09.45 Chair’s Welcome

Focus Day Chairperson: Allen Norris
Vice President, Head of IP
UCB Group

10.00 Effective Interaction Between IP And Regulatory Affairs

• Legal opportunities for market exclusivity in the pharmaceutical field
• Patent Term Extensions in different jurisdictions
• Requirements for getting Patent Term Extensions
• Case Law related to Patent Term Extensions

Frank Burket
European Patent Attorney
Bayer Healthcare

10.45 Recent Cases And Legislative Changes Concerning Supplementary Protection Certificates In The UK

• Conditions for SPC to be granted: e.g. Basic patent covers API
• SPC’s and combination products
• Basic guideline for approval process

Lawrence Cullen
Deputy Director
UK IPO

12.00 Discussion Session: SPCs And Patent Term Extensions – Target’s For Litigation

• Analysis of the growing trend in generic attack of SPC’s and Patent Extensions
• What can be protected? and the importance of claims
• Assessing the balance between marketing authorisation and litigation, recent case-law

Facilitated by Focus Day Speakers

13.30 Extending Your Patent Lifecycle: An Agrochemical Perspective

• Considerations to the similarities and differences between the Pharmaceutical and Agrochemical sectors
• Global case law analysis: conclusions to make positive decisions impacting your patent lifecycle
• Positive impact on us as a business: ROI

Marian Flattery
Global Head of IP
Syngenta Crop Protection

14.45 Gaining Paediatric Exclusivity Europe

Europe

• The EC Regulation requirements (Paediatric Investigation Plan, SPC)
• SPCs: Case Law Update / paediatric exclusivity
• Strategy considerations for new paediatric indication or orphan drugs

US

• Request from the FDA to perform paediatric studies
• Timelines for obtaining paediatric exclusivity

Eric Ruhlmann
Senior Patent Counsel
Actelion

15.30 Chair’s Closing Remarks

Allen Norris
Vice President, Head of IP
UCB Group

15.45 Close Of Conference Media Partners