When applying for a marketing authorisation for a medicinal product, the MEB assesses the benefit/risk balance for one or more applications. An SmPC and a package leaflet for the patient are drafted as part of the submission. This product information can contain one or more patented indications.

Based on patent law, the marketing authorisation holder can remove the patented indication from the printed SmPC and package leaflet as present in the packaging of a medicine. The marketing authorisation holder must notify the MEB about this. However, the MEB Medicines Information Bank mentions all indications - including patented indications. The new policy as of 28 June 2016 is that patented indications are clearly marked as such.

Printed product information

Reporting a patented indication

The marketing authorisation holder can amend the printed SmPC and package leaflet for the patient according to the MEB guidelines as described below. The removal of the correct information and the inclusion of the standard sentence in the printed package leaflet for the patient are the responsibility of the marketing authorisation holder. After all, this party is responsible for defending the patent. The MEB is not involved in this matter. However, the marketing authorisation holder must notify the MEB about this.

The marketing authorisation holder sends the test for the printed product information to the MEB. The product type for this notification is 401. The submission contains:

  • the text of the printed versions of the SmPC and the package leaflet
  • a declaration that the product information meets the guidelines below.

Information about the patented indication of a generic medicinal product that is removed from the printed SmPC and package leaflet for the patient may not include the safety information. The MEB has drafted guidelines about which information may be removed:

  • Only the information about the patented indication in the sections 4.1, 4.2 and 5.1 of the SmPC and the corresponding sections in the package leaflet may be removed.
  • In the interests of prescribers and patients, all safety information pertaining to this indication must be retained. This means that the information in other sections of the SmPC (4.3 through 4.9) that is related to the patented indication must remain in the SmPC and in the corresponding sections of the package leaflet.
  • If a patented indication is not included, the company will include the following standard sentence in the printed package leaflet:
    ‘<Productnaam> bevat als werkzaam bestanddeel <stofnaam>, dat ook is goedgekeurd voor andere aandoeningen die niet in deze bijsluiter staan vermeld. Vraag uw arts of apotheker als u nadere vragen heeft.’
  • The following reference to the MEB website must be included in the printed package leaflet, also refer to the QRD template:
    'Gedetailleerde informatie over dit geneesmiddel is beschikbaar op de website van het CBG via: www.geneesmiddeleninformatiebank.nl.’

Reporting expiration of a patented indication

Once the patent has expired (lapsed or declared invalid), the marketing authorisation holder must ensure that the printed SmPC and the package leaflet correspond to the approved SmPC and the package leaflet. The marketing authorisation holder will send the text of the printed product information to the MEB via a notification with product type 401, as indicated above.

This notification for reporting or reporting expiration of a patented indication must be submitted separately, i.e. not as a part of an ongoing procedure. Both notifications can be submitted parallel to an application or variation. The submission letter for applications or variations must always state that this involves a patented indication.

Other changes to the SmPC and package leaflet

In the case of changes to the SmPC and package leaflet for the patient that are not related to the patented indication, it is not necessary to submit the printed versions of these documents again. However, in the case of such changes, it is necessary to state each time that this involves a patented indication. This also needs to be done if the relevant change in the SmPC and/or package leaflet for the patient does not relate to the patented indication, but involves another change.

Product information in the MEB Medicines Information Bank

The SmPC and package leaflet for the patient (as confirmed upon authorisation) are placed in the MEB Medicines Information Bank along with the complete information, including the patented indication. The patented indication that has been omitted by the marketing authorisation holder of the generic medicinal product will be presented in marked format on the Medicines Information Bank by the MEB. The MEB will also add marking if the MEB is informed about the patented indication by the relevant patent holder.

Markings are applied as follows. An asterisk (*) is placed after the patented indication in the SmPC and the package leaflet. The asterisk is clarified at the end of section 4.1 of the SmPC and the end of section 1 of the package leaflet, respectively, with the following text.

a. in the SmPC:

* Deze toepassing wordt beschermd door een octrooi (ook wel patent genoemd) van een andere vergunninghouder. Meer informatie hierover vindt u op de website van het CBG, www.cbg-meb.nl.

b. in the package leaflet:

* Deze toepassing wordt beschermd door een octrooi (ook wel patent genoemd) van een andere vergunninghouder. Meer informatie hierover vindt u op de website van het CBG, www.cbg-meb.nl.

Following a notification that the patented indication has expired, the MEB will remove the marking and additional sentence in the SmPC and package leaflet for the patient, which it had published on its website in relation to the patent.