BRCA2

Supreme Court Nixes Patenting Human Genes.

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The Justices have decided that isolated sequences of human DNA are not eligible for patent protection, but rules that artificial sequences can be patented.

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 The United States Supreme Court has today (June 13) unanimously ruled that isolated human genes cannot be patented, but the Justices also ruled that synthetic DNA sequences—known as complimentary DNA (cDNA)—are eligible for protection. “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” wrote Justice Clarence Thomas, “but cDNA is patent eligible because it is not naturally occurring.”

The decision throws out patents held by Utah-based Myriad Genetics on 2 genes—BRCA1 andBRCA2—that when mutated cause breast and other types of cancer. Researchers, physicians, and patients who sued Myriad are claiming victory because the ruling means that the company no longer has a monopoly on diagnostic tests based on these two genes. This could result in increased competition, falling costs, and greater access for low-income patients.

“The Court struck down a major barrier to patient care and medical innovation,” Sandra Park, an attorney with the American Civil Liberties Union Women’s Rights Project, told USA Today. “Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing, and scientists can engage in research on these genes without fear of being sued.”

Francis Collins, Director of the National Institutes of Health, added: “The decision represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care. The right to control exclusively the use of a patient’s genes could have made it more difficult to access new tests and treatments.”

The decision is also something of a compromise, however, because it allows biotech companies to patent artificial DNA sequences. Myriad and other companies had argued that a ruling against gene patenting would undermine billions of dollars of investment from the biotech industry and impede medical progress. With this ruling, they still have ways to profit from their research.

Source: http://www.the-scientist.com

 

 

Irradiation Heightens Risk for Breast Cancer in Women with BRCA Mutations .

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Diagnostic radiation studies, especially if done before age 30, increase the risk that women who carry BRCA mutations will develop breast cancer, according to a BMJ study.

Researchers asked some 2000 carriers of BRCA1 or BRCA2 mutations to recall their history of radiation exposure. Based on standard tables, the cumulative radiation dose to the breast was calculated. Compared with no exposure before age 30, the hazard ratios for breast cancer increased with quartiles of increasing cumulative exposure, reaching 3.8 in the highest quartile.

The authors estimate that among 100 BRCA carriers at age 40, roughly 9 will have developed breast cancer. The number would increase by 5 if all had had a mammogram before age 30.

They conclude that their results support using non-ionizing radiation imaging techniques, such as MRI, as the main surveillance tool in young BRCA carriers.

Source: BMJ

DNA not patentable

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In a spine-chilling announcement, the US Department of Justice in October said unmodified human DNA should not be eligible for patent. The department’s stance conflicts with the body of case law on the matter and a longstanding position held by the US Patent and Trademark Office, which has issued more than 10,000 of these patents. The Justice Department announced its position in response to a lawsuit involving patents on breast cancer genes BRCA1 and BRCA2. A US district court in March declared the patents invalid, saying that the genes are products of nature rather than human-made inventions. Patent holders University of Utah and Myriad Genetics, based in Salt Lake City, appealed in June. In an amicus brief filed with the Federal Circuit Court of Appeals the Justice Department agreed that identifying and isolating DNA without further manipulation is not an invention, or patent eligible. How the agency’s declaration will influence justices and the patent office worries biotech companies. But the patent office isn’t easily swayed, says Thomas Kowalski, an attorney with Vedder Price in New York. “The patent office is not going to change what it’s doing in view of what the Department of Justice says,” he says. Besides, international agreements between the American, European and Japanese patent offices, known as Trilateral Co-operation, have concluded that unmodified DNA is patentable.

source: nature biotechnology