Supplementary protection certificates

 

The Authority grants additional protection certificates for substances protected in the Czech Republic by a valid patent if they are active substances of products that are subject to registration before being placed on the market.

On 11 June 2019, Regulation (EU) No. 2019/93 of the European Parliament and of the Council amending Regulation (EC) No. 469/2009, on supplementary protection certificates for medicinal products, was published in the Official Journal of the European Union. The Regulation will enter into force on 1 July 2019.

The new EU regulation introduces a manufacturing exemption from the exclusive protection granted to genuine medicines by Supplementary protection certificates (SPC). Companies established in the EU will be authorised to produce a generic or biologically similar version of an SPC-protected medicinal product during its period of validity, provided that production takes place exclusively for export to countries outside the EU where the SPC has never existed or otherwise expired, or during the last six months of SPC validity for the purpose of storage for placing on the EU market immediately after the expiry of the SPC.

The manufacturer must directly inform the owner of the SPC of their intention to manufacture, in accordance with the exemption, no later than three months before the start of this activity. The manufacturer is also obliged to inform the competent industrial property authorities, which will publish the information thus obtained. The standard notification form for notification to the owner of the SPC and the competent industrial property authority will be published on the IPO website.

The manufacturer is also obliged to inform their supply chain that the concerned products are only intended for export or storage.

Any export of products protected by the SPC outside the EU shall be subject to specific logo labelling requirements in order to facilitate identification that they are exclusively intended for export to third countries.

The production exemption will apply to all new SPC to be requested on or after 1 July 2019. The exemption will not apply to SPC that are in force on 1 July 2019; for SPC that were applied for before 1 July 2019 but are not yet in force on that date, the production exemption will apply three years after the entry into force of this exemption, i.e., from 1 July 2022.

- Regulation (EU) 2019/933 of the European Parliament and of the Council

- Application form for the granting of an additional protection certificate for pharmaceuticals and plant protection products – electronically completable (for printing, without the possibility of online submission)

- Standard notification form for notifications under Article 5(2)(a), (b) and (c), Regulation (EC) No. 469/2009 of the European Parliament and of the Council, as amended by Regulation (EU) No. 2019/933 of the European Parliament and of the Council, (Annex Ia) – electronically completable

Upon submission, the completed notification form can be included as an attachment to Office Form Z 04 General Communication, which is available in both ePods and as an electronically completable form in PDF format.