by Greg Mayer
In a move that got lost in the run up to the recent US elections, the Federal government has reversed its longstanding policy that genes are patentable. Released the Friday before the elections, and covered by the New York Times the following day, with a follow up article the day before the election, the Justice Department’s brief in the case argued that gene sequences unmodified by man are products of nature, and thus ineligible to be patented; and that isolating the sequence doesn’t change its status. Here’s a summary of the argument:
The district court [which invalidated two gene patents] correctly held, however, that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty [an earlier decision, allowing the patenting of genetically modified organisms], the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. 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.
The friend of the court brief was filed in an appeal of a case brought by a group of scientific and medical societies and individuals against Myriad Genetics, which had been granted patents on two genes associated with breast and ovarian cancer. In a surprise ruling last March, US District Court Judge Robert Sweet invalidated the patents (more on the ruling here and here), and the current brief was filed in response to Myriad’s appeal of the adverse ruling. The Feds argue that some aspects of Judge Sweet’s ruling erred, but that it’s main conclusion was correct: “…products of nature do not constitute patentable subject matter absent a change that results in a fundamentally new product. … [T]he purification of native DNA does not alter its essential characteristic– its nucleotide sequence– that is defined by nature…” (pp. 107 & 132 of the ruling, full text here).
The Federal position comes as good news to the scientists and medical groups involved, and to anyone who wants the law to make sense. The notion that a gene is a human invention, rather than a product of nature, is absurd to any biologist (unless perhaps you were granted one of these bogus patents, which may be one of those cases where, as Upton Sinclair put it, it is difficult to get a man to understand something, when his salary depends upon his not understanding it). This is one instance in which the Obama administration has followed up on his promise that “Science and the scientific process must inform and guide decisions of my Administration on a wide range of issues”.