Repackaging law clarified
The 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.
The 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 under patent protection.
The ECJ was asked by the Court of Appeal to advise on how EU law defines a new medicine, and judges have ruled, for instance, that a different physical form would not create a new product.