Companies are patenting your insides.
Myriad Genetics, a molecular diagnostics company based in Salt Lake City, holds patents on the naturally occurring genes BRCA1 and BRCA2, which are used for research and testing on breast cancer.
The American Civil Liberties Union sued Myriad over its patents on the genes in May 2009, saying the genes were not patentable because they were “products of nature” and could therefore not be patented under U.S. patent law.
While ASU does conduct research on genetics, the ruling would not affect ASU’s research either way, said Roy Curtiss, director of the Center for Infectious Diseases and Vaccinology.
“ASU doesn’t claim natural DNA sequences,” he said. “It won’t affect our research directly.”
Tony West, assistant attorney general for the United States Justice Department’s Civil Division, along with others in the Justice Department, published a brief on Oct. 29 arguing that naturally occurring genes cannot be patented simply on the grounds that the genes are isolated by a company.
Third parties currently hold patents on 20 percent of human genes.
“Genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible,” West said in the brief.
The brief, which does not express the opinion of the court, goes against the stance of the United States Patent and Trademark Office, which has held for almost a decade that individual genes, without any modification, are patentable.
“It was originally based on the idea that single genes would be independently important,” said Gary Marchant, professor of law in ASU’s School of Life Sciences. “But most genes work together in the body.”
As a result of its patent, Myriad holds exclusive rights to all tests using the two genes, and each test costs more than $3,000, Marchant said.
Marchant predicts the case will go all the way to the Supreme Court.
Although the movement against Myriad’s patents has gained momentum, Marchant said, the company has a valid argument as well because of the precedent the Patent Office set in 2001.
“Myriad is fairly profitable,” he said. “But their only revenue is from gene patents they hold.”
Under current law, anyone can file for a patent after they isolate a gene in the human body and identify its function, Marchant said.
The party is then required to submit a patent application, which is approved after three years.
When the patent is finally approved, applicants hold exclusive rights to the specific use of that gene for 20 years from the date of filing, Marchant said.
If the courts rule against Myriad and invalidate their patents on the BRCA genes, it “could liberate the science” by allowing other parties access to those genes, Marchant said.
Stephen Johnston, an ASU chemistry and physics professor, is concerned that a ruling against Myriad would stifle commercial development.
“Patents are a good thing if managed responsibly,” he said. He added that a market for genetic research is necessary to promote development.
If companies can’t be compensated for their research, Johnston said, scientific development could come to a halt.
“I have sympathy with the companies,” Johnston said.
He added that the reason the BRCA genes were discovered in the first place was due to the fact that there was a market for that type of research.
Curtiss believes patents on naturally occurring genes should not be allowed.
“The use of genes is patentable, but compositions of matter are not,” he said.
Reach the reporter at alex.ferri@asu.edu
