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

Executive Summary

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.

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EU Policymakers Under Industry Pressure To 'Neuter' SPC Waiver Plan

“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.

EU Policymakers Under Industry Pressure To 'Neuter' SPC Waiver Plan

“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.

‘Unitary SPC’ Proves Popular With EU Stakeholders

A consultation has found that most stakeholders support the idea of a unitary supplementary protection certificate to complement the future unitary patent system in the EU, and that a re-examination of the way the “Bolar” research exemption works would be worthwhile. Interestingly, the consultation revealed that while some innovator company respondents saw the SPC as the main factor in making investment decisions in the EU, most rated it only "moderately" important.

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