Alzheimer's research to go ahead

Lawsuit dismissal removes cloud over Alzheimer's research - August 12, 2011

In a move that researchers called a victory for science, a lawsuit that threatened scientists who use mouse models in Alzheimer’s research has been dismissed.

In February 2010, the Alzheimer’s Institute of America (AIA) in Kansas City, Kansas, filed a lawsuit against the Jackson Laboratory of Bar Harbor Maine, and other institutes and companies. The suit claimed that Jackson Lab and the other defendants had infringed on patents covering a genetic mutation that causes early-onset Alzheimer’s disease.

In June, the U.S. National Institutes of Health in Bethesda, Maryland, intervened on the Jackson Lab's behalf; this week, that intervention led to the dismissal of the suit against the lab. Litigation against the other defendants continues.

In a statement, NIH director Francis Collins said today, “We applaud today’s news in the legal battle over mouse models critical to Alzheimer’s disease research. This action ensures that researchers worldwide will have the tools they need as they strive to understand, treat, and, ultimately, defeat this devastating disease.”

The suit is the latest in almost a decade of legal fights that have had a chilling effect on the Alzheimer’s research field. But the suit against the Jackson Lab was especially troubling because it aimed at the heart of basic research on the disease, alleging that the lab was breaking the law by distributing 22 mouse models that carry the mutation to academic researchers.

Researchers said that stopping distribution of the mouse models would have been a serious blow to science. Rudolph Tanzi, who studies Alzheimer's disease at the Massachusetts General Hospital in Charlestown, said that he understands the need for patent holders to defend their intellectual property. But, he said, "So much Alzheimer's research depends on the transgenic mice that express this mutation. I think you need to respect people's intellectual property, but the impact on field if the mice were not freely available would be devastating."

AIA also wanted the lab to disclose the names of researchers who had received the Alzheimer’s mouse models from the lab. That disclosure could have exposed hundreds of researchers who worked on the models to lawsuits.

But in June, the NIH intervened in the lawsuit by granting the Jackson Lab a special determination that the lab could freely use any invention patented in the United States. Federal government agencies have the power to grant such determinations to government contractors such as the Jackson Lab, which has been distributing the Alzheimer’s mice under an NIH contract since 2003. NIH’s intervention effectively shielded Jackson Lab from lawsuits; it meant that to continue its lawsuit, the AIA would have to sue the federal government - a significantly more costly and burdensome undertaking than suing private companies and institutes.

On 9 August, the AIA agreed to dismiss its lawsuit against Jackson Labs.

David Einhorn, house counsel for the Jackson Lab, called NIH's intervention on its behalf "unprecedented" and said that it could be a boon for the development and sharing of mouse models of Alzheimer's and other diseases.

"[W]e hope and trust that the dismissal will encourage researchers and institutions who have been inhibited by the fear of being sued to use mouse models in their Alzheimer’s research," Einhorn said in a statement. "As well, we trust that the intervention of the NIH on behalf of Jackson will encourage researchers who develop new mouse models, both of Alzheimer’s and other major diseases, to provide them to the Jackson mouse repository so they can be shared with the rest of the research community."

The dismissal does not affect AIA’s lawsuits against the other companies and institutes.

Patent disputes over transgenic mice have long bedeviled researchers; when Harvard University researchers patented the so-called "Oncomouse" in 1984, for example, they licensed it to DuPont, which enraged scientists by requiring scientists who wanted to use it to pay high fees and agree to other onerous terms.

But litigation has been a particular thorn in the side of Alzheimer's research, because there are no effective drugs against the disease and so many people are affected by it.

"It's a market that will be worth billions of dollars per year if you have a good drug any time soon," Tanzi said. "When you have high stakes like that, people are going to be more likely to try to protect and profit from their inventions."

While AIA says on its web site that it supports research on Alzheimer’s disease, the “research” portion of its Web site states, “We at the AIA are working to update our website and anticipate having the information you've requested avalaible [sic] online soon. Please check back later.”

AIA declined to comment on its research activities.

Credit: J. L. Torrance/Jackson Lab | Nature