Key phase of gene-patent lawsuit in judge's hands
This is an archived article that was published on sltrib.com in 2010, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

Myriad Genetics Inc. is awaiting an important decision by a federal judge in a widely watched lawsuit that challenges the Utah company's patents related to genes that are linked to an increased risk of breast and ovarian cancers.

U.S. District Judge Robert Sweet in New York heard arguments Tuesday but did not issue a decision on motions from both sides asking him to rule in their favor on whether such patents are proper under U.S. law and comply with the U.S. Constitution.

Last March, the American Civil Liberties Union and the Public Patent Foundation, representing medical groups, researchers and cancer victims, sued Myriad, the University of Utah Research Foundation and the U.S. Patent and Trademark Office in U.S. District Court in Manhattan.

The ACLU and the patent foundation say Myriad's refusal to broadly allow others to research the genes has meant that women who fear they may be at risk of breast or ovarian cancer are prevented from having anyone but Myriad look at the genes in question. They also contend that development of treatments are being restricted.

Patents aren't allowed for rules of nature, natural phenomena or abstract ideas, although the Patent and Trade Office has said genes can be patented if they are "isolated from their natural state and purified."

ACLU and foundation attorneys told Sweet that because Myriad's patents cover human genes, they should not be permitted. In addition, they said the patents are unconstitutional restrictions on knowledge.

Myriad, which is based in Salt Lake City, said overturning the practice of granting patents related to genes would have negative repercussions.

"Such a ruling would lead to the invalidity of thousands of biotechnology patents, and effectively unravel the foundation of the entire biotechnology industry," Myriad said in a court filing. "Numerous therapeutic drugs and diagnostic tests in development would be jeopardized."

Myriad, a publicly traded company, charges up to $3,000 for a test that can identify whether a woman has genetic mutations that indicate an increased risk of breast and ovarian cancer. On Wednesday, the company reported its profits increased 67 percent, to $35.4 million, for the quarter that ended Dec. 31.

A ruling by Sweet in favor of one side or the other is likely to be appealed to a court in Washington, D.C., that specializes in U.S. patent law.

Myriad, backed by the biotechnology industry, said its patents cover how to sequence the gene to identify its components, then map out that sequence to look for mutations to determine if the woman has a higher risk of developing breast cancer.

"This is not a patent on information," Myriad lawyer Brian Poissant told the judge. "This is a patent on a chemical composition."

Christopher Hansen, an ACLU lawyer, told Sweet that researchers deserved praise but not patents for winning the race to isolate genes related to breast and ovarian cancer. But now important medical research is being hampered because the patents for "BRCA1" and "BRCA2" genes prohibit the study of the genes by others, he said.

"New forms and testing and new ways of using the gene have been inhibited," Hansen said. "That's not good for women's health."

Biotechnology » Myriad, biotech industry defend research rights.
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