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Results: 1-10 of 21

EU Court of Justice interprets law extending patent protection for medicinal products
  • Shook Hardy & Bacon LLP
  • European Union
  • December 15 2011

The Court of Justice of the European Union (ECJ) has issued two rulings interpreting EU law at the request of British courts addressing whether drug makers can obtain a supplementary protection certificate (SPC), which extends patent protection, for products with active ingredients additional to those specified in the original patent


European Medicines Agency seeks feedback on biosimilars guideline
  • Shook Hardy & Bacon LLP
  • European Union
  • December 15 2011

The European Medicines Agency has issued for public comment a “Concept paper on the revision of the guideline on similar biological medicinal product.”


EU regulators charge pharma companies with antitrust violations in pay-for-delay deals
  • Shook Hardy & Bacon LLP
  • European Union
  • August 2 2012

The European Commission (EC) has reportedly charged nine pharmaceutical companies with breaches of European Union (EU) antitrust rules for entering pay-for-delay deals with generic competitors


Universities abroad experiment with no-fee licensing to drive biotech partnerships
  • Shook Hardy & Bacon LLP
  • USA, Australia, Canada, European Union, United Kingdom
  • May 16 2013

Universities in Australia, Canada, Europe, and the United Kingdom have reportedly embraced a 2010 Glasgow University initiative under which companies


EU Medicines Agency plans to appeal interim rulings on release of clinical trial data
  • Shook Hardy & Bacon LLP
  • European Union
  • May 16 2013

According to a news source, European Medicines Agency (EMA) Director Guido Rasi intends to appeal interim rulings recently issued by the European


Wellcome Trust creates £200-million fund for UK, EU biotech startups
  • Shook Hardy & Bacon LLP
  • European Union, United Kingdom
  • March 29 2012

The U.K.-based Wellcome Trust has announced the creation of a £200-million fund to make long-term investments in British and European biotechnology startups


EC approves first gene therapy medicine in western world
  • Shook Hardy & Bacon LLP
  • European Union
  • November 15 2012

The European Commission has given final approval to uniQure’s gene therapy Glybera for the treatment of lipoprotein lipase deficiency patients with recurring acute pancreatitis


European Commission proposes regulation on access to genetic resources
  • Shook Hardy & Bacon LLP
  • European Union
  • October 18 2012

To carry out European Union (EU) obligations under the Nagoya Protocol on Access to Genetic Resources and Benefit-Sharing, the European Commission (EC) has proposed a regulation that would ensure that only legally acquired genetic resources and associated traditional knowledge are used in the EU and that such resources are fairly and equitably shared


EU Court of Justice nixes patents for stem-cell inventions involving human embryo destruction
  • Shook Hardy & Bacon LLP
  • European Union
  • October 20 2011

The European Union (EU) Court of Justice has determined that EU patent law does not protect neural precursor cells and the processes for their production from embryonic stem cells


European Medicines Agency considers changes to biosimilar guidelines
  • Shook Hardy & Bacon LLP
  • European Union
  • October 20 2011

The European Medicines Agency (EMA) has published a concept paper outlining a number of clinical and non-clinical issues that need revision in its current “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance"