Barely a month after their last referral (as reported here), the UK High Court has sent two further questions relating to Supplementary Protection Certificates (SPCs) to the CJEU. The questions in this case relate to whether a Swiss marketing authorisation, which is automatically recognised in Liechtenstein, can constitute the ‘first authorisation to place the product on the market’ within the EEA.

SPCs have the effect of extending the term of a patent relating to an authorised medicinal or plant protection product. The aim is to ‘compensate’ the patent owner for ‘lost’ patent term, caused by the length of time taken to obtain marketing authorisation for the product in question. SPC are national rights granted by the national patent offices. For more information, see our information sheet.

The SPC Regulation states that in order for a certificate to be granted for a particular product, it is necessary that ‘a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC [human medicinal products] or Directive 2001/82/EC [veterinary products], as appropriate’ (Article 3(b) SPC Regulation).

It is also necessary that this authorisation is the first such authorisation (Article 3(d) SPC Regulation).

Under the current SPC regime the ‘first marketing authorisation’ which is used to calculate eligibility for and term of an SPC can be an authorisation to place the drug on the market in the European Economic Area (EEA), not just in the EU itself.

In this latest case (AstraZeneca AB v Comptroller-General), AstraZeneca had obtained, in 2004, a Swiss marketing authorisation for their drug ‘Iressa’.

Switzerland is not part of the European Union nor of the European Economic Area and is not bound by the relevant EU Directives (i.e. Directive 2001/83/EC for human medicines) which are referred to in the SPC Regulation. However, due to the longstanding customs union between Switzerland and Liechtenstein, this Swiss authorisation was also automatically valid in Liechtenstein (part of the EEA).

The Swiss marketing authorisation applied less stringent criteria than would have been required by the EU authorities, under the relevant Directives. The Swiss authorities granted a limited-duration MA and required that better data be supplied to them, within a time limit, in order for a longer-term MA to be granted. This data was not provided by AstraZeneca, so the Swiss MA was withdrawn, thus also terminating its effect in Liechtenstein.

Following more clinical trials and better data AstraZeneca was ultimately granted a European marketing authorisation by the European Medicines Agency (EMA) in 2009 and a new Swiss MA in 2010.

AstraZeneca contended that the 2009 EMA marketing authorisation should be used as the basis for the grant of an SPC, giving an expiry date of 22 April 2021. However, the UK Patent Office decided that the SPC should be granted based on the first Swiss marketing authorisation, giving an earlier expiry date of 1 March 2019. AstraZeneca appealed to the High Court.

In an earlier decision on this point (Novartis) the CJEU (Court of Justice of the European Union) reasoned that such a marketing authorisation did count as the ‘first marketing authorisation’ for the purposes of calculating SPC term, due to its effect in Liechtenstein. However, more recent CJEU decisions have appeared to contradict this and to imply that the relevant marketing authorisation must be one which complies with the requirements of the relevant EU Directives.

The Court therefore decided to refer the matter back to the CJEU, for clarification of the position.

The questions referred were as follows:

"1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?"

Arnold J, in making the referral, suggested that the answers should be: (1) yes, the Swiss MA was the “first authorisation”, and (2) no, the circumstances make no difference. However, it remains to be seen whether the CJEU will agree.