Merck Sharp & Dohme Corporation v The Comptroller-General of Patents, Designs And Trade Marks

For an application for a supplementary protection certificate, a valid marketing authorisation must have been granted in the relevant Member State at the application date. An end-of-procedure notice issued under the decentralised procedure does not itself constitute, or replace, that authorisation. The mandatory nature of the later national decision means that the grant of an authorisation remains more than an administrative formality.

The absence of an authorisation at the application date is not an irregularity capable of cure under Article 10(3) of the SPC Regulation. That provision permits rectification of failures to provide documents required by Article 8. It does not permit a later event to satisfy the distinct condition in Article 3(b).

Merck Sharp & Dohme Corporation appealed against the decision of Dr Lawrence Cullen, Deputy Director, acting for the Comptroller-General, refusing its application for a supplementary protection certificate for Atozet.

When the application was filed, the decentralised marketing-authorisation procedure had ended and the reference Member State had issued an end-of-procedure notice. The United Kingdom marketing authorisation, however, had not yet been granted. It was granted later, within the period allowed for the national decision.

The appeal concerned whether the end-of-procedure notice satisfied Article 3(b) of the SPC Regulation, and, if not, whether the defect could be rectified under Article 10(3).

1. The appeal was dismissed in substance. The court held that the application did not comply with Article 3(b) of the SPC Regulation. At the application date, no valid United Kingdom authorisation to place Atozet on the market had been granted.

2. Under Article 28(5) of the Medicinal Products Directive, each Member State must still adopt a decision granting a marketing authorisation after the decentralised procedure has closed. The decision is expressed in mandatory terms, but the grant is not merely an administrative formality. The national authority remains responsible for deciding whether to grant the authorisation within the prescribed period.

3. An end-of-procedure notice under Article 28(4) records the agreement of the relevant authorities and the closure of the procedure. It has no equivalent legal effect to the national marketing authorisation. The product cannot be placed on the market until that authorisation has been granted.

4. The later grant of the United Kingdom authorisation could not cure the failure. Article 10(3) concerns an application which does not contain the documents required by Article 8. It does not alter the substantive condition in Article 3(b), which requires the authorisation to have been granted at the date of the application.

5. The reasoning in E I du Pont de Nemours & Co v UK Intellectual Property Office [2009] EWCA Civ 966, [2010] RPC 6 was distinguishable. That case concerned an extension application subject to different timing provisions, and Article 3 did not apply to it. The present application was governed by Article 7(1) and (2), under which the patent and marketing authorisation had to exist before the application was made.

6. The court considered that the questions were not acte clair, particularly the second question, and that divergent decisions in other Member States made a reference necessary. Two questions concerning the equivalence of an end-of-procedure notice and the curability of the absence of an authorisation were therefore referred to the Court of Justice of the European Union for a preliminary ruling.

1. High Court (Patents Court) — The appeal from the Comptroller’s decision was heard and the court held that the application failed Article 3(b) and that the defect was not curable under Article 10(3). The court referred two questions to the CJEU.
2. Comptroller-General of Patents, Designs and Trade Marks — Dr Lawrence Cullen, Deputy Director, acting for the Comptroller, refused the application in decision O/117/16 dated 12 January 2016. Article 3(c) was satisfied, but Article 3(b) was not and the defect was not an irregularity capable of cure.