Formally granted marketing authorisation required for SPC applications

15/01/2018

In September 2014, Merck Sharp & Dohme (MSD) applied for a supplementary protection certificate (SPC) to cover their product ATOZET in the UK. Unfortunately for MSD, they had not received the necessary marketing authorisation from the UK before the patent that covered ATOZET expired. However, MSD had received an “End of Procedure communication of approval” (EoP) which effectively stated that they would receive marketing authorisation in due course. MSD applied for an SPC using the EoP in place of the required marketing authorisation leading to a battle between the UK Intellectual Property Office (UKIPO) and MSD that has found its way to the Court of Justice of the European Union (CJEU).

What is an SPC?

To place a medicinal product on the market the product requires marketing authorisation. Developing a medicinal product to the point where marketing authorisation will be allowed can take years. Any patent that was granted to cover the medicinal product may thus have nearly expired and any effective protection left under the patent is often insufficient to cover the investment put into the research and development of the product. Because of this problem SPCs were introduced. An SPC allows extension of the rights of a patent for up to 5 years, which can be extended to 5.5 years in some cases, after expiry of the original patent in the European Economic Area (EEA).

To obtain an SPC in a member state, the original patent must still be in force at the time of the SPC application (Article 3a SPC Regulation) and marketing authorisation must have been given for the product the original patent covers (Article 3b SPC Regulation). One way of obtaining marketing authorisation in a number of EEA member states is through the “decentralised procedure” (DCP). The DCP allows for applications for marketing authorisations to be made simultaneously in several member states, of which one is designated the reference member state. The reference member state co-ordinates the process for approval of the marketing authorisation application. After agreement between member states that marketing authorisation will be granted, the reference member state may send the applicant an EoP. In total, the procedure for granting a marketing authorisation should not exceed 240 days.

The case of MSD

MSD had applied for an SPC for the product “ezetimibe and atorvastatin or pharmaceutically acceptable salts thereof, including atorvastatin as atorvastatin calcium trihydrate” marketed as ATOZET. The patent covering this product was filed on 14 September 1994, granted on 19 May 1999 and expired on 13 September 2014 (see timeline below).

MSD received marketing authorisation and SPCs in relation to two other products covered by the patent earlier in the patent’s life. However, MSD encountered problems with the development of ATOZET and did not file applications for marketing authorisation until September 2013. Furthermore, a key marketing authorisation application filed at a reference member state was not deemed valid until 13 February 2014. MSD received an EoP on 10 September 2014 but did not receive UK marketing authorisation for ATOZET until 10 October 2014. Regardless, MSD applied for a UK SPC on 12 September 2014 (1 day before the patent covering the product expired) using the EoP in place of the marketing authorisation. MSD contended that the EoP showed that the UK had agreed to grant marketing authorisation for ATOZET and that only formal steps remained before a valid marketing authorisation was received.

The UK IPO objected to the SPC application stating that the application did not comply with Article 3(b) of the SPC Regulation and that the EoP did not satisfy the requirements of the missing marketing authorisation. MSD responded by submitting the now-acquired UK marketing authorisation for ATOZET together with the first EU marketing authorisation for ATOZET granted on 12 September 2014. MSD argued that these documents were submitted so as to rectify any irregularities in the SPC application per Article 10(3) SPC Regulations which states:

“Where the application for a certificate [SPC] does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) [in this case the UKIPO] shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time”.

The UK IPO maintained the objection to the SPC application leading to a hearing where the hearing officer agreed that the SPC application did not comply with Article 3(b) and that the irregularity could not be cured under Article 10(3). This led to an appeal at the UK Patents Court which forwarded the following questions to the CJEU:

“1. Is an end of procedure notice issued by the reference Member State under Article 28(4) of Directive [2001/83] before expiry of the basic patent to be treated as equivalent to a granted marketing authorisation for the purpose of Article 3(b) of [the SPC Regulation], such that an applicant for [an SPC] in the Member State in question is entitled to apply for and be granted [an SPC] on the basis of the end of procedure notice?
2. If the answer to question 1 is no: in the circumstances in question, is the absence of a granted marketing authorisation in the Member State in question at the date of the application for [an SPC] in that Member State an irregularity that can be cured under Article 10(3) of [the SPC Regulation] once the marketing authorisation has been granted?”.

The CJEU ruling
The CJEU ruled that the answer to question 1 is “No”. The CJEU argued that Article 3(b) states that marketing authorisation needs to have been “granted” and that an EoP is not a granted marketing authorisation, nor does it have the same legal effect as a valid marketing authorisation.

The CJEU ruled that the answer to question 2 is also “No”. The CJEU argued that Article 10(3) only relates to irregularities of the SPC application and that an absence of a marketing authorisation is “an irregularity in connection with the product… not an irregularity in connection with the SPC application”.

The irony of this ruling is that because it took so long for MSD to develop ATOZET, they have run out of time to protect their product using the very means designed to protect products that take a long time to develop. The ruling also acts as a warning to other future potential SPC applicants: make sure marketing authorisation is applied for and obtained in a timely manner.

This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.