Part I: A Matter of Exclusivity and Offset Losses
Natasha E. Daughtrey
Partner
Goodwin Procter LLP
James T. Evans, Ph.D.
Senior Director | Assistant General Counsel, Dispute Resolution
Regeneron Pharmaceuticals
- What lessons were learned from the Humira biosimilars about the exclusivities afforded under the BPCIA – and now the IRA?
- Assessing the possibility – or impossibility – of circumventing a patent thicket in view of the Humira District Court and Federal Circuit rulings
- Extending exclusivity beyond the initial patent
- Devising strategies for obtaining the longest exclusivity period for your biosimilar
- Negotiating the best settlement agreement for sharing exclusivity period
- Determining entry dates in the U.S. and abroad