US supplier of eClinical software and services etrials Worldwide has followed other electronic data capture (EDC) companies such as Phase Forward and DataLabs in settling a lawsuit brought by Maryland-based Datasci for alleged infringement of the latter’s US Patent Number 6,496,827, which relates to the collection and validation of clinical trial data.

Under the terms of the settlement, etrials has entered into a non-exclusive license arrangement with Datasci and agreed to pay the latter an upfront licensing fee of US$1.75 million for its legacy EDC products ASFlash, QSCapture and WebCapture. In return, Datasci has agreed to dismiss its claims without prejudice and to acknowledge that etrials’ current EDC 2.0 product is not subject to any future royalty obligations.

Chip Jennings, president and chief executive officer of etrials, said the settlement limited any future exposure to patent infringement claims and allowed the company “to focus all of our attention on improving etrials’ core operations and expanding our market share within the rapidly growing market for eClinical technologies and services”.

Although the grant of US Patent Number 6,496,827 in 2002 is generally regarded as an anomaly of the US patent system, since other companies were already engaged in comparable EDC activities at the time, it has been a boon to Datasci, formed by two doctors in 2004. The company describes itself as “committed to assisting clinical research organisations with electronic data capture methodologies that increase the speed and safety of bringing new pharmaceuticals to market”.

etrials is the sixth company to be granted a non-exclusive licence for Datasci’s technology and it looks as though further settlements could be in the pipeline. “As a result of strong financial results achieved by licensees utilising the technology, Datasci estimates that additional licences will be granted over the next five years,” the company stated.