YGEN.L Regulatory News (YGEN)

Premaitha Health plc

("Premaitha" or the "Company")

Update on UK patent infringement claim received in September 2017

Manchester, UK - 26 March 2018: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing ("NIPT"), provides an update on the first stage of its UK defence against the new patent infringement claim, announced on 7 September 2017 ("New UK Claim").

The New UK Claim from Illumina and Sequenom (the "Claimants") was filed in September 2017 and alleges that Premaitha's IONA® test infringes European Patent (UK) 1 524 321 82, known as the "321" patent, as filed by Sequenom in 2003 and as included in a Pooled Patents Agreement (PPA) entered into between Sequenom and Illumina in late 2014. The Claimants have also asserted the patent against other competitors, Ariosa and The Doctors Laboratory ("Ariosa/TDL") (together with Premaitha, the "Defendants"). At a hearing held in the High Court on 16 March 2018, the judge heard applications made by the Defendants, that the New UK Claim was an abuse of the legal process and should be struck out. The Defendants argued that the abuse arose, in part, because the New UK Claim could and should have been brought much earlier by the Claimants, and that this had caused prejudice to the Defendants. No questions of patent validity or alleged infringement were addressed in the proceedings.

In assessing abuse of process claims the courts take a broad, merits‑based approach. After considering all the facts in the case the judge determined that, whilst Illumina and Sequenom ought to have known in 2015 whether they had a claim against the Defendants or not, there was no evidence that they did know and nor that they had deliberately delayed bringing the New UK Claim. The judge also stated that any additional costs incurred by the Defendants as a result of the later filing of the New UK Claim could be redressed at the end of the usual legal process. As a result, the judge denied the applications from the Defendants to strike out the New UK Claim.

The written ruling was made public on 23 March 2018, and at a final order hearing on the same day the judge awarded costs of approximately £50,000 against Premaitha (and also costs against Ariosa/TDL). The New UK Claim will therefore proceed on a normal timetable and is expected to come to trial in early 2019.

Dr Stephen Little, CEO of Premaitha Health, commented: "We made this application in an attempt to minimise any UK business disruption from the New UK Claim. We are disappointed the judge did not agree with our arguments and those of the other parties as to why we feel the claim is an abuse of process, but we remain firmly of the view that the claim itself can be defended effectively. Unfortunately, the UK market remains a challenging legal environment for ourselves and other competitors. Ultimately, the consequence of these various sets of proceedings may restrict the choice of NIPT for British women. We are currently reviewing our options in the UK with new legal advisers and we will update investors on the next steps alongside our year end trading update which is expected in April.

"Over the last three years, and from a standing start, Premaitha has built a significant global business, yet has been hindered in its domestic market by repeated litigation from Illumina and Sequenom. As previously stated it is our intention to operate in territories with maximum opportunity and minimum legal risk and over the past eighteen months we have successfully executed against this strategy, which remains our central focus going forward."

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

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.