Belgian medicines agency updates procedure to remove patented indications from SmPC and package leaflet

Allen & Overy LLP

Allen & Overy LLP

The Belgian Federal Agency for Medicines and Health Products (the FAMHP) has reviewed its procedure to remove or add patented therapeutic indications or dosage forms from the generic medicines' marketing authorisation (MA), summary of product characteristics (SmPC) and package leaflet following a judgment from the European Court of Justice (ECJ) of 14 February 2019 (Dutch and French).

In the ECJ’s judgment in case C-423/17, the ECJ ruled that when carving out a patented indication on the package leaflet or SmPC of a generic medicinal product, the published SmPC or package leaflet may only refer to the non-patented indications. The judgment was issued in response to the preliminary questions referred to the ECJ by the Dutch Regional Court of Appeal in The Hague, which related to the impact on the scope of the MA of a generic product if the patented indication or dosage form of an innovator product is deleted from the SmPC of a generic product. The judgment follows the practice of the Dutch Medicinal Product Evaluation Board, which published the SmPC and package leaflet of generic medicinal products in full on its website instead of a version without the patented indication.

As a reminder, a MA applicant or the MA holder may request the removal of information on a patented indication both during the MA application process, as well as after the MA has been granted through the submission of a variation. The practice whereby an applicant for a generic medicinal product carves out the indications or dosages which are covered by a patented indication from the SmPC is also known as “skinny labelling”.

Following the ECJ’s judgement, if the applicant of a MA or an MA holder wishes to remove information on a patented indication, the following conditions should be met:

  • only information on therapeutic indications, dosage and route of administration and pharmacodynamics properties of the patented indication may be removed.
  • all safety information on the active substance should remain.
  • the applicant must include the following 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."
  • the applicant must also submit a declaration that states that the adapted documents meet the conditions referred to above.

In view of the FAMHP’s clarification, in case of a request for removal of certain information relating to the patented indication, the MA will be granted without the patented indication. Competent authorities may thus no longer publish a 'complete' SmPC and package leaflet also containing the patented indications of an innovator product if an applicant requests a carve-out of a patented indication on the package leaflet or SmPC of a generic medicinal product. This change will increase transparency and legal certainty with respect to the patent protected indications.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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