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Device hybrid approval not the same as substance authorisation, rules CJEU

Patrick Wingrove, London


In a decision that will disappoint medical device manufacturers, the CJEU in the Boston Scientific case has addressed the authorisation that must form the basis of an SPC. This is in contrast to recent referrals that address what products can be protected

CJEUIn a new supplementary protection certificate (SPC) development, the CJEU has ruled that the authorisation procedure for a pharmaceutical medical-device hybrid cannot be treated as an authorisation procedure for the substance.

In its judgment on the Boston Scientific case (C-527/17),...


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