The US Patent & Trademark Office (PTO) issued a final written decision in favor of Argentum Pharmaceuticals, finding all claims of US Patent No. 7,214,506 ("'506 patent") to be unpatentable for obviousness. The '506 patent is listed in the Food & Drug Administration's Orange Book as covering Valeant Pharmaceuticals' Jublia (efinaconazole 10% solution) drug. According to the Orange Book, the '506 patent will not expire until October 5, 2021.
On May 12, 2017, Argentum filed an inter partes review (IPR) petition challenging all claims (claims 1 and 2) of the '506 patent.
In its final written decision, the Patent Trial & Appeal Board concluded that Argentum "has shown by a preponderance of the evidence that claims 1 and 2 of the '506 patent are unpatentable."
Commenting on the Board's decision, Argentum's CEO Jeffrey Gardner stated: "Argentum is pleased with the Board's thorough and detailed decision holding all claims of the '506 claims to be unpatentable. This decision once again shows that the IPR process is an efficient and effective tool to obtain expert agency review of Orange Book listed patents that should not have been granted in the first place.
Argentum's core mission is to lower the cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices. The IPR process has been shown to work for the benefit of American patients by improving their access to the high quality, safe, and effective FDA-approved generic alternatives that they deserve."
Argentum is a generic drug company with core competencies in intellectual property and pharmaceutical operations.