Generic drug company Argentum Pharmaceuticals LLC said the US Patent & Trademark Office (PTO) granted its petition for inter partes review (IPR) against all claims of the last-expiring patent listed in the Food & Drug Administration’s Orange Book covering Novartis AG’s blockbuster multiple sclerosis drug Gilenya.
Argentum Pharmaceuticals said it challenges claims 1−6 of Novartis’ U.S. Patent No. 9,187,405, which the Orange Book states will expire in 2027.
“In instituting Argentum’s IPR, the PTO concluded that Argentum established a reasonable likelihood that it would prevail in showing the unpatentability of claims 1–6 of the ‘405 patent,” said Argentum.
“The decision marks the beginning of an IPR trial that will be conducted by three specialist patent judges within the PTO’s Patent Trial & Appeal Board.
“A final decision on patentability in the IPR is expected by July 2018.”