SPC Manufacturing Waiver

SPC Manufacturing Waiver – learn more!

The Regulation introducing the Supplementary Protection Certificate (“SPC”) Manufacturing Waiver (“MW”) has been adopted by the EU Parliament on the 17th of April.
In the EU SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of patent protection to approved drugs and biologics.
The new SPC MW now allows European generic and biosimilar manufacturers, like Polpharma, to produce & supply SPC-protected products for export to non-EU countries where intellectual property protections for those products have expired or never existed. In addition, the SPC MW will now also allow for the stockpiling of generics and biosimilars during the final six months of the SPC protection to enable day-one entry on the EU market for these products.
We expect this Regulation to come into effect in July 2019 and it will be effectively applicable to most SPCs as of July 2022. It is a major achievement of our generic and biosimilar sector advocacy efforts.
This enables Polpharma to produce top quality generics in Europe following European high standards upon patent expiry but before expiry of the patent extension and thus Polpharma products can be launched on day one after intellectual property expiry in markets of interest, for example in the US. Polpharma will use this opportunity to deliver its products to its clients in a time competitive manner.
Provided by: Karin Pramberger , IP Director

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