“Consisting of” Consequences: Prosecution Disclaimers Outweigh Pretrial Stipulations
By EsqSocial Corporation 16/04/25
The Federal Circuit recently opined on whether a stipulation in litigation can overcome a disclaimer made during the prosecution history of a patent. The Hatch-Waxman Act allows generic drug companies to use clinical results from brand-name drugs in the FDA approval process. In exchange, the brand-name drug companies get a short-term monopoly before the FDA approves any generics. Alkem filed an Abbreviated New Drug Application (“ANDA”) with the FDA, and Azurity alleged the ANDA showed a...
By: Irwin IP LLP