Gene Ruling Could Have Wide Implications

A judge has struck down a company's patents on two genes linked to an increased risk of breast and ovarian cancer. The ruling has far-reaching implications for the patenting of human genes. If upheld, it could affect the biotechnology industry and genetics-based medical research.

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A federal judge in New York has struck down patents on two human genes. It's the first time a court has ruled that genes cannot be patented. So far about 20 percent of all human genes are under patent. The New York case involves two genes linked to a higher risk of breast and ovarian cancer. If the decision stands, people on both sides of the issue say it could have far-reaching effects on medicine and research.

NPR's Richard Knox reports.

RICHARD KNOX: Judge Robert Sweet's decision comes in a 152-page decision that reads like a molecular biology textbook. But Sweet's conclusion is simple, says attorney Chris Hansen. A gene is not patentable.

Mr. CHRIS HANSEN (Attorney): What he says is it's still an invention of nature. It's not an invention of a human being.

KNOX: Hansen works for the American Civil Liberties Union, one of the plaintiffs. He says if Sweet's ruling is upheld, it will shake up patent law. It will also make genetic tests cheaper and more widely available. And he says it will liberate scientists to do more research on genes without worrying if they're infringing on somebody's patent.

Mr. HANSEN: He struck down all of the claims that we challenged and did so in such a way that it casts doubt on other patents on human genes.

KNOX: Myriad Genetics is the defendant in the case. It's a Utah company whose fortunes are built on its tests for the gene's BRCA1 and BRCA2. Most of its clients are women who are worried they carry mutant forms of these genes that sharply raise their risk of breast and ovarian cancer. The company charges more than $3,000 for the test.

Judge Sweet pointed out that in a recent year, Myriad made $222 million on tests that cost $32 million to run. Sweet's decision invalidates seven of the nearly two dozen patents that Myriad licenses on the BRCA genes. At midday, shares of Myriad's stock were down about seven percent. Myriad says it will appeal the ruling. The company didn't respond to interview requests but company founder Mark Skolnick stoutly defended gene patenting. Here's an excerpt from a 2007 interview with Joanne Rudnick, producer of a documentary called "In the Family."

(Soundbite of film, "In the Family")

Mr. MARK SKOLNICK (Founder, Myriad Genetics): People aren't upset about having patents for their iPods or patents for their telephones or patents for their computers or patents for their cars. If it weren't for patents, modern society would not exist.

KNOX: Skolnick told Rudnick that many women owe their lives to Myriad Genetics and says the company wouldn't have developed its test without patent protection. But the lawsuit against Myriad had the support of the American Medical Association, the March of Dimes Foundation and an array of geneticists, women's groups and researchers. They say Myriad's tight hold on the cancer genes tests put the test out of reach for many women and it frustrated researchers.

Dr. ROBERT NUSSBAUM (Chief of Medical Genetics, University of California San Francisco): I think it's a major obstacle to providing personalized medical testing.

KNOX: Dr. Robert Nussbaum is chief of medical genetics at the University of California in San Francisco. Nussbaum says the decision is timely. Soon, he says, doctors may be able to sequence all of a patient's genes to make decisions on how to treat her.

Dr. NUSSBAUM: So, can you imagine a situation where you have 4,000 out of the 25,000 genes patented and you're forbidden from looking at the sequence of 4,000 of those 25,000 genes without getting individual permission from each of the patent holders for each of those genes?

KNOX: Nussbaum says the whole idea behind the Human Genome Project is that the fruits of the research should be made available to everybody.

Richard Knox, NPR News.

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