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Former UGA Researcher Launches Online Resource to Educate Faculty Inventors About Tech-Transfer Procedures

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This story was originally published on May 21.

ATLANTA — A former University of Georgia researcher who claims that the university grossly undersold the rights to a dry-eye medication that she invented launched this week an online resource designed to help other academic inventors and their institutions avoid such discrepancies.

The site, IPAdvocate.org, was launched this week at the BIO 2009 conference here as a non-profit company by Renee Kaswan, a former professor at the University of Georgia College of Veterinary Medicine.

Kaswan told BTW this week that she is in the process of visiting top US academic institutions to seek best practices in technology transfer and identify individuals to serve on an advisory panel for the website.

IPAdvocate is "dedicated to bringing integrity and transparency to university technology transfer and intellectual property policies, processes, and procedures," and will "inform and equip academic inventors to face the challenges of technology transfer and the commercialization of their life’s work," according to the website.

Thus far, Kaswan has visited the California Institute of Technology tech-transfer office to discuss the site, and is planning to visit several other schools with leading tech-transfer programs in northern California in the coming weeks.

"We are seeking and incorporating their advice," Kaswan said. "And we want to see where there are some common agreements where a change of policy might be more effective."

Kaswan said that discussing her plan with the CalTech tech-transfer office "was like preaching to the choir," and that she expected that other universities such as Stanford and the Massachusetts Institute of Technology would also have tech-transfer policies in place to protect and serve their faculty.

"I think that a lot of universities have gotten this right," Kaswan said. "They recognize the importance of supporting their faculty inventors. Without them, there is no tech transfer. That's an important part of the equation that can't be forgotten.

"Most of the larger research universities that have been doing this for a long time, their methods should be transferred to some of the smaller state schools," she added. "We want to see best-practice guidelines put in place that will institutionalize all of the rhetorical promises often made by tech-transfer offices."

Kaswan, who has resigned her faculty position at UGA and currently runs a private veterinary practice in Atlanta, launched IPAdvocate following what she perceived as a mishandling of her life's work, research that served as the basis for Restasis, a topical treatment sold by healthcare company Allergan to remedy chronic dry-eye disorder.

Last year, Kaswan went public with claims that the University of Georgia negotiated a licensing deal with Allergan for her work that may have cost the university and Kaswan hundreds of millions of dollars in lost revenue.

Specifically, according to a case study provided on the new site, Kaswan originally developed the medication in conjunction with the University of Georgia Research Foundation as Optimmune for treating dry-eye disorder in dogs.

The case study alleges that under the university's original contracts with Allergan, it would have realized an estimated $300 million in royalties from the drug's licensed sales. However, the study claims that "in secret meetings with the pharmaceutical firm [that] excluded the inventor," UGA agreed to a "buy-down deal at a small fraction of that price."

The study further alleges that although the innovation behind Restasis dates back to the mid-1980s, inventor's equity ownership rights at UGA didn't become public knowledge until 1996 when UGA published its IP policy. Kaswan claims that the policy required the UGA Research Foundation to reassign her patents to her — despite the fact that Bayh-Dole provisions would typically stipulate that such IP be assigned to the university — and that it had agreed to do so until Restasis won regulatory approval on Dec. 24, 2002.

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Kaswan maintains that UGARF then initiated a series of pre-emptive lawsuits against her and a startup she had formed, KB Visions; and that UGA attorneys "acted aggressively" to block her request for a faculty peer review and "deprive[d] her of ownership in her work."

Meantime, the case study alleges, Allergan approached UGARF with a proposal for an upfront buy-down of the Restasis royalty contract and proposed to co-defend the patent ownership dispute against Kaswan. It also claims that Allergan insisted that UGARF prevent Kaswan from learning about their renegotiations until the deal was signed, which allowed Allergan to undervalue the Restasis royalty stream owed to UGA and Kaswan.

"The deal UGARF accepted was well below market rate and ultimately lost them over $220 million in royalty income they would have made if they had simply let the original licensing agreement executed in 1993 continue," the study alleges.

Officials from UGARF or Allergan were not immediately available for comment.

According to Allergan's 2008 annual report, Restasis is the only prescription therapeutic dry-eye product available in the US, and had with $444 million in sales in 2008.

Kaswan and IPAdvocate are maintaining that the university's actions "are a case in point for the need for reform in the academic intellectual property arena," and argue that "this case and the accompanying litigation have deprived UGA, the state of Georgia, and its taxpayers much needed funds; sullied the reputation of this prestigious institution; and disenfranchise[d] the faculty researcher who made the discovery."

Kaswan told BTW that her case is only one example of similar deals occurring at universities around the US. "I could be wrong about this — which is why we want to consult with a lot of other universities to see what other peoples' opinions and policies are — but at a lot of universities the policy requires that the inventor assign their patents solely to the university, which then has a lot of discretion, and often sole discretion, on how to commercialize that."

Kaswan said that IPAdvocate believes that the inventor is the most knowledgeable about the invention, and as such "is the only person highly likely to remain consistently involved in the tech-transfer process," which can take up to 30 years from when an idea is conceived to when a patent expires.

"During that time, administrators come and go, policies change, and we're most concerned that the inventor remains intimately involved in the tech-transfer process," Kaswan said. "Without the inventor, there is no consistent expert to safeguard that process and make sure that it doesn't go awry.

"Mine was just one incident, but we're seeing other instances at a lot of universities," she added. "We're concerned that policies and strategies at universities are laid out in a concrete fashion so that they can't be tampered with."

Indeed, the IPAdvocate site features several other case studies, such as the University of Pittsburgh suing two of its faculty members over the rights to IP surrounding a combined PET/CT scanner; and Purdue University and Cook Biotech suing a former Purdue professor and Harvard University colleague for alleged patent infringement regarding work with extracellular matrices.

The site also notes "positive" case studies, such as Emory University's continued support of its faculty inventors during patent litigation surrounding the school's lucrative HIV/AIDS therapeutic IP portfolio.

Most of the negative case studies, Kaswan noted, occurred only after "big money" came into the equation.

"This is a very long process, and at times there is a lot of money involved, and unfortunately money often turns iron rules to rubber bands," Kaswan said. "If you don't have a policy that is transparent, we're concerned that we could have a huge breakthrough such as a cure for cancer that is sold to a company for destruction and not invention."

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