In a Hatch-Waxman case, the District of Delaware denied a motion for summary judgment seeking to apply the ANDA filing date as the date of the hypothetical negotiation used to calculate reasonable royalty damages. Instead, the court determined that the appropriate date to use for the hypothetical negotiation is the launch date.
Here, Plaintiffs sued Defendants for infringing patents directed to inhaled nitric oxide (“iNO”) products after Defendants submitted an ANDA for a generic iNO product. Plaintiffs moved for summary judgment on several issues, including for a ruling that the hypothetical negotiation date for calculating reasonable royalty damages was November 2022—the date Defendants amended their ANDA to include paragraph IV certifications for the Orange Book-listed patents. Defendants countered that the correct date for purposes of the hypothetical negotiation was a year later, November 2023, when Defendants launched their generic product.
The court rejected Plaintiffs’ arguments, finding the correct date to be Defendants’ launch date. In reaching this conclusion, the court explained that the filing of an ANDA is an artificial act of infringement. While it gives the Plaintiffs the right to sue, it does not create a situation in which a defendant needs a license. The “hypothetical negotiation” is premised on a theory that there is an imminent need for a license, i.e., there is a willing licensor and a willing licensee. As the court noted, “it makes little sense” for the hypothetical negotiation date to be “a date when a license is not needed.” According to the court, because Defendants do not need a license until their product is launched, the hypothetical negotiation date should be set according to the launch date.
Practice tip: This decision clarifies that even in the ANDA context, the hypothetical negotiation date aligns with when the accused infringer would need a license—here, at product launch as opposed to ANDA filing. Practitioners involved in ANDA litigation where damages are at-issue should be mindful that filing an ANDA, though considered an “artificial” act of infringement, does not likely set the hypothetical negotiation date.
Mallinckrodt Pharmaceuticals Ireland Limited et al v. Airgas Therapeutics LLC, 1-22-cv-01648 (D. Del. Aug. 20, 2025)