On January 22, 2015, the General Court of the European Court of Justice held that an orphan medicinal product that has the same therapeutic indication as a previously authorized orphan but that has been independently authorized enjoys 10 years of independent market exclusivity. The case was bought by Teva against a decision of the European Medicines Agency to reject the marketing authorization application for the generic version of the previously authorized orphan (imatinib) on the basis that the later and independently authorized orphan (nilotinib) continued to have market exclusivity for the therapeutic indication in question. Teva's action was dismissed.
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