Application requirements for the grant of an SPC
The active ingredient of the product must be protected by an Irish patent (the “basic patent”). In addition, you must have a valid marketing authorisation to place the active ingredient on the Irish market as a pharmaceutical or plant protection product.
The requirements for filing a request for an Irish SPC are:
(1) The name, address and nationality of the applicant.
(2) The patent number of the basic Irish patent
(3) The title of the invention.
(4) The number and date of the first marketing authorisation to place the product on the market in Ireland, together with a copy of the authorisation that identifies the product. The authorisation should include the summary of the product characteristics listed in Article 4a of Directive 65/65/EEC (pharmaceutical products) or Article 5a of Directive 81/851/EEC (veterinary products), or Article 4 of Directive 91/414/EEC (plant protection products) as appropriate. Note that the “product identity” is defined in Article 1 of Council Regulation (EEC) No. 1768/92 (Codified by Regulation (EC) No 469/2009) or Regulation (EC) No. 1610/96) as being:
(i) The product (i.e. active ingredient or combination of active ingredients) for which a certificate is requested:
(ii) Information to satisfy the Controller that the product at 5(i) above is protected by the basic patent identified at 2 above.
The name, brand, trade name or other description by which the product is commonly known, must also be indicated.
(5) If the marketing authorisation referred to at (4) is not the first authorisation to place the product on the market in the EU, the number, date and country of the first EU authorisation, together with information establishing the identity of the authorised product are required. Additionally, you must identify the legal provision under which the first authorisation was given and provide a copy of the notice publishing the authorisation in the appropriate official publication (where appropriate a translation of this notice is also required). Failing such a notice, you should provide any other document proving that the authorisation has been issued, the date on which it was issued and the identity of the product authorised.
(6) Information confirming that the product is covered by the basic patent is also required. This may be an indication of a claim of the basic patent that covers the product.
(7) Payment of a fee of €95 upon filing the request for the grant of a certificate.
How to apply
Applicants are requested to use the online e-filing system to file an application for an SPC or for an SPC Extenstion. The SPC e-filing system [GB1] provides for the upload of an authorisation of agent (PDF only) and the upload of all accompanying documentation, required marketing authorisations etc (in PDF or WORD format), and for payment of the prescribed application fee by credit or debit card.
Alternatively if it is desired to apply on paper and by post the following forms may be downloaded:
If filing by post payment of the filing fee can be made credit or debit card by telephoning the Office:
Lo-Call Tel: 1890-220223 (within Ireland)
or alternatively by EFT using the following protocol.