The two small businesses, FoodQuestTQ, LLC and Projectioneering LLC are charging that FDA took patent-protected computer automated risk management tools they developed and are now making them available on the government’s website for free.
These include the FDA Food Protection Plan, Food Defense Plan Builder, Food Defense Mitigation Strategies Database, iRisk, and the Food Related Emergency Exercise Box (Free-B). Over the past weekend, the two companies issued a warning to all food companies that all five products on the FDA website are “owned intellectual property” being offered without their permission.
Intellectual property experts not involved in the case say that while information on a government website generally cannot be copyrighted, it is possible that if the government entity acquired copyrighted material without permission, it might be protected.
Bruce H. Becker, president of FoodQuestTQ, and John H. Hnatio, president of Projectioneering, say they don’t really want the patent dispute to extend to third parties, but acknowledged it would happen: “We are trying to be responsible here and warn everybody as soon as we can; it was never our intent to drag the industry into this mess but folks at FDA wouldn’t work with us in a way to resolve the matter.”
Food Safety News invited FDA to comment, but hadn’t received any response by Monday night. Becker and Hnatio are circulating a 34-page “technical paper” on their issues with FDA to federal executive and legislative branches. It includes a ten-page letter from Dale D. Berkley of the Office of the General Council for the Department of Health and Human Services (HHS), FDA’s parent agency.
“We have uncovered no evidence that FDA or its contractors took or used any trade secrets that you might own,” Berkley’s letter concludes.
He says FoodQuestTQ failed to provide the documents FDA requested in order to be able to do a thorough investigation.
Further, Berkley says no statues were violated in either FDA’s or their contractors’ dealings with the two small businesses. The general council’s office pushed back frequently in the letter by pointing to alleged non-cooperation by the two companies with the investigation.
Needless to say, Becker and Hnatio do not see it that way.
Like others in the private sector, they saw opportunity in the 2011 Food Safety Modernization Act.
They began introducing their risk management software to FDA in 2009.
“Our ideas and trade secrets are based on a patent that looks at risk in a new way,” says Hnatio.
The pair say that after working with FDA and investing millions of their own money and that of an angel investor, they learned last fall that the agency had brought on the giant Battelle Memorial Institute. They claim the patent infringement followed.
Once they understood what FDA was doing, the pair offered to give the agency a $1 per year software license to cover all government employees while salvaging its potential for private sales. But they say FDA would not do that.
They then asked for a “good faith review, “ but say that turned into the general council’s defense of FDA’s and HHS’s decision-making on the issue. They’ve now responded with their technical paper.
Hnatio says FDA wants to force them out of business, and the two men have launched a cautionary campaign for other small businesses that might want the federal government as a client.
“The way the system works now the government can steal from small businesses with impunity,” Hnatio says.
Hnatio warns against “sharing anything of value with FDA even if they promise to protect it under the law (Title 18 USC); always remember that anyone including the government can steal your ideas when there’s no one willing to enforce the law.”© Food Safety News