The Future of Genetic Research
The Future of Genetic Research
The justices solved this problem by making no mention of "human" versus "nonhuman" DNA in their decision and ruled simply that naturally occurring DNA sequences are ineligible to be patented; this settles the concerns of many critics. But the Court also held that complementary DNA (cDNA) can be patented because it does not occur in nature—it is a transcript of natural protein-encoding DNA sequences from which noncoding sequences called introns have been removed. Because cDNA is synthesized and used constantly in genomic research and in pharmaceutical production, the ramifications of this decision for future studies are unclear.
"The opinion is not terribly coherent," says Dan Burk, a professor of law at the University of California, Irvine, who holds degrees in molecular biology and biochemistry. "It's a short opinion that leaves a lot of questions unanswered."
The opinion, written by Justice Clarence Thomas, begins by laying out some basics of molecular biology. Thomas notes that a gene isolated in the laboratory contains the same genetic information as a gene in a living cell, and concludes that isolated genes are therefore products of nature and not patent eligible. But cDNA, which is transcribed in the laboratory from messenger RNA, is free of the introns found in the native genome. cDNA sequences are useful because they carry genetic information identical to that found in nature, but that detail was deemed irrelevant.
Myriad's patent claims applied to the information contained in the chemical structure of DNA, not to the exact chemical formula of the structure itself. One could hold that you can't patent information, i.e., sequence data, but you can patent chemical structures that you have isolated and purified.
David Resnik, National Institute of Environmental Health Sciences
Burk believes this philosophical shifting of gears mid-decision shows the justices were seeking a way to limit gene patenting without undermining the numerous patents involved in the biotechnology and pharmaceutical industries. Jacob Sherkow, a fellow at Stanford University's Center for Law and the BioSciences, agrees that the Court's decision frees up clinical genetic testing, which nearly always uses isolated genes.
Other processes, such as splicing human DNA into bacteria in order to mass-produce a human protein, require the use of cDNA. But Sherkow believes such patents won't present much of a practical problem. "Any clever researcher or patent agent will be able to work their way around patents on cDNAs," he says. "Add a couple nucleotides, take out one exon, manipulate the sequence a bit, and you're almost certain to fall outside of patent protection."
Bioethicist David Resnik of the National Institute of Environmental Health Sciences explains that the justices were grappling with the longstanding question of just how much human ingenuity is required to transform a natural object into an invention. He thinks the Court struck a reasonable balance. "Raw sequence data will be freely available," he says, "but significant changes to the sequence data will be protected."
The impact of this decision could reverberate beyond genetic medicine. It might mean that chemicals found in plants or microbes-which are the sources of many pharmaceuticals-can no longer be patented.
Jon Harkness, University of Minnesota
Striking a Balance
The justices solved this problem by making no mention of "human" versus "nonhuman" DNA in their decision and ruled simply that naturally occurring DNA sequences are ineligible to be patented; this settles the concerns of many critics. But the Court also held that complementary DNA (cDNA) can be patented because it does not occur in nature—it is a transcript of natural protein-encoding DNA sequences from which noncoding sequences called introns have been removed. Because cDNA is synthesized and used constantly in genomic research and in pharmaceutical production, the ramifications of this decision for future studies are unclear.
"The opinion is not terribly coherent," says Dan Burk, a professor of law at the University of California, Irvine, who holds degrees in molecular biology and biochemistry. "It's a short opinion that leaves a lot of questions unanswered."
The opinion, written by Justice Clarence Thomas, begins by laying out some basics of molecular biology. Thomas notes that a gene isolated in the laboratory contains the same genetic information as a gene in a living cell, and concludes that isolated genes are therefore products of nature and not patent eligible. But cDNA, which is transcribed in the laboratory from messenger RNA, is free of the introns found in the native genome. cDNA sequences are useful because they carry genetic information identical to that found in nature, but that detail was deemed irrelevant.
Myriad's patent claims applied to the information contained in the chemical structure of DNA, not to the exact chemical formula of the structure itself. One could hold that you can't patent information, i.e., sequence data, but you can patent chemical structures that you have isolated and purified.
David Resnik, National Institute of Environmental Health Sciences
Burk believes this philosophical shifting of gears mid-decision shows the justices were seeking a way to limit gene patenting without undermining the numerous patents involved in the biotechnology and pharmaceutical industries. Jacob Sherkow, a fellow at Stanford University's Center for Law and the BioSciences, agrees that the Court's decision frees up clinical genetic testing, which nearly always uses isolated genes.
Other processes, such as splicing human DNA into bacteria in order to mass-produce a human protein, require the use of cDNA. But Sherkow believes such patents won't present much of a practical problem. "Any clever researcher or patent agent will be able to work their way around patents on cDNAs," he says. "Add a couple nucleotides, take out one exon, manipulate the sequence a bit, and you're almost certain to fall outside of patent protection."
Bioethicist David Resnik of the National Institute of Environmental Health Sciences explains that the justices were grappling with the longstanding question of just how much human ingenuity is required to transform a natural object into an invention. He thinks the Court struck a reasonable balance. "Raw sequence data will be freely available," he says, "but significant changes to the sequence data will be protected."
The impact of this decision could reverberate beyond genetic medicine. It might mean that chemicals found in plants or microbes-which are the sources of many pharmaceuticals-can no longer be patented.
Jon Harkness, University of Minnesota
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