When researchers at the San Diego-based Scripps Institute, one of the country's largest private, non-profit biomedical research facilities, began collaborating with German pharmaceutical giant Merck KGaA (unrelated to the U.S. pharmaceutical company Merck) in the 1990s, they knew they were headed toward something big. Unfortunately that something turned out to be a lawsuit when Integra LifeSciences, a small New Jersey-based medical technology company, sued them in 1996 for infringing on its patented peptide sequence in pre-clinical trials.
A federal court jury in southern California decided in favor of Integra and awarded the company $15 million in damages. Scripps and Merck appealed the decision to the Federal Circuit in Washington D.C. in 2000, where the lower court's verdict was affirmed, but the damages were lowered to $6.4 million. Finally, on April 20, the Supreme Court heard oral arguments for Merck KGaA v. Integra LifeSciences, et al.
The research in question that Scripps and Merck were conducting involved the use of RGD peptides to starve tumors. Integra owns the patent to the peptides. Scripps was researching ways to use the peptides to block blood vessels from growing in the direction of tumors. They carried out the research on animals and then Merck used the data to apply to the FDA for permission to conduct clinical trials to test the drug out in humans.
"Our view was the relationship between this data and the FDA was pretty damn direct," Rosenkranz says.
This could be an issue if the court decides to reverse earlier decisions for not addressing alternative legal grounds in the statute. The Federal Circuit Appeals court has expanded the scope of exemption over time to also apply to medical devices--not just drugs.
"Our position is that the instruction was correct so the jury was properly instructed but the jury reached the wrong conclusion because it heard so much evidence on issues that were irrelevant to the issue before them," Rosenkranz says.