It ain’t over. A bitter intellectual property lawsuit is still hanging over the electronic patient diary trade. The suit is presumably enough to worry upper management at the diary companies but not sufficient to deter customers. The industry is increasingly splurging on
handheld diaries and fretting about wholesale fabrications that routinely find their way into paper diaries.
In the winter of 2004, PHT sued two fast-growing rivals: invivodata and CRF. A few months later, PHT added EDC vendor etrials to its list; etrials frequently bundles patient-reported options into its trials.
PHT’s contention is that a 1995 patent, #6,095,985, has been infringed. A mid-May 2005 ruling on the meaning of certain legal terms has gone almost entirely in PHT’s favor. U.S. District Court judge Gregory M. Sleet agreed with PHT’s lawyers on the meanings of disputed terms such as “subjective data,” “single unified portable unit,” “data transmission device capable of connecting directly to a communication network,” and “digitized representation of the detected writing.”
“We are pleased with the results of the ‘Markman’ hearing and believe this decision represents an important victory for PHT,” said Philip Lee, president and CEO. “The Court’s ruling was consistent with PHT’s positions on all of the major issues and is a significant step forward in our efforts to protect our valuable intellectual property.” If PHT prevails in the suit, it could presumably extract significant financial and technical concessions from its rivals. A trial is scheduled for April 2006.
PHT has a genteel former academic as a co-founder, leaving some in the industry to assume the company’s financial backers are the force behind its legal strategy. The company has embarked on an industry-leading 160 trials with 70,000 patients. Realizing – as most in the industry do – that clinical sites need additional training to deploy such devices, PHT recently inked a deal with ePharmaLearning for advanced training. In 2004, PHT expanded its workforce by 38 percent, bringing its headcount to 110.
The other parties to the lawsuit have another interpretation of the recent ruling. They maintain the May ruling is but one preliminary skirmish in a long battle. For them, the lawsuit is a bizarre attempt to distract the customers of any diary company that has captured market share at PHT’s expense.
Doug Engfer, president and CEO of invivodata, insists the decision is a defeat for PHT. “We ended up with a stronger case on the argument on invalidity,” he says, contending that the terminology favored by the judge will open up the discussion of diary prior art as long ago as the late 1980s. Engfer added: “We’re very happy with the outcome of [the Markman ruling] and remain confident we’re going to prevail.”
Coincidentally, invivodata recently introduced an integration tool to capture data from instruments making physiological measurements of patients (functionality PHT has long possessed). And invivodata recently snared a patent of its own, #6,879,970, which covers the management of patient compliance in clinical research. One drug and one biologic have been approved by the FDA using data collected by Palms with invivodata software. The diary company claims to have discussions with regulators that are both frequent and cordial. Invivodata has started 100 trials with 35,000 patients.
Another defendant in the lawsuit is equally optimistic. “There are many e-diary prior art references that were not disclosed to the Patent and Trademark Office (PTO) that provide a very strong case that the claims at issue in the PHT lawsuit are invalid,” Pamela McNamara, CEO of CRF, said in a statement. “We continue to believe that the lawsuit filed by PHT ... is a bad faith attempt to influence the market while the case is pending. Those with knowledge of the history of e-diaries and the prior art can readily understand the invalidity of this patent.”
CRF has its own good news. The company claims patients using its technology have the highest compliance rates in the industry, at more than 95 percent. Having European roots, CRF is exploring the use of mobile phones in clinical trials more aggressively than rivals and has deployed its devices to 100,000 patients speaking 48 languages in 58 countries. Some 85 trials have been initiated.
This article first appeared in Bio-IT World’s eCliniqua newsletter. Sign up for a free subscription