SPC notification rules
The Court of Justice of the European Union (CJ) has now decided on the issue of 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 decision 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 UK Intellectual Property 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 CJ's decision is that the answer to question 1 should be that the SPC Regulation should be interpreted to mean the date of the first authorisation is a matter of EU law.
Regarding question 2, the CJ has decided that the correct date is the date the notification of the decision granting the marketing authorisation is given to the addressee (ie, the applicant for the SPC).
The CJ's decision is binding on the national Patent Offices and Courts of all EU countries. Consequently, it will result in the expiry date of SPCs throughout the EU which have been 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 publication of the notification in the OJ to calculate SPC expiry dates, the term may be shortened by a few days. It will not affect those SPCs whose expiry date is capped at five years from basic patent expiry.
Now that the CJ's decision has been issued, many patent offices will 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. However, while some patent offices will automatically recalculate the date of all SPCs, others may only do so at the request of the applicant.
As a result of this decision, we strongly recommend that all SPC applicants and proprietors review their SPC portfolios to establish whether they will be entitled to additional days' SPC protection for the product. We would be pleased to review these portfolios and advise on the most convenient and cost-effective way to obtain these valuable extra days for their approved products.