MARCH 1, 2019
KANSAS CITY – The University of Missouri sued a former pharmacy professor this week, accusing him of stealing a graduate student’s research and secretly using it to sell a new drug that it said could make him millions.
In the lawsuit against the former professor, Ashim Mitra, the university’s Kansas City campus claimed ownership over the invention of a new treatment for dry eye that Dr. Mitra sold to a drug company. The university said a Ph.D. student under Dr. Mitra’s advisement performed the research that was central to the discovery but was not credited in the patents granted by the United States Patent and Trademark Office.
The lawsuit said Dr. Mitra had already made about $1.5 million from the inventions.
“The university seeks to restore its rightful ownership interest in and its resulting right to a fair share of the proceeds to be generated from the groundbreaking, patented inventions that led to this new F.D.A.-approved drug formulation,” the lawsuit said.
The university said in a statement that Dr. Mitra assisted drug companies in patenting and commercializing these inventions, all the while concealing his efforts and denying his involvement to university officials. The drug at the center of the dispute, Cequa, uses nanotechnology to make it a more effective treatment than traditional eyedrops. It received approval from the Food and Drug Administration in August, and its website advertised it as “coming soon.”
The lawsuit, filed Tuesday, described a yearslong scheme Dr. Mitra orchestrated to steal the work of a gifted graduate student, Kishore Cholkar, for his own financial gain. It also accused Dr. Mitra’s wife, Ranjana Mitra, who was employed as a research associate at the university, of aiding him in the plot.
The university said in its statement that Dr. Mitra resigned in January during proceedings to consider his dismissal. The university had been investigating Dr. Mitra for potential misconduct since May. It did not specify the nature of the alleged misconduct.
In a statement provided by Ms. Mitra, Dr. Mitra called the lawsuit “unexpected and disappointing.”
“All of the alleged wrongdoing on the part of myself and my wife can be proven to be false,” he said.
Dr. Cholkar began pursuing his doctorate in pharmaceutical sciences in 2008 and focused his studies on using nanotechnology to deliver drugs, according to the complaint. During his research, the lawsuit said, Dr. Cholkar discovered a novel way of delivering a pharmaceutical drug to the eye using hydrogenated castor oil and a chemical called Octoxynol-40. The formulation was intended to deliver drugs to the back of the eye better than typical eye drops.
The university said that in 2011, Dr. Mitra passed along Dr. Cholkar’s experimental results to Auven Therapeutics, a pharmaceutical company based in the United States Virgin Islands that eventually entered into a contract with Dr. Mitra and patented the inventions.
A 2015 patent for this nanotechnology, crediting Dr. Mitra and an Auven employee as the inventors, uses Dr. Cholkar’s work without mentioning his name, the lawsuit alleges.
The lawsuit said that Dr. Mitra and Ms. Mitra, or people responding to their orders, removed or destroyed Dr. Cholkar’s laboratory notebooks that he used to document the experiments. In an email, Ms. Mitra denied those allegations.
Dr. Cholkar did not respond to multiple requests for comment.
The lawsuit also names as defendants Auven and Sun Pharmaceutical Industries, which acquired Auven’s ocular technologies in 2017. An emailed statement from Auven said the company believes there is no merit to the university’s complaints as they relate to Auven and Sun Pharma. A spokesman for Sun Pharma, a company based in India, did not immediately return a request for comment.
In addition to suing Dr. Mitra for fraud and unjust enrichment, the university also claimed that he breached his contract, which includes patent regulations. The lawsuit said that when Dr. Mitra signed his contract in 1994, he agreed that the university would own all inventions made “within the scope” of his employment.
Because he will receive 1 percent of the royalties from the sales of Cequa over the next five years, it estimated he could receive about $10 million.
If the university had been considered the rightful owner of that technology, the financial windfall of the research would have been doled out much differently. According to the university’s patent regulations, one-third of the money that the university receives from a patent goes directly to the inventor; the university considers Dr. Cholkar as one of the main inventors who should have been credited.
In Dr. Mitra’s statement, he said he has evidence that the university knew about his partnership with the pharmaceutical companies in 2007. Ms. Mitra did not respond to a request to provide that evidence. Dr. Mitra also said he could “unequivocally prove” that the invention was created by him and the other named contributors.
Dr. Mitra wrote that Dr. Cholkar, whom he called “an accomplished student of mine,” and the university were “trying to reap the benefits of the tireless work myself and others have put in to make this a success.”
Alleged fraud has not been the only focus of the university’s investigations into Dr. Mitra’s conduct. In November, The Kansas City Star reported on allegations that he compelled his graduate students — specifically those from India — to “act as his personal servants,” under the threat of having their visas revoked. Dr. Mitra denied making such threats.
Courtesy/Source: NY Times