On Aug. 18, 2022, Federal Circuit affirmed district court’s non-infringement decision in Vasostrict® Hatch-Waxman litigation.

Federal Circuit said that here inquiry begins and ends with Eagle’s ANDA specification. Both the release and stability specification directly and unambiguously address the pH range of Eagle’s proposed product, ie pH between 3.4–3.6. Both patents-in-suit require that the vasopressin compositions have a pH of between 3.7 and 3.9. Eagle (Defendant) acknowledges it is bound by its representations to the FDA and that its ANDA product must have a pH between 3.4–3.6 throughout its shelf life, not just at release.

Par (Plaintiff) argued the district court erred by finding no discernable upward drift in pH and rejecting the relevance of even minor pH fluctuations. But Federal Circuit found no error in district court’s analysis. The court thoroughly considered the post-release pH data, along with Eagle’s expert testimony assessing that data, and found that, while the pH measurements fluctuated over time, there was no discernable trend—and certainly not an inevitable upward trend—in the fluctuations. Eagle’s ANDA specification thus controls and defines a non-infringing product.

You can read the previous district court’s decision “here” on this blog for more information.