Feds' Gene Patent Rule Surprises Biotech After a company patented two genes used in a popular test for breast and ovarian cancer, a judge ruled that the genes should not be patentable. Recently, the Justice Department sided with the judge, a decision that could overturn 30 years of legal precedent.

Feds Surprise Biotech Industry With Gene Patent Rule

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STEVE INSKEEP, Host:

Some other news now. Biotech companies have been receiving patents on genes for decades. But the government suggested sharply limiting those patents in a court filing last week. The government's move has thrown open an old debate about where to draw the line in patenting parts of nature. NPR's Richard Harris reports.

RICHARD HARRIS: But a judge in Manhattan sided with plaintiffs who said genes like this shouldn't be patentable in the first place. The company appealed. And Myriad lawyer Richard Marsh says they asked the Justice Department to weigh in, figuring the government would defend its long-held position. The government weighed in, but largely against Myriad.

RICHARD MARSH: In that regard, yes, it was surprising to see that there's been this switch in thinking, I guess, by the current administration.

HARRIS: Marsh says even if the company loses the court case, their tests are still protected by several other patents, which aren't being challenged.

MARSH: As to Myriad this case is not going to have any material impact. What we're concerned about is, you know, we're part of the biotech industry, and we believe as to the biotech industry that this will have a very, very significant impact.

HARRIS: Gene patents are critical for companies like Myriad. He says if Myriad hadn't had patent protection, it would never have invested $500 million to develop these tests in the first place. It would be too easy for other companies to swoop in and use that knowledge. But Bob Cook Deegan, from Duke University, says the issue is actually not as sweeping as all that.

BOB COOK DEEGAN: Every jurisdiction in the world has decided, yes you can patent genes when what they're doing is producing a valuable thing.

HARRIS: But the patents that are now under fire have their value simply because they describe the genetic sequence on the DNA. Diagnostic tests look for that sequence.

COOK DEEGAN: What's never really been contested in court until now, is this new context of diagnostics.

HARRIS: And that's now a concern because soon there will be a whole new testing technology which will allow labs to look at thousands of genes all at the same time. Will a company ever be able to develop that test if many of those genes are patented by other companies?

COOK DEEGAN: We don't want 15 different companies, or 100 different companies testing a hundred different genes. It just makes no sense. And this is the first time a judge has had to make a decision about that new context, and looked at those patents in that new light.

HARRIS: But the example that Cook-Deegan raises, doesn't trouble Scott Kieff at the George Washington University Law School. He says consider your laptop computer. There are thousands of patented inventions in there. The company that makes the laptop just needs to take the time and spend the money to license those technologies from the patent holders.

SCOTT KIEFF: While it's conceivable that patents could clog the market, could create a gridlock, and could be anticompetitive, our markets have shown over the last 30 years the opposite story.

HARRIS: Kieff argues that biotech took off in the United States, but not in Europe or Japan, precisely because the U.S. is more generous in allowing companies to gene patents. Overturning that policy, he says, would be bad for U.S. business. But what about consumers, who might benefit from the next generation of genetic tests? Myriad doesn't have to let other companies use its patented genes. But Richard Marsh, at the company, says don't worry.

MARSH: We clearly appreciate and agree that it would be very inappropriate to have a patent on a given technology and not let it be utilized in a fashion to benefit the public.

HARRIS: Richard Harris, NPR News.

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