The United States Court of Appeals for the Federal Circuit made clear in its decision to overturn a preliminary injunction granted to Novo Nordisk that it was not commenting on the strength of the underlying growth hormone patent case.The Court stated that its sole task was to determine whether the district court erred in granting Novo Nordisk's request for a preliminary injunction earlier this year. Novo Nordisk was granted that preliminary injunction in June against Bio-Technology General Corp. (BTG) for violating a Novo Nordisk patent covering synthetic growth hormone.
Martin Soeters, president, Novo Nordisk Pharmaceuticals Inc said, "The court determined that in the ongoing litigation, BTG will have the burden of proving their case by clear and convincing evidence."He added, "Novo Nordisk has successfully enforced this patent against competitors in numerous litigations and will continue to vigorously assert its growth hormone intellectual property moving forward."
Norditropin (somatropin rDNA origin) received Food and Drug Administration approval in 1995 for treatment of growth hormone deficiency in children.In 1999, Novo Nordisk introduced a new pen system to Europe and Japan to deliver liquid hGH, while using NovoFine needles, some of the thinnest and finest needles available.The premixed Norditropin cartridge (somatropin [rDNA origin] injection) and NordiPenMate auto-insertion device became available in 2001.
In the United States Novo Nordisk has begun a pediatric research program and multicenter trials dedicated to developing optimal treatment strategies for children with growth hormone deficiency.