Last May, US District Court judge Robert Sweet threw out patents on BRCA1 and BRCA2, a pair of human genes in which mutations are linked to breast and ovarian cancer. In his decision, Sweet ruled the patents were “improperly granted” since they involved a “law of nature.” He rejected the notion that isolating a gene made it patentable, calling that “a ‘lawyer’s trick’” which circumvents the “prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”
The BRCA case had been brought by the American Civil Liberties Union, patients and medical organizations. Among other things, they argued that patents drive up testing costs and stifle biomedical innovation.
Sweet’s ruling caused quite a stir at the time, since nearly 20% of all human genes had already been patented, and entire industries had been created around the intellectual property rights granted by these patents.
Myriad Genetics is the company that holds the BRCA patents. It markets a $3,000 test that detects the offending mutations in those genes. Not surprisingly, Myriad appealed the ruling.
As the appeal moved forward, the US Department of Justice surprised many observers by releasing an amicus brief in which it asserted that human, and indeed all genes should not be eligible for patent protection. This amounted to a complete reversal of its position on the issue.
“We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,” the brief stated.
Explaining the about-face, the government said that Sweet’s earlier decision had prompted it to review its policies. Now, it was of the opinion that the mere isolation of a gene, without further alteration or manipulation, did not change its nature. Furthermore, the brief said, “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.”
Elsewhere in the brief, the government implied that its new stance would not materially impact the biotechnology industry since man-made DNA manipulations, such as those used to create genetically modified crops or gene therapies, could still be patented.
It new position by the Justice Department seems to split the difference between the plaintiffs in the case (the ACLU and others as listed above) and the defendants (Myriad and the US Patent and Trademark Office). That’s confusing to everybody. Indeed, the Patent Office is a part of the US government, just like Justice. It has issued thousands of patents on genes from hundreds of living things including humans.
To make matters worse, the Patent Office announced two days after the amicus brief was released that it plans to continue considering applications for gene-related patents.
This case is headed for the Supreme Court. The sooner it gets there, the better.