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Biotech company Illumina has won a dispute with Columbia University, after the Court of Appeals for the Federal Circuit backed an earlier ruling that the university’s DNA-sequencing patents were invalid.
The Federal Circuit finalised two decisions from the Patent Trial and Appeal Board (PTAB) in June and September 2019, which ruled in favour of a challenge by Illumina that claims in five of the university’s patents were unpatentable.
The patents involved were US numbers 9,718,852, 9,719,139, 9,708,358, 9,725,480 and 9,868,985.
The ’852, ’139, ’358, ’480, and ’985 patents are directed to nucleotide analogues and a method of using nucleotide analogues to sequence DNA called ‘sequencing-by-synthesis’ (SBS).
Illumina’s successful petitions for inter partes review (IPR) asserted that certain combinations of prior art references would have rendered obvious the use of a “labelled nucleotide analogue with an allyl capping group”.
On appeal, Illumina was accused by the university of teaching away from the established SBS model involving the usage of nucleotide analogues to sequence DNA.
The university’s argument centred on debunking one of Illumina’s claims regarding the use of a ‘capping group’ in its IPR petitions. The university argued that the board erred in determining that a person of ordinary skill would have been motivated to pursue an alternative allyl capping group for use with the SBS model.
However, in a ruling handed down on February 2, the Federal Circuit said Illumina was not guilty of teaching away and the board’s decision was supported by substantial evidence.
“Teaching away requires ‘clear discouragement’ from implementing a technical feature’,” said the court, ruling that Columbia had not demonstrated that there was any such “clear discouragement”, making its claims of teaching away invalid.
“We have considered Columbia’s remaining arguments and find them unpersuasive,” said the court. “The board’s decisions were supported by substantial evidence and were not erroneous as a matter of law. For the foregoing reasons, the decisions of the board are affirmed.”
This is the latest in a series of disputes between the two parties. In 2017, the Federal Circuit upheld an earlier PTAB ruling that invalidated three of Columbia’s patents.
In 2019, the university hit back with an infringement suit, claiming that Illumina had sold DNA sequencing instruments which infringed on two of its own patents.
California-based Illumina focuses on developing, manufacturing and integrating systems for analysing genetic variation and biological function.
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Illumina, Columbia University, PTAB, inter partes review