Earlier today this weblog published a paediatric poser concerning plans for paediatric extensions in Switzerland and asked if any reader could assist. Kilian Schärli, (a Rechtsanwalt with meyerlustenberger lachenal) has kindly obliged with the following information:
"Switzerland is indeed planning to introduce paediatric extensions to its SPC (new Art. 140n PatG) along the same lines as the EU’s legislation with the Ordinary Revision of the Therapeutic Products Act (stage 2).
Here's the Explanatory Report (p. 98 f.) and the Results of the Consultation concerning the Ordinary Revision of the Therapeutic Products Act (p. 72 ff.). Unfortunately, both documents are not yet available in English.
The Federal Office of Public Health (FOPH) is in charge for the Ordinary Revision of the Therapeutic Products Act. According to FOPH’s webpage the following persons should be able to provide up-to-date information regarding the expected date for its entry into force: Matthias Enderle / Amedeo Cianci Tel: +41 31 324 50 41 / +41 31 322 63 19; email matthias.enderle@bag.admin.ch; website www.bag.admin.ch
In this regard, it is worth to mention that the Swiss Federal Institute of Intellectual Property has changed its practice (sic! 6/2012, p. 419 f.) regarding the grant of SPC with a negative term of protection – effective as of now – based on the decision in Case C-125/10 Merck in June 2012".The SPC Blog has tried, so far without success, to email its personal gratitude to Kilian, so for the time being all we can say is a very public "thank-you!"
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