Judge Orders USC to Restore Control of Alzheimer’s Study to UCSD

Xconomy San Diego — 

[Updated, 8:25 am PT, with court document] A San Diego judge yesterday ordered the University of Southern California and a prominent Alzheimer’s disease researcher to restore control over a nationwide Alzheimer’s research program to UC San Diego “with all deliberate speed.”

The five-page preliminary injunction (posted below), signed by Superior Court Judge Judith Hayes, is intended to preserve the “status quo” until civil lawsuits filed by the warring research universities can be resolved. The term refers to what Hayes describes as “the last actual peaceable, uncontested status which preceded the pending controversy” between UC San Diego and USC.

That means returning control of the data and computer systems that former UC San Diego neuroscientist Paul Aisen and his team have been using to manage the Alzheimer’s Disease Cooperative Study (ADCS). UC San Diego has argued that Aisen and his team took root control of the ADCS computer system and database, and precluded UC San Diego from maintaining its authority over the network.

USC hired Aisen away from UC San Diego in mid-June with a job offer that made him the founding director of USC’s new San Diego-based Alzheimer’s Therapeutic Research Institute, reportedly with an annual salary of $500,000.

In a lawsuit filed July 2, UC San Diego alleged that USC and Aisen conspired to “misappropriate” the Alzheimer’s study by moving the ADCS program to USC.

UC San Diego founded the study in 1991 as a kind of joint venture with the National Institute on Aging, with funding provided by federal research grants, the pharmaceutical industry, and private foundations. UC San Diego hired Aisen to oversee the study in 2007.

The order came as no surprise. Following arguments by lawyers for both sides during a July 24 hearing, Hayes said she would grant UC San Diego’s request for an injunction against USC. In issuing the order, Hayes wrote that UC San Diego “demonstrated a likelihood of succeeding on the merits of one or more claims” made in its lawsuit. A USC spokesman said last week that the university was planning to appeal the injunction.

USC, however, could also claim a partial victory yesterday, after Eli Lilly (NYSE: LLY) notified UC San Diego it was ending its contract with UCSD to manage Lilly’s Anti-amyloid treatment in Asymptomatic Alzheimer’s disease (A4) study. The A4 study is a trial testing Lilly’s Alzheimer’s antibody drug, solanezumab, in older patients showing evidence of amyloid buildup—the telltale protein clumps that are a hallmark of Alzheimer’s—in their brains, yet don’t have any symptoms of disease.

In its statement, Lilly says, “From the outset of this unfortunate dispute, Lilly has publicly stated that the company’s objectives are to maintain the safety of the A4 participants, ensure scientific and data integrity for the study and maintain our obligations as the regulatory sponsor…Lilly has determined that it is in the best interest of the A4 study and its participants to end UCSD’s management of the study.”

The Indianapolis-based company said it has begun meeting with USC to discuss moving the A4 study to the private university in Los Angeles.

Judge Hayes also named attorney David Garrett as a special master to ensure that USC and others comply with her order. Garrett is the managing director of the San Francisco office of Stroz Frieberg, a firm that provides specialized computer-related services in legal disputes.

The judge also named Karl Kieburtz, a neurobiologist at the University of Rochester Medical Center, to serve as Garrett’s consultant and act as the primary decision-maker in any issues or disputes that might arise in the contentious case.

The two sides will equally share the cost of Garrett’s legal bills in the case, which pencil out at a billing rate of $770 an hour, and for Kieburtz, who bills at $500 per hour.

Preliminary Injunction in UCSD v. USC