Intellectual Property Law

ACLU: Human Gene Patents Infringe Speech

By David Kravets

The American Civil Liberties Union is suing the Patent and Trademark Office and a research company awarded exclusive rights to human genes known to detect early signs of breast or ovarian cancer. The group claims the patents violate speech by restricting research.

The novel case, if successful, opens the door to challenges of a host of other patented genes: about one-fifth of the human genome is covered under patent applications and claims. The ACLU’s case is believed to be the first to challenge a patented gene under a civil rights allegation.

According to the federal lawsuit, (.pdf) filed in the Southern District of New York, the First Amendment is at stake because the patents are so broad they bar scientists from examining and comparing the BRCA1 and BRCA2 genes at the center of the dispute. In short, the patents issued more than a decade ago cover any new scientific methods of looking at these human genes that might be developed by others.

“All identifying of differences, including those that are found in the future by anyone to correlate with an increased risk of cancer, are patented. Myriad did not create any of the differences found in the genes. Nature did,” said the suit, referencing patent holder Myriad Genetics of Salt Lake City.

The ACLU, representing dozens of patients and researchers, said the case challenges the legality and constitutionality of granting patents covering the “most basic element of every person’s individuality.” The civil rights group maintains that, “What is patented is the abstract idea that nature has made the two genes different in a manner that increases that person’s risk” of cancer.

The patents at issue gave Myriad Genetics a virtual monopoly on such predictive testing for breast and ovarian cancer, according to the suit. Women who fear they may be at an increased risk are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder, which charges about $3,000 per test.

Myriad, which had issued a cease-and-desist order to Yale University scientists researching the genes,  said it would prevail in the case. Richard Marsh, Myriad’s general counsel, said in a telephone interview that the patent office “has granted tens of thousands of genetic and genetic-related patents which cover a large number of pharmaceutical and diagnostic products. Myriad strongly believes that its patents are valid and enforceable, and will be upheld by the courts.”

About 10 percent of women with breast cancer are likely to have a mutation inherited from their parents in the genes at issue, according to the suit.

Patents for exclusive genetic testing have also been issued for a host of genes, including those related to cystic fibrosis, heart arrhythmias and hemochromatosis.

The Patent and Trademark Office first issued a patent for a human gene in 1982 to the Regents of the University of California in connection to a hormone promoting breast development during pregnancy.

Photo: hibiotech
See Also:

• Flying in the Face of Infertility
• Humans Aren’t So Complicated
• Study: Human Genes Undercounted
• What Your Genes Do for You
• Lambs Get Human Genes
• Scientists Map the Brain, Gene by Gene
• Celera Unmasks Gene Variations

Full post as published by Threat Level on May 13, 2009 (boomark / email).