Cancer Drug may also be used to treat Osteoporosis

15/09/15

The General Court in Luxembourg has dismissed appeals brought by Novartis against two Commission decisions in cases concerning a medicine used to treat cancer and osteoporosis. The cases concerned marketing authorisations for generic products granted to Teva and Hospira respectively, and they were heard together. The Court confirmed earlier case law on regulatory data protection, including Case 368/96 Generics, and held that Aclasta (used to treat osteoporosis) was included in the same global marketing authorisation as Zometa (used to treat cancer). The Court rejected the arguments of Novartis which relied on the fact that the two products had separate marketing authorisations and different names. The Court also held that the fact that the authorisations were granted under the centralised procedure by the Commission, rather than by national regulatory authorities, did not affect the substantive legal analysis.