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 the hypothetical negotiation date should be in 2022 (when Airgas added Paragraph IV certifications for the asserted patents to its ANDA) or 2023 (when Airgas launched its product).
Judge Andrews held that that the actual launch date in 2023 was the correct date:
The hypothetical negotiation contemplating a "willing licensor-willing licensee" negotiation on the eve of infringement indicates the negotiation is based on a scenario where an infringer needs a license for its imminent launch. An ANDA holder does not need a license to file its ANDA, even if that ANDA is found to infringe. But the ANDA holder would need a license to launch the infringing product. The "willing licensor-willing licensee" framework makes little sense if the hypothetical negotiation date is a date when a license is not needed. The appropriate hypothetical negotiation date is thus November 2023, when Airgas launched its product.
Id. at 7.
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