University takes on US National Institutes of Health over animals used for Alzheimer’s research.
Like a zombie that keeps on kicking, legal battles over mutant mice used for Alzheimer’s research are haunting the field once again — four years after the last round of lawsuits. In the latest case, the University of South Florida (USF) in Tampa has sued the US National Institutes of Health (NIH) for authorizing the distribution of a particular type of mouse used in the field. The first pre-trial hearing in the case is set to begin in a federal court on 21 March.
The university holds a patent on the mouse, but the NIH has contracted the Jackson Laboratory, a non-profit organization in Bar Harbor, Maine, to supply the animals to researchers. The USF is now claiming that it deserves some of the money that went to the contractor.
If the suit, filed in December 2015, is successful, it could set a precedent for other universities, cautions Robert Cook-Deegan, an intellectual-property scholar at the Washington DC centre of Arizona State University in Tempe. And that would threaten the affordability of and access to lab animals used to investigate Alzheimer’s disease more broadly.
“It feels greedy to me,” Cook-Deegan says. “If other universities start doing this, all it does is push up the cost of research tools.”
The mice, on which the USF filed a patent in 1997, express mutated forms of two genes1. These modifications help researchers to study how amyloid plaques develop in the brain, and enable them to investigate behavioural changes that manifest before those plaques appear.
The current suit has dredged up uncomfortable memories of a similar case that centred on other types of mutant mice used in Alzheimer’s-disease research. In 2010, the Alzheimer’s Institute of America (AIA), based in St Louis, Missouri, sued the Jackson Laboratory directly. But the NIH eventually stepped in because it had contracted the Jackson Lab to distribute the mice. That move shifted the lawsuit to the federal government — a more costly and formidable defendant to take on in court.
The AIA dropped its case in 2011, and lawsuits that it had filed against other biomedical companies were eventually tossed out as well.
But these cases exacted a toll: all together, they amounted to some 18.7 cumulative court years in 6 jurisdictions, involved at least 98 lawyers and produced 1,143 court filings2. The lawsuits also raised concerns that the AIA would sue researchers who had used the mice in question. This was a fear that, the Jackson Lab argued, hindered researchers from sending mouse strains to facilities such as theirs for maintenance and distribution.
Nevertheless, the USF decided to pick up where the AIA left off, by suing both the NIH and the Jackson Lab in 2015 over its double-mutant mice. If the university is successful, it could entice others to follow suit, says Tania Bubela, a legal scholar at the University of Alberta in Edmonton, Canada.
But such lawsuits could risk damaging an academic institution’s reputation, Bubela adds. “Whether other universities are crazy enough to follow the lead of the University of South Florida is another question,” she says. “I can’t imagine more research-intensive universities engaging in this kind of behaviour.”
Two researchers formerly at the USF who are listed as inventors on the university’s double-mutant-mouse patent — neuroscientists Karen Duff, now at Columbia University in New York City, and John Hardy, now at University College London — declined to comment specifically on the current lawsuit. A lawyer for the USF also did not comment on the case. But Hardy says: “I do think these things are better sorted out without recourse to lawyers and the courts.”
The case is unlikely to set Alzheimer’s research back if access to the mice is restricted as a result of the lawsuit, says neuroscientist Sangram Sisodia of the University of Chicago in Illinois. Several alternative models have been developed since the Nature publication in 1998 that first described the USF double-mutant mouse1. In 2001, for example, a team led by neuroscientist David Borchelt at the University of Florida in Gainsville described a way of introducing the two mutated genes in one step3. “It saved a lot of time and money,” says Sisodia.
Sisodia’s team developed a double-mutant mouse4 similar to the USF’s version before Hardy and Duff described their mutants. Did Sisodia want to patent his mice? “No,” he says: “Not interested.”
Holcomb, L. et al. Nature Med. 4, 97–100 (1998).
Bubela, T., Vishnubhakat, S. & Cook-Deegan, R. J. Law Biosci. 2, 213–262 (2015).
Janowsky, J. et al. Biomol. Eng. 17, 157–165 (2001).
Borchelt, D. et al. Neuron 5, 1005–1013 (1996).