The University of Kansas wants recognition—and a piece of the action—for the years of work it says two of its researchers contributed to developing an important and lucrative anticancer drug.
Through its patenting arm, the university has taken the unusual step of suing the National Institutes of Health to force the agency to add the two Kansas researchers as inventors on two key patents used to make the blockbuster drug known as Velcade, which is used in treating multiple myeloma.
With its researchers named as co-inventors, Kansas would gain a say over how the patent was commercialized, including the right to negotiate for royalties.
The patents list only an NIH scientist as the inventor.
In 2002, the NIH licensed exclusive rights to the patents to Millennium Pharmaceuticals, of Cambridge, Mass. A year later Millennium received approval from the U.S. Food and Drug Administration to sell the drug.
Lawyers for the university said they do not know how much NIH earns from its license with Millennium, but they note that worldwide sales of Velcade now exceed $800-million.
University of Kansas officials say Valentino J. Stella, a professor of pharmaceutical chemistry at the institution for 35 years, deserves to be listed on the patents as well, along with Wanda Waugh, his former research assistant who has since retired.
According to the lawsuit, beginning in 1992, the two worked under an NIH agreement on anticancer drugs and helped to develop a technique for keeping stable the key compound that makes up Velcade.
The two patents related to the technique were granted in 2004 and 2005. University officials said that they hadn’t realized the patents excluded their personnel until after they were granted, and that they tried for several years to persuade the NIH to include the two researchers as inventors, but the agency refused to do so.
The NIH could not be reached for comment, but the university said the agency disagreed that its two researchers merited credit on the patent.
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.”)
Steven F. Warren, vice provost for research and graduate studies, said the university decided to sue, despite the potential of undermining the patents, because “the risk to not doing it and just walking away” seemed greater.
He said the exclusion of the two researchers “just wasn’t right.”
Universities tell their professors that they will back them in pursuit of patents, and “if the university will not stand behind them, then we’re a poor partner,” he added.
If the university prevails, it could demand royalties for itself from Millennium or, as a co-owner of the patent, decide to challenge the exclusive arrangement with Millennium and seek other licensing partners. That possibility gives the NIH a strong incentive to resolve the case without a court fight.
Velcade is Millennium’s biggest drug and is believed to have been the main reason that Takeda Pharmaceutical Company Limited of Japan, agreed last April to pay $8.8-billion to acquire the company.
