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Illumina Gets Favorable Ruling in UK NIPT Patent Infringement Lawsuit

NEW YORK (GenomeWeb) – The High Court of Justice, Chancery Division, Patents Court in the UK today largely found in favor of Illumina in its patent infringement case against Premaitha Health, The Doctors Laboratory, TDL Genetics, and Ariosa Diagnostics.

In March 2015, Illumina and its wholly owned subsidiary Verinata Health filed a patent infringement suit against Premaitha over IP covering noninvasive prenatal testing, specifically referring to European Patent (UK) 0 994 963 B2 and European Patent (UK) 1 981 995 B1, both relating to the use of cell-free fetal DNA for NIPT.

Illumina licensed the patents exclusively from Sequenom and Stanford University. Stanford joined the suit because it is the registered owner of the '995 B1 patent. In the suit, the plaintiffs claimed that Premaitha's Iona test infringes the patents, including its use of next-generation sequencing to analyze cell-free fetal DNA from maternal blood.

In January 2016, llumina filed two patent infringements lawsuits in the UK against The Doctors Laboratory, TDL Genetics, and Ariosa Diagnostics, alleging that The Doctors Laboratory's and TDL Genetics' use of the Harmony NIPT tests supplied by Ariosa infringed on Illumina's European Patent 0 994 963. Illumina further alleged that two companies in Poland — Centrum Badan and Medgenetix — were using Premaitha Health's Iona NIPT test in violation of Illumina's European Patent 2 183 693.

These lawsuits were consolidated and heard in a combined trial in July. In total, the lawsuits alleged infringement on five different NIPT patents: European Patent (UK) 0 994 963 B2, European Patent (UK) 1 981 995 B1, European Patent (UK) 2 183 693 B1, European Patent (UK) 2 385 143 B1, and European Patent (UK) 2 514 842 B1.

The five patents in question were referred to by the UK court under the names of the scientists whose research underlies the IP — Dennis Lo of the Chinese University of Hong Kong, and Stephen Quake of Stanford.

The Lo1 patent, which belongs to Sequenom and which Illumina claimed was exclusively licensed to it, was alleged to have been infringed by Premaitha and Ariosa. The UK court found that Ariosa's Harmony NIPT test's polymorphic assay didn't infringe on any valid claim for that patent, but that the test's non-polymorphic assay partly infringed on the patent "insofar as it [Harmony] is used for sex determination." The same determination of partial infringement was made for Premaitha's Iona NIPT test. The court also found that Illumina is not the exclusive licensee for the Lo1 patent.

The Quake 1 and 2 patents, which belong to Stanford and which Illumina claimed were exclusively licensed to its subsidiary Verinata, were alleged to have been infringed by Premaitha. The court found that the Iona test infringed these patents, and that "Verinata is an exclusive licensee of the Quake Patents and the Iona test falls within the licensed field."

Finally, the Lo 2 and 3 patents, which belong to the Chinese University of Hong Kong and which Illumina claimed were exclusively licensed to it, were alleged to have been infringed by Premaitha. The court found that the Iona test infringed these patents as well, and that "Illumina is an exclusive licensee for commercial purposes of the Lo 2 and Lo 3 patents."

Ariosa's parent company, Roche, had no official statement regarding to court's decision except to say that it is "currently evaluating the judgment."

Premaitha CEO Stephen Little responded with disappointment at the court's ruling, saying in an email that the company "deeply disagrees with the interpretation the judge has given to precise technical language in the patents. The effect of the judgment could potentially limit the access of UK patients to NIPT and, in certain respects, diverges from decisions made in other jurisdictions. We are seeking leave to appeal and continue to believe that the motivation behind these legal actions is competitive rather than technical."

Pending that appeal, he added, Premaitha will continue to offer NIPT testing to pregnant women and their clinicians in the UK, and will continue to expand its business into territories "where we can operate with greater legal certainty." The firm is also accelerating plans to broaden its menu of tests beyond NIPT, which should be cash generative in 2018.

Illumina currently has an outstanding patent infringement lawsuit against Premaitha, which it filed in September in the same court in the UK. The patent in question is one that Illumina licenses from Sequenom, the European Patent (UK) 1 524 321 B2 titled, "Non-invasive Detection of Fetal Genetic Traits." Illumina is seeking damages and injunctive relief.