Judge Andrews had an interesting decision yesterday on the hypothetical negotiation date in an ANDA case.
Obviously, damages issues like a hypothetical negotiation date don't come up very often in an ANDA case. Mallinckrodt PLC v. Airgast Therapeutics LLC, C.A. No. 22-1648-RGA, D.I. 461 (D. Del. Aug. 20, 2025), was a little different, however. In that case, the Defendant Airgas had actually filed its ANDA 12 years before the case was filed, and before any of the asserted patents were added to the orange book. Accordingly, there was no 30-month stay.
By the time summary judgment came around, Airgas had launched its product and damages were thus in play. The parties disputed whether …
