CJEU takes strict stance on the procedural requirements for obtaining SPCs

The CJEU hands down judgment in the first of two SPC decisions expected in December 2017.

​In the first of what will be a long line of SPC decisions following the recent flurry of referrals, the Court of Justice of the European Union (CJEU) gave judgment in Case C-567/16 this month.

The decision was succinct and in short, the CJEU maintained a strict approach to the need to have a full, granted marketing authorisation (MA) at the date that a supplementary protection certificate (SPC) application is filed. In this respect, both questions referred were answered in the negative and the CJEU held that:

  1. the End of Procedure Notice obtained at the penultimate step of the decentralised procedure is not enough to satisfy the requirements to have a valid MA according to Article 3(b) of the SPC Regulation, and
  2. the failure to have a valid MA at the date of your SPC application cannot be rectified under Article 10(3) of the SPC Regulation.

The decision responds to the questions of Mr Justice Arnold, which were referred from the UK High Court in late 2016 (Merck Sharpe & Dohme Corporation v The Comptroller-General of Patents, Designs and Trade Marks [2016] EWHC 1896 (Pat)) and the CJEU’s answers concur with those proposed by the Judge. We previously commented in more detail on this case, along with the parallel Dutch case, in our article which can be accessed here. This is also a reasonably speedy decision, being handed down in just over a year from the referral date.

Background

The SPC in this case related to the combination of ezetimibe and atorvastatin, the active ingredients of Merck Sharpe and Dohme’s (MSD) cardiovascular drug Atozet.

This was the third SPC application based on the same basic patent (EP (UK) 0,720,599), and MSD had already been granted an SPC in the UK for ezetimibe alone (in 2003) and ezetimibe in combination with simvastatin (in 2006). We understand that a fourth SPC application has also been applied for in certain European jurisdictions based on the combination of ezetimibe and rosuvastatin (and for example, was initially rejected in Ireland and it is currently under appeal with the hearing expected in March 2018).

The circumstances of this case concern a race to the line; namely for MSD to complete its application and obtain the MA for Atozet under the decentralised procedure before its patent expired in September 2014. In the end, MSD did obtain its MA in some countries, but in other countries, including the UK, only got as far as the “End of Procedure Communication of Approval” (EoP Notice). MSD filed its SPC application anyway and sought to rely on the EoP Notice as being a valid MA (under Article 3(b)), or argued that it was able to rectify its SPC application once its MA was granted shortly after its application was filed (under Article 10(3)).

The UK Intellectual Property Office (IPO) rejected MSD’s application. On appeal at the High Court, Arnold J agreed with the Hearing Officer that the application should be rejected. However, recognising the differing treatment of the SPC application across the EU, he stayed the proceedings and referred the matter to the CJEU for a preliminary ruling.

As noted above, both of MSD’s arguments were rejected. We look at each issue in more detail below.

The first question - Article 3(b)

The CJEU applied a literal interpretation to the meaning of Article 3(b), stating that on a natural reading, the word “granted” in Article 3(b) can only refer to an action that has been completed. This means that a “valid authorisation to place a product on the market” must be in the form of a document which meets the requirements of Directive 2001/83. The EoP Notice according to Article 28(4) of Directive 2001/83 represents only an “intermediate stage” in the DCP, and therefore does not have the same legal effects as a “valid” MA.

In this way, the CJEU confirmed that whilst the EoP Notice may fulfil some of the functions of an MA, such as providing a guarantee that the product is safe, identifying the product to which the SPC relates, and calculating the SPC duration, it does not perform the crucial function of an MA ie - “placing” the product on the market as a medicinal product.

The CJEU also referred to its previous decision in Forsgren (Case C-631/13), which confirmed that an SPC can only be granted on the basis of a valid MA, not a patented product.

The second question - Article 10(3)

The CJEU held that the absence of a valid MA does not constitute an irregularity that can be rectified under Article 10(3), because in this case the irregularity is not in relation to the SPC application per se but lies with the underlying product.

In other words, Article 10(3) only covers administrative defects in the SPC application itself, such as the need to provide evidence of the existence of a granted MA, and it cannot be used to cure defects in the underlying MA. This is essentially the same point as argued by the UK IPO and Arnold J (at paragraph 47 of his decision), and follows the literal interpretation also applied to question 1.

Conclusion/comments

The CJEU’s decision in this case is consistent with the concordant decisions of the UK IPO and the High Court, and reflects the strict, literal approach taken by CJEU to interpretation of procedural aspects of the SPC Regulation, including the need for a full, granted MA.

The case highlights the balance between, on one hand, the need for consistency in order to provide legal certainty for all parties, and on the other hand, the need for pragmatism and flexibility. In this case, MSD’s plea that they should not be prevented from gaining SPC protection on mere administrative grounds which were entirely outside of its control was not enough. This is notwithstanding that this position was not without precedent, in that, for example the Dutch Patent Office had considered that MSD’s SPC application had satisfied Article 3(b) on that basis.

Lastly, while of course no question was referred, it is interesting that there is no mention in the decision of the multiple SPC applications that have been filed and granted by MSD based on the same basic patent. For now, following the CJEU’s decisions in Sanofi (Case C-443/12) and Boehringer (Case C-577/13), the CJEU appears to be content not to comment on Article 3(c), which is one of the few parts of the SPC Regulation which is not subject to any pending referrals.

This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.