By Monica Heger
Verinata Health has licensed a patent recently issued to Stephen Quake of Stanford University for the use of next-generation sequencing to diagnose fetal aneuploidies, the company said last week.
Verinata is currently developing a next-gen sequencing-based fetal trisomy diagnostic based on the technology. However, Sequenom believes that the development of such a test would infringe a patent it currently holds.
The new patent, No. 8,008,018, titled "Determination of fetal aneuploidies by massively parallel DNA sequencing," was issued to Quake's group last week and its claims cover a method for determining fetal aneuploidy in maternal tissue using next-gen sequencing (CSN 8/31/2011).
Verinata, which has been developing a sequencing-based prenatal diagnostic test that it plans to launch either late this year or early next year, also holds the rights to a previous patent issued to Stanford University, No. 7,888,017, "Non-invasive fetal genetic screening by digital analysis."
The company told Clinical Sequencing News that its test would be based on technology described in both of these patents, but declined to comment further.
Meanwhile, Sequenom, which is also developing a sequencing-based fetal diagnostic test for trisomy 21 that it plans to launch either late this year or early next, also holds IP in the space, including US Patent No. 6,258,540, "Non-invasive prenatal diagnosis," a broad patent that Sequenom licensed from Dennis Lo of the Chinese University of Hong Kong that covers "a method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female."
Ron Lindsay, Sequenom's executive vice president of research and development, told Clinical Sequencing News that if Verinata launches a sequencing-based fetal trisomy test, it would infringe the '540 patent. "We already warned them last year that when they launch [their test], this would be infringing," he said, adding that the company plans to enforce its patent.
The '018 patent that Verinata has licensed "will not impact our business at all," he added. According to Lindsay, the patent does not apply to using next-gen sequencing to diagnose fetal aneuploidies, despite the patent's title and the fact that sequencing is listed in the claims, because the patent does not specifically "teach how someone would use massively parallel shotgun sequencing as the primary tool" to diagnose aneuploidy.
Even though the patent mentions sequencing, said Lindsay, "our interpretation is that it is an extension of the '017 patent," which was issued for the use of digital PCR for fetal genetic analysis.
The '018 patent's claims include a "method for determining presence or absence of fetal aneuploidy in a maternal tissue sample comprising fetal and maternal genomic DNA, wherein the method comprises … conducting massively parallel DNA sequencing of DNA fragments randomly selected from the mixture of fetal and maternal genomic DNA," which, Quake said, "speaks for itself."
Both Lo and Quake have additional pending patent applications related the noninvasive diagnosis of fetal aneuploidy by sequencing fetal DNA from a maternal plasma sample. Lindsay said it's possible that the US Patent and Trademark Office could find these applications are grounds for patent interference, but did not elaborate. A patent interference proceeding can be initiated by a patent examiner or upon the request of one of the patent applicants.
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