Biotech firm suffers setback in multi-million pound patent battle

Dr Stephen Little

Manchester-based biotech company Premaitha Health has suffered a setback in a multi-million pound legal battle with an American company over the patent of its ground-breaking non-invasive prenatal test for Downs syndrome in unborn children, branded IONA.

A High Court ruling delivered today (Tuesday, November 21) has deemed the IONA test infringes the company Illumina Inc’s patent in “certain respects”.

The judgment also refused the company’s application for declarations of non-infringement in respect of two proposed alternative methods of performing the IONA test.

A Form of Order Hearing (the Hearing) will be scheduled in soon at which the judge will hear applications from the various parties arising from the judgment, including Premaitha’s application for leave to appeal and Illumina’s anticipated application for a proportion of its costs, in the form of an interim payment.

If upheld on appeal, the judgment could impose restrictions on the Premaitha’s ability to sell into the UK market and/or order other remedies against the company, in favour of the patent-holders.

Premaitha chief executive Dr Stephen Little 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.

“The effect of the judgment could potentially limit the access of UK patients to NIPT (non-invasive prenatal test) 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.

“In the meantime we will continue to offer our high quality NIPT solutions and support to pregnant women and their clinicians in the UK, as we continue to expand our business into territories where we can operate with greater legal certainty.

“In addition we are accelerating plans to broaden the menu of tests we offer beyond NIPT and which should be cash generative in 2018. We will also focus on mitigating any financial implications of the litigation.”

In the financial year to March 31, 2015 alone, the legal battle cost Premaitha £5.8m.

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