Diamyd Medical today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent covering the intralymphatic administration of retogatein (rhGAD65) with alum for the prevention and treatment of type 1 diabetes.
The now allowed U.S. application is part of a patent family with corresponding rights already granted in Europe, Australia, Hong Kong, China, Canada, South Africa, Japan, Russia, and Israel. Upon grant, the U.S. patent will further strengthen Diamyd Medical’s international patent protection for a key component of its antigen-specific immunotherapy platform. The patent, when issued, will have an anticipated expiration date in 2035.
“This Notice of Allowance further strengthens our global intellectual property for our precision medicine and antigen-specific immunotherapy in type 1 diabetes,” says Ulf Hannelius, President and CEO of Diamyd Medical. “Securing patent protection in the U.S. is a key milestone as retogatein advances toward potential commercialization.”
The intralymphatic administration method protected by the patent is being used in the ongoing confirmatory Phase 3 DIAGNODE-3 trial in children, adolescents, and adults with newly diagnosed Stage 3 type 1 diabetes. An FDA-aligned interim efficacy readout from the trial is expected end of March 2026.
As a biological product, retogatein is eligible for regulatory market exclusivity in the United States and Europe, independent of patent protection, subject to regulatory approval.
