Research-Based Pharma Urges Redress From Negative Impact Of EU SPC Waiver

The research-based pharmaceutical industry has issued a severe warning that the European Parliament's overwhelming support for IP-related changes that will allow manufacturing of generics and biosimilars during the term of supplementary protection certificates will hit innovation. Some of industry's concerns may be justified, a patent attorney explains.

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EFPIA Fears SPC Manufacturing Waiver Will Harm Innovation • Source: Shutterstock

Europe's research-based pharmaceutical industry has strongly criticized the European Parliament's vote in favour of a new regulation that would allow EU-based companies to manufacture a generic or biosimilar version of a medicine while it is still protected by a supplementary protection certificate (SPC).

The regulation includes a waiver that would allow manufacturing either for exporting the medicines to third countries where protection has expired or never existed, or for stockpiling during the final six months of an SPC to

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