EU SPC Waiver: Originators May Need To Act Soon
A new EU regulation relaxing the rules on generic and biosimilar manufacturing during a product’s supplementary protection certificate period will take effect on 1 July. Originator companies wanting to benefit from a three-year transition period should consider taking action now.
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Changes to how the UK plans to implement the supplementary protection certificate manufacturing waiver after it separates itself fully from the EU following the current Brexit transition period have been criticized by the generics industry, while originators have welcomed the move.
The UK’s plans to amend the supplementary protection certificate waiver legislation in the event of a no-deal Brexit could lead to the curtailment of IP protections, not only the terms of SPCs but regulatory data protection and orphan exclusivity too, the BIA claims.
Draft legislation has been published by the UK’s Intellectual Property Office to ensure that the EU’s supplementary certificate protection manufacturing waiver will continue to function in the case of a no-deal Brexit outcome.