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Supplementary Protection Certificates - The Appeal in Newron Pharmaceuticals SpA v Comptroller

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  Jane Lambert Court of Appeal (Lords Justices Lewison, Moylan and Birss)  Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trade Marks and Designs [2024] EWCA Civ 128 (15 Feb 2024) This was an appeal against the decision of Mr Recorder Campbell KC to uphold  Dr L Cullen's refusal to grant a  supplementary protection certificate ("SPC")  to Newron Pharmaceuticals SpA ("Newron") for the reasons set out in his judgment in  Newron Pharmaceuticals SpA v Comptroller-General of Patents, Trade Marks and Designs  [2023] EWHC 1471 (Ch).  I discussed the proceedings before Dr Cullen and Mr Campbell in  Supplementary Protection Certificates - Newron Pharmaceuticals SpA v Comptroll e r  on 1 July 2023.    What is an SPC?  In that article, I quoted from my reference page on   Supplementary Protection Certificates  which I wrote on 31 Dec 2019 and updated on 11 Jan 2021 "A supplementary protection certifi...

Supplementary Protection Certificates - The Waiver Regulation

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Jane Lambert On 1 July 2019  Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance.)  OJ L 153, 11.6.2019, p. 1–10 came into force.  It consists of 30 paragraphs of recitals but only 2 articles. Art 1 amends  Regulation (EC) No 469/2009 of the Europea Parliament and of the Council f 6 May 2009concerning the supplementary protection certificate for medicinal products OJ 16.6.2009 L 152 p1-9 so as to enable generic and biosimilar manufacturers to make products that are protected by supplementary protection certificates ("SPC") for export to third countries or to stockpile them for distribution from the moment the SPC expires.  Art 2 provided for Regulation 2019/933 to enter into force on the 20th day following its publication in the Official Journal. What is an SPC? An SPC...