Global Strategies for Biosimilars and Innovator Biologics: From Patent Protection to Cost and Market Access

May 31, 2022 9:10am

Rieke Kaup
Case Handler
European Commission

Shohta Ueno, PhD
Director, Dispute Resolution
Regeneron UK Ltd

Otto Licks
Partner
Licks Attorneys

Peter van Schijndel
Partner
Hoyng Rokh Monegier

Heli Pihlajamaa
Director
European Patent Office

In 2022, the introduction of efficient regulatory pathways, the application of competition law and a novel court system in Europe will significantly impact the way in which biosimilar medicines will enter the marketplace. Further, some of the best-known biologic medicines will lose patent protection over the next five years. During this session, topics of discussion will include:

  • Understanding the regulatory framework and legislative developments impacting the global pharmaceutical industry
    • Reviewing the potential adaptation of competition law
    • Taking stock of the impact of the Unified Patent Court
  • Understanding the economics of biosimilars
    • Considerations for market access, sustainable pricing and reimbursement policies
    • Market uptake of biosimilar products
    • Biosimilar v. biosimilar litigation in a crowded market
  • Are biobetters a viable alternative?
  • Innovator v. Innovator litigation
    • Proportionality/appropriateness of injunctive relief
    • Whether the claims of a patent are too broad
    • Increasingly bringing innovator companies with competing pipeline candidates into disputes