When Robert Vince and his research team invented carbovir in the late 1980s, it was unlikely any of them could have foreseen the political whirlwind it would create around them.
Carbovir – a key compound in GlaxoSmithKline’s AIDS drug Ziagen – has generated millions of dollars in royalties for the University. But those dollars, many of which are now being used to pioneer new medicines at the University’s Center for Drug Design, did not come easily.
“It’s a long process,” Vince said.
Before the University made its first dime off the discovery, it waited through years of development and fought a lengthy legal battle which helped make Vince and the University a target for activists who objected to the University’s handling of the compound.
“My expertise is making drugs. I’m not a political person,” Vince said. “I think the University has enough people around involved in making those decisions.”
Vince said there are problems with making certain discoveries public domain or allowing nonexclusive licensing deals.
“If you just give something away, who’s going to develop it?” Vince asked. “If we had made this drug and we just published it and didn’t patent it, I don’t think it would be on the market today. I don’t think anybody would have touched it.”
An interesting compound – patented or not – is still typically a long way from being a fully developed and marketable drug. The common view is that companies need incentive – the financial incentive from exclusive licensing agreements – before they would invest enough into developing a drug.
“If Glaxo wants to give this drug away, we’re not going to stand in their way, but we can’t tell the company what to do,” Vince said. “We had enough trouble getting our money. We had to sue. We’re not in the position to go to Glaxo and say, ‘This is what we want you to do.’ “
Carbovir was patented by the University in 1988 after testing at the National Institutes of Health indicated that it might be effective against AIDS.
“Companies started coming to us right away,” Vince said. The goal was to find a company that would be able to develop the compound to its fullest potential.
The compound’s patent was eventually exclusively licensed to Burroughs Wellcome, which merged into Glaxo Wellcome after the patent was obtained. Glaxo Wellcome used the compound in its drug Ziagen.
In order to reproduce in human cells, the HIV virus must convert its RNA into DNA. With carbovir as one of its ingredients, Ziagen inhibits that process.
Glaxo claimed, however, that the University’s patent did not apply to Ziagen, and the University filed a lawsuit against the company in October 1998. The two sides eventually reached a settlement that gave the University a 10 percent royalty on sales in the United States.
As the dispute between Glaxo and the University was resolved, activists amplified their criticism of the University for making money from drug sales.
“Just because I made something that I thought was useful, I’m being badgered almost like I did a bad thing,” Vince said. He said activists used to regularly phone and follow him.
The University pharmacy professor said for two years his research was sidelined while he spent time retrieving documents for lawyers and answering questions for reporters and activists.
“My research came to a screeching halt. I just couldn’t do anything,” he said.
Through the settlement with Glaxo, the University had received $62 million in royalties as of Dec. 31, 2002. Just over $2 million of that paid for legal bills, and the remaining $60 million has been split between the University and the inventors.
Much of the royalty money entering the University is being invested into the new Center for Drug Design in the Academic Health Center.
“If I can do more, not only for AIDS, I’d like to do that,” said Vince, 62, the center’s director. “I figure at my age, I don’t have that many years left. The Center for Drug Design is something that I’m very confident about.
“The whole idea is to take this money that we’re getting and reinvest it back into making more drugs. And we’re doing a lot of things to make sure that when the royalty money runs out the center will continue to grow and go on its own,” Vince said.
The center’s scope will go beyond AIDS drug development. It will also include work on cancer, antibiotics and antiviral development.
The royalty money is also funding a project in Africa and India that compares the effectiveness of cheaper forms of AIDS drugs to more expensive U.S. versions.