SANTA MONICA, Calif.--(BUSINESS WIRE)--In response to a petition from Koios Pharmaceuticals LLC, the United States Patent and Trademark Office (“PTO”) has instituted inter partes review of the sole Orange-Book listed patent protecting Rasuvo®—a high-cost rheumatoid arthritis treatment—from generic competition.
The PTO will now review the validity of all twenty-two claims of U.S. Patent 8,664,231, and on multiple grounds. In reaching its decision, the PTO noted that it was “persuaded that there is a reasonable likelihood that Petitioner would prevail with respect to the claims challenged in the Petition.” The ’231 patent does not expire until 2029.
The decision moves Koios and its partners closer to introducing a generic alternative to Rasuvo, a methotrexate autoinjector product approved for the treatment of inflammatory autoimmune diseases including rheumatoid arthritis in adults and polyarticular juvenile idiopathic arthritis in children.
Americans spent $30.2 billion on specialty autoimmune medicines like Rasuvo, Humira, and Enbrel in 2015, according to IMS Health, and spending on autoimmune treatments grew 28% from the prior year—more quickly than any other treatment category.
Koios’s mission is to increase Americans’ access to affordable medicines by promoting pharmaceutical price competition. The company leverages novel legal strategies at the intersection of inter partes review and the Hatch-Waxman Act to introduce generic equivalents to high-cost specialty pharmaceutical products before the patents protecting those products would naturally expire.
“We welcome the Patent Office’s decision,” said Kayvan Noroozi, Koios’s President and CEO. “Medac’s patent adds nothing new to the methotrexate molecule or, in our view, to known methods of administering methotrexate. We look forward to proving that.”
Koios is represented by DeAnn Smith of Foley Hoag LLP and William Rothwell of Noroozi PC. The instituted inter partes review will proceed at the U.S. Patent and Trademark Office under case number IPR2016-01370.