Aurinia Pharmaceuticals Announces Allowance of a New and Refined Method of Use Patent for LUPKYNIS® in the Treatment of Lupus Nephritis

Aurinia Pharmaceuticals has announced that the United States Patent and Trademark Office (USPTO) has allowed a method of use patent application titled IMPROVED PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS.

Aurinia’s newly allowed U.S. Patent Application (No. 17/713,140) reflects the unique and proprietary dosing regimen of its currently marketed product, LUPKYNIS. Specifically, this patent further refines the method of using LUPKYNIS in combination with mycophenolate mofetil (MMF) and corticosteroids using eGFR as a method of pharmacodynamically dosing the product in patients with lupus nephritis. The newly allowed application provides patent coverage that supplements Aurinia’s existing U.S. Patent No. 10,286,036, which is listed in the Orange Book and claims an FDA-approved method of using LUPKYNIS. The claims in this additional patent add further specificity on dosing consistent with the FDA-approved product label. This patent has the potential to provide an additional layer of patent protection for LUPKYNIS up to 2037. The Company intends to list this newly allowed patent in the Orange Book once issued.

In addition, Aurinia is also announcing that it has recently received a Notice of Intention to Grant from the European Patent Office (EPO) for a patent application that has similar claims to Aurinia’s existing method of use U.S. Patent No. 10,286,036. This European patent application was pursued through the Patent Cooperation Treaty (PCT) process. Once issued, this patent could provide protection up to 2037 across Europe.

“This allowance by the USPTO and the concomitant news from the European Patent Office further strengthens our Intellectual Property portfolio as it pertains to LUPKYNIS and its unique pharmacodynamic dosing protocol which is detailed in the FDA package insert. These new patents, once issued, will enhance the long-term potential of LUPKYNIS,” said Peter Greenleaf, Chief Executive Officer of Aurinia.