The United States Court of Appeals for the Federal Circuit ruled in a 2 to 1 decision Friday that human genes can be patented because the DNA extracted from cells is not a product of nature.
The court held (PDF) that Myriad Genetics can patent two human genes used to predict the risk of breast and ovarian cancer in women, overturning a previous decision by a federal district court in March 2010. But the court ruled that the method used to determine a patient’s risk of cancer was not patentable.
The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed in May 2009 on behalf of researchers, women patients, cancer survivors and scientific associations against the U.S. Patent and Trademark Office, as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, BRCA1 and BRCA2.
The lawsuit was filed by the Public Patent Foundation and the American Civil Liberties Union, who claimed patents on human genes violate the First Amendment and patent law because genes are “products of nature.”
The court disagreed.
“In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified,” Judge Alan D. Lourie wrote for the majority. “They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.”
Judge Kimberly A. Moore added in a concurring opinion that isolated DNA “is a distinct molecule with different physical characteristics than the naturally occurring” DNA found in nature, noting that the DNA found in nature “is part of a much larger structure, the chromosome.”
In his dissenting opinion, Judge William C. Bryson advocated the “common sense view” that “patents are for inventions” and “a human gene is not an invention.” He also warned that “if sustained the court’s decision will likely have broad consequences, such as preempting methods for whole-genome sequencing.”
“Because the native BRCA genes are chemically bonded to other genes and histone proteins, the majority concludes that cleaving those bonds to isolate the BRCA genes turns the isolated genes into ‘different materials,'” Bryson added. “Yet there is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered.”
The U.S. Patent and Trademark Office (PTO) has already granted thousands of patents on human genes. It is estimated that nearly 20 percent of human genes are patented.
CORRECTION: A previous version of this article incorrectly stated that the three judges were on the U.S. District Court for the Southern District of N.Y.