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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


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”


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


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


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


Increased European patent protection following a landmark ruling on supplementary protection certificates
  • McDermott Will & Emery
  • European Union
  • August 30 2012

The Court of Justice of the European Union (CJEU) rendered judgment relating to a preliminary reference from the English Court of Appeal, holding that the existence of an earlier marketing authorization (MA) of a pharmaceutical product does not preclude the grant of a Supplementary Protection Certificate (SPC) for a different application of the same product


Commission to take Spain to court for ban on herbal products
  • McDermott Will & Emery
  • Spain, European Union
  • March 30 2007

Food supplements such as guaraná, ginseng, espirulina and passiflore, legally marketed in other Member States, are banned from being imported into Spain


Are supplementary protection certificates keeping pace with drug development?
  • McDermott Will & Emery
  • United Kingdom, European Union
  • April 10 2007

The pharmaceutical and biotechnology industries are heavily dependent on patents as a means of securing future revenues


Why life science patents are a breed apart
  • McDermott Will & Emery
  • European Union
  • April 10 2007

Patents are creatures of statute. Once an applicant has disclosed an invention, and subject to the application meeting certain statutory standards as to form and content, the European Patent Office grants a 20-year “monopoly”


Product and disease registries: planning for data protection
  • McDermott Will & Emery
  • European Union, USA
  • April 10 2007

Biopharmaceutical companies have now seen the power of post-market approval and observational registries