It was the first time a federal court has invalidated a patent on genes. The American Civil Liberties Union, which brought the case, said the New York federal court decision “calls into question the validity of patents now held on approximately 2,000 genes.”
U.S. District Judge Robert Sweet agreed with the civil rights group that the patents were invalid because they covered the most basic element of every person’s individuality. “Products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product,” Sweet wrote in a 152-page opinion.
The lawsuit claimed the patents were so broad they barred scientists from examining and comparing the BRCA1 and BRCA2 genes at the center of the dispute. The patents issued more than a decade ago covered any new scientific methods of looking at these human genes that might be developed by others.
The patents gave Myriad Genetics a virtual monopoly on such predictive testing for breast and ovarian cancer. 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 for a test.
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.
Myriad did not immediately respond for comment.