Archive for Friday, November 21, 2008

KU suing National Institutes of Health over drug patent

November 21, 2008, 2:46 p.m. Updated November 21, 2008, 4:41 p.m.


The Kansas University Center for Research has sued the National Institutes of Health, claiming that KU researchers should be listed on patents for a cancer drug.

The lawsuit alleges that Val Stella, a professor of pharmaceutical chemistry, and Wanda Waugh, a research assistant at KU who retired in 1999, were significantly involved in the creation of the drug, Velcade, but were not listed on two patents associated with it.

“They made it possible for this drug to be delivered to human beings in a non-toxic way,” said Steve Warren, president of the KU Center for Research, a non-profit organization affiliated with KU and charged with bringing intellectual property created by university researchers to the market.

Warren said that the KU Center for Research first brought up the patent issue in the spring of 2007, and that discussions ended after NIH didn’t agree that Stella and Waugh should be listed on the patent.

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

Through a spokesman, the NIH declined comment on the lawsuit, saying 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 the lawsuit is successful, and Stella and Waugh are added as co-inventors on the patents, then both KUCR and Stella and Waugh could benefit financially.

Warren said he did not know how much money KUCR or Stella and Waugh could gain, but noted that the drug had been successfully marketed as a treatment for several cancers, including leukemia and myeloma.

“It’s a very successful drug,” he 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.

While the university receives millions of dollars in grant funding from NIH and is applying to be an NCI-designated Cancer Center, Warren said this lawsuit represents a disagreement with one specific portion of the agency.

“We have no concern that this will harm our relationship with NIH in general,” he said.

Attempts to reach Stella for comment on Friday were unsuccessful.


bearded_gnome 9 years, 4 months ago

Revenues from the drug generated $265.2 million in 2007 and $220.5 million in 2006, according to financial reports from Millennium.I'm glad KU is going after this. my sidewalk impression is that KU doesn't do enough of this, and maybe some of the patent money could help offset state cuts in funding. furthermore the profs should have their work defended, most certainly.

davidsmom 9 years, 4 months ago

This was the top story today in The Journal of Higher Education. It gave some additional information that this article does not, and is somewhat contradictory to a statement in the article:University officials acknowledge that suing the NIH is a risky move, in part because of the potential for alienating an agency on which it depends heavily for grants but also, and more significantly, because a lawsuit like this could jeopardize the patents altogether. That is so because patents can be challenged and found invalid if all legitimate contributors to the invention are not included as inventors. (In an attempt to forestall that, the lawsuit at several points takes pains to state that the exclusion of the researchers "was done without any deceptive intent on anyone's part.") However, I have no doubt this was not a decision they made lightly and I think it is the right move.

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