This article has been updated with a comment from the USPTO.
NEW YORK (GenomeWeb News) – The US Department of Justice has filed a friend-of-the-court brief opposing the patenting of genes, arguing that they occur naturally and are not human-made inventions.
The DOJ filed the brief Friday with the US Court of Appeals for the Federal Circuit in the case challenging the legality of the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad Genetics. However, the amicus brief was not filed in support of either the plaintiff or defendant.
In March, Judge Robert Sweet of the US District Court in Manhattan ruled that the BRCA1 and BRCA2 patents were invalid, a decision that Myriad subsequently appealed.
In his decision, Sweet said that the case hinged on the fact that Myriad's patents protect "isolated DNA." While the premise was that DNA should be treated like any other chemical compound "and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character," Sweet said that DNA is "distinct in its essential characteristics from any other chemical found in nature [and its] existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes."
The DOJ in its brief supported part of Sweet’s ruling, but not all of it. It agreed that “genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible.”
The DOJ’s brief was filed on behalf of the US government and reflects the first time that US policy has backed such an interpretation on gene patenting. The policy position also could have widespread impact on the biotech industry.
“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 DOJ wrote in the brief.
For the time being, it appears that the US Patent and Trademark Office does not intend to change its policies regarding gene patents.
"The USPTO will maintain the status quo while this matter is pending resolution by the Federal Circuit," a patent office spokesperson told GenomeWeb Daily News sister publication PGx Reporter today.
The DOJ also pointed out in the brief that it believes a section of the law that has established the threshold for what inventions are patentable is “purposely wide and its threshold is not difficult to cross … however, it said that crossing that threshold “requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.”
The DOJ wrote in its brief, “New and useful methods of identifying, isolating, extracting, or using genes and genetic information may be patented (subject to the prohibition against patenting abstract ideas), as may nearly any man-made transformation or manipulation of the raw materials of the genome, such as cDNAs.”
Thus, the DOJ said, Judge Sweet “erroneously cast doubt on the patent-eligibility of a broad range of man-made compositions of matter whose value derives from the information-encoding capacity of DNA.”
For more on the DOJ brief and the potential impact of its policy position see Pharmacogenomics Reporter.