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University of Kansas Research Arm Sues US Government Over Cancer Drug Inventorship

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The University of Kansas Center for Research last week filed a correction-of-inventorship lawsuit against the US government to add a University of Kansas researcher and his former assistant to a pair of patents related to the cancer drug Velcade.
 
If KUCR wins the suit, the inventors and KU would be in line to receive a cut of the royalties for the drug, which generated approximately $190 million in US sales during the first half of 2008, and is expected to see a 40-percent increase in US sales in full year 2008 compared to the previous year.
 
The suit, filed on Nov. 12 in the US District Court for the District of Kansas, centers on US Patent Nos. 6,713,446 and 6,958,319, both of which are assigned to the US government as represented by the Department of Health and Human Services.
 
In its suit, KUCR alleges that the patents, which cover methods for making boronic acid compounds such as Velcade into a stable liquid formulation, were the product of a research agreement originally inked in 1992 and renewed in 1997 between the National Institutes of Health and KU.
 
The collaboration, between National Cancer Institute investigator and project officer Shanker Gupta, KU professor of pharmaceutical chemistry Valentino Stella, and Stella’s former research assistant Wanda Waugh, aimed to create more effective approaches for the intravenous delivery of compounds that possessed limited solubility, the suit alleges. Waugh has since retired from KU.
 
KUCR claims that Stella and Waugh discovered methods for increasing the solubility of peptide boronic compounds that Gupta had provided them, including a precursor to Velcade.
 
The active ingredient in Velcade, known generically as bortezomib, was originally discovered in the 1990s by the company Myogenetics. That firm eventually changed its name to ProScript and, in 1998, penned a Cooperative Research and Development Agreement with the NCI to continue developing bortezomib.
 
The agreement enabled Gupta to discover how to protect the compounds by creating a freeze-dried powder formulation, according to an NIH Office of Technology Transfer publication.
 
In 1999, ProScript was acquired by Millennium Pharmaceuticals, which continued the research collaboration with NCI and helped carry the drug through clinical trials. During that time, Millennium exclusively licensed the ‘446 and ‘319 patents from NIH.
 
In KU’s lawsuit, which names HHS, NCI, and NIH as co-defendants, KUCR claims that it was Stella and Waugh, not Gupta, who first conceived of the freeze-drying method, as well as other methods, for increasing the drug’s solubility and stability.
 
It further claims that Stella and Waugh’s inventive contributions can be found in the disclosure section of a US provisional patent application that the ‘446 and ‘319 patents claim priority on, but that the same application does not rightfully name them as co-inventors.
 

“We didn’t want to sue. But sometimes you just get frustrated after a while, and we did.”

The suit claims that Stella and Waugh “were inadvertently and without deceptive intent not named as inventors” on the patent application in question. Further, it asserts that since Stella and Waugh were rightful co-inventors of claimed features of one or more claims of the ‘446 and ‘319 patents, the court should issue an order directing the US Patent and Trademark Office to add them as co-inventors of the patents.
 
Gupta is currently the sole inventor on both patents.
 
Steve Warren, president of KUCR, told BTW this week that Stella only became aware of his omission from the pertinent patents after Velcade hit the market in the US.
 
The drug, a proteasome inhibitor, was approved in 2003 as a treatment for multiple myeloma only in patients who have previously received two other types of chemotherapies and whose cancer has still progressed on the most recent therapy. In 2006 it was approved to treat relapsed or refractory mantle cell lymphoma, and this June it was cleared to treat previously untreated multiple myeloma.
 
At some point after Velcade’s initial approval, KUCR “spent some time trying to work with the NIH to correct” the patent omission, Warren said, though he didn’t provide an exact timeline. “As you might expect with a big bureaucracy, they move rather slowly.”
 
He said that NIH sent KUCR a statement that said it didn’t believe a change in inventorship was warranted. “Then we had further conversations with them, which was again very slow and hard to do,” Warren said, adding that after those conversations stalled, KUCR began to consider its options.
 
“It stretched out over time in part because it took a while to discover there was a problem, and then it took a while to go through the normal routines of trying to correct it,” Warren said. “That’s how we got to a position like this. We didn’t want to sue. That’s not your first choice, that’s your last choice. But sometimes you just get frustrated after a while, and we did.”
 
An official from the NIH Office of Technology Transfer declined to comment for this article, citing the agency’s policy of not commenting on ongoing litigation.
 
Warren said that KU’s goal is to correct the patent so that Stella and Waugh are named as rightful co-inventors, but he didn’t deny that eventual financial restitution might be in order. If its suit against the government is successful, “that changes things obviously in terms of royalties and things like that,” Warren said. “But first things first.”
 
Velcade is currently marketed in the US by Takeda Pharmaceuticals, which acquired Millennium for $8.8 billion in April; and in Europe and the rest of the world by Janssen-Cilag, a subsidiary of Johnson & Johnson, through a previous agreement between Millennium and J&J.
 
According to Takeda, sales of Velcade totaled approximately $190 million in the first half of its 2008 fiscal year, which started on April 1. This figure represents a 43 percent increase over the same period last year.
 
The company also estimates that Velcade will see about a 40 percent overall sales growth for the entire fiscal year. Takead has also seen its royalty revenue derived from worldwide J&J sales increase about 75 percent to $63 million in the first half of FY2008.
 
It is unclear what type of royalty the NIH receives from Velcade through its original licensing agreement with Millennium, and Warren declined to comment on what type of royalty KUCR, Stella, and Waugh could be eligible for should they win the pending lawsuit.
 
But the fact that KUCR felt compelled to sue at all is not trivial, Warren said.
 
“It’s not something we go around and do every day,” Warren said. “Sometimes people don’t think a university will sue, and that’s probably a problem.
 
“Anybody can sit back and say that this costs some money to do, so we must be really serious and really sure about what we’re doing,” he added. “And those would be reasonable attributions to make in this circumstance.”

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