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EU SPC Waiver Move Puts Originator And Generic/Biosimilar Firms At Odds

 
• By Ian Schofield

A European Commission legislative proposal to change the EU’s rules on supplementary protection certificates and allow for the production of versions of patent-protected medicines for sale outside the EU has been welcomed by the generics and biosimilars industry – albeit with caveats – but criticized by the originator industry as an attack on intellectual property that could hit investment in Europe.

Intellectual Property law books and a gavel on desk in the library. concept of legal education.
A planned change to EU IP laws would allow generic/biosimilar production during the SPC period, but for export only.

The European Commission has published a draft regulation that would allow European generic and biosimilar companies to manufacture versions of medicinal products still protected by an EU supplementary protection certificate (SPC), provided the products were intended solely for sale outside the EU.

According to the commission, the proposed legislation is intended to boost investment and job creation in the manufacturing of generics...

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