Court of Justice asked to decide on SPC expiry dates
In a new reference to the Court of Justice of the European Union (CJEU), the CJEU has been asked to decide for a second time 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.
Duration of an SPC
Article 13(1) of EU Regulation 469/2009 (the EU medicines 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 same calculation is applied by Article 13(1) of Regulation (EC) 1610/96 (the EU plant protection SPC Regulation). The duration of an SPC for both medicines and plant protection products is capped at five years from the expiry date of the basic patent: an extra six months is added to the SPC term for medicines on which agreed paediatric studies are carried out.
Marketing authorisation grant date or date of notification?
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 (EC). There is often a delay of a few days between the date of the grant of the MA and the official date of notification of the MA to the applicant as published in the EU's Official Journal (OJ). This has created uncertainty about which of these dates (the grant date or the date of notification) should be used to calculate the expiry date of an SPC. This is of great importance to the pharmaceutical industry as even a few extra days of SPC protection can add millions of pounds to the value of an approved pharmaceutical product.
In view of this uncertainty, the CJEU was asked in 2014 to decide in case C-471/14 (Seattle Genetics) which date is the correct date on which the term of an SPC should be based. In late 2015, the CJEU decided that the correct date is the date the MA is notified to the addressee. As the date of the actual notification letter from the EC to the applicant is generally not publicly known, Patent Offices have adopted the date of notification as published in the EU's Official Journal (OJ) as the notification date on which SPC expiry dates are calculated.
Seattle Genetics Inc (C-471/14)
Patent Offices across the EU have universally followed decision C-471/14 to calculate expiry dates of SPCs which were pending or had not yet been filed as of the date the decision issued. However, a further discrepancy in practice has emerged regarding requests for correction of the expiry date of SPCs that had already been granted when the decision issued, particularly where the period for appealing against any aspect of the SPC grant decision had already expired. The Patent Offices of Germany, Spain, Portugal, Czech Republic, Slovakia, Estonia, Latvia and Iceland are accepting requests to correct expiry dates of granted SPCs. However, the Patent Offices in some other countries, in particular France, Sweden, Austria and Italy, have refused such requests.
Questions to the Court of Justice of the European Union
In view of this discrepancy and to obtain a uniform view across the EU on recalculating the expiry date of granted SPCs, the Austrian court has referred two questions to the CJEU, in case C-492/16. These questions are as follows:
- Must [the EU plant protection SPC Regulation] be interpreted as meaning that 'the date of the first authorization to place the product on the market in the Community' is incorrect in an application for a supplementary protection certificate, within the meaning of that regulation and of [the EU medicines SPC Regulation], where that date was determined without taking account of the Court of Justice's interpretation of the law in the judgment in Seattle Genetics (Case C-471/14), with the result that it is appropriate to rectify the date of expiry of the supplementary protection certificate even if the decision to grant that certificate was made prior to that judgment and the time limit for appealing against that decision has already expired?
- Is the industrial property authority of a member state which is entitled to grant a supplementary protection certificate required to rectify, of its own motion, the date of expiry of that certificate in order to ensure that that certificate complies with the interpretation of the law set out in Case C-471/14?
The CJEU is expected to issue its decision on this matter in the second half of 2017. The CJEU's decision will hopefully resolve this issue once and for all and provide clarity to both innovator and generic pharmaceutical companies on the exact date SPCs expire. We will keep you informed of developments and provide an update when the decision issues.
Seattle Genetics Inc v Österreichisches Patentamt, C-471/14, 06 October 2015: http://dycip.com/seattlec-47114