An About-Face On Gene Patents

Reversing decades of government policy, the Department of Justice declared last week that human and other genes should not be eligible for patent protection because they are products of nature.

“The U.S. has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter,” the department said.

Federal attorneys disclosed the policy shift in a legal brief filed in a landmark lawsuit challenging patents held by Myriad Genetics and the University of Utah Research Foundation on two genes: BRCA1 and BRCA2. Myriad, a biotech company based in Salt Lake City, has developed a diagnostic test that detects mutations in the genes that make women susceptible to breast or ovarian cancer.

In March, Judge Robert W. Sweet of the U.S. District Court for the Southern District of New York ruled that the patents were invalid. Myriad and the University of Utah have appealed.

Biotechnology companies argue that DNA-based patents are essential for protecting their investment in the research and development of genetic tests for medical diagnosis.

The U.S. Patent & Trademark Office (PTO) has issued thousands of patents on genes of various organisms; more than 20% of the genes in the human genome are now patented.

“We acknowledge that this conclusion is contrary to the long-standing practice of PTO, as well as to the practice of NIH and other agencies that have in the past sought and obtained patents for isolated genomic DNA,” the Justice Department said.

The brief contends that isolating a DNA molecule, without further alteration or manipulation, does not change its nature. “Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it,” department lawyers wrote.

But Ashley J. Stevens, president of the Association of University Technology Managers, argues that, without the ability to patent isolated DNA molecules, “many promising discoveries would not make their way from the university research lab and into the hands of companies for development of products that improve public health.