As of 1 January 2019 Switzerland grants paediatric extensions, either as an:
- Extension of a pending or granted supplementary protection certificate (SPC) by 6 months (extended SPC, eSPC); or as a
- paediatric certificate (PC), if no SPC has been granted. The PC is linked to the patent term and provides an additional protection for a duration of 6 months.
The purpose of the paediatric extension is to provide adequate incentives for the research and development of high-quality medicinal products for paediatric needs. Unlike the EU, the paediatric extension is not limited to a pending or granted SPC, but is available also if no SPC has been granted.
The grant of paediatric extensions requires that clinical studies have been carried out on children. The study must comply with the paediatric investigation plan (PIP) and its results must be mentioned in the SmPC. The paediatric extension is also available if a paediatric indication has not been obtained provided that the negative results are mentioned in the SmPC.
The application for the marketing authorization with PIP in Switzerland has to be filed no later than 6 months after filing the corresponding application in the EU/EEA. The request for an eSPC/PC must be filed at the latest two years prior to the expiry of the SPC or patent, whichever applicable. For the transitional period the filing deadline is 6 months, i.e. until 30 June 2019.
For a valid paediatric extension the law requires explicitly that the product is "protected" by the basic patent. To evaluate this question, Switzerland traditionally applied the "infringement test", according to which it was enough that one of the active ingredients was covered by the patent claims. However, according to the recent decision of the Swiss Federal Supreme Court in the matter of Gilead's Truvada (Tenofovir) an SPC for a combination product is only valid if all active ingredients are adequately disclosed in the patent claims. With this decision, Switzerland has abandoned the long practiced "infringement test" and adopted the approach established by the CJEU in Medeva (C-322/10) and subsequent decisions. Commenting on its new practice, the Swiss Patent Office emphasized "it is essential that the product is detailed in the patent claims in a form recognizable for a person skilled in the art".
Because the provisions relating to the paediatric extensions refer explicitly to the requirements for granting an SPC, the Medeva case law applies also to paediatric extensions. A paediatric extension is therefore only available, if the active ingredients of a combination product are encompassed by the wording of the patent claims in a way that is recognizable for the skilled person. This requirement is met, according to the amended guidelines of the Swiss Patent Office, if the second active ingredient is part of a claimed group of active ingredients that have the same structure. By contrast, if the active ingredient is part of one or several long lists with a large number of alternatives, the sufficiency of the disclosure might be questionable.
A valid paediatric extension further requires that the authorized use, indication or dosage are equal to what is claimed in the patent claims (e.g. marketing authorization for 50 mg while the patent claims the use of 100 mg of an active ingredient).