Global Intellectual Property Center

Tag Archives: Europe

Clinical Data and Disclosure Policies: The European Union, Member States, and International Best Practices

Clinical Data and Disclosure Policies: The European Union, Member States, and International Best Practices

EMA study cover graphicThe purpose of this report is twofold. First, provide an exhaustive analysis of the clinical data transparency aspects of EU Parliament Regulation 536/2014 on clinical trials and EMA’s finalized policies on Publication and Access to Clinical Trials Data. Second, review the wider policy implications and interface of these central EU-level policies with current data disclosure policies at the EU member state level, looking at five EU countries: Germany, Italy, Spain, Sweden, and the U.K.

What IP Nerds Need to Know About the New European Commission

What IP Nerds Need to Know About the New European Commission

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By Ashley Mergen Scottish (in)dependence, coalition governments in Afghanistan, and potential changing of majorities in the U.S. Congress: everyone loves a good shake-up every now and then. And that’s exactly what the European Commission (EC) delivered early this month, with president-elect Jean-Claude Juncker unveiling his vast reorganization of the bureaucracy in Brussels. Recognizing that there […]

GIPC Previews BIO 2014

GIPC Previews BIO 2014

This week, expect temperatures to rise in San Diego as thousands from one of the hottest fields in innovation converge at the International BIO (Biotechnology Industry Organization) Convention here in Southern California.

Heading in a Different Direction? The European Medicine Agency’s Policy on the Public Release of Clinical Trials Data

Heading in a Different Direction? The European Medicine Agency’s Policy on the Public Release of Clinical Trials Data

EMA study cover graphicThe purpose of this briefing paper is to examine and compare the draft guidelines issued in 2013 by the European Medicines Agency (EMA), titled “Publication and Access to Clinical-Trial Data,” with existing practices in the European Union (EU) and internationally regarding regulatory data protection and data transparency initiatives.

77 Million Reasons Why IP Delivers

77 Million Reasons Why IP Delivers

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The benefits of IP deliver far beyond U.S. borders. Recently, the EU revealed the results of a similar study, finding similar contributions by IP-intensive industries to the EU’s economy. Commissioned by the European Patent Office (EPO) and the Office for Harmonization in the Internal Market (OHIM), the report found that IP-intensive industries create 77 million jobs and generate 40% of the total economic activity throughout the EU – roughly 4.7 trillion euro annually.