In an arguably harsh, but refreshingly clear judgement the Court of Justice of the European Union (CJEU) has ruled in C-567/16 that an SPC application cannot validly be filed on the basis of an End of Procedure Notice.
Supplementary Protection Certificates (SPCs) can only be obtained for patented products for which a valid Marketing Authorisation (MA) has been granted (Article 3(b) of the SPC Regulation 469/2009 (“the SPC Regulation”)). However, an application for an SPC must be filed before expiry of the relevant patent. Delays in the issue of an MA close to a patent's expiry date can therefore represent a serious challenge for a patentee wishing to apply for an SPC.
Merck Sharp & Dohme Corporation (‘MSD’) sought an SPC in the UK for a medicinal product (a combination of ezetimibe and atorvastatin, Atozet), but because the relevant MA was not available before expiry of the relevant patent, the SPC application was filed without an MA. Instead, MSD tried to rely on an End of Procedure Notice.
MSD had used the EU's decentralised procedure for obtaining MAs. Under this procedure, once a designated authority has completed its assessment, an End of Procedure Notice is issued. Each member state subsequently grants a national MA, but typically only after a short delay.
MSD contended that the effect of the End of Procedure Notice was that all EU Member States concerned (including the UK), had agreed to grant MAs for Atozet. They therefore argued that this Notice should be treated as being equivalent to an MA.
In the alternative, they submitted that it should be permissible to file an SPC application without an MA; and requested permission to supplement the SPC application once the UK MA was granted.
The UK Intellectual Property Office referred these issues to the CJEU. The CJEU ruled that an end of procedure notice does not qualify as an MA and, further, that the lack of a formal MA at the time of the SPC application being made is not an “irregularity” that can be corrected after the filing date.
The decision seems rather harsh, since the grant of an MA after issue of the End of Procedure Notice is essentially a mere formality. Moreover, whilst an applicant arguably has some control over the timing of applying for an MA, he has little control over the length of time the regulatory authority takes to issue the MA. It is difficult to see how this decision is compatible with the fundamental objective of the SPC Regulation to ensure sufficient protection to encourage pharmaceutical research.
The CJEU's position can be contrasted with practice in the US, where provisions exist that enable applicants to apply for an interim extension of patent term if a patent is due to expire before the regulatory approval procedure has been completed.
The European Commission is currently considering the creation of a new SPC regime, but it is unlikely that such a new regime, if created, would adopt US practice on this issue.
the absence of a marketing authorisation does not constitute an irregularity which the applicant can rectify