Unexpected challenge to controversial patents on naturally occurring DNA sequences.
In a surprising legal brief filed late last week, the US Department of Justice suggested that the government's long-standing support of the controversial practice of patenting genes might be coming to an end.
The brief, filed on Friday in a landmark gene-patent lawsuit, argues that simply identifying an important DNA sequence within a genome is not enough to justify a patent. Instead, such a discovery is akin to finding coal and removing it from the earth, or separating cotton fibres from cotton seeds, lawyers for the US government wrote.
"Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it," they wrote. By contrast, the brief argues that DNA sequences that have been manipulated in some way should be patentable.
The position on isolated DNA sequences represents a dramatic shift from decades of government endorsement of gene patents. Biotechnology companies have argued that such gene patents are necessary to protect their investment in research and development. Any change would particularly affect companies involved in developing genetic tests for medical diagnosis — part of the burgeoning area of 'personalized medicine', in which treatments might be tailored to an individual's genetic makeup.
"If adopted, the Department of Justice's position would undermine US global leadership and investment in the life sciences," said a statement from Jim Greenwood, president and chief executive of the Biotechnology Industry Organization, based in Washington DC.
The brief serves as a blow to an industry that is still reeling after an unfavourable ruling on 29 March this year, concerning two genes associated with breast and ovarian cancer. The New York federal district court ruled invalid several claims in patents governing the use of the genes BRCA1 and BRCA2 for genetic testing (see 'Breast cancer gene patents judged invalid').
That judgment came as a shock because US courts traditionally have supported such patents, but it did not affect decisions at the US Patent and Trademark office (USPTO). Similarly, the Department of Justice brief does not directly affect the USPTO, but it could be a bellwether of changing federal opinion on gene patents. There have been whispers for months among biotechnology industry insiders that President Barack Obama's administration is discussing gene patents internally, and that it takes a critical view of the practice.
Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it. Department of Justice , US government
Meanwhile, Myriad Genetics of Salt Lake City, Utah, which holds the BRCA1/BRCA2 patents, appealed its case to the Court of Appeals for the Federal Circuit. A decision in that court would affect USPTO practices, as the office falls under its jurisdiction.
Before the Department of Justice brief, the expectation was that the federal circuit court would overturn the lower court's 29 March ruling, in part because the biotechnology industry would flood the court with briefs detailing the importance of gene patents for that sector, says Mark Lemley, a professor of law at Stanford Law School in California, and a partner in the law firm Durie Tangri in San Francisco. But now, "having a brief from a respected authority on the other side could give the federal circuit pause", he notes.
Nevertheless, the government's brief does not support overturning all gene patents. The brief is careful to note that claims involving manipulated DNA would be valid, and includes within that category a commonly claimed form of DNA called cDNA, which is constructed in the laboratory from RNA. "Many of the most important types of DNA patents aren't going to be affected," says Lemley.
Furthermore, the brief does nothing to challenge patent claims governing methods, says Robert Cook-Deegan of the Institute for Genome Sciences and Policy at Duke University in Durham, North Carolina. "Those claims tend to be the ones that most get in the way of genetic diagnostics, more than the claims on DNA sequence," he says.
William Simmons of the law firm Sughrue Mion, headquartered in Washington DC, notes that the brief might be subject to attack, in part because it does not distinguish between discoveries of DNA and discoveries of other substances in living organisms, such as proteins and metabolites, which have long been the subject of patents. "It's really a very interesting brief, but I'm not sure that it goes far enough to make a strong case against patenting genes," he says.
If the brief does reflect changing governmental attitudes towards gene patents, that could hurt the industry that has built up around genetic diagnostic tests, says Michael Hopkins, a research fellow who studies science and technology policy at the University of Sussex, UK. "Now that industry may need to find something other than gene patents to sustain itself," he says.
But some within the gene-testing industry may welcome a change, adds Lemley. Genetic tests are becoming more complicated and involve larger sets of genes, raising concerns that diagnostic companies may have to license an unwieldy number of patents to put together a single genetic test.
"We might in fact see companies that are happy to see patents of this sort go away," he says, "because it opens up new business opportunities."
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Ledford, H. US government wants limits on gene patents. Nature (2010). https://doi.org/10.1038/news.2010.576