[UPCKat] Has the UPC set too high burden to stop generic entry in Boehringer Ingelheim v Zentiva? By Annsley Merelle Ward at Tuesday, June 10, 2025 #IPKat AmeriKat imminent infringement marketing authorisation preliminary injunction upc UPCKat +
Fordham 27 (Report 12): SPCs By Annsley Merelle Ward at Tuesday, April 30, 2019 AmeriKat CJEU event report fordham 2019 manufacturing waiver marketing authorisation pharma R&D regulatory approval SPC SPC manufacturing waiver SPC regulation +
Orphan Drugs, a successful regulation after all? Or just about to experience its pitfalls? By Frantzeska Papadopoulou at Saturday, January 05, 2019 marketing authorisation Orphan Drug Designation significant benefit +
EMA/Commission guidance re centralised procedure and Brexit By Eibhlin Vardy at Monday, June 05, 2017 Brexit central MA Commission EMA marketing authorisation pharmacovigilance Q&A QPPV +
Shall we dance? Regulatory approval, trade secrets and the transatlantic biosimilars patent wars By Annsley Merelle Ward at Sunday, March 12, 2017 AmeriKat biologics biosimilars BPCIA EFPIA fujifilm marketing authorisation patent litigation patent strategy regulatory approval regulatory data trade secrets us patent litigation +
Does the economic impact of SPCs necessitate SPC Regulation reform? The European Commission wants to find out By Annsley Merelle Ward at Thursday, January 19, 2017 AmeriKat data and market exclusivity data protection economics of pharmaceutical IP EU Commission marketing authorisation regulatory data SPC tender SPCs +