A graduate student's innovative and potentially lucrative idea for getting drugs to the eye is at the center of a lawsuit filed by the University of Missouri system against a former pharmaceutical professor. The school says Ashim Mitra patented the student's idea and sold it in a deal potentially worth millions.
The lawsuit comes months after the Food and Drug Administration gave approval to a dry-eye drug called Cequa — which the university says is based on work done by Dr. Kishore Cholkar when he was a graduate student under Mitra at the University of Missouri-Kansas City School of Pharmacy.
Cequa, the school says, "is expected to compete for a substantial portion of a multi-billion-dollar annual market."
The curators of the University of Missouri are suing Mitra, his wife and two pharmaceutical companies, accusing them of appropriating Cholkar's work. The school says it owns Cholkar's invention. It alleges Mitra and the drug companies — Sun Pharmaceutical and Auven Therapeutics — conspired to keep all of the profits for themselves.
Mitra has already made more than $1.5 million from the drug, the lawsuit says, citing his deal with Auven, a pharmaceutical development company. After Mitra and Auven obtained a patent for the drug, the suit says, Auven sold "all of the intellectual property for a $40 million payment, as well as ongoing royalties, to Sun Pharma, a large multi-national pharmaceutical conglomerate."
"All of this occurred without any disclosure to—let alone approval from—the University," the lawsuit states.
Responding to the lawsuit, Mitra sent a statement to member station KCUR in which he called the university's claim "unexpected and disappointing." (KCUR is licensed to the University of Missouri Board of Curators and is an editorially independent community service of the University of Missouri, Kansas City.)
Mitra said he can "unequivocally prove" that the eye drug breakthrough "was conceptualized by myself and the rightful co-creators."
"Dr. Kishore Cholkar is an accomplished student of mine who wrote a paper on other aspects of the Cyclosporine formulation after the patent had already been submitted to the FDA for approval," Mitra said. "It is clear to see that both him and UMKC are now trying [to] reap the benefits of the tireless work myself and others have put in to make this a success."
The suit also has an international aspect, listing Auven Therapeutics as being based in the U.S. Virgin Islands, with subsidiaries in Switzerland. And it says Sun Pharmaceutical Industries Ltd. is based in Mumbai, India.
The lawsuit alleges that Auven intentionally avoided discussing its plans for the drug with anyone at the university other than Mitra — and that the company would have known the professor had "a clear conflict of interest," the lawsuit states.
University Of Missouri curators are now asking a federal court to name Cholkar as the rightful inventor on the drug's patents and declare the university's ownership interest in the work. They're also seeking damages from Mitra, and the companies involved, and Mitra's wife, Ranjana, who has worked both at the pharmaceutical school and in a consulting business with her husband.
The school alleges that Mitra, a tenured professor at the school who previously served on its patent committee, breached the terms of his employment.
Mitra started working at the University of Missouri-Kansas City School of Pharmacy in August 1994. He reached an agreement to resign in January, after an internal investigation into potential violations of the university's faculty conduct standards. His resignation will be final on March 31, 2019.
Mitra came under scrutiny in 2018 because of allegations that he used his leverage as a tenured professor to pressure students — particularly students from his native India — into performing menial tasks for him.
As KCUR's Laura Ziegler reported last month:
"The Kansas City Star reported on the investigation last fall, talking to dozens of students who claimed that Mitra had threatened their student status and even their student visa status if they refused to do household chores. Students reported being asked to clean Mitra's flooded basement, take care of his dog and serve food at Indian cultural events. One student described the work as 'modern slavery.' "