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Snapshot of Sunshine rules in EU countries for the pharmaceutical industry part 1 - June 2014
  • McDermott Will & Emery
  • European Union, United Kingdom
  • June 12 2014

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. In 2013


Controlling and processing data in EU clinical trials
  • McDermott Will & Emery
  • European Union
  • November 22 2010

The legal regime for the conduct of clinical trials of medicinal products for human use in the European Union is set out in Directive 200120EC (the Clinical Trials Directive


European Commission fines pharmaceutical companies for Citalopram pay-for-delay agreements
  • McDermott Will & Emery
  • European Union
  • June 30 2013

On 19 June 2013, the European Commission announced a fine of 93.8 million for H. Lundbeck AS (Lundbeck) and a further 52.2 million of fines levied


Repackaging and parallel import of pharmaceutical products
  • McDermott Will & Emery
  • European Union
  • May 22 2007

On 27 April 2007, the European Court of Justice (the “ECJ”) handed down yet another decision in the case of Boehringer Ingelheim & others v Swingward Ltd and Dowelhurst Ltd, Case C-34804 (“Boehringer II”


The extent of supply limitation on EU pharmaceutical trade
  • McDermott Will & Emery
  • European Union
  • December 16 2008

In its 16 September 2008 judgment, the European Court of Justice (ECJ) gave further guidance on how a dominant pharmaceutical supplier can justify limiting supplies to wholesalers


What did you say? $31 million awarded for infringement of hearing aid patent
  • McDermott Will & Emery
  • European Union
  • November 29 2012

In a case involving the alleged infringement of two patents related to hearing aids, one of which was found under judgment as a matter of law (JMOL) to not be infringed


EPO Enlarged Board of Appeal invites the public to determine whether stem cells are contrary to morality
  • McDermott Will & Emery
  • European Union
  • July 30 2008

On 24 and 25 June 2008, in a public hearing on Wisconsin Alumni Research Foundation (WARF) Stem Cell patent application (G-0206), the European Patent Office (EPO) took the usual step of asking the public to assist it in making a determination regarding a patent application involving an invention in the controversial area of stem cell patenting


Lawfulness of new packaging in which drugs are marketed in another EEA state by a parallel importer
  • McDermott Will & Emery
  • European Union
  • March 27 2009

On a reference from the Austrian Supreme Court concerning Article 7 of the Trade Marks Directive (89104EEC) and the parallel importation of pharmaceuticals, the European Court of Justice (ECJ) has followed the lead of Advocate General Sharpston and concluded that the lawfulness of the new packaging, in which drugs are marketed in another European Economic Area (EEA) State by a parallel importer, is to be measured solely against whether it is capable of damaging the reputation of the trade mark and its proprietor


EMEA and FDA focus on clinical research safety and enforcement
  • McDermott Will & Emery
  • European Union, USA
  • August 20 2009

Recent policy changes emphasize the need for sponsoring organizations to be even more vigilant in establishing, updating and monitoring their systems for compliance with clinical research requirements, whether conducted domestically or in a foreign locale


Mergers: Commission approves Nestlé’s acquisition of Novartis' Medical Nutrition business
  • McDermott Will & Emery
  • European Union
  • July 6 2007

The European Commission has cleared the merger of Nestlé S.A. and Novartis' Medical Nutrition business (NMN) following a first phase investigation