The new guidelines for the substantive examination of national patent applications will come into effect on 1 January 2019.

From this date, those carrying out paediatric studies for medicinal products can request at the IPI an extension to a supplementary protection certificate (SPC) or, if no conventional SPC exists, a paediatric SPC.

The IPI has therefore integrated the relevant legislative changes (Art. 140a – 140z and 149 of the Patents Act, and Art. 127a – 127zocties of the Patents Ordinance) into the Guidelines for the Substantive Examination of National Patent Applications (available in German and French only). The following points are particularly noteworthy:

-    The revised Chapter 13 describes – in addition to the conventional SPC for medicinal and plant protection products – the procedure for granting a “paediatric extension” for SPCs for medicinal products.
-    Chapter 14, which is new, clarifies the specifics on the granting procedure of the paediatric SPC for medicinal products.

The guidelines also contain various editorial changes. In addition, Chapter 11.4.2 further specifies the requirements regarding disclosing the source of genetic resources and traditional knowledge.

The guidelines were last updated in October 2018 as a result of Federal Supreme Court decision 4A_576/2017 in which the IPI retroactively changed its granting practice for SPCs and thus Chapter 13.2.1. of the guidelines.