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8th EGA Legal Affairs Forum
22-23 March 2012, Brussels
Full Programme
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LOCATION: Renaissance Brussels Hotel - Rue du Parnasse 19, B-1050 Brussels
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Recent developments on SPCs:
• SPC caselaw and legislation update
- The galanthamine and the memantine decisions
- The Medeva and the Georgetown references to the CJEU
- Paediatric extensions: negative term SPCs
• Combination products in the pipeline
- the effect of the Medeva judgment
• Litigating SPCs around Europe - escitalopram case study
- What is the product/active ingredient? Regulatory and litigation strategies
• Roundtable presentations on national escitalopram SPC cases: Germany, France, The Netherlands, Belgium
Maximising legal professional privilege:
• Privilege in litigation in Europe
(General overview, comparing approach in different Member States)
• US perspective on Privilege
(US approach to privilege and discovery, issues with cross-border communications in “touch base” rules vs comity rules, practical guidelines for litigants/potential litigants)
• Privilege and European Commission investigations/patent settlement cases
(The Akzo Nobel case, practical issues arising from investigations - privilege and disclosure, update on the Commission’s investigations into patent settlements)
Patent enforcement in Europe:
• Views on the review of Directive 2004/48/EC on the enforcement of IP rights
• Views on the changes in the EU patent system: single court and patent with unitary effect
• Update on court cases that impact the industry
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Click here to BOOK NOW YOUR ACCOMMODATION at the Renaissance Brussels Hotel
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FOR A DECADE, THE PREMIER EU EVENT ON BIOSIMILAR MEDICINES!
Come and meet the EU and international regulators and the leading EU companies in biosimilars. The pre-symposium workshop will explore the mechanics of the Biologics Act with an emphasis
on how the Act relates to the involved intellectual property and how the intellectual property may impact the biosimilar applicant’s strategy for entering the market.
Symposium Highlights 2012:
• Get the IMS outlook on the biotechnology and biosimilars global market and its opportunities
• Become familiar with the roadmap for an EU policy for biosimilars
• Hear the investors’ insights into mergers & acquisitions and the financial market perspective of the biosimilars market
• Exchange views on the experience with the national uptake of biosimilars
• Get a detailed update from the EU regulators on the revised biosimilar guidelines and the adopted biosimilar monoclonal antibodies guideline
• Learn about the latest status of the US FDA biosimilar guidelines and the developments in Japan and major Latin American countries
• Join the discussion on the need for a framework supporting global development for biosimilars
• Come and meet regulators from all over the world and take advantage of networking opportunities within the biosimilar industry
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BOOK YOUR ACCOMMODATION at the Millenium Hotel London Mayfair
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• KEYNOTE SPEECH - The European Union's vision in the European year for active ageing and solidarity between generations - Commissioner John Dalli, European Commissioner for Health and Consumers
• Society undergoing transformation: how to better match the medicine needs of society and improve healthcare sustainability
• Price cuts, tendering systems, price reference systems: the way forward to a sustainable generic medicines industry
• How can European generic and biosimilar medicines companies succeed in a changing world?
• The role of generic and biosimilar medicines in response to patients’ needs
• Future scenarios for the generic and biosimilar medicines industry: viewpoints from investors and analysts
• CEO PANEL – What is the future of the EU generic and biosimilar medicines industry in the period of global economic upheaval and demographic changes:
the views of global CEOs from leading generic and biosimilar medicines companies
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