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Court decision on gene patents impacts GM crops


By MATEUSZ PERKOWSKI



Analysis



Capital Press



Biotechnology companies fear that a recent U.S. Supreme Court decision banning patents on human genes will undermine protections for genetically engineered crops.



The nation's highest court has ruled that a naturally occurring sequence of DNA isn't eligible for patent protections, voiding human gene patents held by a medical testing company.



The underlying conflict in the case pertained to genes that carry mutations associated with breast and ovarian cancers, but experts say the ruling has implications for agricultural biotechnology and beyond.



"The decision applies equally to all genes," said George Kimbrell, an attorney for the Center for Food Safety, a nonprofit that opposes plant and animal patents.



How the ruling affects biotech traits remains to be seen, but it does have a groundbreaking effect on gene patents, he said. "Those are no longer valid."



In a unanimous decision, the Supreme Court held that simply isolating a gene isn't enough to warrant patent protection for the company that discovered it.



"To be sure, it found an important an useful gene, but separating that gene from its surrounding genetic material is not an act of invention," wrote Associate Justice Clarence Thomas.



However, the justices held that so-called "complementary DNA," or cDNA -- a synthetic form of a genetic sequence -- does qualify for patent protections.



Modification of genes, like splicing one sequence into another, remains patentable under the ruling, said Hans Sauer, deputy general counsel for the Biotechnology Industry Organization.



The decision may nonetheless weaken patent protections for transgenic crops because the underlying gene is fair game for competitors, he said. "Because the gene is often the first thing that gets discovered it's prudent to get a patent on that."



Patents that incorporate a genetic "promoter" to amplify the gene's activity without actually changing it could be considered unpatentable, Sauer said.



Obtaining patents on genes themselves as well as alterations was basically a belt-and-suspenders approach to patent protections for biotechnology, he said.



The ruling has reduced those protections, which may prove crucial for some developers, Sauer said. "You may be stuck without the belt."



While the ruling seems fairly clear-cut, it's probably destined to create further confusion in patent disputes, said Chris Holman, a law professor specializing in biotech patents at the University of Missouri-Kansas City.



"More work for lawyers," he said.



During oral arguments in the case, the Supreme Court justices heard several analogies pertaining to the patentability of genes.



Opponents said isolated genes could no more be patented than a kidney separated from a human body.



Proponents claimed the process of isolating the gene is akin to carving out genetic material, much like a "baseball bat doesn't exist until it's isolated from a tree."



The court distinguished between DNA and cDNA, but the line between synthetic and natural isn't so obvious, said Holman, who helped write a court brief in favor of gene patenting for the Biotechnology Industry Organization.



While the ruling makes clear that cDNA can be patented, it doesn't address other genetic sequences that are synthetic but are similar or identical to natural DNA, he said.



"The justices probably don't understand the molecular technology, so they're working with anecdotes," Holman said.



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