Fed Circuit restores two Illumina DNA patents in blow to Roche
The US Court of Appeals for the Federal Circuit has ruled that two Illumina DNA detection patents are valid, in a reversal of a California district court.
In the precedential ruling, issued yesterday, March 17 the Federal Circuit overruled the US District Court for the Northern District of California, which had previously held that the two patents were directed to ineligible subject matter.
The two patents cover a method for distinguishing fetal DNA from maternal DNA in the mother’s bloodstream.
The patent claims are based on the inventors’ discovery that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream.
The Northern California district court had invalidated the patents on the grounds that they were directed towards this naturally-occurring phenomenon.
But according to yesterday’s Federal Circuit decision, the two patents are not directed towards that natural phenomenon itself but rather a “patent-eligible method that utilises it”.
The patents cover methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA, resulting in a DNA composition that differs from the fraction that naturally occurs in the mother’s blood.
“Thus, the process achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon,” the Federal Circuit ruling said.
The dispute originally arose after Illumina sued Roche and a subsidiary Ariosa Diagnostics for infringing the two patents.
Roche responded by claiming that the patents should be invalidated as being directed to patent-ineligible subject matter. The Northern California district court granted Roche’s request for summary judgment on these grounds.
But the Federal Circuit has now sent the case back to the California court for proceedings in line with its ruling that the claims are patent-eligible.
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