EU General Court confirms 10 years of independent orphan market exclusivity for independently authorised similar orphan medicinal product

The 10 year period of orphan market exclusivity is different from and not equivalent to the 8+2 year period of regulatory data protection and market exclusivity

On 22 January 2015, the General Court of the Court of Justice of the European Union issued its judgment in the case between Teva and the European Medicines Agency (“EMA”) concerning market exclusivity for orphan medicinal products.

In summary, the Court considers that a second similar orphan medicinal product that has been granted orphan designation and has been approved independently from a previously authorised orphan medicinal product, benefits from an independent 10-year period of orphan market exclusivity.

Legal framework

The EU Orphan Regulation No 141/2000 was adopted in order to promote the development of effective treatment for patients suffering from rare diseases.

The EU Orphan Regulation provides that where a marketing authorisation is granted for a medicinal product that has been designated as an orphan medicinal product, for a period of 10 years, no marketing authorisation application shall be accepted and no marketing authorisation shall be granted for the same therapeutic indication in respect of a similar medicinal product.

The EU Orphan Regulation provides for a derogation of this 10-year period of orphan market exclusivity if (a) the holder of the authorisation for the original orphan medicinal product has given his consent, (b) the holder of the authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the product, or (c) the second applicant demonstrates that the second product is safer, more effective or otherwise clinically superior.

Factual background

In 2001, the medicinal product imatinib (Glivec) was designated as an orphan medicinal product  for the treatment of chronic myeloid leukaemia (“CML”) and a marketing authorisation was issued the same year.

In 2006, the medicinal product nilotinib (Tasigna) was designated as an orphan medicinal product for the treatment of CML. Imatinib and nilotinib were considered to be similar medicinal products. In derogation from the orphan market exclusivity for imatinib, the marketing authorisation holder for imatinib consented to the marketing authorisation being granted to nilotinib for the same therapeutic indication. Marketing authorisation for nilotinib was granted in 2007.

In 2012,  more than 10 years after the first marketing authorisation of imatinib (Glivec), Teva applied for a marketing authorisation for a generic copy of imatinib for, inter alia, the treatment of CML.

The EMA refused to validate Teva’s application regarding the therapeutic indication of CML on the basis that the therapeutic indication of CML was covered by the orphan market exclusivity for the medicinal product nilotinib (Tasigna). Teva subsequently applied to the General Court for an anulment of the EMA’s decision to refuse to validate Teva’s application.

Judgment

The Court ruled that when a similar medicinal product (nilotinib) is independently authorised as an orphan medicinal product for the same therapeutic indication as a previously authorised orphan medicinal product (imatinib), the second product enjoys independent orphan market exclusivity.

The Court refers to the objectives of the EU Orphan Regulation, namely to encourage investment in research, development and marketing of orphan medicinal products and concludes that market exclusivity must be granted in all cases in which an orphan medicinal product has been given marketing authorisation.

The judgment also confirms that the 10-year period of orphan market exclusivity is different from and not equivalent to the 8+2 years of regulatory data protection and market exclusivity.

Therefore, Teva’s action was dimissed. Teva may appeal the General Court’s judgment before the Court of Justice of the European Union.