CJEU – Abraxis Bioscience LLC v. Comptroller General of Patents / Opinion AG / SPC

Posted: January 7th, 2019

Abraxis Bioscience LLC v. Comptroller General of Patents, Opinion of AG SAUGMANDSGAARD ØE, 13 December 2018, Case C‑443/17 In the light of all the foregoing considerations, I propose that the Court give the following answer to the question referred by the High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom: Article […]


NL – G.D. Searle v. Sandoz

Posted: November 6th, 2018

G.D. Searle LLC. v. Sandoz B.V., PI Judge District Court The Hague, 1 November 2018, Case no. ECLI:NL:RBDHA:2018:13017 Sandoz, without any prior warning, introduced a generic version of Prezista® at risk on the Dutch market. Sandoz included its product in the October version of the ‘G-Standaard’, which is the Dutch database containing information on all […]


NL – MSD v. Teva, Pharmachemie and centrafarm / SPC

Posted: October 26th, 2018

MSD v. Teva, Pharmachemie and centrafarm, Court of Appeal The Hague, 23 October 2018 The Court of Appeal in interlocutory proceedings finds that MSD’s SPC for the combination product of ezetimibe and simvastatin is likely to be found invalid in proceedings on the merits in view of Article 3 c) of Regulation No 469/2009 (“SPC […]


DE – Merck Sharp & Dohme Corp. v. ratiopharm – Ezetimibe/Simvastatin

Posted: October 9th, 2018

Merck Sharp & Dohme Corp. vs. ratiopharm GmbH et al., District Court of Düsseldorf, 1 October 2018, docket no. 4b O 39/18 – Ezetimibe/Simvastatin The Düsseldorf District Court recently overturned several preliminary injunctions (“PIs”) that it had initially granted ex parte against generic companies, including ratiopharm GmbH. The case concerns the German supplementary protection certificate […]


CJEU – Opinion AG / Staat der Nederlanden v. Warner Lambert / SPC / Carve out

Posted: October 5th, 2018

Opinion of Advocate General Kokott, 4 October 2018, Case C‑423/17, Staat der Nederlanden v. Warner-Lambert Company LLC A communication whereby the marketing authorisation applicant or holder for a generic medicine, notifies the authority that he is not including in the summary of product characteristics and the package leaflet, those parts of the summary of product […]


NL – Dutch Patent Office v. Bayer

Posted: September 24th, 2018

Dutch Patent Office v. Bayer Schering Pharma Aktiengesellschaft, Administrative Jurisdiction Division of the Council of State, 19 September 2018, Case No.  ECLI:NL:RVS:2018:3058 The Dutch Patent Office earlier rejected Bayer’s SPC application for a multi phase birth control pill (Qlaira) based on natural estrogens estradiol valerate and dienogest. The Dutch Patent Office rejected the SPC application, […]


CH – Gilead / Truvada SPC – Switzerland to move away from the “infringement test” for future SPCs for Combination Products

Posted: June 21st, 2018

Validity of Gilead’s Swiss TRUVADA® SPC confirmed but Switzerland will move away from the “infringement test” for future SPCs for combination products, By Simon Holzer, Kilian Schärli and Marco Borer, Meyerlustenberger Lachenal * English translation of the decision now included * The Swiss Federal Supreme Court issued a landmark decision concerning the requirements for Supplementary Protection Certificates […]


EU – Teva and Mylan v. Gilead

Posted: April 26th, 2018

Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) trading as ‘Mylan’ v. Gilead Sciences Inc. Request for a preliminary ruling, Opinion of Advocate General Wathelet, 25 April 2018, Case C-121/17, ECLI:EU:C:2018:278 “In the light of all the foregoing, I propose that the Court should answer the question referred for a preliminary […]


NL – Merck Sharp & Dohme v. The Dutch Patent Office

Posted: April 20th, 2018

Merck Sharp & Dohme Corp. vs. the Dutch Patent Office, District Court of The Hague, 10 April 2018, ECLI: NL:RBDHA:2018:4081 The issue at hand is whether the Dutch Patent Office (“DPO”) has rightfully refused the application for a Dutch supplementary protection certificate (“SPC”) for a combination product of ezetimib and rosuvastatin on the basis of […]