Hungary Amends SPC Regulations

Apr 7 2022 - 14:33

Amendments to Hungary’s Decree 26/2004 (II.26.) on the rules necessary for the implementation of the European Community Regulations concerning the creation of supplementary protection for certain products entered into force on March 1, 2022, introducing important changes relating to Supplementary Protection Certificates (SPCs).

SPC Manufacturing Waiver

The amendments harmonize Hungarian legislation with EU Regulation 2019/933, enabling companies in Hungary to produce a generic or biosimilar version of an SPC-protected medicine during the SPC term, for the purpose of:

  • Exporting to countries where SPC protection is not available or not enforceable; or
  • Stockpiling during the final six months of the SPC term in order to place the product on the EU market once the SPC expires.

SPC Term Recalculation

The Hungarian Intellectual Property Office now allows SPC holders to request recalculation of their SPC duration, based on the judgment of the Court of Justice of the European Union (CJEU) in case C-492/16 (Incyte Corporation) from December 2017. In this case, the CJEU stated that its decision in case C-471/14 (Seattle Genetics) from October 2015 had retroactive effect. In the Seattle Genetics case, the CJEU was asked how “the date of the first authorization to place the product on the market” in Article 13(1) of the SPC Regulation should be interpreted, considering that a marketing authorization had two dates:

  • The date of the decision granting the marketing authorization; and
  • The date the applicant is notified of the marketing authorization approval.

The CJEU decided that the date to be used should be the notification date, meaning that the duration of SPC applications following the Seattle Genetics judgement should be calculated on the basis of the marketing authorization notification date.

After this case, certain national intellectual property offices in the EU allowed holders to request the recalculation of the duration of SPCs granted before October 2015. Other offices, including the Hungarian IPO, refused to accept retroactive recalculation requests. With the new amendments of Decree 26/2004 (II.26.), the Hungarian IPO will now accept such requests.

SPC Application Amendments

The SPC application can be now amended to cover a different product or different marketing authorization than the one indicated when the application was first filed. It will still not be possible to amend the application so that the SPC relates to a basic patent other than the one originally designated. Detailed transitional rules determine to which SPC cases the new rules apply, depending on the date of application, grant or entry into force.

Prepared by: Balázs Csányi and Erika Farkas

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Source: Hungarian Intellectual Property Office website

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