SPCs and orphan drugs-- is the double layer getting messy or is it just a matter of timing? A new ruling of the District Court in the Hague to shed some light?
The ruling of the District Court in the Hague in the case C/09/595262 KG ZA 20-605 concerns the pharmaceutical Exjade (generic substance deferasirox), protected both by a patent and subsequently a Supplementary Protection Certificate as well by an Orphan Drug Designation. Novartis sued Mylan for infringement of the SPC (under the term of its Paediatric Extension) on Exjade; Mylan countersued alleging the invalidity of the Paediatric Extension. The specific ruling concerns preliminary relief proceedings.
The legal framework
The Paediatric Regulation is clear that there is a distinction between the rewards and incentives it offers for products protected by a patent (or SPC), on the one hand, and between products that are designated as orphan medicinal products and those that are not, on the other. Orphan medicinal products are excluded from the right to the six-month SPC extension offered in Article 36(1) of the Paediatric Regulation. However, orphan medicinal products (irrespective of whether they are patent protected or not) are granted an extension of the market exclusivity provided for in Article 8 of the Orphan Medicinal Products Regulation, from 10 to 12 years, based on Article 37 of the Paediatric Regulation.
On the issue of whether preliminary relief should be granted for the infringement of Novarti’s SPC, Mylan based its arguments on its interpretation of Articles 36(4) and 37 of the Paediatric Regulation, claiming that the double prohibition against the Paediatric Extension (both on the orphan drug as well as on the SPC) also applies when a medicinal product was designated as an orphan medicinal product in the past. Mylan argues, therefore, that Novartis has in effect cherry picked between applicable forms of protection; enjoying both SPC and orphan drug designation, it finally ultimately opts for receipt of an SPC Paediatric Extension rather than an orphan drug extension.
Furthermore, Mylan argues that Novartis delayed the procedure stipulated under the Paediatric Regulation (the Paediatric Investigation Plan, PIP, and its completion) in order for Exjade to be eligible for a Paediatric Extension only after the orphan drug designation would have expired. In this way, Novartis has (according to Mylan) attempted to manipulate the system and receive an SPC Paediatric Extension.
The applicable legal framework is in this respect clear; a pharmaceutical may not enjoy both an SPC Paediatric Extension and a two-year extension of its orphan drugs designation. The question posed by Mylan is whether the exception to this double incentive also applies to pharmaceuticals that have previously been designated as orphan drugs, but for which the ten-year term of protection has expired.
The court concludes that taking into consideration the objectives of the Peadiatric Regulation, Articles 36(4) and 37 of the Regulation may not be interpreted in any other way other than that an SPC Paediatric Extension may be granted on a medicinal product, even if this was previously designated as an orphan drug, as long as this designation is no longer valid (either expired or withdrawn). Furthermore, the court ruled that Mylan’s claim regarding the delay in the PIP proceedings may not be taken into consideration, since this objection should have been raised within the framework of the PIP procedure.
This Kat is not surprised by the ruling of the Hague District Court. To be honest, any other interpretation of the Paediatric Regulation would have been surprising. This decision confirms that the regulations at hand (the SPC Regulation, the Orphan Drugs Regulation and the Paediatric Regulation) have been drafted as separate legislative acts and are not seen as part of the same overarching regulatory framework.