In May 1984 Dr. Renee Kaswan, then a faculty researcher at the University of Georgia, disclosed her first invention. In 1987 she made a second discovery that is considered one of the university innovations that "changed the world."
In a UGA Invention Disclosure form filed in 1984, Kaswan disclosed that she had begun testing an ophthalmic cyclosporine preparation to treat ocular inflammation. Later in 1987, Kaswan discovered that ophthalmic cyclosporine was even more effective in treating dry-eye syndrome in animals. Unlike artificial tears, cyclosporine actually caused the tear glands to regenerate and restored a patients natural tearing. This discovery was not made in the context of a funded research project, but by astute observation of a veterinary ophthalmic patient who happened to have both dry eye and uveitis (inflammation in the interior of the eye), treated by Dr. Kaswan with cyclosporine eye drops. The serendipitous observation and 16 additional years work led to the blockbuster product Restasis®, yet was never recorded on an invention disclosure report.
Question six on the 1984 invention disclosure stumped Kaswan: "Indicate the category under the University of Georgia Patent that you think applies to the invention." Kaswan sought clarification, but university patent office officials were of no help. She filled in her response as "new use for existing product." This unremarkable disclosure would ignite a conflict exceeding $200 million in losses.
Kaswan would not see the form again until many years later -- after her work led to the development of Optimmune® for the treatment of dry-eye in animals and Restasis to treat the same disease in human patients. The disclosure form would become a key exhibit in a court case in which she was challenging the University of Georgia Research Foundation's sale of the drug's royalty stream.
Unbeknownst to her, someone at UGARF changed her answer to the all-important question six. The words she wrote - "new use for existing product" - were stricken and replaced with "II-A." UGARF contends that the response to question 6 on this form gave UGARF ownership to all of her inventions as well as "sole discretion" on commercialization and " total authority" to make decisions for UGARF's unilateral benefit to the detriment of Kaswan's interests.
In the parlance of UGA's invention disclosure protocol, II-A gives the university controlling rights to the invention. Though she was unschooled in the intricacies of the invention classification system at the time, Kaswan believes her invention should have properly been classified as II-C for a "university assisted individual effort," or II-D for an "individual effort."
Either the II-C or II-D designation would have given Kaswan complete ownership and control of her invention. The ownership decision hinged on whether or not there had been federal funding for the discovery. There was no funding of the invention whatsoever. The invention followed a serendipitous medical observation, therefore the category was II-C or II-D, and the invention rightfully belonged to Kaswan according to UGA policy.
"I requested written instructions on how to fill out the report and was told by the UGARF secretary that none was available. I requested oral instructions from the UGARF secretary and was told to use my best ability since she too had no idea how to answer some of the questions," Kaswan said in a 2007 affidavit.
"I did not know what the references to II-A and II-B meant. I was not aware that there were any other categories, and was not informed that there was any other form that I could use for invention disclosure," she said.
Shockingly, when each of the UGARF witnesses were deposed, no one at UGARF could explain how or when this crucial piece of evidence had been altered.
After seeing the altered document in 2003, Kaswan sought a review of the issue by the University Patent Committee, which is charged with examining and settling disputes over patent ownership issues.
In a letter that year, Kaswan's attorney wrote that his client "contends the inventions were improperly categorized under the Patent Policy wrongfully requiring her to assign the inventions to UGARF."
Kaswan was preemptively sued, repeatedly, by UGARF in order to prohibit the UGA faculty from reviewing her petition for appeal under the UGA Intellectual Property Policy. Legal executive VP for President Adams, Stephen Shewmaker, secretly instructed the faculty patent review committee to reject Kaswan's petition. He wrote, "the dispute between Dr. Kaswan and the UGARF is a matter that is currently in litigation. The issues raised in her letter of petition are the same matters that are currently being adjudicated in a court of law. Consequently, I recommend that the Intellectual Property Committee defer to the judicial process that was initially chosen by Dr. Kaswan to resolve this issue." His letter lied to the committee members because as of the time he wrote it, Dr. Kaswan hadn't even countersued the university, and neither the committee nor Kaswan had any inkling that UGARF was secretly selling her property rights to Allergan. In 2008 she would discover his instruction to the committee and learn of this deception too.