One of the hallmarks of the Hatch-Waxman Act is the "offer of confidential access," wherein the generic manufacturer must offer the NDA holder, you guessed it, confidential access to the ANDA before the deadline to file suit.
One of the lesser explored implications of the OCA is the effect of a patentee declining the offer and bringing suit without reviewing the actual ANDA. In particular, how does that decision effect the attorney's fees inquiry if the NDA holder is ultimately unsuccessful at trial?
This was the question Judge Goldberg addressed on Friday in Silvergate Pharms., Inc. v. Bionpharma Inc., C.A. No. 18-1962-MSG (D. Del. Oct. 4, 2024) (Mem. Op.). Bionpharma had prevailed …
