21 November 2017 – Litigation First Instance Judgment

Premaitha Health plc
(“Premaitha” or the “Company” or the “Group”)

Litigation First Instance Judgment

Manchester, UK – 21 November 2017: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing (“NIPT”), announces details of a legal judgment handed down today.

The UK High Court has today delivered its first instance judgment (the Judgment) in relation to the ongoing dispute with Illumina Inc and others concerning three UK patent families, (“Lo 1”, “Quake” and “Lo 2”).  The Judgment has deemed all the concerned patents to be valid, although it has invalidated a number of the claims of Lo 1 and has decided that the Company’s IONA® test infringes that patent only in certain respects.  However, the Judgment also deems that the IONA® test infringes the asserted patents in the Quake and Lo 2 families.  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 late 2017 / early 2018 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 their costs, in the form of an interim payment (pending appeal).  The quantum and timing of any award will not be determined until the Hearing, and the Company will prepare for a range of eventualities.  If upheld on appeal, the Judgment could impose restrictions on the Company’s ability to sell into the UK market and/or order other remedies against the Company, in favour of the patent-holders.

The UK market represents approximately 20% of the Group’s revenues, a proportion which is decreasing as the international customer base expands.

Dr Stephen Little, CEO, 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 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.”

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

For more information, please contact:

Premaitha Health plc
Dr Stephen Little, Chief Executive Office    
Barry Hextall, Chief Financial Officer
Joanne Cross, Head of Marketing    
Tel: +44 (0) 161 667 6865
Cairn Financial Advisers LLP (Nomad)
Liam Murray / James Caithie
Tel: +44 (0) 20 7213 0880
finnCap (Broker)
Adrian Hargrave / Scott Mathieson (Corporate Finance)    
Tony Quirke (Corporate Broking)    
Tel: +44 (0) 20 7220 0500
Vigo Communications
Ben Simons / Fiona Henson / Antonia Pollock    
Tel: +44 (0) 20 7830 9701

About Premaitha
Premaitha is an international molecular diagnostics group which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved genetic screening tests. The Group’s primary focus is on non-invasive prenatal tests (NIPT) for pregnant women – an emerging, multi-billion dollar global market.

Premaitha’s IONA® test was launched in 2015 as the first CE-IVD NIPT test in Europe. It enables laboratories and healthcare practitioners to offer a complete CE-marked NIPT system in-house. The IONA® test is performed on a maternal blood sample – which contains traces of fetal DNA – and estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions.

Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA® test can significantly reduce the number of women subjected to unnecessary invasive follow up diagnostic procedures, such as amniocentesis, which are costly, resource intensive and carry a risk of miscarriage.

In March 2017, Premaitha acquired Yourgene Bioscience, a specialist next generation sequencing and bioinformatics company based in Taiwan, with its own NIPT screening test that operates on the same Thermo Fisher next-generation sequencing platform as Premaitha’s IONA® test. Yourgene brings significant benefits to the Group through expanded market access in Asia – the world’s fastest growing NIPT market – as well as opportunities for cross-selling and the ability to jointly develop expanded test content both within NIPT and beyond.

Premaitha is headquartered in Manchester, England, with Yourgene offices in Taipei and Singapore. Its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information, please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.