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Judge Invalidates Patents on|Human Genes Linked to Cancers

MANHATTAN (CN) - In a case with far-reaching implications, a federal judge ruled on Monday that patents on two genes associated with hereditary breast and ovarian cancer are invalid, because "DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature," and cannot be patented. It is the first time a court has found patents on human genes to be unlawful. Twenty percent of human genes are under patent.

U.S. District Judge Robert Sweet ruled for the plaintiffs: the Association for Molecular Pathology (a group of patients and scientists), the ACLU and the nonprofit Public Patent Foundation.

Judge Sweet decided that patents for "isolated DNA" should not be granted. He invalidated the seven patents owned by Utah-based Myriad Genetics related to the BRCA 1 and BRCA 2 genes, and denied Myriad's motion for summary judgment.

He also granted the U.S. Patent Office's request to be dismissed as a defendant.

Judge Sweet said he sought the governing principles of molecular biology and patent law when weighing his decision on the controversial issue, and recognized the far-reaching impact it will have.

"The resolution of the issues presented to this court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their inventors, and those seeking to advance public health," he wrote.

The BRCA1 and BRCA2 genes have been linked to susceptibility to breast and ovarian cancer. Mutations along the BRCA1 and 2 genes are responsible for most cases of hereditary breast and ovarian cancers, the plaintiffs claimed.

Women with a history of breast and ovarian cancer in their families may choose to undergo genetic testing to determine if they have the mutations on their BRCA genes. The information may help them decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal.

The patents granted to Myriad gave the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes. They prevented researchers from even looking at the genes without permission from Myriad.

This made it impossible for women to seek alternate tests or a comprehensive second opinion about their test results, and allowed Myriad to charge what it would for the tests, according to the complaint.

"The court correctly saw that companies should not be able to own the rights to a piece of the human genome," said Daniel Ravicher, executive director of PUBPAT and a co-counsel in case. "No one invented genes. Inventions are specific tests or drugs, which can be patented, but genes are not inventions."

Judge Sweet wrote: "The claims-in-suit directed to 'isolated DNA' containing human BRCA 1/2 gene sequences reflect the USPTO's practice of granting patents on DNA sequences so long as those sequences are claimed in the form of 'isolated DNA.' This practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character.

"Many, however, including scientists in the field of molecular biology and genomics, have considered this practice a 'lawyer's trick' that circumvents the prohibitions on the direct patenting on the DNA in our bodies but which, in practice, reaches the same result. The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature.

"It is concluded that DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unpatentable subject matter."

The plaintiffs said that Myriad refused to license the patents to labs that were capable of performing even more comprehensive tests than its standard "full sequencing" tests.

"These labs would also include large rearrangement testing after a negative test result is received from full sequencing," Judge Sweet wrote. "In addition, labs would perform genetic testing on tumor specimens preserved in paraffin from deceased family members, which Myriad does not regularly perform even though, according to plaintiffs, such testing can often provide valuable genetic information for living relatives and is often necessary for accurate test interpretation."

Judge Sweet's 156-page opinion steered clear of the constitutionality of the issue because he had already granted summary judgment in favor of the plaintiffs.

"Today's ruling is a victory for the free flow of ideas in scientific research," ACLU attorney Chris Hansen said. "The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."

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