SWITZERLAND CREATES NEW EXTENSION FOR SPC

SWITZERLAND CREATES NEW EXTENSION FOR SPC

Supplemental Protection Certificates (SPC) can extend a patent right for a maximum of five years. A six-month additional extension is available in accordance with Regulation (EC) No 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a Pediatric Investigation Plan (PIP). PIPs are required to support the authorization of medicines for children. They ensure that enough data is collected on the effects of the medicine on children. The extension compensates for the additional clinical trials and testing that PIPs require.

According to the new Swiss Patents Act, which has come into force January 1, 2019, holders of an SPC from now on can apply for a supplemental pediatric extension (PE). What required is:

(a) a certification issued by the Swiss Agency for Therapeutic Products (Swissmedic) that all studies agreed upon in the accordant pediatric investigation plan (PIP) were completed. And the

(b) evidence that the application for a market authorization (MA) has been made within 6 months after the filing of the respective MA in the EU. If such an MA application is filed in Switzerland first, it is sufficient to make a declaration that no application has been filed in the EU yet.

Within a transitional period on January 1, 2024, the time limit for filing an application for a pediatric extension is six months before expiry of the SPC. After this transitional period, the PE application has to be filed two years before expiry of the SPC at the latest.

For marketing authorizations with a PIP that are filed within six months after entry into force of the New Patents Act, the six-month time limit between the marketing authorization in the EU and the marketing authorization in Switzerland is not applied. After this period the MA in Switzerland has to be filed within six months after the application for the marketing authorization in the EU.

We wish to thank our Swiss colleagues for this information.

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