Developments in global non-invasive prenatal testing (NIPT) market

Dr Philippa BriceMonday, 13 October 2014

Commercial non-invasive prenatal testing (NIPT) company Sequenom has acquired new global intellectual property from Isis Innovation, the University of Oxford’s technology transfer entity.

The transaction, which gives Sequenom ownership of methods for ‘non-invasive prenatal genetic diagnostic testing on paternally inherited fetal nucleic acids derived from maternal plasma or serum’, carried a $14.55 million (over £9m million) price tag. This included $3.2 million in outstanding license payments from Sequenom to Isis for previous exclusive rights to the use of key NIPT intellectual property.

Isis held significant intellectual property relating to NIPT derived from the original work of inventor Professor Dennis Lo, then at the University of Oxford. Now Sequenom owns NIPT patents not only for Europe, the US and Canada but also for Japan, Hong Kong and Australia; the press release notes that the portfolio includes ‘valid and enforceable’ patents for all of these regions except for the US. This is because Sequenom recently faced a set-back in terms of its intellectual property portfolio when the US Patent and Trademark Office invalidated claims on a key US patent.

However, the purchase of fresh IP suggests that the company believes that it can still make good returns even if it has lost significant ground in the US market; earlier this year they alluded to plans to create a low cost-test expected ‘to facilitate international access and potential future entry into the low-risk market’. Referring to the purchase from Isis, Chief Executive William Welch said: “We look forward to leveraging this important intellectual property for additional applications of our technology In the future”.

The Asia-Pacific region is seen as an enormously important market for non-invasive prenatal testing of both high-risk and low-risk maternal populations; some countries such as Japan are showing a sharp trend towards older (and hence higher-risk for fetal aneuploidy) mothers, whilst the sheer size of markets such as China and India represent potentially massive returns for a successful product.

However, not only are there already significant players for the Asian markets, but Asian companies are also players in the Western market; Chinese sequencing monolith BGI was recently granted a new patent for NIPT technology not only for China by the State Intellectual Property Office of China, but also for Europe by the European Patent Office (EPO) in a ruling that applies to fifteen member states including England, France and Germany. BGI became the first NIPT provider to receive approval from the China Food and Drug Administrationearlier this year, and is now the first mainland Chinese registered company to have an NIPT patent approved by the EPO.