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8 January 2021AmericasRory O'Neill

Roche urges SCOTUS to cancel Illumina patent win

Roche has asked the US Supreme Court to declare that methods of separating DNA are not patent-eligible.

The petition stems from a US Court of Appeals for the Federal Circuit decision issued last March which held that two Illumina DNA patents were valid.

Illumina had sued Roche for infringing the patents, which cover methods of 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 petition for review of the Federal Circuit’s decision, Roche told the Supreme Court that the Illumina patents claimed “conventional techniques” of separating DNA.

The Federal Circuit’s decision also violates Supreme Court precedent, set down in the 2013 Myriad decision, the pharma companies argue.

In Myriad, the Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”.

The Federal Circuit ruled last March that the Illumina patents did not merely cover a natural phenomenon, but rather a “patent-eligible method that utilises it”.

The appeals court subsequently declined to review its decision en banc in August, prompting Roche to petition the Supreme Court.

“While a method involving unconventional steps for separating DNA might plausibly survive Section 101 review, no such method is at issue here,” the petition said.

“Indeed, the patents claim the very method the patentees used to study and characterize the size distribution of naturally occurring DNA fragments, thereby preventing others from using that method to analyze the natural phenomenon they allegedly discovered,” it continues.

Roche also claims that the specific size thresholds listed in the patents are derived from “off-the-shelf laboratory kits”, rather than the “patentees’ ingenuity”.

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More on this story

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6 August 2020   The US Court of Appeals for the Federal Circuit will not revisit its ruling that saved the patent eligibility of two DNA test patents owned by biotechnology company Illumina, after the court rejected an en banc request from a subsidiary of Roche.
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19 March 2020   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.
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