IP Hatch-Waxman Team Successfully Defends Alkem Laboratories
Thursday, April 10, 2025
The IP Hatch-Waxman Act team of Alan Pollack and Josh Miller successfully defended Alkem Laboratories, Ltd. in both the district court and before the Federal Circuit.
After the Delaware district court found that Alkem’s propylene-glycol containing Vancomycin oral solution product did not infringe the asserted patent of Azurity Pharmaceuticals because Azurity disclaimed the use of propylene glycol, the Federal Circuit affirmed, finding that “the infringement inquiry here is very simple: propylene glycol was disclaimed; the ANDA contains propylene glycol; therefore there is no infringement.”
On April 8, 2025, the Federal Circuit affirmed the District Court’s ruling in a precedential opinion. Read the opinion.
