AIM ImmunoTech Inc. announced on June 12, 2025, that the United States Patent and Trademark Office has granted U.S. patent No. 12312376, titled "Therapeutic Double Stranded RNA and Methods for Producing the Same," providing manufacturing protection for its lead drug candidate Ampligen until January 25, 2041.
Patent Strengthens Manufacturing Control
The newly granted patent covers methods involving the manufacture of therapeutic double-stranded RNA (dsRNA) products, including Ampligen (rintatolimod). This manufacturing patent, combined with AIM's existing compositions and methods patents, further secures the company's control over the synthesis and use of the first-in-class drug.
According to AIM CEO Thomas K. Equels, "This patent is a significant milestone for AIM as it represents the final step in a multi-year project to strengthen and secure our global patent portfolio surrounding Ampligen. AIM now has extended patent protection for the manufacture of Ampligen, the composition of Ampligen and the way in which Ampligen can be utilized as a therapeutic for a diverse collection of unmet medical needs, from deadly cancers to Post-COVID conditions to endometriosis."
Comprehensive Intellectual Property Portfolio
AIM's overall intellectual property portfolio now encompasses both manufacturing and therapeutic applications of Ampligen. The company holds patents for Ampligen in cancer treatment (U.S. patent 11,813,279, expires August 9, 2039), Post-COVID condition of fatigue (Netherlands' patent 2032813, expires August 21, 2042), and endometriosis (U.S. patent 12,102,649, expires October 22, 2040).
The patent protection extends beyond manufacturing rights to include multiple Orphan Drug Designations from both the FDA and European Medicines Agency. FDA designation grants seven years of market exclusivity after commercial approval, while EMA designation provides 10 years of market exclusivity. AIM's orphan drug designations span multiple conditions including Metastatic Melanoma (US), Renal Cell Carcinoma (US), Pancreatic Adenocarcinoma (US and EU), Ebola Virus Disease (US and EU), Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (US), and HIV (US).
Clinical Development Implications
The extended patent protection significantly increases the potential development runway for Ampligen, providing AIM additional time to develop its drug program as it seeks FDA approval across multiple indications. Ampligen has demonstrated broad spectrum activity in clinical trials for globally important cancers, viral diseases, and disorders of the immune system.
Ampligen is characterized as a dsRNA and highly selective TLR3 agonist immunomodulator. As AIM's lead product, it represents the company's primary focus in developing therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19.
