Skip to content

C-492/96 Incyte – CJEU’s preliminary ruling allows rectification of SPC durations to bring them in line with Seattle Genetics

The Court of Justice of the European Union closed the year by adding a favourable preliminary ruling for SPC holders to the flurry of recent SPC referrals and decisions.

The history of the one rendered today in C-492/16 (Incyte) goes back to the judgment made in C-471/14 (Seattle Genetics) in October, 2015.

In that case the Court interpreted the meaning of the ‘date of the first authorisation to place the product on the market in the [European Union]’ in Art. 13 (1) of Regulation 469/2009/EC (MP Regulation) as being the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.

The new interpretation changed the earlier practice of most national patent offices which used to calculate SPC durations using the date of issue instead of the date of notification. As the latter is a few days later the judgment was then welcome by SPC holders as it provided longer SPC durations.

However, the story did not end here. Soon after the ruling in Seattle Genetics came out, Incyte Corporation having a medicinal SPC granted on the basis of the old way of calculation applied to the Hungarian Intellectual Property Office to have the duration of its already granted SPC rectified and brought into conformity with Seattle Genetics judgment. However, in Incyte’s case the appeal possibility against the SPC granting decision under national law has expired.

In front of the national court Hungarian administrative procedural rules occurred as potential legal basis for correcting the duration but also Art. 17 (2) of Regulation (EC) No 1610/96 on the creation of a supplementary protection certificate for plant protection products (PPP Regulation), which allowed the rectification of the duration of the SPC should the date of the first marketing authorization in the Community prove to have been given incorrectly in the application. Importantly, the MP Regulation does not have an identical provision, however, recital 17 of the PPP Regulation orders that Art 17(2) shall apply mutatis mutandis also for the interpretation of the respective Article of the MP Regulation.

The Hungarian Metropolitan Court stayed the proceeding and referred questions to the CJEU seeking interpretation of Art. 17 (2) and whether an SPC term is incorrect and thus rectifiable if it its duration was calculated in line with the interpretation before Seattle Genetics. Also the Hungarian court wished to know if the SPC Regulation is to be interpreted as providing recourse to rectifying the duration even if the national appeal deadlines against the decision granting the SPC have expired.

On 20theDecember, 2017, the Court of Justice handed down its ruling, stating the following:

“In light of the Article 17 (2) of 1610/96 EC Regulation, Article 18 of 469/2009 EC Regulation must be interpreted in such a way that the date of the first marketing authorization indicated in the application for the granting of a supplementary protection certificate – based on which the national authority competent to issue such certificate calculated the duration of the certificate – is incorrect, in a situation such as in the basic procedure, when this authority determines the duration of the mentioned certificate using a calculation method which does not comply with Article 13 (1) of 469/2009 as interpreted in a later judgment of the CJEU.

“In light of Recital 17 and Article 17 (2) of 1610/96 EC Regulation, Article 18 of 469/2009 EC Regulation must be interpreted in such a way that – in a situation as described in point 1 of the operative part of the present judgment – based on the mentioned Article 18, the holder of the supplementary protection certificate is entitled to appeal for the rectification of the duration indicated in the certificate as long as the mentioned certificate is not expired.”

[translation of the author, official English version of the judgment is not yet available]

The Court came to these responses first of all by relying on the ex tunc effect of the Seattle Genetics judgment. The Court stated that in line with the interpretation given in Seattle Genetics, the date given in the application should have been the notification date and any different date is incorrect. By this the Court clearly extended the scope of “incorrect” in Art. 17 (2) beyond clerical errors and the like. Regarding the second response the Court referred to its earlier judgments and the principles laid down regarding the review of final administrative decisions in Kühne & Heitz, C 453/00 and Byankov C 249/11.

However, the court pointed out that as opposed to cited cases in this proceeding the national authority does not need to review its own decision only rectify the SPC duration, which draws the balance elsewhere between the requirement of lawfulness under Union law and legal certainty. Namely, the rectification of the duration is much less detrimental to legal certainty than more essential reviews of administrative decisions.

The Court further underlined that the right of the SPC holder to have the duration rectified shall be available based on Art 17(2) of the PPP Regulation as long as the SPC is in effect. The court referred to the purposes and objectives of the SPC system and particularly pointed out that the duration and expiry are following from Articles 13 and 14 of the MP Regulation directly, and national authorities have no room for discretion determining it.

The decision (in various languages) is available here.

Headnote: Eszter Szakács, Sár and Partners Attorneys-at-Law and Zsolt Lengyel, Danubia Patent and Law Office LLC, Budapest