The Higher Regional Court of Vienna has recently made a reference to the Court of Justice of the European Union (CJ) requesting a ruling on how to calculate the correct expiry date of a Supplementary Protection Certificate (SPC). SPCs are granted in the European Union (EU) for medicinal and plant protection products which require a marketing authorisation by a regulatory authority prior to being placed on the market. The ruling has the potential to change expiry dates for many SPCs, both pending and granted, throughout the EU. This is of considerable potential value to research-based pharmaceutical companies, as even an extra few days’ patent term may add millions of dollars to the sales of a blockbuster drug.
Article 13(1) of EU Regulation 469/2009 (the SPC Regulation) specifies that the duration of an SPC is equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years. This is often expressed more simply as 15 years from the date of the first marketing authorisation in the EU. The duration of an SPC is capped at five years from the expiry date of the basic patent.
When a marketing authorisation (MA) for a medicinal product is granted by the European Medicines Agency, the formal grant decision is made by the European Commission. There is often a delay of a few days between the date of the grant of the MA and the date the MA is notified to the applicant. Sometimes, there is a further delay of a few more days between the date of notification of the MA to the applicant and the publication of the notification of the MA in the EU’s Official Journal. This has created uncertainty about which date should be used to calculate the expiry date of an SPC.
Regarding the date decisions take effect under EU law, Article 297 of the Treaty of the Functioning of the European Union (TFEU), paragraph 2, states that decisions made by EU institutions, which specify to whom they are addressed, shall be notified to those to whom they addressed and shall take effect upon such notification.
In a decision of October 2013 (UKIPO Hearing Officer’s Decision O/418/13), the UK Intellectual Property Office accepted that, based on the above wording of the TFEU, a marketing authorisation granted by the EMA (not the national medicines regulatory authorities) takes effect upon its notification date. Since then, the UKIPO has been using the date of publication of the notification of an MA in the CJ to calculate SPC expiry dates.
In the intervening 12 months, patent offices and courts throughout the EU have differed in their approach to the question of which date is the correct date on which the term of an SPC should be based. The Portuguese IP Court has agreed with the UKIPO’s position, as has the Slovenian Patent Office, but other national patent offices have disagreed with the ruling and continued to base the term of an SPC on the grant date of the MA.
In order to end the uncertainty and obtain a uniform ruling applicable throughout the EU, the Higher Regional Court of Vienna has referred the following two questions to the CJ:
- Is the date of the first marketing authorisation according to Article 13(1) of the SPC Regulation to be determined according to Community law or does this provision refer to the date on which the marketing authorisation comes into effect according to the law of the respective member state?
- If the date of the first marketing authorisation is to be determined according to Community law, is the relevant date the date of the subject authorisation (ie, the grant date of the MA) or the date of the communication (ie, notification) of the authorisation?
The answers to the questions should decide whether the notification date of the MA or the grant date of the MA is the correct date for basing the SPC term, and may also decide whether this method of calculation is solely confined to SPCs based on marketing authorisations granted centrally by the EMA or also applies to SPCs based on MAs granted by the national medicines regulatory authorities. The CJ is likely to rule on this point towards the end of 2015 or the beginning of 2016.