Should Firms Be Able to Own Your Genes?

We may have inherited some of our finest qualities from parents and grandparents, but like anything else, there is a downside: part of that inheritance could be a disposition to a variety of deadly diseases. But the good news is that since the mapping of the human genome, science has made some giant leaps in detecting and treating inherited conditions.

By detecting those genes, for example the genes that predispose women to breast cancer, doctors can offer preemptive treatment. It sounds simple enough, but there's a catch: a woman may have that gene, but strange as it seems, it's really the property of a biotech company that has taken out a patent on it.

So far, nearly 10,000 human genes have been patented, all of them now in question based on a court ruling this past week.

Because, as "60 Minutes correspondent Morley Safer reports, whether you like it or not, under current law a vital part of who you are actually belongs to someone else.

Full Segment: Patented Genes
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Lisbeth Ceriani and Genae Girard were both diagnosed with breast cancer.

Ms. Girard was diagnosed at age 36, Ms. Ceriani at 42. Breast cancer at a relatively young age is often hereditary.

"Because of my age and the disease was already very aggressive in me, they thought there is most likely a genetic component at play," Ceriani told Safer.

The way to find out is through a test called BRAC Analysis, a blood test in which lab technicians at a company called Myriad Genetics examine two genes that exist in all of us.

If mutations - irregularities - are found, it means the risk of getting breast cancer and ovarian cancer is extremely high: breast cancer five times more likely, ovarian cancer as much as 40 times more likely.

Since a positive result usually means the removal of ovaries before cancer can develop, doctors told Ceriani she needed to get tested.

"I did try to have the test done several times," she said. "My insurance actually covers the test and would pay for the test. But the lab won't accept my insurance."

Myriad Genetics charges about $3,200 for the test, and most insurance policies do cover it. But Myriad won't accept Ceriani's plan because it won't pay the full amount.

"I don't have the $3,200 to pay for that test," she explained. "And I spent days trying to track down what is going on. If my insurance covers it, there must be someplace else I can bring this test. I mean it's a simple blood test, it's not a complicated procedure. And after all the research, I found out why and learned Myriad is the only game in town and they want it all."

Myriad Genetics controls all testing on the two breast cancer genes because they own the genes, lock stock and barrel. They patented them and no one else can legally test for them, or look at them, or even develop potential therapies that are based on them without Myriad's consent.

When it comes to inherited breast cancer, it's Myriad or nothing.

Just ask Genae Girard. Since doctors suspected that her cancer was also genetic she too got tested and her results were positive. Doctors recommended that she have a double mastectomy and have her ovaries removed.

"Which was a very tough decision. I mean, I'm still in my 30s and this is going to change my life whether or not I ever wanna have children. And that was a big deal," she said.

So she did the obvious: sought a second opinion - another genetic sequencing from a different lab.

But her doctor told her that wasn't possible.

"I think Myriad Laboratory is a very reputable company. But I know for a fact that there's human error that exists in laboratories and I would have felt a lot better about these decisions if I had that," she said.

"So, whether you like it or not, Myriad owns that gene that's in both of you," Safer remarked.

"Yes," Girard replied.

"No one invented my gene. They didn't change or alter my gene," Ceriani told Safer. "All they're doing is looking at it. It's crazy."

Lori Andrews agrees. She is a professor at Chicago-Kent College of Law and has made a specialty of genetics.

"When we think of patents, we think of things like Thomas Edison and his light bulb, you know, guys who invented things," Safer said.

"Well, you're right about what the patent law was intended to do, which was to reward inventors who brought something new in the world. But the patent on human genes, it's as if the first surgeon who took a kidney out of your body then patented the kidney," Andrews replied.

It all started in 1980, when the Supreme Court ruled that a life form - a genetically altered bacterium used to clean up oil spills - could be patented. Biotech companies saw that as an open door to patent another life form, human genes.

Since then, nearly 10,000 have been patented, nearly a third of the genes in your body.

Andrews says those patents can have serious implications for health care. "A typical gene patent says, 'I own the gene. I own any mutation later found by anybody else. I own any treatment based on the gene later found by anybody else.' And in this case, Myriad owns breast cancer," she explained.

Myriad won a fierce scientific race to identify the first breast cancer gene in 1994. Soon after, they patented the discovery and since then the company has maintained complete control over testing and has aggressively marketed its own test.

More than 400,000 women have been tested for the gene. But Professor Andrews says that Myriad's history of patent enforcement has inhibited research and is preventing better detection.

"Here is the problem with having one company own the gene. There actually is better testing in countries that don't patent the genes. Because then, lots of different pathologists and laboratories can look at those genes. And some find mutations that the Myriad tests missed," Andrews explained.

And there is the issue of cost. In most of Europe and Canada, where Myriad's patents have been challenged or ignored, the test is given at a fraction of the $3,200 Myriad charges.

Asked how much she thinks the test would cost if the breast cancer gene was in the public domain, Andrews said, "I think maybe $300. I've had people, geneticists, tell me they would be willing to do it for less than that."

