Denmark's Novo Nordisk says it will appeal two related US District Courtrulings against the validity and enforceability of the firm's growth hormone patent 5,633,352, which covers recombinant human growth hormone, the active ingredient in Norditropin (somatropin [rDNA origin] for injection). The August 3 decisions by Judge Susan Robinson prevent Novo Nordisk from barring Teva Pharmaceuticals and its licensor, Savient Pharmaceuticals, from marketing human growth hormone in the USA.
Michael Shalmi, Novo Nordisk's vice president of biopharmaceuticals in the USA, said the company "continues to believe that our patent covering human growth hormone is valid and enforceable and we are confident that the district court decisions will be overturned on appeal."
This decision follows two related litigations, one in which Novo Nordisk sued Teva and Savient in April 2002, claiming the companies infringed a patent for Norditropin. In the other, Savient appealed a decision by the Board of Patent Appeals and Interferences that upheld Novo Nordisk's right to its patent covering recombinant human growth hormone. The Federal District Court has now reversed the decision of the Board of Patent Appeals and has ruled that the Danish firm's patent is invalid and unenforceable.
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