Seattle Genetics v Österreichisches Patentamt (CJEU, C-471/14, 2015)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Higher Regional Court of Vienna (Oberlandesgericht Wien), the Court held that the date of the first authorisation to place the product on the market in the Union, within the meaning of Article 13(1) of Regulation 469/2009, is determined by EU law (para 28), and that it is the date on which the addressee was notified of the authorisation decision, not the date on which the decision was adopted (para 40). That date drives the calculation of the certificate’s duration: the gap between adoption and notification, a matter of days in this case, feeds directly into the SPC’s expiry date. The ruling addresses the divergent practices of national offices noted by the referring court.

Facts and procedure

Seattle Genetics holds European patent EP 1 545 613, filed on 31 July 2003, on auristatin conjugates. Takeda Global Research and Development Centre (Europe) obtained a conditional marketing authorisation for brentuximab vedotin (Adcetris), granted by Commission implementing decision of 25 October 2012 and notified on 30 October 2012. Seised on 2 November 2012 of an SPC application based on that patent, the Austrian Patent Office took the date of the decision as the date of first authorisation and set the expiry of the certificate at 25 October 2027. Seattle Genetics asked the Oberlandesgericht Wien to rectify that date to 30 October 2027. Noting divergent practices among national offices, the court referred two questions by decision of 2 October 2014.

The applicable law

Article 13(1) of Regulation 469/2009 sets the duration of the certificate by reference to the date of the first marketing authorisation in the Union. The Court recalled that a concept of EU law which makes no reference to the law of the Member States must be given an autonomous and uniform interpretation (para 23, citing Brüstle), and relied on recitals 7 and 8, which seek a uniform solution at Union level (para 26, citing Medeva). It also drew on the third subparagraph of Article 297(2) TFEU, under which decisions specifying to whom they are addressed take effect upon notification (para 37).

Question

Is the date of the first marketing authorisation in the Union a matter of EU law or of the law of the Member State in which the authorisation takes effect and, if EU law governs, is it the date of the authorisation decision or the date of its notification?

Decision

Article 13 neither defines the concept nor refers to national law; it is therefore an autonomous concept, a conclusion confirmed by the aim of a uniform solution, which a national definition would undermine (paras 24 to 28). Since the wording of Article 13(1) does not settle the choice between adoption and notification (para 30), the Court reasoned from the purpose of the Regulation, which is to restore adequate effective protection by compensating for the period between the filing of the patent application and the first authorisation (paras 31 to 33). The holder may market the product only from notification (para 35); the procedural steps between adoption and notification are outside its control and should not shorten the certificate (para 36). The decisions at issue themselves fixed their effective dates at 30 October 2012 and, for the renewal, 30 October 2014 (para 38). The relevant date is therefore the date of notification of the decision to its addressee (para 40).

Key points for practice

• The date of the first marketing authorisation in the Union is an autonomous concept of EU law, to be applied uniformly by all offices (paras 24 and 28).
• For an authorisation granted by the Commission, the relevant date is notification to the addressee, not adoption of the decision (para 40).
• The reasoning rests on effective protection: duration runs from the moment the holder is actually able to market the product (paras 34 and 35).
• Practical point: the notification date of the authorisation is the date to state in the SPC application and to check in granted certificates, since the gap with the decision date shifts the expiry date.

Provisions applied

Regulation (EC) No 469/2009

Art. 13(1)

Treaty on the Functioning of the European Union

Art. 297(2), third subparagraph

Other provisions

Regulation (EC) No 726/2004

Case law cited

Brüstle (C-34/10); Medeva (C-322/10); Actavis Group PTC and Actavis UK (C-577/13)

Related decisions

• Medeva, CJEU, 24 November 2011, cited on the aim of a uniform solution at Union level (para 26).

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.