The Court of the Hague grants SPC after debate concerning interpretation of ECJ Neurim case

On 1 February 2017, the Court of the Hague annulled a decision of the Dutch Patent Office (DPO) in which the DPO refused a March 2009 application made by Bayer Schering Pharma Aktiengesellschaft’s (Bayer) to obtain a supplementary protection certificate (SPC) for a method of administering a human medicine consisting of tablets containing estradiol valerate and dienogest. The Court confirmed that, in accordance with Neurim Pharmaceuticals (Case C-130/11) [2012] ECR I-0000, an SPC can be obtained even if an earlier marketing authorisation (MA) covering the human use of that medicine exists.

An SPC, which extends the duration of patent protection for a medicinal product, can only be granted if the referenced MA is the first MA to place the medicine on the market in the EU/EEA. In its SPC application, Bayer referred to the MA for the medicine Qlaira® containing the active substances estradiol valerate and dienogest, which is an orally administered contraceptive pill for human use.

However, the DPO pointed to earlier MAs for the human medicines Climodien® and Lafamme® with the same active ingredients as Qlaira® (albeit with different indication and dosage regime). The DPO argued that the MAs for Climodien® and Lafamme® constituted earlier MAs for the same product and thus precluded the granting of an SPC. For the DPO, the Neurim case (according to which an earlier MA for the same active ingredient but with a different indication compared to the referenced MA does not preclude the grant of an SPC) only applies to an earlier MA granted for veterinary medicines and, therefore, is not applicable to this situation. Furthermore, according to the DPO, a broader reading of Neurim would significantly increase the number of SPCs with substantial consequences for the human medicines market.

The Court of the Hague, however, ruled against the DPO's reading of Neurim and stated that an SPC could be obtained even if earlier MAs covering the human use of that medicine exist. It therefore ordered that the SPC must be granted.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2017 Issue (Thomson Reuters).