‘UK Waiver’ For SPCs Proposed In Case Of No-Deal Brexit
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.
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Panellists at the UK’s Westminster Health Forum conference on Biosimilars in the NHS united over concerns of a no-deal Brexit and what it would mean for generics and biosimilars producers.
As the generics and biosimilars industries prepare for the European SPC manufacturing waiver to come into effect on 1 July, Generics Bulletin traces the history of the mechanism from early industry lobbying efforts to its ultimate entry into force.
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.