Patent Strategy for Prenatal Diagnostic Testing
Key Facts
- Roche Molecular Systems is the business unit of Roche Diagnostics that develops, manufactures, and supplies a multitude of innovative medical diagnostic products, services, test, platforms, and technologies.
- Roche acquired Ariosa Diagnostics, a leader in non-invasive prenatal testing (NIPT), in December 2014
The Situation
Professionals on Mintz's prosecution and strategic counseling team have a history of working with Roche on advanced molecular systems. The team handles overall portfolio strategy for mapping out appropriate subject matter to be claimed based on priority dates and competitors’ activities, and has successfully handled section 101 patentability challenges common in diagnostics filings. Following its acquisition of Ariosa, Roche asked the team to take over the large, complex portfolio.
The Approach
Ariosa develops and sells the highly successful prenatal “Harmony” test, which analyzes the DNA in a sample of the mother’s blood in order to predict the risk of certain genetic conditions, including Down syndrome, in the child. The test delivers exceptional accuracy, with a detection rate of over 99%, while traditional blood testing can miss almost 15% of Down syndrome cases in pregnant women. The Ariosa portfolio the Mintz team manages is directed towards this non-invasive fetal DNA detection.
