Indian Insulin patent for Novo Nordisk

Denmark based biotech company Novo Nordisk has lately received an Indian Patent No. 209529 (the ‘529 patent) for chemically stable aqueous insulin preparation using comparatively low halogenide (sodium chloride) concentrations (see Official Gazette Journal No. 50/2007 dated December 14, 2007). The patent is issued by the Chennai Patent Office against the mail-box Application No. 1337/MAS/1997 claiming priority from Danish Application No. 685/96 dated June 20, 1996. Interestingly, the ‘529 patent is Indian equivalent of the US Patent No. 5,866,538 which is currently been listed with the USFDA Orange Book for three approved Insulin Injection products -- namely Novolog (insulin aspart recombinant), Levemir (Insulin determir recombinant), and Novolog Mix 70/30 (insulin aspart protamine recombinant). Considering that stability forms a major technical issue in long-term insulin storage, the ‘529 patent seems to give Novo an edge over the generic competitors in ever-expanding domestic insulin market