Pharmaceutical giant Novo Nordisk filed suit against major competitor Eli Lilly on Aug. 1, alleging that Lilly deliberately created false and misleading packaging information for its new Humulin cartridges.
At issue is the use of Lilly cartridges in Novo insulin pens. While Lilly does not produce pens, an alternative to traditional syringes, Novo Nordisk has been selling pens for years in the United States and abroad. The suit was filed on the heels of Lilly’s release of the cartridges to the U.S. market on July 19.
“We believe that Eli Lilly is trying to create the false and misleading impression that Novo Nordisk has approved the use of Lilly cartridges in Novo Nordisk pen systems,” said Novo spokesperson Susan Jackson.
Jackson said Novo needed to approve the use of Lilly cartridges, but that such permission was never granted. “We have not conducted any scientific studies combining our insulin delivery devices with any insulin cartridges other than our own,” Jackson said. Without these studies, she said, Novo cannot honor warranties for their pens.
But Eli Lilly denies that such permission was required. The only approval needed to sell Lilly cartridges for use in Novo pens came from the U.S. Food and Drug Administration on July 10, said Lilly spokesperson Kelly Sego.
As for the scientific studies proving the safety of using the products together, Sego said that was all part of attaining FDA approval. “We had to conduct scientific studies and submit them to the FDA, just like a new product,” she said.
Sego also denied charges that Lilly’s cartridge packaging is misleading. “If you look at the packaging it simply says the cartridges are for use in particular devices; it’s not telling the patient how to use it,” she said.
The cartridges containing Humulin R, Humulin N and Humulin 70/30 have been used with Novo and B-D pens for years in Europe. Novo Nordisk and Eli Lilly have engaged in fierce competition for insulin cartridge sales since 1991, when Lilly released its Humulin cartridges to the European market.
The pen method of insulin delivery is still not as popular in the United States as it is in Europe. While only one percent of the three million insulin users in the U.S. rely on pens, roughly 60 percent of European insulin users have abandoned traditional syringes in favor of the pens.
Some analysts say the Novo vs. Lilly lawsuit is a case of corporate jealousy. “Sounds a little like sour grapes to me. You would think if Novo was going to raise hell about it, they’d have done it a few years ago,” said David Lebedeff, an analyst at NatCity Investments in a Knight Ridder/Tribune Business News story.
“We believe Novo’s lawsuit is frivolous, without merit, and we intend to prove it. We are going to fight this lawsuit vigorously,” Sego said.