Lawyers have been trying to digest this week's surprising court ruling that invalidated seven patents for the breast cancer genes BRCA1 and BRCA2.
Myriad Genetics Inc. had held an exclusive license for these patents and consequently controlled the market for DNA tests designed to gauge women’s risk for developing breast and ovarian cancer. Many scientists also said the company forced them to halt research projects involving the two genes.
U.S. District Judge Robert Sweet ruled that Myriad “discovered” the DNA sequences that make up the two genes, but it did not “invent” them. Therefore, the genes cannot be patented.
“It’s certainly a bombshell,” Robert Cook-Deegan, an expert on gene patents at Duke University, said in an interview. “The blogosphere is pretty shocked at this outcome.”
Companies have won patents on thousands of genes, and the idea that they could be worthless has whipped biotech firms into a frenzy, said Lisa Haile, an attorney with the DLA Piper in San Diego who co-chairs the firm’s global life sciences practice. Haile said she has advised her clients that the ruling is sure to be appealed.
“It’s definitely not the last word,” she said in an interview. “I see this going up to the Supreme Court.”
Why? It’s not just gene patents that are at issue, Haile said. If DNA can’t be patented because it is created by nature, what about patents for proteins, enzymes, bacteria and other biological entities that companies have turned into medicines and other useful products? “That’s where I think this could get blown out of proportion,” she said.
Sandra Park, an attorney for the American Civil Liberties Union, one of the plaintiffs in the lawsuit, said it’s not just anti-business liberals who oppose the idea of gene patents.
“This is not a partisan issue,” she said in an interview. “A lot of very conservative religious folks have come out against gene patents because they believe God has given us these genes, and they should not be parsed out for patents.”
Park noted that an advisory committee in the Department of Health and Human Services approved a report in February about gene patents and their impact on diagnostic tests for patients. The report suggests that Congress pass legislation that would prevent monopolies on diagnostic genetic tests and allow scientists to conduct research on any gene regardless of its patent status, Park said.
Had such a law been in place already, she said, “our clients – who are labs and researchers and patients – would not have been motivated, most likely, to bring this lawsuit.”
You can read the full decision here. It includes a very readable primer on genetics and DNA.
-- Karen Kaplan