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EU Pharmaceutical Law Forum
Hybrid Event
20-22 May, 2025Steigenberger Wiltcher's, Brussels
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Key Sessions
Anna Vernet
KEYNOTE ENFORCERS’ ROUNDTABLE: Priorities and Focus
European Commission
Karin Pramberger
Unitary SPC and Wider Legislative Changes Affecting Patents
Polpharma Group
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Day 1 - CET/CEST (Cent Europe Summer, GMT+2)

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Day 1 - CET/CEST (Cent Europe Summer, GMT+2)
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Showing 1 of 1 Streams
08:00 - 08:50
Registration
08:50 - 09:00
Opening Remarks from Chair
  • Mélanie Thill-Tayara - Antitrust/Competition Partner, Dechert
09:00 - 09:30
Update from EU Commission on Competition Law Enforcement
  • Recent updates on competition law enforcement in the EU pharmaceutical sector
  • Current and future focus for 2025 and beyond
  • Anna Vernet - Head of Unit, DG Competition, European Commission
09:30 - 10:20
Merger Control Developments and the Practical Commercial Implications
  • Developments since the Illumina/ Grail ruling and implications for merger control strategy
  • National competition authority developments and thresholds for merger control
  • Comparison of EU developments to global trends in merger control
  • Approaches to navigating regulatory regimes for below-threshold deals
  • Angélique de Brousse - Head of Competition Law and Policy Group EMEA, Johnson & Johnson
  • Héctor Armengod - Partner, Latham & Watkins LLP
  • Julia Wahl - Partner, Copenhagen Economics
10:20 - 10:50
Networking Break
Showing 1 of 1 Streams
10:50 - 11:30
Promotional Strategies and the Misuse of the Regulatory System
  • Implications of product denigration and disparagement in the Vifor Pharma and Teva cases
  • How are the national regulators approaching disparagement?
  • Misuse of the regulatory system and wider strategies employed for preventing competition involving regulatory processes
  • How far can originators go and what is the scope for generic manufacturers to challenge this?
  • Jacob Westin - Global Head of Legal Antitrust, Sandoz
  • Nicolas Pourbaix - Senior Counsel, Amgen
  • Ingrid Vandenborre - Partner, Antitrust/Competition, Skadden, Arps, Slate, Meagher & Flom
11:30 - 12:10
Has the Servier Case Changed What it Means to be in a Dominant Position?
  • The definition of relevant market and dominance after the Servier Case and implications for the industry
  • Should market definition for the pharmaceutical industry only be based on economic substitution?
  • Are the outcomes of Servier case workable going forward?
  • Is there a difference between abuse of dominance and merger cases?
  • James Killick - Partner, White and Case
  • Julia Wahl - Partner, Copenhagen Economics
  • Amalia Athanasiadou - Lead Counsel, CSL Vifor
12:10 - 12:50
EU Commission Revision of 102 Guidelines: Impact on Pricing and Rebates
  • Update on the implications of draft Article 102 guidelines: examining the notion of competition on the merits
  • Review of authority approach: recent excessive pricing decisions, challenges in assessing and enforcing theories of harm based on excessive pricing
  • Court of Justice ruling in Google and Apple cases and the implications for the pharmaceutical industry
  • Implications and practical actions in light of new guidance for the industry
  • Niels van Nuland - International Competition Law Counsel, Senior Director Legal, Gilead
  • Michael Clancy - Partner, Van Bael & Bellis
12:50 - 14:20
Networking Lunch
Showing 1 of 1 Streams
14:20 - 15:10
KEYNOTE ENFORCERS’ ROUNDTABLE: Priorities and Focus
  • Understanding competition authority priorities and focus for 2025 and beyond on antitrust matters
  • Updates on competition authority activity levels
  • To what extent are competition authorities cooperating in the pharmaceutical space?
  • Anna Vernet - Head of Unit, DG Competition, European Commission
  • Elisabetta Lanza - Officer (Legal Expert), Italian Competition Authority
  • Anne-Charlotte Prévot - Co-ordinator for Health & Pharma Task Force, Belgian Competition Authority
15:10 - 15:50
Unitary SPC and Wider Legislative Changes Affecting Patents
  • SPC legislative changes and case law: will the proposed streamlined approach to obtaining EU-wide SPC protection positively impact pharmaceutical companies?
  • Other EU legislative updates including Bolar Provisions and RDP and compulsory licensing
  • Karin Pramberger - Head of IP, Polpharma Group
  • James Horgan - Chief IP Counsel - International Litigation and Policy, Merck Sharp & Dohme
  • Partner ,, Private Practice
15:50 - 16:20
Networking Break
Showing 1 of 1 Streams
16:20 - 17:00
Unified Patent Court (UPC): Early Conclusions and Implications on your IP Strategy
  • Current experience, practicalities, and challenges related to the UPC
  • Review of trends on how innovators, generics and biosimilar companies can utilise the Unitary Patent & UPC
  • What are the consequences for your IP strategy?

  • Kristin Cooklin - Group Head of IP, Recordati
  • Toni Santamaria - Senior Vice President Intellectual Property & Legal, Adalvo
  • Partner ,, Private Practice
17:00 - 17:40
Are Transparency Regulations and Requirements a Threat to Trade Secrets and Patent Filings?
  • Patent considerations for clinical trial data: data requirements that could preclude patent protection
  • Implications of the European Health Data Space legislation for trade secrets and patents
  • Practical approaches and avoidance strategies: penalties for non-compliance vs. value of data
  • Implications on your lifecycle management
  • Nicolás Vincent Ruiz - Global Intellectual Property Head, Esteve
  • Partner ,, Private Practice
17:40 - 18:40
Close of Competition, Patents and SPCs Followed by Networking Reception
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