Having disputed portions of Novartis’ patent for Gilenya (fingolimod), an immunosuppressant used to treat multiple sclerosis (MS), Argentum Pharmaceuticals LLC has successfully obtained a special petition from the U.S. Patent & Trademark Office.
The office found that Argentum’s claim of “unpatentability” was valid. Argentum’s petition challenges the product’s last-expiring patent, currently listed in the U.S. Food and Drug Administration Orange Book. Specifically, Argentum objected to claims 1-6 of Novartis’ U.S. Patent [No. 9,187,405], which currently expires in 2027.
The ruling now enables an inter partes review trial to begin, during which three expert patent judges from the Patent Trial and Appeal Board will examine and review material. A final decision on the product’s patentability should be rendered by July 2018, according to Argentum spokespersons.
Argentum focuses on generic drugs and specializes in intellectual property (IP) and pharmaceutical operations. It strives to lower prescription drug costs for consumers by challenging patents that artificially escalate medication prices.
Working closely with both branded and generic pharmaceutical firms and health care organizations, Argentum acquires, develops and markets new generic medications.
“Argentum has a unique understanding of the strategic use of intellectual property, including how some companies build ‘artificial’ IP estates to extend exclusivity of a drug franchise while offering little innovation or additional benefit to society,” the company said on its website, adding that it is not “anti-patent” but instead an advocate for strong, innovative patents.
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