DIA Pharmaceutical Patents and Regulatory Exclusivity Workshop

Venue: NH Harrington Hall Hotel

Location: London, United Kingdom

Event Date/Time: Oct 30, 2008 End Date/Time: Oct 31, 2008
Report as Spam


Who will attend?
• Inhouse patent specialists and life cycle management teams
• Regulatory experts interested in the principles of patents
• Outside counsel
• Officials of the national patent and medicines agencies and of EC institutions

Learning Objectives:
• Provide an overview of recent developments affecting exclusivity rights of the pharmaceutical industry
• Updates on the conditions for patent protection and effective enforcement
• Explore the limits of European harmonisation and the impact of the international perspective
• Detailed analysis of the new Paediatrics Regime and opportunities for extension of SPCs
• Understanding competition law

Overview of sessions:
• Key Developments on Pharmaceutical Patents
- Recent developments on patentability
- Update on biotechnology patents
- Second medical use patent claims

• Key Developments on Data Exclusivity
- Interpretation of the revised pharmaceutical legislation
- Biosimilars
- Generic prescribing and substitution

• National Developments in Patent Law and Practices
- Germany
- UK
- The Netherlands

• International Perspective
- Challenges in other European countries - View from Turkey
- Doha and compulsory licensing
- International view from industry

• The Paediatric Regulation and Intellectual Property (IP) Rights (jointly with the DIA Paediatric Forum)
- Overview of the IP aspects of the Paediatric Regulation
- Basic principles of SPCs
- Basic conditions for obtaining the SPC extension

• Challenges for Obtaining the Supplementary Protection Certificate (SPC) Extension (jointly with the DIA Paediatric Forum)
- Practices of National Patent Offices
- How to obtain the necessary regulatory documents?
- Industry perspective - Will the regime be effective?

• What Will the Future Bring for Patents?
- EC 2000 and further European harmonisation
- Better tools for enforcement?

• Update on SPCs

• Competition Law and Exclusivity Rights
- The sectoral investigation by DG Comp
- The legal principles and policy considerations