University sues Pfizer over COX-2 research

Brigham Young University and Daniel Simmons, a researcher in its Department of Chemistry and Biology, have filed a lawsuit alleging that Monsanto, a precursor company to Pfizer, misappropriated Simmons' research on COX-2 to develop its blockbuster painkiller Celebrex. 

The suit, filed against Pfizer in the U.S. District Court in Salt Lake City, Utah, comes after more than five years of discussions between the parties, including failed efforts at mediation earlier this year. "We know what we are dealing with, and we are prepared to persevere," BYU spokesperson Michael Smart told The Scientist. 

According to the plaintiffs, Monsanto entered a contract with BYU and Simmons in 1991 to partner on the development of painkillers that targeted COX-2, but left COX-1 unaffected. 

Simmons and BYU claim that Monsanto subsequently used their research methodologies and data to develop Celebrex outside of the partnership in order to avoid having to share the profits. They are requesting actual and punitive damages, and asking that 75 patents be amended to include Simmons among the inventors. 

The suit claims that Simmons first identified COX-2 mRNA at the end of 1998, while at Harvard University. After he relocated to BYU the following year, he characterized the gene and sequenced it, noting the applicability of his discovery immediately. However, during contract negotiations, Monsanto "wrongly advised Dr. Simmons that he should not patent these items because any such patent would not be enforceable or defensible," the suit alleges. 

Instead, the contract gave Monsanto responsibility for patent applications, and Simmons divulged his confidential genetic sequences, regents and methodologies to the company, the suit states. 

By the spring of 1992, Monsanto had begun to focus in-house resources on COX-2 inhibitors, marking what the suit describes as "an abrupt and dramatic corporate shift in thinking and approach requiring reallocation of valuable resources and personnel." The company did not contact Simmons or the university to alert them about the in-house research, nor did it include Simmons on patents related to the research, in spite of the fact that the work made use of his discoveries, the suit states. 

The lawsuit alleges that as Monsanto moved forward with its own COX-2 inhibitor development program, the company terminated the contract with Simmons and BYU "so Monsanto could secretly misappropriate the project." 

According to the suit, Monsanto deemed the collaboration "unworkable" because Simmons was not communicating with Monsanto project leaders. But the plaintiffs claim that phone records prove he placed "more than sixty calls to Monsanto during the period the agreement was in effect" and that he and his BYU colleagues accepted many calls from Monsanto. 

Pfizer spokesperson Bryant Haskins would not discuss the specifics of the case, but denied the overall allegations. "The facts clearly show that Monsanto met all its obligations with BYU and with Dr. Simmons," he said. "Dr. Simmons played no role in the discovery of Celebrex, and the allegations raised by BYU and Dr. Simmons are baseless." 

Simmons declined to comment on the suit. 

Ronald Cahill, partner at Nutter McClennen & Fish LLP, a Boston-based law firm specializing in life science patent law, said battles like the one between BYU and Pfizer aren't uncommon. It used to be that one company would discover, develop and manufacture a product, but now that collaborations are more common and more entities are involved, there is "less control in the research project from beginning to end, which means less control of the IP along the way," he told The Scientist. 

Still, Cahill said that partners are beginning to learn how to protect themselves better early on, which could lead to less litigation down the road. "Universities have gotten more sophisticated, start-ups have gotten more savvy, and big companies are getting more careful," he said. "Now most universities won't let [their scientists] publish or go talk to companies about research unless they've had the opportunity to see if it warrants a patent application."