The most controversial patents in biotechnology—covering breast cancer genes BRCA1 and BRCA2—were declared invalid yesterday by a U.S. district court. Judge Robert Sweet, of the federal court in New York City, rejected the BRCA patents in a 156-page opinion that sides with advocacy groups and medical organizations that sought to have the patents tossed out. Among other points, the opponents argued that human genes are a product of nature, and for that reason cannot be patented. The judge didn't buy all of the logic, but did agree to scrap the patents. The company that lost the case, Myriad Genetics of Salt Lake City, immediately declared that it will appeal the judge's decision.
Myriad, which licensed the BRCA genes from the University of Utah and others who discovered them, runs a testing service to check for mutations that convey a risk for breast cancer. If the New York ruling is upheld on appeal, experts say, hundreds or even thousands of human gene patents could be put in limbo. Not so, says Myriad CEO and President Peter Meldrum. In a statement, Meldrum described the New York decision as affecting only "certain claims in seven of the 23 patents" covering the company's BRACAnalysis cancer testing service. "We are very confident that [the courts] will reverse this decision and uphold the patent claims," he added.
The groups opposing Myriad-the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) of New York-called the decision historic. "Today's ruling is a victory for the free flow of ideas in scientific research," ACLU lawyer Chris Hansen said in a press release.
"The court correctly saw that companies should not be able to own the rights to a piece of the human genome," added PUBPAT's Daniel Ravicher. They argued that patenting human genes is legally indefensible and ethically wrong because it inhibits the sharing of basic scientific data and restricts access to medical information.
The Biotechnology Industry Association of Washington, D.C., which supported Myriad, denies that gene patents impede the flow of information. In a statement, BIO President and CEO James Greenwood notes that Judge Sweet's decision "explicitly excluded" the ACLU-PUBPAT argument that gene patents harm research and medicine.
Robert Cook-Deegan, an ethicist, historian, and expert on gene patenting at Duke University in Durham, North Carolina, says that the New York ruling on the BRCA patents is a "bombshell." It could undercut certain gene patents that seek to claim DNA sequences themselves as an invention rather than as part of a process. He adds, however, that "it will take a while to figure out what it means." He notes that the judge's decision directly attacks part of the subtle legal reasoning behind such patents—the notion that intellectual property attaches only to "isolated" DNA sequence, which is a human invention, and not to the DNA in genes that's considered a product of nature (even though the sequences are identical).
" I don't think this decision is necessarily going to become a dagger through the heart" of inventions that claim DNA sequences as part of a multi-component diagnostic test, said Cook-Deegan, although it seems likely to limit the scope of future claims.