Research Rules Tightened

October 1, 2003

Plug in a device. Pour in a reagent. And now, Duke is asking its researchers to do something else: check whether they are using equipment or materials that may pose legal problems. In the aftermath of a federal case involving Duke, the rules by which academic researchers may use patented technologies have tightened.

Medical school dean R. Sanders Williams M.D. '74 sent a memo in August to the school's faculty and chairs, urging them "to consider their current use of proprietary technologies (i.e., experimental methods, reagents, or devices patented, or potentially patentable, by others) in basic research and to take steps to use alternative experimental approaches if available." The memo also advised researchers to "purchase reagents, devices, or kits from commercial suppliers who have already acquired the appropriate license(s) and pass those rights on to purchasers. In addition, investigators should retain any correspondence with companies who supply reagents or devices as part of a basic research collaboration."

The university's vice provost for research, James Siedow, sent a similar memo to campus researchers.

Both memos follow the U.S. Supreme Court's decision in June not to review an appellate court decision in Duke v. Madey, the dispute between the university and former faculty member John M.J. Madey, now a professor at the University of Hawaii. Madey sued Duke for infringing upon two of his patents involving the free-electron laser, which he brought to Duke when he was recruited from Stanford University.

In its decision, the U.S. Court of Appeals for the Federal Circuit challenged a long-standing principle of intellectual-property law called the "experimental use exemption." For years, investigators at Duke and other academic institutions had understood the principle to mean that they could use patented technologies without being subject to a claim of patent infringement, if they pursued basic research without direct prospects for commercial gain.

The federal appellate court, however, interpreted this "research exemption" more narrowly, so much so that Duke said the ruling could seriously impede basic research and slow the discoveries that lead to new medicines, technologies, and other advances. A number of leading universities and scientific organizations agreed, joining with Duke in asking the Supreme Court to review the case. After consulting with the federal solicitor general's office, however, the high court declined.

" We were disappointed not to get our day in court to argue at the highest level why this case is so important to Duke and to academic researchers across the country," says Williams, whose own laboratory has made important discoveries about the genetic underpinnings of heart disease. "We're still hoping for further judicial interpretation, and we may join with other universities in seeking a legislative remedy. But in the meantime, we have to deal with the appellate ruling. Our first step is to get a clearer picture of what Duke researchers are using in their labs and to encourage them to use alternatives when appropriate."

Williams says he and other Duke officials expect the university to argue the case anew when it returns to federal court in Greensboro for further proceedings.