Tagged: orphan drug exclusivity

Pernicious Effect of Similar Medicinal Product’s Orphan Exclusivity: CJEU Dismisses Teva’s Appeal (C-138/15 P)

By Mayank Dixit

In a significant, yet unusual judgment the Court of Justice of the European Union (CJEU) upheld the General Court’s decision (T-140/12; Teva Pharma v. EMA) that had affirmed the European Medicines Agency’s (EMA) rejection of Teva’s generic drug application for Glivec® (active substance-imatinib), not due to the reference product’s own orphan drug exclusivity but in view of orphan drug exclusivity of a similar medicinal product – Tasigna® (active substance-nilotinib).

The judgment is bizarre not only because it interprets the underlying orphan drug regulation in a manner incongruous with the spirit and substance of the legislation, but also for its potential to provide an unfair leg-up to the brand drug companies for extending their market monopolies indefinitely. It simply fails to fathom the underlying welfare rationale of the Regulation, which is meant to ensure the same quality of treatment for patients of rare conditions as those suffering from other diseases. The Court’s decision provides a skewed playing field where the interest of patients and generic pharmaceutical companies will be impacted by the unjustified extension of monopoly periods of brand drug products thus ensuring exploitative pricing of life-saving drugs. Continue reading