In this edition we report on a range of recent developments, at EU national level, relating to patent and SPC decisions and regulatory news. We hope you enjoy reading this update and are happy to address any comments or questions you may have, either through your usual contact or through any of the contacts listed in this update.
CJEU: Swiss authorisation automatically recognised in Liechtenstein may be regarded as the first authorisation when calculating SPC duration
Ewan Grist, London
On 14 November 2013, the CJEU gave a reasoned order in AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks, following a reference from the High Court of England & Wales (C-617/12).
GlaxoSmithKline Biologicals SA (GSK) & Anr v Comptroller-General of Patents, Designs and Trade Marks C-210/13
Rebecca O'Kelly, London
Recently the CJEU gave a reasoned order in relation to questions arising from the UK Patent Comptroller-General's refusal to grant GSK two supplementary patent certificates ("SPCs").
Italy: preliminary injunction against a generic sustained release formulation of quetiapine lifted
Giovanni Galimberti and Evelina Marchesoni, Italy
By decision filed on October 4 2013, the Court of Rome lifted the preliminary injunction granted in August 2013 in favour of AstraZeneca AB and AstraZeneca S.p.A. (jointly "AstraZeneca") against Teva Italia S.p.A. ("Teva"), which had launched a generic sustained release formulation of an anti-psychotic drug known as quetiapine in Italy (marketed by AstraZeneca under the trademark "Seroquel").
Poland: Outsourcing of API manufacture is not covered by the Bolar exemption
Marta Koremba, Aleksandra Karpińska
On 23 October 2013, the Polish Supreme Court rejected a cassation appeal filed by Pharmaceutical Works Polpharma S.A. ("Polpharma"), a leading Polish producer of Active Pharmaceutical Ingredients ("APIs"). The case concerned the European "Bolar" exemption, especially with respect to the admissibility of an API's manufacture by a subcontractor.
General Court overrules European Commission on Orphacol marketing authorisation
Trevor Cook, Former Bird & Bird, London Partner
Article 10a of EU Directive 2001/83/EC, as amended, provides a route by which an applicant seeking marketing authorisation for a medicinal product can secure such an authorisation without the need to submit pre-clinical data and clinical trial data as to safety and efficacy, or to cross reference (after expiry of the period of regulatory data protection) an existing marketing authorisation for the same active substance based on such data.
Czech Republic: New obligation to give reasons for interrupted drug supplies and first ban on drug export
Jiří Malý, Vojtěch Chloupek, Prague
A recent amendment to the Czech Act on Pharmaceuticals created a new obligation on marketing authorisation holders to provide the State Institute for Drug Control ("SIDC") with reasons for interruptions to the supply of particular pharmaceutical products. The Czech market also realises that in practice, the limited availability of particular pharmaceutical products on the market is not always as a result of problems with their supply, but may also be associated with their exportation abroad. The market is therefore considering steps to try to limit such exportation and the Czech Ministry of Health has actually prohibited the export of a pharmaceutical product for the first time in modern history.
Swedish Government and pharmaceutical industry agree on a new pricing model for pharmaceutical products that have been on the market for more than 15 years
Johanna Elvander Juhlin and Mathilda Nordmark
As a result of an agreement between the Swedish Government and the Swedish trade association for the researched-based pharmaceutical industry , LIF (Sw. Läkemedelsindustriföreningen), the price of pharmaceutical products that have firstly, not been subject to competition from generic products; and secondly, which are older than 15 years will be reduced by 7.5 percent as of 1 January 2014.