New CJEU referral on interpretation of Article 3(b) of the SPC Regulation

August 2016

The UK High Court has referred questions to the CJEU regarding interpretation of Article 3(b) of the SPC Regulation (EC 469/2009).  

In Merck Sharp & Dohme (MSD) v Comptroller-General of Patents [2016] EWHC 1896, MSD appealed against refusal of its SPC application for Atozet® (SPC/GB14/062) by the UK IPO.  The questions referred are:

(1) Is an end of procedure 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?

(2) 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?

Background & Facts

Article 3 of the SPC Regulation defines the conditions for obtaining a certificate. The part relevant to this dispute reads:

“A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

[…]

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;

[…]”

In September 2013, MSD filed applications for marketing authorisations in a number of member states in respect of Atozet® (a combination of ezetimibe and atorvastatin) under the decentralised procedure and designated Germany as the reference member state (RMS). The RMS coordinates the approval of the authorisation and, unless objections are raised, its decision is adopted by the other member states involved.

The basic patent on which MSD’s SPC application was based was EP0720599, filed on 14 September 1994 and granted on 19 May 1999.  There was no dispute that a pharmaceutical composition comprising ezetimibe and atorvastatin is protected by claim 17 of the patent. The patent expired on 13 September 2014.

One day before patent expiry, MSD filed its SPC application at the UK IPO.  However, at this time, MSD did not have a UK marketing authorisation for Atozet® and therefore MSD could not provide details of any UK marketing authorisation in its application.  Instead, MSD relied upon an “End of Procedure” (EoP) notice from the German regulator dated 10 September 2014.  Under the decentralised procedure, following the issue of the EoP notice to the applicant, member states have 30 days to grant a marketing authorisation.

In a cover letter accompanying its SPC application, MSD argued that the EoP notice was an indication that all states, including the UK, had agreed to grant marketing authorisations for Atozet® and therefore MSD requested that it be permitted to supplement its application when the UK marketing authorisation was granted.  Subsequently, MSD submitted a copy of the UK marketing authorisation (granted 10 October 2014) together with the first EU marketing authorisation for Atozet®, which had been granted in France on 12 September 2014.  MSD argued that these documents rectified any irregularities in its original application.

The UK IPO did not accept MSD’s arguments and refused the application for failing to comply with Article 3(b).  It also held that failure to comply with Article 3(b) was not an irregularity that could be corrected under Article 10(3) of the SPC Regulation by later submission of the appropriate documents.

Appeal to the High Court

MSD appealed the UK IPO’s decision to the UK High Court.  Mr Justice Arnold found in favour of the UK IPO both on the decision that MSD’s application did not to comply with Article 3(b) and on the decision that the absence of a marketing authorisation was not an irregularity that could be corrected under Article 10(3).  However, the judge did not consider these points to be “reasonably clear and free from doubt”. In particular, the judge noted that MSD’s applications in other member states had led to divergent decisions.  For example, applications were refused in Portugal and Sweden on the same grounds as in the UK, but applications were granted in Denmark, Greece, Italy and Luxembourg.  The Dutch Patent Office also found there to be no objection under Article 3(b), but refused the application on different grounds.

In light of these divergent decisions, Mr Justice Arnold held that there was sufficient reason to refer the two questions above to the CJEU for a preliminary ruling.

This update was prepared by Mark Ness, Patent Director in our London Office.  If you would like further advice on this or any other matter please contact Mark or your usual HGF representative or visit our Contact page to get in touch with your nearest HGF office.