• Regulatory NewsRegulatory News

    EU High Court Upholds Orphan Exclusivity Ruling

    Earlier this month, the EU's top court upheld a major ruling with implications for orphan drug exclusivity by rejecting an appeal by generic drugmaker Teva Pharmaceuticals Europe. In its appeal, Teva contested the ruling of a lower court that found orphan product exclusivity covers all indications a product is approved for. Background In 2001, Novartis won marketing authorization for its orphan product Glivec (imatinib), marketed as Gleevec in the US, as a first-line t...
  • Regulatory NewsRegulatory News

    EU Court Rules on Orphan Product Exclusivity

    A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity. In its ruling, which has the potential to influence how companies develop orphan products, the court found that authorized orphan products are entitled to market exclusivity, even when they are similar to an already approved product. Background Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141...