The UK Patents Court has ruled that two separate non-invasive prenatal tests (NIPT) infringe patents licensed by the US firm Illumina.
Illumina successfully claimed that the Iona test offered by Premaitha Health was in infringement of five patents, and a gender testing component of Ariosa Diagnostics' Harmony test infringed one patent. Unless the judgment is successfully appealed, both tests may be subject to restrictions limiting their sale on the UK market.
Charles Dadswell, Senior Vice President and General Counsel at Illumina has said: 'We are pleased that the court ruled in our favour. The court's judgment validates the investments Illumina has made, the value of this technology and the significant contributions of the inventors in this field.'
Tests such as Iona and Harmony can detect either the gender of the fetus or chromosomal anomalies by assaying fetal cfDNA in the mother's blood. The techniques are therefore considered to be 'non-invasive' forms of prenatal testing, and offer women an alternative to methods such as amniocentesis and CVS that involve sampling cells from the amniotic fluid and placenta respectively, and are associated with increased risk of miscarriage.
NIPT is available on the NHS for pregnancies considered to be at high risk of trisomies (See BioNews 876). Premaitha's contracts to provide Iona to over 50 NHS hospitals could potentially be affected by the ruling.
The court heard claims involving three different patent families licensed by Illumina: Lo 1, Lo 2&3, and Quake 1&2, named for the scientists on whose work they are based (Professor Dennis Lo of the Chinese University of Hong Kong, and Dr Stephen Quake from Stanford University in California respectively). The patents are owned by the universities, except Lo1 which is held by US firm Sequenom, who offer their own NIPT product: MaterniT21. Illumina claimed that it held exclusive licences for all five.
Both Premaitha and Ariosa claimed that the patents under which they are sued are invalid. However, the court ruled in favour of Illumina, stating that all patents are valid and that the tests involved do, at least in some circumstances, infringe upon them. It is expected that the decision will be appealed by the defendants.
Dr Stephen Little, CEO of Premaitha Health, 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.'