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11th EGA Legal Affairs Forum
26 - 27 March 2015
Thon Hotel EU
Rue de la Loi/Wetstraat 75 – 1040 Brussels, Belgium
Thursday 26 March 2015
11th EGA Legal Affairs Forum
13:00
Registrations & Welcome buffet lunch
14:00
Welcome by Nick Haggar, President, EGA (TBC)
14:10
Session I - “EGA 2020” - where are the latest trends leading this sector?
A panel Discussion with EGA Members’ Senior Lawyers
Chair  Adrian van den Hoven, Director General, EGA
Panel discussion with
Shannon Klinger, Global Head Legal and General Counsel, Sandoz
Suzanne Smith, Executive Director, Legal, Actavis
Falk Nuernberger, General Counsel Europe, Mylan
Panelists TBC
15:10
Questions & answers
15:20
Coffee break
15:50
Session II - A Supplementary Protection Certificate (SPC) export exception: the
way forward?
Chair  Julia Pike, Head Global IP Litigation, Sandoz
Speaker  Alexander Wittkopp, Partner, Maiwald
Panel discussion with
François Arbault, Heads of unit DG MARKT, European Commission
Thomas Kolzau, Patent Affairs, Helm
Panellists TBC
16:50
Questions & answers
17:00
End-of-day cocktail
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209
11th EGA Legal Affairs Forum
Friday 27 March 2015
08:00
Networking coffee
Session III - The interplay between IP and regulatory matters
Chair  György Thaler, Chair Legal Affairs Committee, EGA
09:00
Second medical use and dose regimen claims
Fiona Bor, Director of Intellectual Property, Mylan and Duncan Curley, Founder &
Head of Patents, Innovate Legal
09:20
Orphan drugs exclusivities
Speaker TBC
09:40
Sunset clause
Javier Huarte, Partner, Grau & Angulo, Spain
10.00
Euro-Bolar situation
Christoph de Coster, Taylor Wessing
(TBC)
10:20
EMA policy on Clinical Trial Transparency
Trevor Cook, Partner, WilmerHale
10:40
Coffee break
11:10
Panel debate
Stefano Marino, Head of Legal Department, EMA
Javier Huarte, Partner, Grau & Angulo, Spain
Ravinder Chahil, Director of Intellectual Property, Polpharma
Panellists TBC
12:00
Questions & answers
12:15
Networking Buffet Lunch
Session IV - The latest trends in patent litigations globally and in the EU – How is
the European industry affected?
Chair  Ravinder Chahil, Director of Intellectual Property, Polpharma
13:30
General update on court cases that impact the industry
Speaker TBC
13:50
Questions & answers
14:00
Presumption of patent validity in patent litigations – the new trends
Kristof Roox, Partner, Crowell & Moring
14:20
Questions & answers
14:30
The global impact of the changes in the US Patent Guidance: Post Myriad v
Prometheus decision: New rulings for patentability under 35 U.S.C. §101
Albin J. Nelson, Ph.D., J.D., Senior Shareholder SLWIP
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209
14:50
Questions & answers
15:00
Biosimilars patent litigation
Speaker TBC
15:20
Questions & answers
15:30
End of Forum Coffee
For further information and to register on-line, please visit:
www.egaevents.org/laf or www.egagenerics.com
Lucia Romagnoli - T: +44-7562-876873 - E: [email protected]
Registrations close officially on 18 March 2015 and are subject to availability.
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209