An Oklahoma City federal court ruled Wednesday that the Oklahoma Medical Research Foundation may proceed with legal action against pharmaceutical giant Eli Lilly and Company for patent infringement, fraud, constructive fraud and unjust enrichment.
The lawsuit involves a treatment for severe sepsis, sometimes referred to as “blood poisoning”, which kills more than 215,000 people each year in the United States. Sepsis is the nation’s ninth leading cause of death, and the largest non-cardiac cause of death in U.S. intensive care units.
In groundbreaking research, OMRF scientists Dr. Fletcher Taylor and Dr. Charles Esmon invented a treatment for sepsis in the 1980s using activated Protein C, a substance that occurs naturally in the body in small amounts.
OMRF received a United States patent for the treatment in 1991, and licensed the treatment to Lilly in 1994. Lilly developed its Xigris brand activated Protein C drug and received FDA approval to distribute the drug in November 2001. Xigris is the first drug approved by the FDA for treatment of severe sepsis.
The drug has received substantial recognition, having been granted the Translational Medicine Award, co-sponsored by the University of California, the San Diego Institute of Molecular Medicine, the Salk Institute of Biological Studies and the journal Nature Medicine. Xigris also was recognized by Med Ad News as the Best New Medicine of 2001.
However, Lilly informed OMRF in early 2001 that it did not intend to pay OMRF under the license for its sales of Xigris. OMRF then filed suit for breach of contract, and subsequently added a claim for patent infringement.
In her ruling Wednesday, U.S. District Judge Robin Cauthron denied Lilly’s motion to strike OMRF’s patent infringement claim, and granted OMRF permission to amend its complaint to add claims against Lilly for fraud, constructive fraud, unjust enrichment and estoppel.
Judge Cauthron also adopted OMRF’s construction of disputed terms in the patent claims, interpreting the claims to require a range of amounts of the drug that includes the amount of Xigris approved for use by the FDA.
“We were delighted to learn of the court’s favorable rulings because these are significant steps in securing for OMRF and its research teams led by Drs. Taylor and Esmon the appropriate recognition they deserve for inventing this life saving treatment,” said OMRF President J. Donald Capra, M.D. “We take no pleasure in being in court, however. Our place is in the laboratory. We therefore continue to hope for a prompt resolution of this matter with the full recognition of OMRF’s role and the compensation that OMRF and its researchers have earned.”
Charles T. Esmon, Ph.D., is considered one of the world’s experts in the field of blood coagulation and heart disease research. He is considered a major developer of the protein C pathway and how it is involved in inflammation and other disease processes.
Fletcher B. Taylor, Jr., M.D., a noted physician, studies primate models of inflammatory disorders involving the vasculature, including sepsis, systemic inflammatory response syndrome, deep vein thrombosis and microvascular thrombosis.
Chartered in 1946, OMRF is a private, non-profit, biomedical research institution which employs over 400 scientists, physicians, technicians, and administrative and support personnel. Along with Alzheimer’s disease, OMRF focuses on several critical areas of research: cancer, heart disease, diabetes, lupus and other autoimmune diseases, stroke, AIDS, aging, children’s diseases and genetic disorders.