Melinta Therapeutics, LLC v. Nexus Pharmaceuticals, Inc.

Melinta Therapeutics, LLC v. Nexus Pharmaceuticals, Inc. The Federal Circuit affirmed the judgment as to the '802 patent, upholding the district court's constructions of "composition" and "administering" and rejecting Nexus's written-description challenge. Because the '802 and '105 patents shared the same expiration date and the affirmed '802 judgment supported the same relief, the court declined to reach the '105 patent issues. The decision is a practical reminder that closed "consists of" formulation language may still be read in view of the administration context and specification, including required dilution steps, and that written-description comparators will be assessed against the invention actually described. Affirmed as to the '802 patent; issues concerning the '105 patent not reached. The asserted '802 claims recited administering an aqueous minocycline/magnesium/base composition, with a magnesium-to-minocycline ratio and pH range, whereby injection-site hemolysis is reduced relative to a composition without magnesium. Nexus argued that the closed "consists of" language excluded any diluent before administration, so its ANDA product could not infringe because it required dilution before IV use. The Federal Circuit agreed with the district court that "composition" referred to the reconstituted three-ingredient solution before further dilution, while "administering" meant giving the diluted composition intravenously; the specification, expert testimony, and prescribing information supported that reading. On written description, the court held the relevant comparator was the same minocycline formulation without magnesium or other metal cations—not formulations using calcium—because the specification focused on adding divalent cations to prior minocycline formulations lacking such cations. The court found Nexus preserved its comparator argument despite raising it briefly below, but affirmed the district court's no-invalidity finding for lack of written description. Hatch-Waxman / ANDA claim construction infringement § 112(a) waiver / forfeiture injunction / stay non-precedential Hatch-Waxman / ANDA claim construction infringement § 112(a) waiver / forfeiture non-precedential claim construction infringement § 112(a) Hatch-Waxman / ANDA