7 December 2017Big Pharma

CJEU rules on marketing authorisations and SPCs

An end of procedure notice issued by a reference EU member state before the expiry of a basic patent may not be treated as equivalent to a marketing authorisation (MA).

A supplementary protection certificate (SPC) is therefore prevented from being granted based on that notice.

That was the verdict of the Court of Justice of the European Union (CJEU) in a decision handed down earlier today, December 7.

The case centred on a dispute between Merck Sharp & Dohme (MSD) and the UK Comptroller General of Patents, Designs and Trademarks over Atoznet, a drug that lowers cholesterol.

MSD began development of a fixed dose combination of two active ingredients in tablet form between 2006 and 2013.

In September 2013, MSD submitted MAs in a number of member states under the decentralised procedure.

MSD requested Germany to act as the reference member state for Atozet, with the validity of the applications acknowledged in February 2014, according to the ruling.

In September 2014, the German Medicinal Products Agency issued an end of procedure notice, two days before the first MA for Atoznet was filed in France.

MSD then filed an SPC with the UK Intellectual Property Office, which rejected it since MSD did not hold a valid UK MA.

However, in October 2014, the UK Medicines and Healthcare Products Regulatory Agency granted an MA for Atozet to MSD.

Despite this, the Comptroller General of Patents, Designs and Trademarks rejected the SPC request.

MSD appealed to the English High Court, which stayed the proceedings asking if an end of procedure notice issued by the reference member state before expiry of the basic patent is to be treated as equivalent to a granted MA.

If the answer is no,  the English High Court wanted clarification on whether the absence of a granted MA at the date of the application for an SPC is an irregularity that can be cured once the MA has been granted.

The court said 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 before the expiry of the basic patent “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”.

Also, the court said that article 10(3) of the SPC regulation “is to be interpreted as meaning that the fact no marketing authorisation has been granted at the time the SPC application is lodged in that member state does not constitute an irregularity that can be cured under that provision”.

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