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Patent-Protected Technology Ended Up on FDA Website, Companies Charge

Two small Maryland companies have launched a campaign to publicize their allegations that the U.S. Food and Drug Administration (FDA) stole their patented technology.

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
  • Oginikwe

    Hey, guys, change your names to Monsanto and then you’ll get whatever you want.

  • http://burningbird.net Shelley Powers

    Thirty-five pages all talking about a patent that is not identified. Hard to evaluate the truth of the arguments if you can’t even view the patent.

  • http://burningbird.net Shelley Powers

    Ooops, never mind, I found it.

    PN 8,103,601

  • http://burningbird.net Shelley Powers

    Covering this story seems to border on the, well, you know, I’ve not figure it out yet.

    First, why aren’t the creators of the patent suing? I know there’s issues with the government and patents, but the people can still sue for compensation. Correct?

    The paper says they aren’t because it will cost millions of dollars and take years. Well, knock knock—the same will happen if a company uses the FDA application and these people wanted to sue. So I’m not sure what they expect to get by warning people away from using the FDA applications.

    This ‘campaign’ _seems_ more like a disinformation effort brought about to intimidate companies into not using the free FDA systems, but to use the paid system created by these people. Unless they’re willing to take this court, that’s what it _appears_ to be.

    One of the problems with patents is that it’s not unusual for multiple groups to develop an idea in parallel. This is especially true with technology. The only way you can determine patent infringement is via a court of law. Even then, it’s a crap shoot.

    Regardless, this whole thing is bizarre, with little fact in evidence and a whole lot of accusation and hyperbole. Haven’t a clue why you covered it. It’s not newsworthy. Seriously, Dan—look at the so-called “technical paper”, and the list of recommendations, starting with “Immediately require the legal counsels and all employees of HHS and FDA to re-new their oaths of government service to uphold the laws and Constitution of the United States”.

    Look at the so-called ‘legal brief’ these people included in their ‘technical brief’. Note the dates given?

    Really, Dan?

    I mean … really?

    If anyone wants to view patent, link below. Bring popcorn. And whiskey.

    http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.htm&r=1&p=1&f=G&l=50&d=PTXT&S1=8,103,601.PN.&OS=pn/8,103,601&RS=PN/8,103,601

  • ethanspapa

    Why is a phone call between two parties perceived by law to be private and in need of a qualified legal warrant to listen in. The same should go for an email between two private parties.
    Atta boy Scalia. So much for our civil liberties. This gentleman wouldn’t know since he lived with Mother most of his life and been cloistered from what the good citizens actually do in this country, to make it great.
    I want the Constitution and Bill Of Rights back as written if you don’t mind.
    While Congress is at it you can rescind the Homeland Security and Patriot Acts as horrid law.
    If you haven’t noticed we live in a police state now.

    They ( our leaders) reacted stupidly. when the twin towers came down and the pentagon was penetrated by a bunch of suicidal idiots. Follow the Constitution and declare war on jihad and you would of gotten results a lot quicker and easier..

  • Stanley Paul

    Gee, gov’t steals customers from this business so they are broke, and you want to know why they’re trying to settle and are not suing yet? Are you serious? Get off your high horse Shelly. Where will the money come from to sue? It is newsworthy because it is happening far too often. This is not a one time thing. Gov’t is not supposed to compete with private business. (see link below and do some investigating on your own – I don’t have time to go into that further) They knew damn well about this small company and their software – read the story. These guys shared their ideas – they gave it right to them in good faith. They trusted our gov’t. Go figure. And for that they’ve been about put out of business. THAT is what is bizarre.They got their patent several years ago – did it all correctly. Biggest point is they GOT the patent – they hold it – it is theirs. Period. You are supposed to check for a patent on your new idea FIRST Shelly, and if you don’t, and if the person holding the patent catches you, you must cease. It’s very clear. Not at all a crap shoot. Where do you get your information Shelly? For the FDA to turn around and try to put the burden of proof on this small business, AFTER THEY KNEW THEY HELD THE PATENT, and have the balls to ask them to share even MORE secret information, is ludicrous. Wake up America – we should ALL be outraged that gov’t have gotten away with it thus far. If it comes to it this company can sue, and they can take into that case the companies that have been warned not to use the FDA illegal/free tools. Seems to me they’re putting their ducks in a row. If they find a legal team and go to court they may as well do it right. If these companies weren’t warned they couldn’t be bothered. But now that they have been warned they can’t claim not to know. Smart move for this little company. Thanks Dan for covering this. I will be looking out for follow-up coverage to see how this ends. This is not just one little company’s fight – this is small business in America vs. our corrupt government. It affects all.

    http://www.governmentcompetition.org/uploads/BCFC_Comment_to_SBA-OMB-DOC_TaskForce06302010.pdf