Medidata Solutions faces a patent infringement lawsuit from a smaller competitor in the clinical trials software business, according to Fierce BiotechIT. Cleveland-based Datatrak International said it has served a complaint to Medidata for alleged unauthorized use of its intellectual property.

Medidata revealed to regulators last month that Datatrak had filed such a complaint on March 4 in U.S. District Court for the Northern District of Ohio. Datatrak said today that Medidata's Rave product infringes on its patent for "methods and systems for unifying data from a plurality of heterogeneous databases with each having business-context related data and a data access mechanism."

While patent infringement suits are filed all the time in the IT world, this one comes as Medidata continues to distance itself from competitors in the electronic data capture (EDC) business. And if the New York-based company is a target for litigation, it's certainly becoming a bigger target. Its customer base has grown from 92 at the start of 2008 to 232 at the end of the first quarter of 2011, as more drug developers and life sciences companies use its web-based system for managing data in clinical trials.

Still, Datatrak seems poised for a legal battle with its larger competitor. "The patent is an important asset in Datatrak's technology portfolio, and we vigorously protect our intellectual property," Laurence Birch, chairman and CEO, said in a statement.

"After months of attempting, with little success, to engage proactively with Medidata and its counsel, it has become clear that the only way we will be able to obtain any relief from this apparent infringement is through litigation," Birch said. "We will seek both injunctive and monetary relief, asking the Court to order Medidata to cease all activities that violate Datatrak's intellectual property rights and to pay damages for its infringement."