The Advocate General of the Court of Justice of the European Union (CJ) has issued his opinion on the issue of how to calculate the correct expiry date of a Supplementary Protection Certificate (SPC) [see notes below for case details]. SPCs are granted in the European Union for medicinal and plant protection products which require a marketing authorisation by a regulatory authority prior to being placed on the market.
If followed by the full court, the opinion has the potential to change the term of 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 pounds to the sales of a patented 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 (OJ). This has created uncertainty about which of these three dates (the grant date, the date of notification to the applicant, or the date of the OJ's publication of the notification) should be used to calculate the expiry date of an SPC.
In view of this uncertainty, 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 United Kingdom Patent and Trade Mark Office (UKIPO) has since October 2013 used the date of publication of the notification of an MA in the OJ to calculate SPC expiry dates, as have the Belgian and Slovenian Patent Offices. The Portuguese IP Office has preferred the date of notification to the applicant. However, other national patent offices have 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 following two questions were referred to the CJ:
- Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) [of the SPC Regulation] determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the member state in question?
- If the court's answer is that the date referred to in question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification?
The Advocate General's opinion, released today, has indicated the answer to question 1 should be that the date of the first authorisation is a matter of Community law, and that is should not depend on the regulations of member states, and notably not on the member state in which the marketing authorisation has effect.
Regarding question 2, the Advocate General is of the opinion that the date the marketing authorisation is notified to the applicant should be the correct date.
Although the full court is not bound to follow the Advocate General's opinion, the court does so in the majority of cases. Should the Advocate General's opinion be followed in this case, this may result in the expiry date of SPCs throughout the EU which are calculated based on the date of grant of the marketing authorisation being extended by a number of days. However, in those countries such as the UK which have used the OJ publication of the notification to base SPC expiry dates, the term may be shortened by a few days. It would not affect those SPCs whose expiry date is capped at five years from basic patent expiry.
D Young & Co's SPC experts have been monitoring this case together with our network of SPC experts in other countries. We are already aware that, should the Advocate General's opinion be followed in this case, many patent offices throughout the EU are prepared to recalculate the expiry date of SPCs, both pending and granted, so they are based on the date the marketing authorisation is notified to the applicant.
The CJ is likely to reach its decision towards the end of 2015 or the beginning of 2016. We are monitoring the CJ website and will provide readers with a further update as soon as the full court issues its decision, and a full article on this issue will follow in our patents newsletter.
Case information (InfoCuria) for CC-471/14 Seattle Genetics Inc: