Kansas University Research Center Sues National Institutes of Health

November 25, 2008

The University of Kansas Center for Research has filed a federal lawsuit claiming that two of its researchers should be listed on patents for a cancer drug.

The research center sued the National Institutes of Health because Val Stella, a professor of pharmaceutical chemistry, and Wanda Waugh, a research assistant who retired in 1999, helped create the drug Velcade.

The research center’s president, Steve Warren, said Stella and Waugh made it possible for the drug to be delivered to patients in a nontoxic way.

The University of Kansas Center for Research is a nonprofit organization affiliated with the university that works to get intellectual property created by university researchers to the market.

Warren said the research center brought up the patent issue in the spring of 2007 but discussions stopped because the NIH didn’t agree that Stella and Waugh should be listed on two patents.

The Department of Health and Human Services and the National Cancer Institute also are defendants in the lawsuit. The two federal institutions are linked to the National Institutes of Health.

The NIH said it would not discuss pending litigation.

The lawsuit alleges that the NIH and its project officer on the drug, Dr. Shanker Gupta, asked Stella to research how to make a stable liquid solution for the drug so it could be delivered safely to humans.

If Stella and Waugh are eventually added as co-inventors on the patents, the research center, Stella and Waugh could benefit financially, although Warren said he didn’t know how much money they would make.

“It’s a very successful drug,” Warren said. It is obviously worthwhile to be an inventor on it.”

Velcade is marketed in the United States by Millennium Pharmaceuticals Inc., which was acquired by the Japanese Takeda Pharmaceutical Co. earlier this year. According to the lawsuit, Millennium has exclusively licensed two patents for the drug.

Revenues from the drug generated $265.2 million in 2007 and $220.5 million in 2006, according to financial reports from Millennium.

Information from: Lawrence Journal-World, http://www.ljworld.com

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