Negotiating Generic Drug Launch Entry Dates with Generic Manufacturers
Hatch-Waxman patent litigation between innovator biopharma and generic manufacturers can cost $20M in legal fees. Here is how General Counsel structure authorized generic launch settlements.
Amit KasliwalCEO & Founder, Dehurdle
March 10, 20234 min read
The Authorized Generic Settlement Script
Recommended Spoken Script
"Rather than continuing multi-year Paragraph IV patent litigation through the Federal Circuit, we propose a formal settlement granting your firm an exclusive authorized generic license to launch 6 months prior to our composition-of-matter patent expiration, with standard 50/50 net profit sharing."
The 2-Minute Practice Drill
2-Minute Spoken Drill
The 2-Minute Practice Drill
Practice Hatch-Waxman IP settlements in Dehurdle.