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USPTO Board Nullifies Illumina NIPT Patent Claims

NEW YORK(GenomeWeb) – The US Patent and Trademark Office Patent Trial and Appeal Board has nullified 13 claims of a patent held by Illumina that is at the center of litigation filed by the company against Ariosa Diagnostics alleging patent infringement. 

On Wednesday, the USPTO board nullified claims 1-13 of US Patent No. 8,296,076 after an inter partes review determined that Ariosa Diagnostics, which petitioned for the review, "demonstrated by a preponderance of the evidence that the challenged claims of the … patent are unpatentable." 

Illumina and Ariosa declined to comment. 

The '076 patent is one of several patents that have spurred litigation among Illumina, its Verinata Health business, and their competitors in the non-invasive prenatal testing space including Ariosa, Sequenom, and Natera. Verinata, which was acquired by Illumina in January 2013, sued Ariosa two years ago over the '076 patent. The case is being tried in the US District Court for the Northern District of California. 

Illumina also has sued Ariosa alleging infringement of US Patent No. 8,318,430 and 7,955,794.

According to the '076 patent abstract, the technology is a method for the digital quantification of DNA using shotgun sequencing, "followed by mapping to the chromosome of origin, and then enumeration of fragments per chromosome." Stephen Quake and Christina Hei-Mun Fan are listed as the inventors. The technology was assigned to Stanford University's board of trustees.

Piper Jaffray analyst William Quirk said in a note today that he expects Illumina to appeal the USPTO decision to the federal circuit and noted that the USPTO board recently invalidated certain claims of US Patent No. 6,258,540, which is held by Sequenom. "It appears ultimately little NIPT IP may survive legal challenges, thus putting more competitive emphasis on business strategy and distribution," he wrote. 

He added that although "this loss of IP is negative for [Illumina]… given [its] strategy of IVD kits, we expect the decision to have little impact on the business."

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