• Recent updates in the EU pharmaceutical Law sector on competition law enforcement
• Insight into abusive dominance through excessive pricing
• Latest developments on reverse payment settlements

• Update on abusive dominance through excessive pricing case law
• Practical advice following decisions and developments in recent cases
• What constitutes excessive: identifying appropriate value indicators for originator products and understanding value to whom and compared to what

• Insight into the Lundbeck and Servier case: practical implications for patent settlements and market definition
• Acquisitions of technology: can this be considered an abuse of a dominant position?
• How do you define the relevant market from a competition law perspective to define dominance?

• Recent competition law rulings and case law for parallel trade: update on dual pricing
• Drivers of parallel trade across Europe, key risks and implications
• Exploring the impact of Brexit on the EU market and parallel trade practices
• Models and approaches for pharmaceutical companies: what opportunities and risks will Brexit offer?

• Examining cases, rulings and review for product hopping as a lifecycle management strategy
• Update on the expansion of antitrust scrutiny on product lifecycle strategies
• Strategies to minimise competition law risks and protect your product

• Update on the law of “protected by a basic patent force”: how is Gilead being applied by National Courts and Patent Offices? Royalty Pharma and Janssen references
• The latest on SPCs based on 3rd party Mas: what is the direction of travel?
• SPCs for novel and inventive formulations: the Abraxis decision
• SPCs for medical devices and combined medical devices/medicinal products – the CJEU decision in Boston Scientific
• Reform of SPC law - the Max Planck report and other initiatives: evaluating the proposed manufacturing exemption

• Examining recent trends in the granting of relief by the major European Patents Courts
• Are final injunctions no longer to be the norm following a finding that a patent is valid and infringed?
• What role could compulsory licences pay?
• Cross-border relief
• Update on Arrow declarations

• Examining the UKSC decision in the pregabalin case and the implications for plausibility, amendment of patents and cross-label use
• Practical steps to be taken when enforcing a second medical use patent
• How much data needs to be included in a patent? How to find the sweet-spot in which to file an application

Competition Law for Biosimilars

• Focus on competition authorities approach and enforcement for biologics and biosimilars
• To what extent do the competition law principles developed for generic drugs apply to the biological space?
• Status of abusive dominance: pricing practices and lifecycle market strategies

Intellectual Property Considerations for Biosimilars: Challenges and Opportunities

• Practical guidance for Biosimilars and patent infringement
• Strategies with respect to biosimilar launch and patent expiry

Regulatory Frameworks for Biosimilars

• How are biosimilars defined and interpreted in Europe
• What is the regulatory legal framework applicable to biosimilars?
• Insight into the interchangeability of biosimilars and national substitution policies
• Reviewing pricing and reimbursement considerations for biosimilars: country specific case studies