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10 October 2018Americas

Federal Circuit upholds ruling in Roche TB patent clash

The US Court of Appeals for the Federal Circuit yesterday upheld a district court ruling that invalidated a patent owned by Roche Molecular Systems, a division of Roche that makes equipment and reagents.

In a precedential holding, the Federal Circuit affirmed the US District Court for the Northern District of California’s decision to find that claims of US patent number 5,643,723 are directed to patent-ineligible subject matter.

Roche’s patent, called “Detection of a genetic locus encoding resistance to rifampin in microbacterial cultures and in clinical specimens”, is used to detect the pathogenic bacterium, Mycobacterium tuberculosis (MTB). MTB infection is a major cause of tuberculosis.

The court explained that the diagnostic test of the ‘723 patent involves subjecting DNA “to amplification by polymerase chain reaction using a short, single-stranded nucleotide sequence (a ‘primer’) that can hybridise (ie, bind) to at least one of the eleven position-specific signature nucleotides in the MTB rpoB gene”.

Molecular diagnostics company Cepheid makes and sells “Xpert MTB/RIF Assay”, which can detect MTB in a biological sample and identify rifampin-resistant MTB.

In 2017, Roche sued molecular diagnostics company Cepheid, claiming that Cepheid’s Xpert MTB/RIF Assay, a procedure that can detect MTB in a biological sample, was infringing the ‘723 patent.

Cepheid filed a motion for summary judgment, arguing that the claims are ineligible subject matter as they are natural phenomena under 35 USC section 101.

The district court granted Cepheid’s motion, finding that the primer claims of the patent, “which have genetic sequences identical to those found in nature, are indistinguishable from those held to be directed to non-patentable subject matter”, making them invalid.

Additionally, the court found that the method claims are invalid because they are directed to “non-patentable laws of nature or natural phenomena”.

Roche appealed, but the Federal Circuit sided with the district court after following the two-step test laid out by Alice Corp v CLS Bank and Mayo v Prometheus.

According to Roche, the primer claims (17–20) are patent-eligible because they are directed to artificial primers that are different from naturally-occurring DNA.

But the court said: “In Re BRCA1 forecloses Roche’s arguments. There, this court examined the subject matter eligibility of similar primer claims and held that those primers ‘are not distinguishable from the isolated DNA found patent-ineligible in Association for Molecular Pathology v Myriad Genetics’ and thus are not patent-eligible.”

In the In Re BRCA1 case, the Federal Circuit found that the primers were structurally identical to the ends of DNA strands found in nature.

“It is undisputed that the primers before us have the identical nucleotide sequences as naturally-occurring DNA”, just like the primers found to be subject matter ineligible in the In Re BRCA1 decision, said the court in yesterday’s decision.

Turning to the method claims, the court concluded that they do not contain an inventive concept that transforms the claims into patent-eligible subject matter.

The district court’s summary judgment ruling was affirmed.

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