Swiss paediatric extensions: a swift answer from the "crowd"

Following this morning's blogpost calling for a crowd-sourced response to a plea for information as to where Switzerland currently stands with regard to paediatric extensions, we have received the following response from a two-man crowd consisting of Simon Holzer & Kilian Schärli (meyerlustenberger | lachenal Rechtsanwälte) who write:

Crowds of Swiss Rechtsanwälte gather round to answer
readers' questions -- but Simon and Kilian were first!

On 7 May 2014, the Swiss National Council adopted the revision of the Swiss Therapeutic Products Act (see excerpt of the Official Bulletin of the National Council of 7 May 2014 [in German and French only]). The legislative proposal now goes to the Council of States. The Federal Office of Public Health, which is leading the revision of the Therapeutic Products Act, expects that the revised version will come into force on 1 January 2016. 

With regard to transitional provisions the new Art. 140o of the Swiss Patent Act stipulates that the application for the paediatric extension can be filed no earlier as with the application for the grant of an SPC and no later then two years before the expiry of the SPC, but no later than six months after the first authorization to place the product on the market as a medicinal product in the European Economic Area with the exception of the Principality of Liechtenstein, and only if the associated medicinal product information reflects the results of all studies that have been carried out in compliance with the paediatric investigation plan considered during the marketing authorization. Further, the new Art. 140s para. 2 sets forth that for the procedure (as well as for the register and for the publications) the rules of the European Union shall be taken into account. 

More information can be found on the following websites:

• Federal Office of Public Health, here

• Swiss Agency for Therapeutic Products, here

• Swiss Federal Institute of Intellectual Property, here

Thanks so much, Simon and Kilian -- this is really helpful!