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Akron Univ. School of Law

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Tuesday, May 12, 2009

Patenting Genes

The New York Times reports on a recent law suit filed against Myriad Genetics for patenting a genes closely linked to breast and ovarian cancer.  John Schwartz writes,

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. . . .

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. . . .

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. . . .

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. . . .

http://lawprofessors.typepad.com/healthlawprof_blog/2009/05/patenting-genes.html

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