In a post-trial Hatch-Waxman opinion issued this week, Chief Judge Connolly sided with the defendant regarding the sole infringement dispute: whether the defendant's ANDA product had an infringing pH. The plaintiffs' patents required that the claimed compositions have a pH of between 3.7 and 3.9. The defendant's ANDA undisputedly required that the defendant's generic product have a pH between 3.4 and 3.6. Importantly, the ANDA required that the product stay within the 3.4-3.6 range both upon release and during the stability testing period (24 months).
Given that the ANDA's requirements are binding on the manufacturer of the generic product, and given that the ANDA is the operative document for the purposes of the infringement inquiry in Hatch-Waxman cases, you might think that would be the end of the inquiry. Indeed, Judge Connolly noted that in these circumstances, a judgment of noninfringement "must necessarily ensue."
However, the plaintiffs challenged this conclusion...