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...

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