A reference has been made to the CJEU regarding interpretation of the SPC Regulation. The main issue is whether an “end of procedure notice” can be considered to be equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the Regulation.

SPCs

SPCs are an IP right that extend the protection for patented active ingredients in new medicinal and plant protection products (we will discuss within our main article on the effect of Brexit on SPC’s in our Autumn/Winter Inside IP 2016).

To qualify for SPC protection, an active ingredient of a medicinal product must be protected by a patent in force in the country of interest, and there must be a valid marketing authorisation in that country.

Marketing authorisations can be obtained via the de-centralised procedure (DCP), which is based upon the principle that grant of a Marketing Authorisation in one Member State should be recognised by all other Member States.   The applicant designates a ‘reference member state’ (RMS) which co-ordinates the process for approval of the application.

Background

Atozet is a medicinal product used to lower cholesterol containing the active ingredients ezetimibe and atorvastatin.

In September 2013, Mercke Sharp & Dohme Corp (MSD) filed marketing authorisation applications in a number of Member States in respect of Atozet under the DCP.  Germany was designated as RMS.

The basic patent on which the SPC application relied, EP(UK) 0720599, provided protection for ezetimibe and combinations of ezetimibe with other active ingredients.

On 12 September 2014, one day before EP0720599 expired, MSD filed an SPC application at the UK IPO. At the time of filing, MSD did not have a UK marketing authorisation for Atozet, and instead relied upon the ‘End of Procedure Communication of Approval Notice’ (EoP) from the German Medicines Agency, which stated that the DCP had ended with approval.  MSD submitted that the EoP meant that all affected Member States, including the UK, had agreed to grant marketing authorisations for Atozet.   MSD requested permission to supplement the SPC Application when the UK marketing authorisation was granted.

The UK IPO Examiner objected to the application on the ground that it did not comply with Article 3(b) of the SPC Regulation, which specifies the requirement for a granted UK marketing authorisation.

On 10 October 2014 a UK marketing authorisation was granted for Atozet, which MSD submitted to the UK IPO, together with the first EU marketing authorisation (from France).

The UK IPO examiner maintained the objections, and, at the resulting hearing, the hearing officer concluded that the SPC Application did not comply with Article 3(b) of the SPC Regulation, and that this could not be cured under Article 10(3), which allows for rectification of irregularities in applications.

Appeal to the High Court

MSD appealed the UK IPO decision to the UK High Court.  Mr Justice Arnold considered the UK IPO’s decision to be correct, both in that MSD’s SPC application did not to comply with Article 3(b), and that the absence of a marketing authorisation was not an irregularity that could be corrected under Article 10(3).
He stated that the SPC Regulation referred repeatedly to the requirement for a marketing authorisation yet  there was no reference to EoP Notices, which had no legal effect.

With regards to Article 10(3) Arnold J. commented that even if it were permissible to belatedly submit a marketing authorisation, this could not cure the defect in the application, namely the impossibility of satisfying a mandatory condition for the grant of an SPC.

However, Arnold J. did not consider these points to be ‘reasonably clear and free from doubt’, and noted the divergent decisions in other states, wherein SPC applications had been refused in Portugal and Sweden on the same grounds as in the UK, but applications had been granted in Denmark, Greece, Italy and Luxembourg.  In addition, the application had been refused in the Netherlands on the ground of Article 3(c) of the SPC Regulation, whilst no objection under Article 3(b) had been raised as it had been accepted that the EoP Notice was equivalent to a marketing authorisation.

Referral to the CJEU

Mr Justice Arnold thus held that there was sufficient reason to refer two questions, worded along the following lines, to the CJEU:

  • Is an EoP notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation.
  • If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

Concluding Comments

The SPC Regulation specifically recognises that the period between filing a patent application for a new medicinal product and authorisation to place the product on the market makes the period of protection conferred by the patent insufficient to cover the research investment; it took MSD 7 years to reach the point of applying for a marketing authorisation for Atozet.

It will therefore be interesting to see whether the CJEU adopts a strict meaning of the SPC Regulation, or whether arguments regarding the underlying purpose of the SPC Regime will lead to a more generous interpretation.