OmniComm Systems has become the latest in a line of eClinical specialists to reach a patent settlement with DataLabs, a Maryland-based company widely regarded as having exploited a blunder by the US Patent and Trademark Office.
No details of the legal settlement were released, although OmniComm said it had entered into a licensing arrangement with DataSci, effective from 9 April 2009, that would “provide our customers an assurance that our EDC application TrialMaster is free from any patent issues”.
TrialMaster is OmniComm’s flagship technology, a web-based software system that enables clinical trial sponsors and investigative sites to collect, validate, transmit and analyse clinical study data. OmniComm operates out of Fort Lauderdale, Florida.
Other companies that have settled with DataSci over alleged infringement of US Patent Number 6,496,827, which relates to the collection and validation of clinical trial data, include etrials Worldwide, Phase Forward, DataLabs and DSG.
Datrak International reached a settlement with DataSci in July 2007, under which DataSci agreed to dismiss its claims without prejudice and without any payment by Datatrak. The latter did, however, accept a “non-exclusive licensing agreement on a going-forward basis, including certain royalty obligations” for any Datatrak products implementing Patent Number 6,496,827 that might be launched in the future.
Although the grant of Number 6,496,827 in 2002 was generally seen 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.
Elsewhere described as a “shell company”, Datasci says it is “committed to assisting clinical research organisations with electronic data capture methodologies that increase the speed and safety of bringing new pharmaceuticals and medical devices to market”.
