The University of Wisconsin-Madison and Lentigen will use a $1.3 million grant from the Bill & Melinda Gates Foundation to screen influenza viral protein libraries to identify mutations that allow avian influenza to infect humans, UW-Madison said recently.
Under the grant, the Wisconsin Alumni Research Foundation and Lentigen have agreed to “broadly disseminate” knowledge generated from the project to the scientific community, as well as relinquish ownership of any pertinent intellectual property that is created — primarily patents that would cover gene sequences implicated in human-to-human transmission of avian flu.
In addition, the project may serve as a stepping stone for additional collaborations between UW-Madison and Lentigen that could help the company develop an avian influenza vaccine, a Lentigen official said this week.
Likewise, for WARF and UW-Madison, the agreement may serve as a template for conducting future research supported by the Gates Foundation or other charitable organizations, and how that research might be disseminated in a socially responsible manner while balancing the school’s obligation of patenting and licensing its faculty’s inventions, according to a WARF official.
The collaboration, which WARF announced in late March, comes at a time when the threat of a global avian flu pandemic has been reasserted: This week, doctors reported in The Lancet that a Chinese man who died of avian flu in December likely directly infected his father, the latest of several recent isolated incidents of human-to-human transmission of the virus.
The fear, experts say, is that the avian flu virus — which most commonly is transmitted from infected poultry to humans — could mutate in such a way that would allow easy transmission between humans and therefore trigger a global epidemic.
Under the Gates Foundation grant, Yoshihiro Kawaoka, who has a joint professorship at UW-Madison and the University of Tokyo, will lead a team that will conduct high-throughput screens of protein libraries from different strains of avian flu to identify genetic sequences in which a mutation would enable human-to-human infection.
Lentigen, whose influenza vaccine program is based on a patented lentiviral-based manufacturing method, will lend its expertise to speed up the process by which Kawaoka’s lab makes the mutant influenza viruses for testing.
Bob Keefe, associate director for infectious disease at Lentigen, told BTW that Kawaoka “will make the mutations and send us the genes. We’ll make the lentivirus and send that back to him, and then he’ll screen for binding to human residues. He’s doing a lot of the work in Wisconsin as far as the actual screening.”
Keefe added that Lentigen is “putting those mutants into a format that would allow that screening to be done in high throughput.”
If WARF and Lentigen identify specific mutated sequences that would enable human infection, they said that they intend to make them widely available, which in turn could enable other researchers and companies — including Lentigen — to develop diagnostic tools and vaccines for avian flu for use in developing nations.
“The goal would be to identify … a limited set of mutations that conferred that ability to make the jump” from bird to human, Tim McCauley, a licensing associate at WARF, told BTW. “That would be the best-case scenario in terms of developing a diagnostic or vaccine, because you’d be dealing with a set of new sequences that would allow that, and it would be easier to test samples from the field.”
“It certainly rises to a different level when a group like the Gates Foundation comes forward because they have a different interest than the federal government in terms of what happens with the resulting research.”
McCauley said that WARF had “a lot of discussions” with the Gates Foundation to determine the “most appropriate way to structure IP that comes from this,” and determined that “the obvious IP would be around the mutant sequences.”
As such, the decision was made that the identified sequences would be put into the public domain, likely through publication, and that patents on the mutations would not be sought, McCauley said.
“That doesn’t mean that we gave up all IP rights on everything,” McCauley stressed. “We basically agreed that that IP is so important that it should be publicly disseminated and allowed to be used anywhere. But, with Lentigen as a partner in this, [for] anything that is generated using their technology platform, we still have the right to seek patent protection on it in conjunction with them.”
McCauley said that it is hard to predict what kind of collateral IP might come out of the project, but that provisions for such a situation were negotiated up front in discussions with the Gates Foundation and Lentigen, as is common in sponsored research agreements.
“We typically find that when you get a research grant, the research goes in a particular direction to fulfill the obligations of the grant, but oftentimes you discover things along the way that aren’t directly related,” he said.
The idea of so-called “socially responsible” patenting and licensing has gained in popularity at university tech-transfer offices and companies in recent years. WARF has remained a lightning rod for controversy in this area mostly due to disagreements regarding important stem cell patents controlled by the university.
However, WARF was also one of the signatories on an AUTM-sponsored white paper released last year that outlined nine key points of university technology licensing, one of which concerned the important role universities play in ensuring its intellectual property was broadly disseminated to countries that needed it the most but could not afford to access it via traditional means (see BTW 3/19/2007).
McCauley said that WARF has picked up its internal discussions about socially responsible patenting and licensing over the past year or more, and that the Gates grant spurred these discussions on.
“At the end of the day, we’re a patenting and licensing organization, so we don’t give away all of the IP,” McCauley said. “Bayh-Dole legislation states that when we have government funding here, we have obligations to seek patents on inventions if the professor brings those to our office.
“It certainly rises to a different level when a group like the Gates Foundation comes forward because they have a different interest than the federal government in terms of what happens with the resulting research,” he added. “I don’t think it changes the internal mindset here at WARF, though, where we recognize an obligation to help people in the developing world who wouldn’t have the resources to pay royalties, et cetera.”
McCauley added that the Gates Foundation grant has also opened an ongoing dialogue with the foundation about how to best pursue and balance these mutual interests.
“We’d like to receive more grants from them, but in advance of that we would love to put in to place a mutual understanding of how we could continue good patenting and licensing work here in the US and in other developed nations, but make sure that other developing nations receive what they need,” McCauley said.
According to Lentigen’s Keefe, the company has a similarly “humanitarian” goal with an added incentive of possibly using some of the findings to further its influenza vaccine-development program.
“It’s a humanitarian mission for us,” Keefe said. “Our mission statement is to improve human medicine and health. We’re all a bunch of biomedical scientists that have also worked in hospitals and academic institutions here and there.
“Now, we are a company because we are making some technologies that, in addition to curing disease, we will make a lot of money on,” he added. “If we were only doing this project, it wouldn’t sustain a company. But since we have a company, we can do these side projects. And since the funding was provided by the Gates Foundation, there is no cost to us.”
And, the collaboration with UW-Madison may allow Lentigen to further leverage Kawaoka’s expertise in the future through additional research projects.
“At this point, we won’t be screening every possible mutant under this grant, so if this first stage works, we can scale it up even further and have this gigantic library of millions of mutants,” Keefe said.
He added that when designing vaccines that might be useful in the case of a pandemic, Lentigen and other vaccine makers have to rely on public databases of information about the disease to anticipate the vaccine’s content.
“If we identify genes with this collaboration, we could also use those,” Keefe said. “We’re not going to keep them secret here. We could use those, and so could other companies. This is a scary disease, so I don’t care who cures it. If there is a cure to be had, I would certainly like us to help find it.”