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The outcome of the upcoming presidential election may have a big impact on a set of regulations governing the release of research data, predicts William L. Kovacs, vice president of environmental and regulatory affairs for the U.S. Chamber of Commerce. He’s referring to the controversial Shelby Amendment, which requires research institutions that receive federal funding to respond to Freedom of Information Act (FOIA) requests for data that are the basis for various kinds of federal regulations. The regulations were developed by the Office of Management and Budget at the end of 1999 and, Kovacs says, “If Bush wins, it could happen that we will be back there with the OMB.” His view is that the current regulations do not go far enough in forcing data release. But for many IP lawyers, the standard response to FOIA requests for research data is “no,” says Gerald P. Dodson, a litigation partner at San Francisco’s Morrison & Foerster. Dodson spends about half his billable hours representing universities in IP cases. In the process, he fends off a number of requests made under FOIA for research data that are filed as part of grant applications. “Lawyers have to protect this kind of thing. It’s not a close question,” he says. Vigilance is needed because typical FOIA requests come from competitors or litigation opponents to companies that, under the Bayh-Dole Act, have been partners with the federal government in funding university research, says Lawrence B. Ebert of the Princeton, N.J., office of Newark, N.J.’s Reed Smith Shaw & McClay. FEAR OF SPYING When Congress passed the Shelby amendment in 1988, many researchers and their lawyers worried that FOIA requests could force premature data disclosure and thwart their attempts to protect intellectual property. The measure required a U.S. agency awarding research grants and basing regulations on that research “to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act.” Sen. Richard Shelby, R-Ala., sponsored the legislation after he was frustrated in his attempts to get his hands on data that the Environmental Protection Agency had used to formulate emissions control standards. Researchers at Harvard University had gathered the data but refused to release it, claiming that patients’ confidential medical records would be made public. Eventually a compromise was reached, with Harvard making the data available to an independent third party for review. Meantime, the Chamber of Commerce is a party to the suit before the U.S. Supreme Court challenging the setting of these emission standards. American Trucking Associations v. Browner, No. 99-1426. Learned societies and educational institutions reacted with alarm to the legislation, fearing potential loss of intellectual property and a violation of confidentiality agreements. REPAIR KIT The Office of Management and Budget issued a set of implementing regulations at the end of 1999 that assuaged some fears. They excepted from release “trade secrets, commercial information [and] materials necessary to be held confidential by a researcher until they are published.” OMB Circular A-110. Given these regulations, “I don’t think the amendment is dangerous,” Ebert says. “The intellectual property protections that are inherent in the Bayh-Dole Act against disclosure of intellectual property will be applicable in any application of the Shelby amendment.” Harvard can live with the amendment, says Joyce Brinton, director of that institution’s Office for Technology and Trademark Licensing: “As far as I am concerned as the person licensing Harvard’s intellectual property, I do not see it as a major threat to our ability to be able to protect intellectual property.” But for some groups, concerns remain alive. Attendees at the American College of Epidemiology’s recent annual meeting held extensive discussions about the guidelines. Some participants warned that researchers’ work could be “scooped” and IP protections lost. The first challenges to the amendment will probably not surface before next year, predicts Kovacs of the U.S. Chamber of Commerce. That’s because the guidelines say the amendment cannot be applied retroactively, and to date no controversial regulations have been issued based on unavailable research data.

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