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.
Speaker(s):
Chuck Klein
Partner
Winston & Strawn
Shana Cyr
Head of Patent Litigation
Bristol Myers Squibb
Viviane Kunisawa
Partner
Daniel Law
Time:
09:55am - 10:45am
Agenda Track No.:
Track 3
Session Type:
Track
Force Inline Description:
0