YGEN.L Regulatory News (YGEN)

Premaitha Health plc

("Premaitha" or the "Company")

Patent litigation rescheduled

Manchester, UK - 20 April 2016: Premaitha Health plc (AIM: NIPT), developer of the leading CE-marked complete non-invasive prenatal screening system, provides the following update on the legal proceedings in connection with two patent infringement suits previously filed by Illumina, Inc. and others. The patents covered by these actions are European Patent (UK) 0 994 963, European Patent (UK) 1 981 995 and European Patent (UK) 2 183 693.

At a Case Management Conference ("CMC") heard at the High Court in London (the "Court"), the Court rejected an application by Illumina to change which patents would be determined at the previously scheduled trial in October 2016, and instead accepted Premaitha's counter-proposal for a combined trial on all three patents to be held at the next available date, which is likely to be in summer 2017.

The trial will now be held in conjunction with proceedings Illumina has brought against TDL Genetics Limited ("TDL"), The Doctors Laboratory Limited ("The Doctors Laboratory") and Ariosa Diagnostics, Inc ("Ariosa"). Ariosa and Premaitha will cooperate on their patent invalidity attacks. 

In arriving at this decision, the Court accepted Premaitha's argument that the patents in question are all closely connected and that only a combined trial would allow all relevant matters to be addressed appropriately. The October 2016 trial date has therefore been cancelled.

In addition, the Company's application to include an antitrust defence and counterclaim was presented to the Court. Premaitha alleges that Illumina's actions raise serious anticompetitive issues. The Court ordered that Illumina has until 28 May 2016 to present any arguments as to why Premaitha's application to include the antitrust defence and counterclaim should not be accepted.

Stephen Little, CEO, said: "The Court accepted our position that these three patents are all centred on the same technology. As a result, the Court has adopted the timetable suggested by Premaitha, meaning all patent claims will be assessed simultaneously. We continue to believe the patents held by Illumina are invalid and that, in any event, the IONA® test does not infringe them. 

"We are also very pleased that the Company's antitrust defence has been presented to the Court and will be heard again within two months. We have long believed that Illumina's motivation in pursuing these claims is to protect and extend its dominant position in the next generation sequencing market. If such anticompetitive conduct is allowed to go unaddressed by the UK courts, it will have severe repercussions for the non-invasive prenatal screening market, reducing choice and slowing down innovation in the clinical management of pregnant women.

"In our view, the decisions at the CMC provide a good platform for us to make our case to the Court and we remain confident that we will prevail. In addition, the removal of the October trial date allows us to continue to build on our current business momentum, accelerating growth and adoption of the IONA® test, unencumbered by an imminent court date. We remain focused on offering expectant parents the choice to use our safe, accurate and regulated non-invasive test wherever they are in the world."

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About Premaitha

Premaitha is a molecular diagnostics company which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved non-invasive screening tests for pregnant women.

Premaitha's lead test - the IONA® test - was launched in February 2015 and is the leading CE marked complete system which estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions. The IONA® test is performed on the mother's blood sample - which contains traces of fetal DNA - and then analysed using next generation DNA sequencing technology from ThermoFisher Scientific.

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 stressful and invasive follow up diagnostic procedures which are costly, resource intensive and carry a risk of miscarriage.

Non-invasive prenatal screening is an emerging, multi-billion dollar global market and Premaitha's complete CE Marked system enables laboratories and health care practitioners to offer an approved, non-invasive prenatal screening system in-house.

Premaitha is based in Manchester Science Partnerships, United Kingdom and 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.