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Showing posts with the label Regulation 469/2009

Supplementary Protection Certificates - the Genentech Appeals

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Jane Lambert Court of Appeal (Lord Justices Floyd and Arnold and Lady Justice Nichola Davies) Genentech Inc v Comptroller and Master Data Center v Comptroller   [2020] EWCA Civ 475 (31 March 2020) These were appeals from the decision of Mr Recorder Campbell QC in Master Data Center, Inc v Comptrolle r [2020] EWHC 572 (Pat) (11 March 2020) which I blogged in Supplementary Protection Certificates - Master Data Center, Inc v The Comptroller   on   18 March 2020.  The cases are remarkable for the speed with which they progressed from the hearing officer to the Court of Appeal.  They were before Mr  Micklewright on 21 Feb 2020 (see  R e Genentech, Inc. and Master Data Center, Inc . BL O/111/20 21 Feb 2020), Mr Campbell on 4 March 2020 and the Court of Appeal on 26 of that month ( Genentech Inc v Comptroller and Master Data Center v Comptroller [2020] EWCA Civ 475 (31 March 2020).   The cases are also remarkable for being...

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...