English High Court rules on Merck SPC case

The English High Court has referred two questions on supplementary protection certificates (SPCs) to the Court of Justice of the European Union (CJEU) in a case between Merck Sharp & Dohme (MSD) and the UK Intellectual Property Office (IPO).

The case is an appeal by MSD against a previous decision handed down by the IPO which rejected its application for an SPC.

In January this year the IPO refused the application because it said it did not comply with article 3(b) of the EU’s SPC Regulation, which centres on conditions for obtaining a certificate, and that MSD did not have a UK marketing authorisation (MA) for its cholesterol drug Atozet (stofnaam ezetimibe/atorvastatine) at the time it made its SPC application.

In his ruling, published on July 29, Mr Justice Arnold asked the CJEU to determine whether an end of procedure notice issued by a member state under article 28(4) of the Medicinal Products Directive can be equivalent to an MA for the purposes of article 3(b) of the SPC Regulation.

An end of procedure notice is a letter that ends “assessment step II”, which is not the final stage of an MA.

The final step of the decentralised procedure is the “national step”, which immediately follows the end of “assessment step II” and provides 30 days for the member state to grant an MA based on the documents agreed and approved at the end of the "assessment step II".

Michael Pears, partner at law firm Potter Clarkson, said: “The [first] question effectively is, ‘is it sufficient to reach the end of 'assessment step II' when a marketing authorisation is obtained via the decentralised procedure, for the purposes of obtaining an SPC, or do national regulatory authorities actually need to grant the marketing authorisation by the time the SPC application is filed?'"

He added: “At the IPO, the hearing officer decided that reaching the end of 'assessment step II' was not sufficient on the basis that he did not consider the national step to be purely administrative. Arnold agreed, but believed a reference was necessary given that different patent offices had taken different viewpoints on the issue.”

Arnold’s second question asks whether, assuming the answer to question one is 'no', the absence of a granted MA at the date of the application for an SPC is an irregularity which can be cured under article 10(3) of the SPC Regulation once the MA has been granted.