Myriad declined our interview request, but in a statement the company says its patents have greatly advanced women's health, that Myriad has encouraged research, and the company argues that there are ways for women to get second opinions.

But those second opinions do not include a full comprehensive screening.

Myriad is not the only company that aggressively enforces its gene patents. Dr. Aubrey Milunsky, a world renowned geneticist, knows that first hand. He is the head of Boston University's Center for Human Genetics.

"The detection of genes and gene defects have become critically important because of the massive advances in technology," Dr. Milunsky told Safer.

"And yet you're prohibited from looking at certain genes," Safer remarked.

"We have been stopped from offering some 14 different tests for relatively common conditions," he replied.

Asked by whom they have been stopped, Milunsky said, "I'm really not allowed to talk about them. I'm legally muzzled about that particular subject."

He can't talk about it but we can.

Milunsky can no longer perform gene tests for disorders like muscular dystrophy, polycystic kidney disease and for a gene that can cause deafness. That's because a company called Athena Labs sent him a cease-and-desist letter when it found out he was testing people for genes they owned.

"A gene is a natural, living thing. How on Earth can anyone allow patenting of a gene?" Milunsky asked.

He is particularly concerned because we've now reached a point where our entire genetic makeup can be examined in one relatively simple test.

"But, you may have problems because if there is a gene within that bunch that indeed has been patented, you can't even report on it, actually. And the lawyers say you shouldn't even be testing it because that's infringing the patent," Milunsky explained.

But Kevin Noonan maintains it's those very patents that are responsible for scientific breakthroughs. He's a molecular biologist and patent lawyer who often defends the biotech industry.

"Without the biotech companies, you don't have the things that give you better health in the first place," Noonan argued.

Noonan says that patents reward financial risk and that biotech companies would not undertake the huge investment necessary if there were no economic payoff. And while he can't speak for Myriad and their breast cancer genes, he believes the price they charge for their test is a fair one.

"You're not only paying that $3,000 for this particular test. But how many years did people try to find this gene and not succeed? And how many other genes have they looked at, and not succeeded?" Noonan asked. "That costs money. That costs investment."

This whole debate is a far cry from the days of Jonas Salk, who in 1955 announced he had developed a vaccine for polio.

Asked by CBS' Edward R. Murrow who owns the patent to the vaccine, Salk replied, "There is no patent. Would you try to patent the sun?"

"He said it was like trying to patent the sun," Safer remarked.

"Yes, I know. But maybe it was a slightly different time. Today you're gonna have to have people to get their investment back," Noonan replied.

"But they're not selling cars. They're selling health," Safer pointed out.

"Whether it's cars or health, there has to be a profit for some investor to invest. If we want to eliminate profit, we're talking about a different economic system," Noonan said.

"I don't think people are talking about the elimination of profit. They're talking about reasonable cost," Safer said.

"Again, I think that, yes, I'd like the test to be cheaper. And when the patents expire, they will be," Noonan replied.

The last of Myriad's patents on the breast cancer genes expires in eight years, but if Chris Hansen has his way that could be even sooner.

He is the lead lawyer for the American Civil Liberties Union in what could be a landmark case against Myriad Genetics and the U.S. Patent Office. The case has the support of nearly the entire medical establishment that deals with genetics.

"All of those people are saying, 'The patents in this case hurt women's health,'" Hansen told Safer.

Hansen says that Myriad's patents are unconstitutional and should be invalidated.

"There's a long standing patent law doctrine that says you can't patent the laws of nature and products of nature and abstract ideas. And that's what happens when you patent genes," Hansen argued.

Asked what the patent office's rationale was approving this in the first place, Hansen said, "That isolating and purifying the gene is so transformative that it makes it a different thing."

"But it's still not an invention?" Safer asked.

"They would say that by taking it out of your body and stripping away some of the pieces, it's no longer a product of nature. It's now an invention. We think that's nonsense," Hansen said. "If Myriad develops a new drug, a new treatment, a new test, they can get a patent and they should be able to get a patent. What they shouldn't be able to do is get a patent over the gene itself."

Lisbeth Ceriani and Genae Girard are two of the plaintiffs in the lawsuit.

Since our interview, Myriad contacted Ceriani and said she was eligible for a non-profit program for patients who cannot afford the test. She took the test and her results were positive. She had her ovaries removed a few weeks ago.

But the anxiety caused by her genetic inheritance doesn't end there.

"Given your genetic history, what about your daughter?" Safer asked.

"She will have to assume that she's at higher risk going forward," Ceriani replied. "And one way or the other, I'll make sure she's tested."

Girard did go forward with the surgery to have her ovaries removed on the basis of the results of that single test. She still finds it hard to accept that a gene inside her own body is essentially the property of a corporation.

This past week, a federal judge ruled in favor of the ACLU in its suit against Myriad Genetics. The judge wrote that the patents on the breast cancer genes were improperly granted because human genes are indeed products of nature.

The ruling could have enormous implications for the biotech industry. Myriad Genetics is appealing the decision.

Produced by Deirdre Naphin