Legal Strategies for Developing Generic Medicines

Hear practical and in-depth presentations on:

• The new European Pharmaceutical legislation
• The Bolar Provision and disparities between EU Member States
• Patent litigation: a year in review
• Patent considerations before a generic drug launch
• Authorised generics and how to steal a march on your competitors
• The legal and regulatory landscape for biosimilars in the EU
• Formulation patents
• Evergreening policy of originators and possible counter-measures of the generic side

Crowell & Moring's Kristof Roox will be participating in a panel discussion, The Legal and Regulatory Framework for Biosimilar Products in the EU. His discussion will address the need for a different abridged regime; the regime essentials; the new guidelines (quality, non-clinical and clinical issues/specific products); Omnitrope and Valtropin and implications.