Lawsuit attacks patent giving company control over genetic test for cancer risk

By Kari Lydersen
Tuesday, March 2, 2010; HE06

After receiving a diagnosis of aggressive breast cancer at age 43, Lisbeth Ceriani wanted to find out whether she had the BRCA gene mutation, which makes women much more likely to get breast and ovarian cancer. If she tested positive for the mutation, she decided, she would have her ovaries removed preemptively.

But Massachusetts, where Ceriani lives, is one of 24 states where Medicaid does not cover the $3,120 test, which is offered only by the Utah biotech company Myriad Genetics. Coordinator of a Boston au pair program where she does not get health insurance or earn enough to purchase it on her own, Ceriani said she could not afford the test. She is one of the plaintiffs in a lawsuit claiming that Myriad's exclusive right to conduct tests for the mutation is unconstitutional.

The plaintiffs' attorneys, from the American Civil Liberties Union and a nonprofit called the Public Patent Foundation, hope the case will redefine how patent law is applied to genetic testing and research. They say that Myriad's patents on the isolated BRCA sequences impede research and women's access to their own genetic information through testing.

Richard Marsh, Myriad's executive vice president and general counsel, counters that the test might never have been developed and become widely available if it weren't for the financial incentives offered by a patent. And he said the patents will expire in 2014 and 2015, at which point any company will be able to offer the test.

"It is an expensive test; affordability is a concern," said Marsh. "But the whole patent system is to incentivize people to go out and develop a product and make it more accessible. We've literally spent hundreds of thousands if not millions to convince physicians and insurance companies that if you can diagnose someone with a predisposition [to cancer,] you'll save more money by paying for the $3,000 test than hundreds of thousands on chemotherapy and surgeries."

All Myriad tests are done at its lab in Salt Lake City. Doctors around the country send patients' blood samples there and get results from Myriad: positive, negative or inconclusive. Doctors or genetic counselors then discuss the meaning of the findings and different options with their patients. Medicaid covers the test in Virginia and Maryland but not in the District.

'A product of nature'?

Patents cover thousands of human genes, about 20 percent of the human genome, according to the ACLU. While it is illegal to patent products of nature, laws of nature or abstract ideas, federal courts have decided that a DNA sequence that has been extracted and isolated does not qualify as a product of nature.

Critics say these patents have a severe chilling effect on research because the patent-holder could claim ownership of any commercial applications that result. But Marsh points out that numerous papers have been published on BRCA genes since Myriad obtained the patent, and the company is also continuing to research the genes and refine its tests.

DNA sequences related to Alzheimer's, spinal muscular atrophy and other diseases are among those covered by patents. ACLU staff attorney Chris Hansen said many were obtained by research institutions committed to keeping the genetic information in the public domain and away from companies that might seek exclusive use of it. He said that the parties behind the litigation chose to sue over the BRCA patents because Myriad has enforced them and because breast and ovarian cancer affect so many Americans.

"Taking a gene out of the body doesn't take it from being a product of nature to a creation of man," said Hansen. "People have a common-sense reaction that it shouldn't be right for some company to own a piece of my body."

"It's like saying I can't look at my own blood," said Ceriani.

Patent attorney and molecular biologist Kevin Noonan said "sound and fury" has obscured the legal realities of the case.

"Saying the consequence of these patents is that women may not be able to obtain the information is like saying I can't call someone in New York because I don't want to pay to use a telephone," he said. "Free speech doesn't mean something should be free, it just means the government can't suppress it."

Mark Stoler, president of the American Society for Clinical Pathology, a plaintiff in the suit, is concerned that Myriad's monopoly on the test prevents patients from seeking a second opinion that might be available if other companies offered the same or similar tests.

Marsh said Myriad has licensed several universities to do tests that can confirm a positive finding.

"No test is perfect. No matter how many layers of quality control you put on something, there are still mistakes made," said Stoler. "Our first question is, is it good lab practice to have a monopoly? The second question is, should genes be patented? Most of us agree the answer is no, genes should not be patented, and there should not be monopolies on lab tests."

In December Ceriani tested positive for the BRCA mutation after Myriad donated free test kits to a local nonprofit. Marsh said the donation was driven largely by Ceriani's advocacy.

Chicago filmmaker Joanna Rudnick tested positive in 2001 for the gene mutation, and later got a second opinion in Canada while she was there producing a documentary about BRCA. While Canadian doctors often send samples to Myriad for testing, some Canadian universities and researchers do a different type of test that can confirm mutations of the BRCA gene.

A second opinion is "an option most women don't have," Rudnick said, since insurance typically wouldn't cover a second test. Her documentary argues that Myriad's patents impede development of a more accurate and cheaper test.

"If they had a non-exclusive patent, they could still be testing and making money, they'd just have competition," Rudnick said. "That's American."

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