetic testing, and many patents had been allowed to lapse.
Moreover, it will soon be possible to sequence a person's entire genome for less than the $4,000 that Myriad charges to analyze just two genes, which are called BRCA1 and BRCA2. And whole genome sequencing might not infringe patents on isolated genes.
The case before the Supreme Court was filed in 2009 by the American Civil Liberties Union and the Public Patent Foundation on behalf of some medical societies, researchers and patients.
The question before the court is whether isolated human genes are products of nature, and therefore ineligible for patents, or are sufficiently different from the genes found inside the body's cells.
The plaintiffs won the first round when Judge Robert W. Sweet of Federal District Court in Manhattan said that isolated DNA was the same as DNA in the body in what really mattered — the genetic information it carries.
But Myriad prevailed at the United States Court of Appeals for the Federal Circuit, twice, by 2-to-1 decisions. One of the majority opinions said that DNA was a chemical, not an information medium, and that disconnecting DNA from the chromosome changed it enough structurally to qualify for patenting.
The plaintiffs, appealing to the Supreme Court, are challenging this. "Under this rationale, a kidney 'isolated' from the body would be patentable, gold 'isolated' from a stream would be patentable and leaves 'isolated' from trees would be patentable," they say in their brief.
Myriad and allies argue that patents can and have been granted on products derived from nature — like the immune-suppressing drug rapamycin, which comes from a bacterium — as long as sufficient inventiveness is involved.
Anda sedang membaca artikel tentang
As Court Considers Gene Patents, Case May Overlook Relevant Issues
Dengan url
http://healtybodyguard.blogspot.com/2013/04/as-court-considers-gene-patents-case.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
As Court Considers Gene Patents, Case May Overlook Relevant Issues
namun jangan lupa untuk meletakkan link
As Court Considers Gene Patents, Case May Overlook Relevant Issues
sebagai sumbernya
0 komentar:
Posting Komentar