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6 August 2020AmericasMuireann Bolger

Federal Circuit won’t revisit revived Illumina DNA test patents

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.

On Monday, August 3, the Federal Circuit denied a petition from molecular diagnostics testing lab Ariosa and instead offered a modified opinion.

The dispute between the two companies began in May 2018, when Illumina sued Ariosa on two counts of patent infringement, claiming that Ariosa’s “Harmony Prenatal Test’ infringed its patents, numbers 9,580,751 and 9, 9,738,931. Illumina is the exclusive licensee of both patents, which are called “non-invasive detection of fetal genetic traits”.

The patents cover the extraction of foetal DNA from plasma samples of pregnant women and the removal of the DNA fragments. Ariosa’s test detects foetal chromosomal abnormalities by sequencing DNA from blood samples drawn from pregnant women. In July 2018, Ariosa claimed that the patents should be declared invalid as they covered naturally-occurring phenomena.

In December 2018, The US District Court for the Northern District of California agreed that the patents covered tests of naturally-occurring DNA, and did not transform the naturally-occurring product into something new. The court entered judgment in favour of Ariosa, and Illumina appealed.

On March 17, the Federal Circuit reversed this decision, holding that the inventors “patented methods of preparing a DNA fraction”, and that the “the claimed methods utilise the natural phenomenon that the inventors discovered by employing physical process steps”. The court concluded that the claims of the ’751 and ’931 patents were “patent-eligible subject matter”.

This week, the Federal Circuit further explained that the patents were valid because this was “not a diagnostic case”, but rather was “a method of preparation” case. It held that while diagnostic claims have been held ineligible under Athena Diagnostics v Mayo, this case did not fall into that category.

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More on this story

Americas
12 August 2020   McDermott Will & Emery has strengthened its IP practice in Boston with the addition of Michael Siekman and Jenny Chen as partners.
Americas
17 August 2020   The US Court of Appeals for the Federal Circuit has thrown out a patent infringement lawsuit brought by two Illinois doctors against more than 300 hospitals.
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