In the EU, several different rewards and incentives apply for conducting clinical trials in the paediatric population. Supplementary Protection Certificates (SPCs) can be extended with a 6-month paediatric extension. The 6-month paediatric extension of SPCs is not available for orphan medicinal products, which benefit from a separate 2 years paediatric extension of orphan market exclusivity. The question has arisen whether the 6-month paediatric extension of SPCs is available for medicinal products which were originally designated as orphan medicinal products but were subsequently (voluntarily) removed from the EU's Community Register of Orphan Medicinal Products.

In a judgment of 30 March 2016 (published 4 April 2016) in summary proceedings before the Provisions Judge of the District Court of The Hague (the Netherlands) between Novartis and Teva concerning Novartis' product Glivec (imatinib), the court confirmed that the 6-month paediatric extension of SPCs is available for a former orphan medicinal product, i.e. a product that was previously designated and authorised as an orphan medicinal product, but was subsequently (voluntarily) removed from the EU's Community Register of Orphan Medicinal Products.

Factual background

Novartis holds a centralized EU marketing authorisation for the medicinal product Glivec (imatinib). The initial marketing authorisation was granted on 7 November 2001 for the treatment of chronic myeloid leukemia (CML). The product was designated as an orphan medicinal product and benefited from a period of 10 years of orphan market exclusivity. Subsequently, additional therapeutic indications were approved, including the treatment of adult patients with acute lymphoblastic leukemia (ALL). The additional indications were also orphan indications which enjoyed orphan exclusivity until 27 May 2012, 18 September 2016 and 1 December 2016. Novartis performed clinical studies in the paediatric population, in accordance with an agreed paediatric investigation plan (PIP) for the treatment of paediatric patients with ALL. On 9 March 2012, the European Medicines Agency (EMA)'s Paediatric Committee issued a positive opinion concerning completion of the PIP.

In April 2012, Novartis requested the European Commission to remove the orphan designation for imatinib from the Community Register of Orphan Medicinal Products for all therapeutic indications. The European Commission confirmed that imatinib had been removed from the Register as of 16 April 2012.

On 8 June 2012, Novartis applied for extension of the marketing authorisation to include the paediatric indication.

Novartis' product was protected by a European patent which was granted on 19 January 2000. The patent protection period was extended in the Netherlands by a Supplementary Protection Certificate (SPC) which initially provided protection until 21 June 2016. Similar SPCs were granted in other EU Member States.

On the basis of the completed PIP, Novartis obtained a 6-month paediatric extension of the SPC for imatinib, thus providing protection in the Netherlands until 20 December 2016. Similar paediatric extensions were obtained in other EU Member States.

Novartis brought infringement proceedings vis-à-vis Teva seeking an injunction enjoining Teva from launching Teva's generic imatinib product before the expiry of the 6-months paediatric extension of the SPC.

Teva argued that imatinib was a former orphan medicinal product and could therefore not benefit from the 6-month paediatric extension of the SPC. 

EU Legal framework

Article 36(1) of the EU Paediatric Regulation (EC) No 1901/2006 on medicinal products for paediatric use, as amended, provides that if a marketing authorisation application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan (PIP), the holder of the patent or SPC shall be entitled to a 6-month paediatric extension of the SPC protection period. Article 36(4) provides that this shall not apply to medicinal products designated as orphan medicinal products. Article 37 provides that designated orphan medicinal products benefit from a 2-year paediatric extension of the 10 years orphan market exclusivity.

Article 5(12) of the EU Orphan Regulation (EC) No 141/2000 on orphan medicinal products, as amended, provides that an orphan designation can (voluntarily) be withdrawn and a designated orphan medicinal product can be removed from the Community Register of Orphan Medicinal Products at the request of the company that obtained the designation of a medicinal product as an orphan medicinal product.

The decision of the Provisions Judge of the District Court of The Hague of 30 March 2016

The court, in summary proceedings, confirms that former orphan medicinal products can enjoy a 6-month paediatric extension of an SPC. The court considers that a key principle of the EU Paediatric Regulation is that paediatric research should be rewarded. The court considers that the orphan medicinal product imatinib was removed from the EU Community Register of Orphan Medicinal Products before the date of filing of the application for approval of the paediatric indication or the inclusion of the results of the conducted PIP compliant studies in the marketing authorisation and therefore could not enjoy a 2-year paediatric extension of the 10-year orphan market exclusivity. The court considers that the product imatinib should be able to enjoy a 6-month paediatric extension of the SPC so that paediatric research would be adequately rewarded.

The timing of removal of the product from the Community Register of Orphan Medicinal Products is important. The court considers that the date of filing of the application for approval of the paediatric indication or the inclusion of the results of the conducted PIP compliant studies in the marketing authorisation is the determining date for obtaining a paediatric reward (i.e. 2-year extension of the 10-year orphan market exclusivity or 6-month extension of the SPC). In this case, Glivec (imatinib) was removed from the Community Register of Orphan Medicinal Products on 16 April 2012 and Novartis applied for approval of the paediatric indication on 8 June 2012. Therefore, at the time of applying for approval of the paediatric indication, the product was no longer an orphan medicinal product and the paediatric reward available at that time was the 6-month paediatric extension of the SPC.

The court concludes that former orphan medicinal products are not excluded from benefiting from a 6-month paediatric extension of SPC.

As far as we are aware, this appears to be the first case in the EU in which a court has addressed the issue of paediatric extension of SPC for former orphan medicinal products.

The decision is subject to appeal.