A federal judge in Manhattan decided Monday not to allow human genes to be patented, a move heralded as a boon for genetic research and public health.
On Monday, U.S. District Judge Robert Sweet ruled on a summary judgment motion that invalidated patents licensed to Myriad Genetics Inc. of Salt Lake City.
The genes that make people human included seven patents covering the BRCA1 and 2 genes that are linked to breast cancer that runs in families.
The licenses were issued exclusively to Myriad by the University of Utah Research Foundation.
The company has 16 other patents related to the BRCA genes.
As technology evolves, the uncomfortable question becomes necessary – can a private company patent basic genetic information about humans? Essentially can nature be patented and owned as intellectual property? U.S. law says it cannot, unless the genes have been changed in some form.
Myriad’s claim was that the isolated genes could be patented, But Judge Sweet in a 152-page ruling on challenges by patient advocates and the ACLU, ruled that the information contained on DNA is the genetic code and “is not markedly different from native DNA as it exists in nature.”
Myriad plans an appeal.
Patenting a gene or series of genes, sometimes linked to specific human disease, prevents other companies or researchers from exploring gene-based applications, ultimately slowing research and innovation on genetic tests customized for individual patients.
The Wall Street Journal reports that biotech companies want to be able to protect their financial investment if they are making a scientific advancement. In the case of Myriad, its BRCA test isolated the two genes using them as a basis to diagnose the risk of breast and ovarian cancer.
The ruling could lead to legal challenges over other patents of genetic sequences linked to various medical conditions such as Alzheimer’s disease and hearing loss.
“It’s really quite a dramatic holding that would have the effect of invalidating many, many patents on which the biotechnology industry has invested considerable money,” Rebecca S. Eisenberg, a law professor at the University of Michigan, reports the New York Times.
Attorney Dan Vorhaus, writing a summary on the case, in the Genomics Law Report says the dismissal was based on the doctrine of constitutional avoidance, meaning that invalidating the patents means the Court does not have to rule on Constitutional issues.
The Center for Genetics and Society called the ruling a victory for patients, consumers and responsible research.
The New York Times reports that many biotechnology stocks fell Tuesday amid investor questions about the future of thousands of gene patents.
Judge Sweet, in a footnote to his 152-page ruling, said he doubted that his ruling would destroy the industry. #