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 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.
The ACLU said it expected to issue a release about the opinion. 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.
On the Net:
National Cancer Institute: http://www.cancer.gov/cancertopics/factsheet/risk/brca
FORCE support group: http://www.facingourrisk.org/index.php