Recent court decisions in Skinny Label cases show that liability increasingly focuses on post-launch conduct and real-world use, not label text alone. A panel of leading in-house counsel and litigators with innovative, biosimilar, and regulatory perspectives will address shifting litigation strategy.
- How branded and biosimilar companies should align legal, regulatory, and commercial behaviour.
- Analyse GSK v. Teva (Coreg) and the evidentiary role of marketing materials, sales conduct, and physician messaging.
- Discuss the original ruling in Amarin Pharma v. Hikma (Fed. Cir. 2024) , and examine the significance of Supreme Court review.
- Clarify evolving boundaries of permissible conduct for medical affairs, market access, and commercial teams.
- Compare with decisions made in other key jurisdictions including Canada and Europe.
Chuck Klein
Daniel Hoppe
Sanjaya Mendis
Sanjaya Mendis is a partner and life sciences IP litigator at McCarthy Tétrault LLP based in Toronto, Canada. The IP Litigation group is ranked Band 1 in Chambers and recently received the Patent Litigation Firm of the Year by LMG Life Sciences. Sanjaya handles complex cross-border contentious patent disputes and has represented clients in all levels of Canadian courts, including the Supreme Court. Sanjaya’s recent notable experience includes: Regeneron/Bayer (aflibercept); AbbVie (adalimumab); Merck (sitagliptin); and BMS/Pfizer (apixaban).
Shana Cyr
