ECJ REPACKAGING CASE
May 1st, 2004
BY KEITH NUTHALLTHE EUROPEAN Court of Justice (ECJ) has clarified European law over how different one pharmaceutical product must be from another to require a fresh market approvals and hence additional patent protection. It intervened in a case between Novartis Pharmaceuticals and the UK's Medicines Control Agency, regarding drugs marketed by Sang Stat UK Ltd and Imtix-Sang Stat UK Ltd. They had secured an approval for a drug SangCya, saying it was similar to an old Novartis drug Sandimmun. But Novartis claimed it was based on a successor medicine Neoral, still ...
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