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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


Paying Royalties for Technology that Competitors Can Use for Free - AG Wathelet’s Genentech Opinion
  • McDermott Will & Emery
  • European Union
  • April 28 2016

The Court of Justice of the European Union (CJEU) recently issued its opinion on a question referred to it by the Paris Court of Appeal regarding the


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


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


SPCs: is a simplistic system becoming too complicated?
  • McDermott Will & Emery
  • European Union
  • November 22 2010

Obtaining and enforcing Supplementary Protection Certificates (SPCs) for medicinal products in the European Union is a fertile ground for challenge and the law is still unclear in a number of key areas


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”


Preventing parallel trade in the European Union
  • McDermott Will & Emery
  • European Union, Greece
  • October 31 2008

Lelos and Others v GSK C-46806 concerned a dispute between the Greek subsidiary of GlaxoSmithKline (GSK) and a number of Greek wholesalers


General Court of the EU Confirms Fines Imposed on Lundbeck and Generic Drug Manufacturers for Entering into Patent Settlements
  • McDermott Will & Emery
  • European Union
  • September 22 2016

On 8 September 2016, the General Court of the EU (GCEU) handed down five judgments upholding a decision by the Commission of 19 June 2013 imposing


The case of ophthalmic drugs in Italy and France: a lesson to learn - parallel antitrust investigations and cooperation between national competition authorities
  • McDermott Will & Emery
  • European Union, France, Italy
  • May 7 2014

The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the


International news: focus on compliance - winter 2014
  • McDermott Will & Emery
  • China, European Union, Germany, Global, USA
  • December 2 2014

As regulatory oversight of companiesfrom Sarbanes Oxley and the Dodd-Frank Act to the Foreign Corrupt Practices Act (FCPA) and the UK Bribery