Genae Girard (Benjamin Sklar for The New York Times)|
When Genae Girard received a diagnosis of breast cancer in 2006, she knew she would be facing medical challenges and high expenses. But she did not expect to run into patent problems.
Ms. Girard took a genetic test to see if her genes also put her at increased risk for ovarian cancer, which might require the removal of her ovaries. The test came back positive, so she wanted a second opinion from another test. But there can be no second opinion. A decision by the government more than 10 years ago allowed a single company, Myriad Genetics, to own the patent on two genes that are closely associated with increased risk for breast cancer and ovarian cancer, and on the testing that measures that risk.
On Tuesday, Ms. Girard, 39, who lives in the Austin, Tex., area, filed a lawsuit against Myriad and the Patent Office, challenging the decision to grant a patent on a gene to Myriad and companies like it. She was joined by four other cancer patients, by professional organizations of pathologists with more than 100,000 members and by several individual pathologists and genetic researchers.
The lawsuit, believed to be the first of its kind, was organized by the American Civil Liberties Union and filed in federal court in New York. It blends patent law, medical science, breast cancer activism and an unusual civil liberties argument in ways that could make it a landmark case.
Companies like Myriad, based in Salt Lake City, have argued that the patent system promotes innovation by giving companies the temporary monopoly that rewards their substantial investment in research and development.
Richard Marsh, Myriad’s general counsel, said company officials would not be able to comment on the lawsuit until they had fully reviewed the complaint.
The coalition of plaintiffs argues that gene patents actually restrict the practice of medicine and new research.
“With a sole provider, there’s mediocrity,” said Wendy K. Chung, the director of clinical genetics at Columbia University and a plaintiff in the case.
Dr. Chung and others involved with the suit do not accuse Myriad of being a poor steward of the information concerning the two genes at issue in the suit, known as BRCA1 and BRCA2, but they argue that BRCA testing would improve if market forces were allowed to work.
Harry Ostrer, director of the human genetics program at the New York University School of Medicine and a plaintiff in the case, said that many laboratories could perform the BRCA tests faster than Myriad, and for less money than the more than $3,000 the company charged.
Laboratories like his, he said, could focus on the mysteries still unsolved in gene variants. But if he tried to offer such services today, he said, he would be risking a patent infringement lawsuit from Myriad.
Christopher A. Hansen, senior national staff counsel for the civil liberties union, said the problem was with the patent office, not the company. He recalled that when he first heard that the office had granted a patent for a gene, “I said that can’t be true.”
As the A.C.L.U. explored the restrictions on competition that companies like Myriad had put in place — blocking alternatives to the patented tests, and even the practice of interpreting or comparing gene sequences that involved those genes — the restrictions started to look like not just a question of patent law, Mr. Hansen said, but of the First Amendment’s guarantee of free speech as well.
“What they have really patented,” he said, “is knowledge.”
A patent was also granted to a single company for genetic testing on long QT syndrome, which can lead to heart arrhythmias and sudden death, and to the HFE gene, linked to hereditary hemochromatosis, a condition in which iron accumulates in the blood and can cause organ damage. Doctors and scientists have complained about both patents.
On the other hand, the company that owns the patent to the gene CFTR, which has been linked to cystic fibrosis, has licensed the testing to dozens of laboratories, drawing praise from the medical world.
The decision to allow gene patents was controversial from the start; patents are normally not granted for products of nature or laws of nature. The companies successfully argued that they had done something that made the genes more than nature’s work: they had isolated and purified the DNA, and thus had patented something they had created — even though it corresponded to the sequence of an actual gene.
The argument may have convinced patent examiners, but it has long been a sore point for many scientists. “You can’t patent my DNA, any more than you can patent my right arm, or patent my blood,” said Jan A. Nowak, president of the Association for Molecular Pathology, a plaintiff in the case.
So far, however, two panels of government experts who have looked at the issue have not found significant impediments to research or medical care caused by gene patents. A 2006 report from the National Research Council found that patented biomedical research “rarely imposes a significant burden for biomedical researchers.”
That report and others, however, warn that the patent landscape “could become considerably more complex and burdensome over time.”
In the future, genetic tests are likely to involve the analysis of many genes at once, or even of a person’s full set of genes. Some 20 percent of the human genome is already included in patent claims, amounting to thousands of individual genes, says a draft report from the National Institutes of Health. The report warns that “it may be difficult for any one developer to obtain all the needed licenses” to develop the next generations of tests.
For Lisbeth Ceriani, a single mother from Newton, Mass., and a plaintiff in the case against Myriad, the biggest obstacle that gene patents present is one of cost. She has had breast cancer and a double mastectomy, but wants to have BRCA testing to determine her risk of ovarian cancer and help her decide whether to have her ovaries removed. But Myriad has refused to work with her insurance plan, Mass Health, and paying for the test herself is beyond her means.
She is reluctant to have surgery that might prove unnecessary, she said, but she also worries about her 8-year-old daughter and the inherited risk she might face. Which is why, Ms. Ceriani said, she wants to “find out if I have the mutation, so I can take the necessary steps to stay on the planet.”
“I want to be here,” she said, “to make sure she does her screening by the time she’s 30.”
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