Prenatal test infringes Illumina patents, rules English High Court
A prenatal test sold by molecular diagnostics company Premaitha Health infringes patents owned by genetic sequencing firm Illumina, a UK court has ruled.
Yesterday, November 21, the English High Court found that the Iona test breaches the valid claims of the patents. Each patent relates to non-invasive prenatal diagnosis, genetic testing on a foetus that requires only sampling of the mother’s blood, or another non-invasively collected analyte.
Premaitha’s Iona test, a non-invasive prenatal test that estimates the risk of a foetus having Down’s syndrome and other genetic conditions, was at the centre of the dispute.
Illumina alleged that the test infringed European patent numbers 0,994,963 B2; 1,981,995 B1; 2,183,693 B1; 2,385,143 B1; and 2,514,842 B1.
The High Court combined the Premaitha proceedings with a lawsuit that Illumina had brought against Ariosa Diagnostics, a Roche subsidiary.
Ariosa developed a non-invasive prenatal test called Harmony, which Illumina claimed infringed the ‘963 patent. Ariosa counterclaimed for invalidity, while Premaitha challenged the validity of all the patents.
Mr Justice Henry Carr found that the ‘963 patent was not obvious in light of prior art, but that amended claims 1, 2, 5 and 7 were not entitled to the claimed priority date.
“It is accepted by Illumina that claims which are not entitled to priority are invalid,” said Carr.
He went on to find that the Harmony test didn’t infringe any valid claim of the ‘963 patent, but that both tests partly infringed the patent “insofar as it is used for sex determination”.
Carr found that the Iona test infringed patents ‘995 and ‘143 (known as the Quake patents), which belong to Stanford University and are exclusively licensed to Verinata, a subsidiary of Illumina.
He said that patents ‘693 and ‘842 were not obvious in light of prior art, were entitled to their claimed priority date, and were infringed by the Iona test.
Premaitha said that a hearing will be scheduled in late 2017/early 2018 at which the judge will hear applications from the parties, including Premaitha’s application for leave to appeal and Illumina’s expected application for a proportion of the company’s costs, in the form of an interim payment (pending appeal).
Stephen Little, CEO of Premaitha, said: “We are very disappointed with this ruling and deeply disagree with the interpretation the judge has given to precise technical language in the patents.”
Premaitha is seeking leave to appeal against the decision.
Charles Dadswell, senior vice president and general counsel at Illumina, said: “The court’s judgment validates the investments Illumina has made, the value of this technology and the significant contributions of the inventors in this field.”
Tim Powell, partner at Powell Gilbert and representative of Illumina, added: “It is rare to have the opportunity to work on inventions which can truly be described as revolutionary and have changed the direction of a whole field of medicine.
“It is always satisfying to see the courts recognise such innovation, and we are very pleased with the result for our client.”
Illumina filed another patent infringement suit against Premaitha Health in the High Court in September this year, focusing on European patent 1,524,321 B2.
Called “Non-invasive detection of foetal genetic traits”, the patent is licensed to Illumina from Sequenom, a genetic testing company.
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