On May 26, 2026, Amneal Pharmaceuticals, Inc. and Kashiv Biosciences petitioned for inter partes review (IPR2026-00260) of all claims of U.S. Patent No. 12,030,959 (“the ’959 patent”), assigned to Novartis AG and Genentech, Inc. The ’959 patent is generally directed to methods for treating pediatric patients having food allergies by administering subcutaneous omalizumab at certain dosage amounts and frequencies. The patent is listed as one of eight patents in the Purple Book for Novartis and Genentech’s XOLAIR.
In the Petition, Amneal and Kashiv raise five grounds for unpatentability of the claims. For four of the grounds, Petitioners argue that a subset of the claims are either anticipated or rendered obvious by articles disclosing results from Phase 1 and Phase 2 trials for omalizumab. For the final ground, Petitioners argue that all claims are obvious over a combination of three references: a clinical study protocol for the OUtMATCH clinical study, the label/prescribing information for XOLAIR, and a clinical article discussing omalizumab as a monotherapy for food allergies.
The Petition follows Amneal’s submission of a Biologics License Application (BLA) to the U.S. FDA for ADL-018, a proposed biosimilar to XOLAIR, on September 26, 2025. While related patents have been previously asserted against other parties in biosimilars litigation, this IPR is the first challenge to the ’959 patent. It is also the first legal proceeding between these parties that concerns omalizumab.
At this time, Celltrion’s OMLYCLO (omalizumab-igec) is the only biosimilar approved by FDA, approved in March 2025. It has been reported that Celltrion will be able to launch as early as September 1, 2026, as part of its settlement agreement with Genentech.
Stay tuned to Big Molecule Watch for further updates on this IPR and omalizumab.