The applicant or marketing authorisation holder for a generic medicine may decide not to include the patented indications or dosage forms in the marketing authorisation and not to mention them in the summary of product characteristics and package leaflet. Applicants/marketing authorisation holders must follow specific procedures to remove or reinsert the patented indication.
Following the judgment C-423/17 of the Court of Justice of 14 February 2019, the FAMHP has reviewed the procedure for the removal of certain patented data from the summary of product characteristics (SmPC) and the package leaflet.
The applicant or marketing authorisation holder can decide to adjust the SmPC and package leaflet themselves.
The removal of information from a patented indication and the inclusion of the standard phrase in the package leaflet are the responsibility of the applicant or marketing authorisation holder.
Procedure for the removal of a patented indication
Follow the procedure applicable to your specific situation in order to remove data from the SmPC and package leaflet that are covered by a patent.
1. During the marketing authorisation (MA) application.
- Via National Procedure (NP): if the company does not apply for the patented indication during the application for a national MA, then the FAMHP grants the MA without the patented indication.
- Via Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP):
- the indication under patent is part of the common EU text: the data under patent can be extracted from the SmPC and package leaflet during the national closing phase.
2. After the MA has been granted.
- Via NP: via submission of an IB C.I.6.b. variation
- Via MRP/DCP: via submission of a national IB C.I.6.b. variation
- Only the information on the patented indication in sections 4.1, 4.2 and 5.1 of the SmPC and the corresponding sections of the package leaflet may be removed.
- In the interest of prescribers and patients, all safety information on the active substance should be retained.
The safety information in other sections of the SmPC (4.3 to 4.9) and the corresponding sections of the package leaflet that are related to the patented indication should be retained.
If the marketing authorisation holder nevertheless wishes to remove or change information in these sections, for example, removal of text traceable to the patented indication, this must be justified.
- If a patented indication is not included, the company shall include the following standard phrase in the package leaflet:
"<Product name> contains the active substance <substance name>, which is also used in the treatment of conditions not mentioned in this package leaflet. Please contact your doctor or pharmacist if you have any questions."
Procedure for the reinsertion of a patented indication
Follow the procedure applicable to your specific situation in order to reinsert the data to the product information after the patent has expired.
1. MA authorised via NP: via submission of an IB C.I.2.a. variation
2. MA authorised via MRP/DCP:
- Indication/data included in common EU text: via submission of a national IB C.I.2.a. variation.
- Indication/data not included in common EU text: via submission of an IB C.I.2.a variation via MRP.
In addition to the adapted product information, a declaration must be submitted stating that the adapted documents meet the conditions mentioned above.
For MRPs/DCPs for which you submit a national variation, you should submit a "country-specific" sequence of eCTD, as this variation is national. In exceptional situations, where a "country-specific" eCTD sequence is not possible, it can also be submitted in NeeS format.
In the application form, always state the procedure number without chronological serial number, e.g. XY/H/1234/001-002/IB/NP.
The declaration of conformity – MRP/DCP has also been adapted to this new procedure.