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'Isolated' DNA can't be patented, judge rules

Thu, Apr 1st 2010 12:00 am
By LARRY NEUMEISTER
Associated Press

NEW YORK - A judge struck down a company's patents Monday on two genes linked to an increased risk of breast and ovarian cancer in a ruling that was being closely watched in the medical research community.

The ruling by U.S. District Judge Hon. Robert Sweet challenging whether anyone can hold patents on human genes was expected to have broad implications for the biotechnology industry and genetics-based medical research.

Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body nor the information it encodes.

He rejected arguments that it was acceptable to grant patents on DNA sequences as long as they are claimed in the form of "isolated DNA."

"Many, however, including scientists in the fields of molecular biology and genomics, have considered this practice a ‘lawyer's trick' that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result," he said.

He said he used "long-recognized principles of molecular biology and genetics" to resolve the claims.

Last March, the American Civil Liberties Union and the Public Patent Foundation sued Myriad Genetics Inc., based in Salt Lake City, the University of Utah Research Foundation and the U.S. Patent and Trademark Office.

The ACLU and the patent foundation said Myriad's refusal to license the patents broadly has meant that women who fear they may be at risk of breast or ovarian cancers are prevented from having anyone but Myriad look at the genes in question.

"Today's ruling is a victory for the free flow of ideas in scientific research," Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, said in an ACLU press release. "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."

Lawyers for Myriad and the U.S. Patent and Trademark Office did not immediately return messages for comment.

Testing for mutations in the so-called BRCA genes has been around for just over a decade. Women with a faulty gene have a three-to-seven-times greater risk of developing breast cancer and a higher risk of ovarian cancer.

Men can also carry a BRCA mutation, and if either parent does, a child has a 50 percent chance of inheriting it. The mutations are most common in people of Eastern European Jewish descent.

Myriad Genetics Inc. sells the only BRCA gene test, which costs up to $3,000. Some doctors and researchers contend that this monopoly has long held up not only competing, cheaper tests but has also hindered gene-based research.