Article 3 (b) of the SPC Regulation must be interpreted in such a way that an end of procedure notice drawn up before the expiry of the basic patent can not be equated with an MA and, on the basis of an end of procedure message, no SPC can be obtained. The fact that no marketing authorization was issued on the date of the application for an SPC is not a defect that can be repaired in accordance with Article 10, paragraph 3, of the SPC Regulation.
By its first question, the referring court essentially asks whether Article 3 (b) of the SPC Regulation must be interpreted as meaning that an end-of-procedure notice sent by the reference Member State in accordance with Article 28 (4) of Directive 2001/83 has been drawn up before the expiry of the basic patent referred to in Article 1 (c) of the SPC Regulation, it must be regarded as equivalent to a marketing authorisation, so that an SPC can be obtained on the basis of such a notice.
“42 The decentralised procedure provided for in Article 28 of Directive 2001/83 entails a number of stages, commencing with the submission by the applicant of an application for marketing authorisation in all the Member States concerned and of an application to one Member State to act as the reference Member State. Article 28(4) of the directive provides that the reference Member State is to record the agreement of all parties, close the procedure and inform the applicant accordingly. Under Article 28(5) of the directive, each Member State is to adopt a decision authorising the marketing of the product concerned, in conformity with the approved assessment report and the related documents, within 30 days of acknowledgement of the agreement of all the parties.
46 In the light of all the foregoing considerations, the answer to the first question is that Article 3(b) of the SPC Regulation is to be interpreted as meaning that an end of procedure notice issued by the reference Member State in accordance with Article 28(4) of Directive 2001/83 before the expiry of the basic patent, as defined in Article 1(c) of the SPC Regulation, may not be treated as equivalent to a marketing authorisation within the meaning of Article 3(b) of that regulation, with the result that an SPC may not be obtained on the basis of such a notice.”
By its second question, the referring court essentially seeks to ascertain whether Article 10 (3) of the SPC Regulation must be interpreted as meaning that if, on the date of application of the SPC, no marketing authorisation was issued in the Member State concerned, that fact is a defect that can be restored in accordance with this provision.
It follows from the wording of this provision that the acquisition of a marketing authorization in the Member State concerned is a condition related to the product and it follows from the wording of Article 10 (3) of the SPC Regulation that only a defect in the SPC application can be restored by means of this provision. However, the lack of a marketing authorization is not such a defect, because it is not related to the SPC application, but to the product as a medicinal product.
“54 In the light of the foregoing considerations, the answer to the second question is that Article 10(3) of the SPC Regulation is to be interpreted as meaning that the fact no marketing authorisation has been granted by the Member State concerned at the time the SPC application is lodged in that Member State does not constitute an irregularity that can be cured under that provision.”
IPPT20171207, CJEU, Merck Sharp & Dohme
