Incyte (Approximation of laws Approximation of laws Intellectual, industrial and commercial property Agriculture and Fisheries - Plant health legislation) [2017] EUECJ C-492/16 (20 December 2017)

Incyte (Approximation of laws Approximation of laws Intellectual, industrial and commercial property Agriculture and Fisheries - Plant health legislation) [2017] EUECJ C-492/16 (20 December 2017)

Article 18 of Regulation No 469/2009, read in light of Article 17(2) of Regulation No 1610/96, requires that if the date of the first MA stated in an SPC application is incorrect due to non-compliance with CJEU interpretation, the SPC duration must be rectifiable by appeal, provided the certificate has not expired.

Source-derived case information.

Citation
[2017] EUECJ C-492/16
Parties
Applicant: Incyte Corporation; Respondent: Szellemi Tulajdon Nemzeti Hivatala (National Intellectual Property Office, Hungary)
Jurisdiction
European Union
Procedural Posture
Preliminary Ruling (cjeu) / Judgment on Reference From National Court
Outcome
Reference answered; national court must allow rectification of SPC duration if the MA date is incorrect under CJEU interpretation, provided the SPC has not expired.
Legal Topics
Supplementary Protection Certificate (spc), Rectification of SPC Duration, Interpretation of EU Regulations, Legal Certainty, Appeals in Patent Matters
European Union Law Intellectual Property Law Pharmaceutical Law Supplementary Protection Certificate (spc) Rectification of SPC Duration Interpretation of EU Regulations Legal Certainty Appeals in Patent Matters

Source-derived case record

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Parties

Incyte Corporation

Applicant

Szellemi Tulajdon Nemzeti Hivatala (National Intellectual Property Office, Hungary)

Respondent

Procedural Posture

Preliminary Ruling (cjeu) / Judgment on Reference From National Court

  1. 1 Whether the date of the first marketing authorisation (MA) stated in an SPC application is 'incorrect' if it does not comply with subsequent CJEU interpretation;
  2. 2 Whether the national authority must rectify the SPC expiry date to comply with CJEU interpretation, even after the appeal period has lapsed.

Ratio Decidendi

Article 18 of Regulation No 469/2009, read in light of Article 17(2) of Regulation No 1610/96, requires that if the date of the first MA stated in an SPC application is incorrect due to non-compliance with CJEU interpretation, the SPC duration must be rectifiable by appeal, provided the certificate has not expired.

Court Disposition

Reference answered; national court must allow rectification of SPC duration if the MA date is incorrect under CJEU interpretation, provided the SPC has not expired.

Orders

  • Article 18 of Regulation No 469/2009, read in light of Article 17(2) of Regulation No 1610/96, means the MA date is incorrect if it does not comply with CJEU interpretation, and rectification must be allowed.
  • Holder of an SPC may bring an appeal for rectification of the duration stated in the certificate, provided the certificate has not expired.