Myriad: Keeping a low profile
The US Supreme Court has ruled that isolated human DNA is not patent eligible and has struck down patents owned by biotech company Myriad, ending a long-running and controversial case.
But in a mixed ruling, the court said that complementary DNA (cDNA), which is synthesised from messenger RNA (mRNA), can be patented under US law.
The court was ruling on a case between the Association for Molecular Pathology and Myriad, the owner of patents directed to mutations in the BRCA1 and BRCA2 human genes. With the patents, Myriad can isolate the genes from the human body and test for a risk of breast and ovarian cancer.
After Myriad’s patents were challenged in 2009, a district court found them invalid because they covered products of nature. But the US Court of Appeals for the Federal Circuit later reversed the decision, finding that isolated DNA and cDNA are patent eligible.
The case, which has generated significant controversy and has led groups such as the American Civil Liberties Union (ACLU) to call for Myriad’s patents to be rejected, made its way to the Supreme Court.
In a unanimous decision on June 13, written by Justice Thomas, the court said that “genes and the information they encode are not patent eligible ... simply because they have been isolated from the surrounding genetic material”.
“Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents”, the court added.
The court said the ruling does not cover patents on “new applications of knowledge about the BRCA1 and BRCA2 genes” and “nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered”.
Turning to cDNA, the court said it does not present the same obstacles to patentability as naturally-occurring, isolated DNA, because the process of creating a cDNA sequence from mRNA creates a non-naturally occurring molecule.
The court said: “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible”.
Justice Scalia dissented in part, saying he was “unable to affirm” some of the “fine details” of molecular biology, but agreed that isolated DNA is the same as that found in the human body.
In a statement, Myriad praised the court for upholding the patent eligibility of cDNA and stressed that the company still has 500 valid and enforceable claims in 24 different patents covering its BRACAnalysis test.
The ACLU claimed victory, writing on its website that “by invalidating these patents, the court lifted a major barrier to progress in further understanding how we can better treat and prevent diseases”.
The US government argued in briefs at the US Court of Appeals for the Federal Circuit and Supreme Court that isolated DNA should not be patented, though the US Patent and Trademark Office (USPTO) declined to sign the government’s brief.
Janis Fraser, principal at Fish & Richardson PC in Boston, said: “The government should have relied on the experts in the patent office rather than imposing their own, not-well-thought-through position.”
She added that the decision was not surprising “in view of the speculation that’s been going on since the oral hearings ... a lot of people came away with the feeling that the court would end up with a decision like this”.
Todd Dickinson, executive director of the American Intellectual Property Law Association and former head of the USPTO, described the ruling as predictable but disappointing. “I’m concerned with the impact on the biotechnology industry, in which the US is a world leader,” he said.
He added that “the breadth of an opinion like this is always a worry ... when you have definitive statements without clarification”.
Mercedes Meyer, partner at law firm Drinker Biddle in Washington, DC, said that the decision may have created a slippery slope. “If it’s naturally-occurring as a gene, it’s not patentable, but [for example] polypeptides are naturally occurring.”
But, she added, “there are ways to work around it. If you had a commercially important patent that contains claims like that ... you can go back and seek a reissue patent in order to obtain claims to a broader group of cDNAs that can produce the same protein”.
Meyer highlighted that there are a lot of patents containing exactly the kind of claims that the court found invalid, notably because the USPTO listed examples of such claims it its patent Utility Guidelines, issued in 2001.
The Supreme Court reasoned that while Myriad’s efforts to isolate the genes were important, “separating that gene from its surrounding genetic material is not an act of invention”.
Commenting on that approach, Meyer said: “I think people are unconsciously employing the molecular scissor approach – and that's wrong. BRCA1 and BRCA2 took labfuls of postdocs and grad students to identify where the gene was [and] figure out which mRNA was responsible for the relevant protein (and there were a lot of mRNAs due to different splice products), let alone figure out which mutation was correlated to a greater propensity of a specific cancer.”
The impact on the industry will take a while to fully assess, and will depend on how lower courts interpret the judgement and how the USPTO reacts, but Meyer said “it may have an initial chilling effect both in venture capital and in disclosure of discoveries as the community tries to figure out what the complete implications of the decision are”.
Fraser agreed, adding: “There will be fewer new gene tests on new mutations developed because there’s no good way to get broad claims ... to allow developers to recoup their investment ... that's no good for patients.”
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myriad genetics, aclu, us supreme court, gene patents, isolated DNA patents, BRCA1, BRCA2