One More Datasci Lawsuit Settled

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One More Datasci Lawsuit Settled

By Deborah Borfitz

April 19, 2007 | Three out of five leading electronic data capture (EDC) suppliers have determined it’s less painful to settle than fight a patent infringement action by Datasci, an obscure Maryland company that has been actively litigating over Patent No. 6,496,827.  Phase Forward was the first to acquiesce, with an $8.5 million payment, in February 2006. DataLabs, since acquired by ClinPhone, was next in August 2006.



Last month, Documents Solutions Group Inc. (DSG) announced that it, too, had better things to do than expend energy in a protracted legal tussle. Other than dismissal of the lawsuit, terms of the agreement between Datasci and DSG are confidential.

DataTrak and etrials, meanwhile, continue to fight the legal assault by Datasci.

The U.S. Patent and Trademark Office granted Datasci a patent for a clinical trial data collection process that had been used for years before the patent was even filed. The patent was originally assigned to inventor Mark Kozan, MD, doing business as MLK Software, in 2002. Datasci filed its suit against Phase Forward in Maryland District Court in 2004. Less than six months after that case was settled, Datasci filed the four additional intellectual property actions.

Dismissal of the lawsuit against Malvern, PA-based DSG is “big news for our customer base,” says CEO Tony Varano. “There has been a lot of anxiety and apprehension.” At least one prospective customer was lost due to uncertainties surrounding the litigation.

Varano’s energies are now heavily focused on DSG’s expansion plans in Japan and Europe. DSG recently signed a partnership agreement with a “highly established” contract research organization (CRO) in Japan and is now working on projects for two major Japanese pharmaceutical companies. The CRO is part of a larger, $16 billion company.

Most recently, DSG announced the release of new eCaseLink software with multi-language capabilities for EDC.  The software now includes Japanese, Chinese, and Western European languages. The first version, eCaseLink J, incorporates double byte characters and data entry features and is “the only end-to-end solution allowing for the entry and submission of PDF documents without conversion,” says Varano.

DSG plans to add two new European offices, including one in the U.K., later in 2007, Varano says. It already has one office in the U.K. and another in India, where it employs a growing trial-building group.

DataTrak President and CEO Jeffrey A. Green, PharmD, FCP, says the Datasci lawsuit against his company has had no apparent effect on customers. “We haven’t had one single question or comment from them…or the Wall Street investment community about it.” The industry-wide impact, he insists, has also been nil. “Companies face patent issues all the time. It’s not a new concept.”

DataTrak, like DSG, was founded several years before Datasci’s 1997 patent filing. Data-capture technology at the time was “probably completely different than [technology used by] Phase Forward, which incorporated right around the time Datasci filed the patent,” says Green. “It is well known that our early platform ran on Citrix, not a pure Web-based application. So, I don’t believe the [patent infringement] case has any merit.”

John Cline, CEO of etrials, says his company is “actively engaged in resolving [its legal] issue with Datasci.” He adds, “To date, we do not believe that Datasci’s actions have had a significant impact on etrials, or the eClinical industry.”