Justice Department Raises Doubt on Gene Patents

The legal battle over gene patents took a surprising twist on Friday when the U.S. Department of Justice issued a brief saying that the breast cancer genes BRCA1 and BRCA2 should never have been patented. The reason, Justice says in an amicus curiae document, is that isolating these genes did not amount to an invention. "Genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible," according to the brief, because it is like coal taken from the ground:

Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell-that is, the relationship between genotype and phenotype-is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is "isolated" from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.

This line of reasoning, filed in connection with a case now under review by the U.S Court of Appeals, echoes an argument made by opponents of gene patenting, made by the Public Patent Foundation (PubPat) and the American Civil Liberties Union of New York City.

They sued the U.S Patent and Trademark Office and Myriad Genetics of Salt Lake City over Myriad's ownership of more than a dozen patents on the BRCA1 and BRCA2 genes, data which the company uses to test people for breast cancer risks. In March, a U.S. district court in New York agreed with PubPat and its allies that key Myriad patents are invalid because "isolated DNA" is a product of nature and not an invention.

The biotech industry lobby disagrees with the New York court and the Justice Department. Biotechnology Industry Organization President and CEO Jim Greenwood said in a prepared statement today that the Justice brief is "inconsistent with the position" the U.S. government has taken at home and abroad for more than 2 decades. Greenwood warned of many consequences: "If adopted, the Justice Department's position would undermine U.S. global leadership and investment in the life sciences, harm U.S. economic growth and competitiveness at home and abroad, and be counterproductive to the Administration's own initiatives to fight cancer, develop renewable sources of energy," and other objectives.

Other independent reports, including one in The New York Times and a scathing review by Washington, D.C., patent attorney Kevin Noonan, have said that Justice's new policy represents a break with the past.

Noonan, for example, writes that the amicus brief "advocates a change in policy" whose authors "exhibit little evident background in science, technology, or patent law." It is, he says, "disturbing as well as contrary to sound patent policy."

Others saw the Justice statement as less radical. It really is "not all that far-reaching, despite the rhetoric," said Robert Cook-Deegan, an expert on genetics and patents at Duke University's Center for Genome Ethics, Law and Policy in Durham, North Carolina. He commented by e-mail that, "for most companies, even in biotech, implementation of the [Justice] position would matter very little." Cook-Deegan argues few biotech companies go to court to enforce claims on naturally occurring DNA sequences. And many of the younger firms, he argues, want fewer legal fences around genes because they are trying to create and market whole-genome technologies that use thousands of genes.

Cook-Deegan notes that the Justice Department brief differs from the New York court's decision in an important respect. It argues that some DNA-based patents should be kept intact—those that, in Justice's view, clearly required human ingenuity. For example, Cook-Deegan says, Justice's policy would not rule out patents on complementary DNA in therapeutic molecules, nor would it block patents on DNA-based vectors for therapy.

PubPat's founder and chief, Daniel Ravicher, says the Justice Department's amicus brief is "good news for us." He only wishes it had gone even further and adopted PubPat's argument—that no patents at all should be granted on isolated DNA.