US Court awards further $100 million over prenatal test patents

A Texas court has awarded $100 million more damages to a company whose patents for non-invasive prenatal testing (NIPT) technology were infringed by a competitor.

Biotechnology company Ravgen Inc, from Columbia, Maryland, began legal proceedings against at least seven companies in 2020 over patent infringement. Last year, in one of those cases, a jury decided that Labcorp's prenatal test did infringe Ravgen's patent, and awarded damages of $272 million. Ravgen then asked the court to award triple damages, claiming that Labcorp intended harm, but was only partially successful.

'Ravgen does not put forward sufficient evidence to show that Labcorp intended harm,' said US District Judge Alan Albright. 'Yet, Ravgen has presented a strong case for enhancement because Labcorp lacked a good faith belief, Labcorp is a large company, the infringement was for a long time, Labcorp conducted no remedial measures, and there is some evidence of possible concealment by Labcorp'.

The patents protect the processes by which Ravgen screen for chromosomal abnormalities using cell-free DNA. The patents include methods of isolating cell-free DNA from a blood sample, and for looking at a DNA sequence of interest to identify the ratio of chromosomes, to determine if there are too many or too few.

This can be used to look at chromosome changes in the body, such as in cancer cells, but is most often used in prenatal testing to look for trisomies such as Down's, Edwards' and Patau's syndromes. NIPT was rolled out across the NHS from 2018, for women whose pregnancy scans indicate a risk of a chromosome abnormality. NIPT does not increase the chance of miscarriage and can reduce the number of women who need invasive tests such as CVS or amniocentesis.

Ravgen's lawyer, Kerri-Ann Limbeek from Desmarais LLP, called the ruling 'a critical step showing the degree to which Ravgen's innovations in non-invasive prenatal genetic testing technology were infringed.' She told Law360: 'This is just one example of several companies that were fully aware of these patents but declined to take a license prior to creating their own rival products built on Ravgen's breakthroughs'.

Another of the cases reached a settlement earlier this year when Illumina and Ravgen reached a 'mutually satisfactory' agreement according to Ravgen's lawyer John Desmarais. Details of the deal have not been made public. Several other companies are also believed to have reached out-of-court settlements with Ravgen.