SPCs are important assets for pharmaceutical patent holders as they compensate the loss of duration of exclusive exploitation right of their invention due to the time lapsed between the filing of a patent application and obtaining a marketing authorization. Namely, it is only the marketing approval that enables the launch of the patented product and allow the patentee to actually benefit from their exclusive rights and recover investments.

Regulation (EC) 469/2209 concerning the supplementary protection certificate for medicinal products provides directly applicable provisions for obtaining certificates in each member state. It lists the requirements of granting an SPC and lays down rules on how its term will be calculated, which is then added to the patent term after its expiry. SPCs for plant protection products are governed in Regulation (EC)1610/96 which contain certain provisions that are to be applied mutatis mutandis in Regulation (EC) 469/2009.

Article 13 of Regulation No 469/2009, is entitled ‘Duration of the certificate’, paragraph 1 states: ‘[t]he certificate shall take effect at the end of the lawful term of the basic patent for a period 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’.

As many may recall in case C-471/14 (Seattle Genetics) the CJEU was asked in a preliminary ruling procedure to interpret ‘the date of the first authorisation to place the product on the market’ contained in the above cited provision.

As it was then widely discussed a marketing authorisation issued by the European Medicines Agency has two dates that could potentially be taken as ‘date of the first authorisation to place the product on the market’. Namely it can be either (i) the date of the decision that grants the marketing authorization; or (ii) the date the applicant is notified of the granting of the marketing authorization, which may occur some time after the decision date and would therefore mostly result longer SPC duration.

In the Seattle Genetics case the CJEU ruled that article 13(1) of the Regulation is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market’ is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.

The decision changed the practice of member state patent offices about what date they take into account when granting SPCs and the judgment was widely welcome by SPC holders who can now obtain SPC terms longer than with the decision-date based calculation. However, the Seattle Genetics decision left it open how the national patent offices should handle this change regarding earlier granted SPCs, the term of which had been calculated based on the decision date instead of the notification date of the marketing authorization.
This year we may expect further clarification from the CJEU in case C-492/16 (Incyte Corp.) where the Metropolitan Court in Budapest referred the following questions.

“Must Article 17(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products 1 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 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, 2 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 questions establish direct connection with the Seattle Genetics case and evidently seek answers to the question left open, that is: is it and if yes on what legal basis possible to correct SPC terms retrospectively.

The questions were published in the Official Journal on 5th December, hence a ruling may be expected still in this year.

Summary: Eszter Szakács, Sár & Partners