For medicinal products and plant protection products, approval or official authorisation must be obtained (from Swissmedic, the Federal Veterinary Office or the Federal Office for Agriculture, for example) before they can be used commercially. This authorisation procedure can sometimes take up to ten years, during which time the term of protection for the associated patent is already running. Therefore, to compensate for this situation, it is possible to request a supplementary protection certificate (SPC). The term of protection of the SPC begins as soon as the maximum term of protection (20 years) of the patented active ingredient expires. An SPC extends protection for up to a further five years.
For an SPC to be granted, the following criteria must be fulfilled:
- SPCs can only be granted on the basis of a valid patent and official authorisation or approval.
An SPC must be requested within six months from:
- the first official authorisation or approval in Switzerland; or
- the grant of the patent if this is granted later than the first official authorisation or approval.
Extending protection for paediatric medicinal products
Anyone carrying out paediatric studies for patented medicinal products can extend patent protection by six months with an SPC, or – if no conventional SPC exists – request a "paediatric SPC", which is also valid for six months.
- Patent Examination Guidelines (in French)
- Form to request an SPC (in German)
- Form to request an SPC (in French)
- Form to request an SPC (in Italian)
- Change of practice for granting supplementary protection certificates (SPCs)
- Guidelines, Chapter 13.2.1 (in German)
- Case studies of guidelines 13.2.1 (in German)
- Swiss Patents Act (PatA)
- Patents Ordinance (PatV) in German
10.04.2019 | Event
The IPI at the Exhibition of Inventions in Geneva from 10 to 14 April 2019 - why not stop by and see us?
Info event on using strategic patent analyses on 11.4.2018 in Zurich