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Notice of 25 September 2019

concerning the Regulation (EU) 2019/933 of the European Parliament and the Council of 20 May 2019 amending Regulation (EC) no. 469/2009 concerning the supplementary protection certificate for medicinal products

On 1 July 2019, the Regulation (EU) 2019/933 of the European Parliament and the Council of 20 May 2019 amending Regulation (EC) no. 469/2009 concerning the supplementary protection certificate for medicinal products entered into force (OJ no. L 153 of 11 June 2019, p. 1 = Official Gazette (Blatt f. Patent-, Muster- und Zeichenwesen) 2019, 317).

The Regulation provides for an exception from the protection conferred by supplementary protection certificates for medicinal products, which allows makers who are established in the European Union, for example,

  • to make products protected by supplementary protection certificates, or medicinal products containing those products for the purpose of export to third countries and
  • to make, no earlier than six months before the expiry of the certificate, products protected by supplementary protection certificates or medicinal products containing those products, for the purpose of storing them in the Member State of making, in order to place them on the market of Member States after the expiry of the certificate (Art. 5(2) (a) Regulation (EC) no. 469/2009).

Precondition for the exception from the protection conferred by supplementary protection certificates is that the competent industrial property authority of the Member State in which that making is to take place is notified in good time (Art. 5(2) (b) and (c), (5) Regulation (EC) no. 469/2009), among other things.

If the making is to take place in the Federal Republic of Germany, the relevant information must be notified to the German Patent and Trade Mark Office (DPMA). For this purpose, form P 2041 is to be used; a free copy of the form can be obtained from the DPMA or downloaded from the DPMA website on the page "Forms and more", clicking "Patents" and "Forms concerning supplementary protection certificates".

The DPMA will publish the information notified in the DPMAregister publication and register database for the file number of the respective supplementary protection certificate. In addition, a mention of the notification is published in the Patent Gazette (Patentblatt) (Art. 11(4) Regulation (EC) no. 469/2009).

1243/1-4.3.2/2019-2

Last updated: 14 October 2019