Novartis v Sun Pharmaceutical: a battle over second medical use patents

Sun Pharmaceutical and Novartis have been in dispute over a second medical use patent, EP 1296689 (‘689 patent), which relates to the treatment of osteoporosis using a specific acid, zoledronic acid. It was granted on September 21, 2005. Novartis developed a medicine with zoledronic acid as an active ingredient that is used in the oncological field. Novartis commercialises the product with zoledronic acid as the active compound under the trademark ‘Zometa’.

Sun, which sells and distributes drugs, obtained a licence for generic zoledronic acid in the Netherlands on July 29, 2013. The licence covers the treatment of osteoporosis and Paget’s disease, but Novartis already had a patent for the treatment of osteoporosis. At Sun’s request, the indication for osteoporosis was deleted (carved out) from the summary of its product characteristics and patients information leaflet.