(CN) – After more than a decade of legal wrangling, a Brigham Young University scientist who claims he discovered the critical ingredient to the multibillion-dollar drug Celebrex is set to go to trial against Pfizer.
Daniel L. Simmons, a professor of biochemistry and chemistry at the private college in Provo, Utah, says he isolated the COX-2 enzyme in the early 1990s and soon after entered an agreement with Monsanto – which has since merged with Pfizer – to develop the discovery.
But Simmons and BYU claimed that Pfizer breached the agreement and independently patented and marketed the enzyme as Celebrex, one of the most commercially successful drugs in recent history with “total sales to date well over $42 billion.”
They sued Pfizer after a 2001 tolling agreement failed to produce a settlement. For nearly six years the parties have been locked in contentious discovery, but a series of recent summary judgment rulings have cleared the way to a jury. The May 29 trial is expected to last six weeks.
The case hinges on differing interpretations of the research agreement.
“In breach of the research agreement and acting in bad faith, Monsanto, through Dr. Philip Needleman, Monsanto’s Chief Scientific Officer, fraudulently terminated the research agreement and secretly misappropriated Dr. Simmons’s discovery and the project for its own gain,” the plaintiff’s 2010 amended complaint states.
“With the benefit of Dr. Simmons’s discovery and Brigham Young University’s project, Monsanto was the first pharmaceutical company with the capability of systematically testing and identifying a COX-2 selective inhibitor,” the complaint adds. “With that advantage, Monsanto was the first to market this type of drug. By Monsanto’s own admission, the discovery of COX-2 was ‘critical’ to the creation of what Monsanto called its ‘super aspirin,’ the COX-2 selective nonsteroidal anti-inflammatory drug (‘NSAID’), Celebrex.”
Pfizer claims that it lived up to the agreement and did nothing untoward.
COX, or cyclooxygenase, is an enzyme that produces prostaglandins, which are responsible for inflammation, pain and fever, but also promote protective mucus secretion in the stomach. The isolation of COX-2 enzyme allowed for creation of a nonsteroidal anti-inflammatory drug without the usual negative side effects.