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Eli Lilly and Novo Nordisk are brawling in courts worldwide over Novo's steps to introduce its rapid-acting insulin.
In September, Novo announced an FDA new drug application for its rapid-acting insulin, insulin aspart. It is called NovoRapid in places outside the United States, but will have a different brand name here.
The cloud hanging over the FDA approval process for insulin aspart is a Lilly lawsuit in the United Kingdom that accuses Novo Nordisk of infringing upon a Lilly insulin patent. Novo says this lawsuit threatens its plans to market its rapid-acting insulin here in the United States.
To stop Lilly, Novo filed in U.S. District Court in Delaware, asking the court to invalidate Lilly's patent or to rule that insulin aspart does not infringe on it.
Steve Zelson, Novo Nordisk's director of corporate patents in the United States, says his company "made a strategic decision to be proactive" here in the American market, because it "felt threatened" by Lilly's actions in the United Kingdom. The suit is a pre-emptive strike to prevent Lilly from similar actions in U.S. courts. A Lilly spokesperson stated that they do not comment on pending litigation.
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.