CJEU confirms orphan drug market exclusivity

We reported in March 2015, that the General Court of the CJEU ruled in Teva v the European Medicines Agency (Case T-140/12) that a second, similar, orphan medicinal product that has been granted orphan designation for the same indication as the first is entitled to an independent 10-year period of orphan market exclusivity when it has been approved independently from the first authorised orphan medicinal product. This decision was subsequently appealed to the Court of Justice, which has now upheld the General Court's decision (C-138/15 P).

In this case, imatinib (Glivec) was granted orphan status and received a marketing authorisation in 2001. It therefore benefited from market exclusivity until 2011 for similar products for the same indication. Subsequently, Novartis developed another similar product, nilotinib (Tasigna), which also obtained an orphan designation on the basis that it could provide significant benefit for the treatment of chronic myeloid leukaemia ("CML") because it might improve the long-term outcome of the patients in comparison to the existing products which included imatinib. A marketing authorisation for Tasigna was granted in 2007, during the marketing exclusivity of Glivec. Because imatinib and nilotinib were similar medicinal products and were both indicated for CML, it was necessary for consent to be given for the authorisation of Tasigna by the holder of the authorisation for Glivec (the same company, Novartis), as required by article 8(3) of Regulation No 141 / 2000 governing orphan medicinal products (the "Regulation"). The data exclusivity period of Tasigna for CML does not expire until 2017 and so was still in place at the time that Teva made a marketing authorisation application for generic imatinib. This application was therefore rejected by the EMA on this basis that imatinib was a similar product indicated for the same indication (CML).

The General Court ruled that the EMA had been right to refuse the marketing authorisation for imatinib. Teva's appeal before the Court of Justice was based on three arguments, which are considered in the judgment of the Court of Justice:

• An orphan product authorised pursuant to the derogations of Article 8(3) of the Regulation should not enjoy a period of market exclusivity.
  
  The Court of Justice noted that there was no express provision in the Regulation that an orphan product granted a marketing authorisation under one of the derogations in article 8(3) should be denied market exclusivity. The Court of Justice held that, on the contrary, it was important that market exclusivity was awarded to all orphan products in order to ensure the objective of the Regulation was met and that investment in research, development and marketing of orphan drugs was encouraged.
• The General Court's finding would be at odds with the purpose of the Regulation because it would, in effect, lead to the prolongation of the market exclusivity of the initial product beyond 10 years.
  
  The Court of Justice held that there is no provision for an extension of the period of the marketing exclusivity in article 8(1) and that the only provision for reducing the duration of the marketing exclusivity of an orphan product is contained in article 8(2) in circumstances where the product no longer satisfies the conditions of an orphan product in article 3 of the Regulation. There is no other basis for curtailing the market exclusivity of the second product.
• The General Court misunderstood Teva's alternative case and so failed to address it properly.

The Court of Justice held that the General Court had correctly summarised Teva's arguments as being that the market exclusivity granted to a second product should only prevent authorisation of products that are similar to the second product and not the first product. Those arguments were rejected by the General Court and it was entitled to do so.

The Court of Justice has therefore confirmed that the regulator must not grant a marketing authorisation for a similar product for the same indication as an orphan medicinal product which has been given marketing authorisation for 10 years from the grant of that marketing authorisation. This applies regardless of the effect on an earlier product for which market exclusivity may have expired.

The decision

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