Pharma update: Cross border injunction imatinib granted against Teva

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In his decision of 30 March 2016 in the matter Novartis AG v Teva Nederland B.V. et al., the Provisions Judge of the District Court in The Hague held that Novartis is entitled to a Paediatric Extension for Glivec® (imatinib), based on Supplementary Protection Certificate no. 300086. The Provisions Judge has provisionally prohibited Teva to bring imatinib on the market in various European countries.

Novartis AG (hereafter: “Novartis”) is the proprietor of EP 0 564 409 (“EP 409”) protecting the substance imatinib. EP 409 expired on 24 March 2013, but imatinib is still protected by Supplementary Protection Certificate no. 300086 (“SPC”) and a Paediatric Extension (“PE”) based thereon. The SPC expires on 20 June 2016, the PE on 20 December 2016.

Novartis commenced interim relief proceedings against Teva Nederland B.V. and five of its affiliates (hereafter together referred to as: “Teva”), for Teva had announced that it would not respect Novartis’ rights under the PE. According to Teva, the PE is invalid as it had been issued in violation with Article 36 (4) of Regulation (EC) 1901/2006 (“Paediatric Regulation”). Article 36 (4) of the Paediatric Regulation states that no PE shall be issued if the medicinal product at hand is designated an orphan medicinal product. The incentive for paediatric research on orphan medicinal products, according to Article 37 of the Paediatric Regulation, is an additional two years market exclusivity on top of the ten years market exclusivity that orphan medicinal products enjoy pursuant to Article 8 of Regulation (EC) 141/2000 (“Orphan Regulation”). Imatinib has been designated an orphan medicinal product in the past, and it would thus not be eligible for protection by a PE. Issuing a PE in that case would provide Novartis with a double incentive, which is not permitted according to Recital 29 of the Paediatric Regulation.

Novartis argued that the PE for imatinib is valid nonetheless. According to Novartis, in the present case there is no double incentive. The designation of imatinib as an orphan medicinal product for the indication CML was removed from the Community Register on 12 November 2011 (the remaining indications were removed on 16 April 2012). Imatinib, for this reason, was no longer eligible for extended market exclusivity pursuant to Article 37 of the Paediatric Regulation. In light of Teva’s announcement, Novartis requested the Provisions Judge to impose a cross border injunction on Teva for all European countries where Novartis holds a PE.

The Provisions Judge held that Novartis is entitled to a PE, not only in The Netherlands, but also in other European countries. According to the Provisions Judge, it follows from the objective of the Paediatric Regulation that paediatric research should be rewarded, also if the medicinal product at hand is an orphan medicinal product. If a medicinal product is no longer designated an orphan medicinal product and thus lost the right to extended market exclusivity, not granting a PE would be in conflict with this objective. In the present case, according to the Provisions Judge, Novartis has not enjoyed a double incentive as Novartis did not enjoy an extension of market exclusivity from 10 to 12 years. Moreover, from the correspondence and reports cited by Novartis, it follows that both the European Commission and EMA assume that a PE can be granted for medicinal products which were previously designated as orphan medicinal products.

The Provisions Judge prohibits Teva to infringe the Dutch SPC and PE by commercialising medicinal products containing imatinib. The Provisions Judge furthermore agreed with Novartis that, given Teva’s announcement and the fact that Teva has invoked the nullity of the PE in various European countries, an imminent threat exists that Teva or other companies within the Teva group will put generic imatinib on the market,. In light thereof and in light of the fact that Novartis has an interest in obtaining a ‘first mover advantage‘, the Provisions Judge orders Teva not to give permission to its affiliates to put products containing imatinib on the market nor to make use of Teva’s marketing authorisations, as long as the SPCs and the PEs are valid in Austria, Belgium, Czech Republic, Germany, Spain, France, Greece, Hungary, Ireland, Luxemburg, Portugal and Sweden.