The U.S. Supreme Court heard oral arguments on a case closely watched by the biotechnology industry that addresses the patentability of genes, Association for Molecular Pathology v. Myriad Genetics.
In 2009, the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit charging that Myriad’s patents on the BRCA1 and BRAC2 genes, which have been linked to hereditary breast and ovarian cancer, should not have been awarded because they are products of nature and therefore ineligible for patent protection. They argue that the patents harm innovation because Myriad can control who can use these genes.
Myriad argues that by isolating the genes from DNA and producing man-made copies of the isolated DNA, it created unique chemical composition not found in nature or the human body. “We patented synthetic molecules based on the genes that were created in the lab in order to delivery life-saving tests to patients,” the company says on its website. “Those molecules are not found in the human body and are different from the DNA found in cells.”
The case is one of great concern to academic researchers as well as the biotechnology industry. The ruling could have lasting effects on the ability to commercialize products, such as molecular diagnostics, alter the valuation of companies, the ability to raise capital, and the willingness to invest in certain research and development.
“There’s a lot riding on this obviously,” says Jim Greenwood, president and CEO of the trade association the Biotechnology Industry Organization. “If they get it wrong, they can really do some damage to our ability to innovate new products.”
The oral arguments reflect the difficulty the justices had in getting at some of the complexities in the case, evident in the variety of metaphors used to describe aspects of their considerations, ranging from baseball bats to chocolate chip cookies.
In the end, the justices appeared to be concerned about striking a balance between the need to allow researchers and others the freedom to operate without erecting disincentives and barriers to innovation.
“The patent law is filled with uneasy compromises, because on the one hand, we do want people to invent,” said Justice Stephen Breyer. “On the other hand, we’re very worried about them tying up some kind of whatever it is, particularly a thing that itself could be used for further advance.”
April 19, 2013