Fed Circuit rejects Stanford DNA test appeal
The US Court of Appeals for the Federal Circuit yesterday, July 10, handed victory to researchers at the Chinese University of Hong Kong (CUHK) in a case involving a foetal testing patent.
In a defeat for researchers at Stanford University, the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision which had rendered the Stanford patent, US patent number 8,008,018, invalid.
In three interference proceedings, the PTAB had found that four claims of the ‘018 patent were unpatentable for lack of written description. The board also found that claim 25 of a Stanford patent application was unpatentable for the same reason.
The ‘018 patent claims cover a method of determining the presence of a chromosomal abnormality (aneuploidy) in foetuses by using massively parallel sequencing (MPS) technology to sequence DNA fragments from a sample of the mother’s blood.
Stanford professors Stephen Quake and Christina Fan (called Quake in the ruling) and CUHK professor Dennis Lo had requested interferences to determine who invented the “random sequencing method” and when it was invented.
According to the Federal Circuit, the ‘018 patent claims recite a “random MPS method for the detection step, meaning that all of the DNA in the sample is sequenced, as opposed to sequencing specific, targeted sequences”.
However, Quake’s specification only expressly describes the detection of target sequences in its thirty-plus column specification, using the term “target” more than 60 times throughout the patent.
In 2013, the US Patent and Trademark Office declared three interferences would take place between Quake’s patents and applications and Lo’s patents and applications.
Four years later, in June 2017, the Federal Circuit vacated and remanded the PTAB’s decision to invalidate the patent, after finding that the board relied on improper evidence to support its key findings.
On remand, the PTAB found that a citation to a reference and a single sentence in Quake’s specification support random sequencing, but that the two are insufficient to describe the claimed method of determining fetal aneuploidy through random MPS.
Quake appealed against the decision, arguing that the patent specification sufficiently describes using random MPS to determine fetal aneuploidy.
But, this time, the Federal Circuit backed the PTAB and rejected Quake’s arguments.
While the court agreed that there had been limited disclosure of random MPS, “substantial evidence supports the board’s finding that those two items together are not adequate to convey using random MPS to determine fetal aneuploidy as claimed”.
In addition to finding that the PTAB was correct to find the claims unpatentable for lack of written description, the court also concluded that the board was within its discretion to not reopen the record for the admission of certain testimony.
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