By Matt Jones
NEW YORK (GenomeWeb News) –The Supreme Court of the United States on Friday began considering whether to take up the case between Myriad Genetics, the Association of American Pathology, and other plaintiffs and defendants that could either shore up or change current US laws covering gene patenting.
The Myriad gene patents case, officially the Association of Molecular Pathology, et al. v. US Patent and Trademark Office, centers on the assertion by AMP and others that 15 patents exclusively licensed Myriad covering BRCA1 and BRCA2 genes should be invalid because they claim rights to products of nature and as such are not patentable.
The case began its journey toward the highest court in 2009 when it was first filed in the Federal District Court, Southern District of New York against Myriad. The AMP suit was joined by the American Civil Liberties Union, the Public Patent Foundation, patient advocacy groups, and the academic research community, all with different interests in gene patenting policies.
The lawsuit claimed that Myriad maintains a monopoly over any genetic testing to determine the presence or absence of mutations on the human BRCA1 or BRCA2 genes, thereby stifling research and limiting women's options regarding their medical care.
In 2010, Judge Robert Sweet ruled that the Myriad patents are invalid, because the isolated DNA the patents covered are not markedly different from native DNA as it exists in nature, and are not patentable.
That ruling, however, which left Myriad and other companies holding similar genetic patents on uncertain ground, was mostly overturned on appeal – which was requested by both plaintiffs and defendants – by the US Court of Appeals for the Federal Circuit last summer.
The Court of Appeals decided that some kinds of DNA can be patented, such as cDNA molecules and other engineered molecules that are not found in nature, so most of Myriad's claims would be valid.
"We disagree [with the district court], as it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit," the court stated in its decision. "The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact."
It also said that the company's claim on an assay for cancer therapeutics is valid because it involved several transformative steps. However, the judges said that five of Myriad's broadest method claim patents are invalid because they effectively referred to a mental act, a way of comparing sequences to look for differences, which cannot be patented.
One aspect of this case that could affect the court's decision is that the Office of the Solicitor General in the Department of Justice filed an amicus brief with the appeals court siding with the plaintiffs and against Myriad.
Solicitor General Neal Katyal argued that the court should uphold what the Supreme Court has historically supported, the notion that there is "a cardinal distinction" between products of nature on the one hand and human-made inventions on the other. The process of isolating DNA would not be enough of a transformation to make it patentable, Katyal argued, otherwise "[the element] lithium would be patentable."
Because the solicitor general joined in the case, Robert Cook-Deegan, director of the Duke University Center for Genome Ethics, Law & Policy, thinks that the Supreme Court may not make an immediate decision to hear the case, but instead it may opt to bounce the case over to the DOJ for another review.
"The two majority judges from the CAFC went out of their way to criticize the solicitor general's oral arguments [in their ruling], and I would think the Supreme Court might want to hear if the solicitor general has changed their mind in light of those arguments, or if they want to have a chance to rebut the judge's arguments," Cook-Deegan told GenomeWeb Daily News.
"This is apparently fairly common. Sometimes the solicitor general is said to be the tenth justice on the Supreme Court," Cook-Deegan said.
Under that scenario, if the solicitor general's office still holds the same position it had in 2011 against gene patents, then the Supreme Court would be likely to take up the case.
After the CAFC ruling, Myriad and companies with similar technologies are in a stronger patent position than they were in the wake of the New York court's decision, Cook-Deegan said, but the field of gene patents can involve unique complexities, and any certainties about patent protections could quickly become less firm in an environment of constantly-evolving technologies. For example, how will deep sequencing in the clinic affect the business models of labs that center on ownership of a few patents?
Cook-Deegan said that the case has already had an impact. "It is actually a pretty big deal that the courts have resettled the matter of whether you can patent a cDNA or an engineered DNA. … It is also a big deal that they threw out the method claims," he said. "Those claims were much more likely to get in the way of whole genome sequencing, whole exome sequencing, and the new technologies, than the DNA molecule claims."
Cook-Deegan said the court could decide what its next step will be as early as this week.
Meanwhile, an Australian federal court this week is hearing arguments in a case challenging Myriad's gene patents there.