On May 27, 2014 Hemispherx Biopharma reported that on May 13, 2014, the United States Patent Office issued U.S. Patent 8,722,874 titled "Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity" to inventors Carter, et al. and assignee Hemispherx Biopharma, Inc (Filing 8-K , Hemispherx Biopharma, MAY 27, 2014, View Source [SID:1234500555]). The patent claims a novel form of rugged dsRNA. Rugged dsRNA are nucleic acids with a unique composition and physical characteristic identified with high specificity of binding to Toll-Like Receptor 3 (TLR3), thereby conveying an important range of therapeutic opportunities. The newly discovered form of dsRNA has increased bioactivity and binding affinity to the TLR 3 receptor because of its reduced tendency to form branched dsRNA which can inhibit receptor binding. Pharmaceutical formulations containing the newly discovered nucleic acid as active ingredients and methods of treatment, with those formulations are also described in the issued patent.
The original U.S. composition-of-matter patent on Ampligen was issued to Johns Hopkins University in the early 1970’s, published in the Journal of Molecular Biology, and thereafter licensed to Hemispherx Biopharma, Inc. exclusively. Upon expiration of the original patent, Hemispherx relied on a continued research program and sizable portfolio of subsequently issued patents to maintain a degree of proprietary protection for novel compositions and treatment methods based on Ampligen technology. The issuance of U.S. Patent 8,722,874 will help ensure that Hemispherx Biopharma retains patent protection for novel formulations of Ampligen products until at least 2029. The current Ampligen formulations, as a mixture of RNA of different sizes and variable binding affinities to cell receptors, affords a unique array of potential disease fighting properties through antiviral and immunomodulatory mechanisms. The newly issued patent discusses how dsRNAs acting thru TLR3 receptor activation are potent antiviral compounds and anticancer agents and through secondary immunomodulators that can enhance the bioactivity of vaccines and treat autoimmune diseases.
The significant extension of proprietary longevity via the new composition-of-matter patent may favorably affect patent longevity of Ampligen in approximately 20-25 countries.
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