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Proposal for an SPC manufacturing waiver

European Union, United Kingdom - June 14 2018 On 28 May 2018, the European Commission announced a legislative proposal to amend Regulation (EC) No. 469/2009 (the SPC Regulation) by introducing an…

Nicholas Fischer.

Advocate General delivers opinion in the first of three CJEU referrals concerning article 3(a) of the SPC regulation

European Union, United Kingdom - April 25 2018 In the first of three referrals pending before the CJEU on the interpretation of Article 3(a) of the SPC Regulation - seeking to clarify what it means…

Nicholas Fischer.

Orphan drug exclusivity: case law update

European Union - April 19 2018 In this article, we recap on the earlier Teva v EMA decision and summarise the recent outcome in Shire v EMA. We have also included relevant parts of…

Lydia Torne.

CJEU confirms the rules for rectifying SPC duration

European Union - January 5 2018 To bring last year to a close and hand down its second supplementary protection certificate (SPC) decision of December 2017, the Court of Justice of…

Nicholas Fischer.

Uncertainty as the EMA ponders implications of its post-Brexit move out of London

European Union, United Kingdom - September 27 2017 The European Medicines Agency (EMA) is searching for a new home. Following Brexit, the EMA will be forced to relocate from London to within the newly…

David Pountney.