ANDA litigation can be an odd beast. You file a case based on a product that a defendant has only applied to manufacture—what then, when the FDA requires an amendment? What of the litigation that may be years in the making and heading into the home stretch?
The somewhat tortured history of Biodelivery Sciences International, Inc. et al. v. Chemo Research, S.L., C.A. No. 19-444-CFC-CJB, gives us several examples of exactly how the Court deals with this situation.
An Early Change to an ANDA Does Not Warrant a New Trial Date
Early on in that case (about 6 months after the scheduling order was entered) one of the defendants—Chemo—received a complete response letter ("CRL") from the FDA requiring them …