YGEN.L Regulatory News (YGEN)

Premaitha Health plc

Progress on anti-trust objections to litigation

Manchester, UK - 4 July 2016: Premaitha Health plc (AIM: NIPT), developer of the leading CE-marked complete non-invasive prenatal screening system, provides an update on anti-trust matters it has raised in connection with the patent legal proceedings previously filed by Illumina, Inc. and others (the "Claimants").

At a Case Management Conference ("CMC") on Friday 1 July, the English Court ("Court") ordered that it would consider Premaitha's competition law defence after the patent hearings scheduled for July 2017, when it would have more certainty on the validity of the technical claims made, and an ongoing investigation by the European Commission (the "Commission") into potentially anticompetitive conduct by Illumina and Sequenom in the NIPT market. Illumina's attempts to have the defence dismissed were refused.

The Court also ordered Illumina to provide an unredacted copy of a Pooled Patents Agreement ("PPA") to the Company's legal advisers, which Illumina had previously refused. The PPA was entered into by Illumina and Sequenom in late 2014 and is the basis for the patent litigation claims made by the Claimants against the Company in the UK and against its customers in Poland and Switzerland, along with similar litigation against other competitors that do not use Illumina sequencing platforms for their NIPT solutions. In its reasoning, the Court stated that disclosure of the PPA will very probably "shed some light on the competition arguments that are being raised."

During the CMC, Premaitha disclosed to the Court that it had been contacted by the Commission in relation to an investigation it opened into potentially anticompetitive conduct by Illumina and Sequenom. Premaitha understands that the Commission is investigating whether the background to - and creation of - the PPA, and the Claimants' behaviour since then, infringes Articles 101 and/or 102 TFEU. The Company understands that the Commission is also examining whether the licensing practices of Illumina (the dominant supplier of DNA Sequencing hardware) raise competition law concerns.

In a connected development, Premaitha announces that it has formally intervened in the defence in the previously announced Polish patent infringement action by the Claimants against its Polish customer, to ensure consistency of defence against the multinational Claimants.

Stephen Little, CEO, commented: "We are very pleased that the EU Competition Commission will be looking closely at Illumina's and Sequenom's conduct in the NIPT sector, and that the English Court will consider the alleged anti-competitive conduct if necessary after the patent hearings, now scheduled for July 2017. We brought this conduct to their attention and will actively cooperate with these investigations to shine a light on what we believe is a pernicious strategy to buy up intellectual property in the sector, and then to use this combined patent pool and aggressive legal actions to stop developers of alternative genetic/sequencing technology, thereby suppressing competition and ultimately restricting patient choice. 

We understand that if Illumina and/or Sequenom have infringed the EU competition rules, then the Commission has the power to impose far-reaching licensing remedies, as well as to impose significant fines against these companies (up to 10 per cent of each company's worldwide group turnover). We hope, therefore, that the Commission's investigation will urgently cause Illumina and Sequenom to reconsider and modify their current practices to address the very serious concerns that have been raised, including amending the infringing provisions of the Pooled Patents Agreement and ending their discriminatory licensing practices. The English Courts also have the authority to impose licences on a fair, reasonable and non-discriminatory basis for any patent claims deemed to be infringed by Premaitha, which we continue to deny.

The conduct of Illumina and Sequenom is denying women's choice and access to high quality localised NIPT screening. Premaitha continues to strongly oppose such conduct and to deliver leading NIPT solutions to an increasingly international population of pregnant women through our customers and partners, which include the NHS and other public and private healthcare providers."

For more information, please contact:

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 Park, 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.