Incyte v Szellemi Tulajdon Nemzeti Hivatala (CJEU, C-492/16, 2017)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Budapest-Capital Regional Court (Fővárosi Törvényszék), the Court held that the date of the first marketing authorisation stated in an SPC application is incorrect where it led to a calculation of the certificate’s duration that does not comply with Article 13(1) of Regulation 469/2009, as later interpreted in Seattle Genetics (para 44). The holder then has, under Article 18 of that Regulation read in light of recital 17 and Article 17(2) of Regulation 1610/96, a remedy to obtain rectification of the duration stated in the certificate, for as long as the certificate has not expired (para 60). The ruling allows certificates granted before Seattle Genetics to be corrected, notwithstanding the expiry of national time limits for appeal.

Facts and procedure

On 24 January 2013 Incyte applied to the Hungarian Intellectual Property Office for an SPC based on a European patent and on the marketing authorisation for Jakavi, a medicinal product for the treatment of myelofibrosis, granted by the Commission on 23 August 2012; the application gave that date as the date of first authorisation in the Union. The certificate was granted on 7 October 2014, expiring on 24 August 2027. After the judgment in Seattle Genetics of 6 October 2015, Incyte asked on 18 November 2015 for the expiry date to be rectified to 28 August 2027, relying on Article 81/A of Hungarian Law CXL of 2004 on administrative procedure. The Office refused, finding no calculation or clerical error in its decision. On appeal, the Fővárosi Törvényszék referred two questions by decision of 31 August 2016.

The applicable law

The referring court relied on Article 17(2) of Regulation 1610/96; since the certificate concerned a medicinal product, the Court brought Article 18 of Regulation 469/2009 into the analysis (paras 29 to 31). Recital 17 of Regulation 1610/96 makes Article 17(2) applicable, mutatis mutandis, to Article 17 of Regulation 1768/92, now Article 18 of Regulation 469/2009 (paras 33 and 34), which makes decisions granting a certificate subject to the same appeals as corresponding national patent decisions (para 35). The Court also recalled its case law on the temporal effect of preliminary rulings (para 41, Manea) and on the finality of administrative decisions (paras 46 to 48, Kühne & Heitz, Kempter and Byankov).

Question

Is a date of first authorisation fixed without regard to Seattle Genetics incorrect and, if so, can the duration of an SPC granted before that judgment be rectified once the time limit for appeal has expired?

Decision

A preliminary ruling clarifies the meaning of a rule as it ought to have been understood and applied from its entry into force (paras 41 and 42). The date that should have appeared in the application was the date of notification of the authorisation; any other date is incorrect (para 43), even though the applicant followed the practice then in force (para 39). On the second question, the Court distinguished rectification of the duration from reopening a final decision: moving the expiry date from 24 to 28 August 2027 is less liable to undermine legal certainty (para 49). Duration follows from precise criteria leaving the office no discretion (para 53), the certificate expires on the date resulting from Article 13 (para 54), and the twin aims of effective protection and uniform application justify allowing the holder to seek rectification at any time before the certificate expires (paras 55 to 57). Since Incyte had applied to the office, the Court did not decide whether the office would have to rectify of its own motion (para 59).

Key points for practice

• The interpretation of Article 13 given in Seattle Genetics applies to certificates granted before that judgment (paras 41 to 43).
• Rectification of duration is not subject to the restrictive conditions governing the reopening of final administrative decisions (paras 47 to 49).
• The rectification remedy remains available until the certificate expires (para 60).
• Practical point: rectification requires an application by the holder, since the Court left open whether the office must act of its own motion (para 59); reviewing the first authorisation dates used in certificates in force identifies those whose duration can be corrected.

Provisions applied

Regulation (EC) No 469/2009

Arts 13(1), 14 and 18

Regulation (EC) No 1610/96

Art. 17(2) and recital 17

Regulation (EEC) No 1768/92

Art. 17

Treaty on European Union

Art. 4(3)

National law

Hungarian Law CXL of 2004 on administrative procedure, Art. 81/A

Case law cited

Seattle Genetics (C-471/14); Kušionová (C-34/13); Manea (C-76/14); Kühne & Heitz (C-453/00); Kempter (C-2/06); Byankov (C-249/11)

Related decisions

• Seattle Genetics, CJEU, 6 October 2015, whose interpretation of Article 13(1) underlies the request for rectification (para 40).

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