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`Page 1 of 2
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`Koios Pharmaceuticals Files Challenge to High-Cost
`Drug’s Patent
`
`July 20, 2016 06:12 PM Eastern Daylight Time
`
`SANTA MONICA, Calif.--(BUSINESS WIRE)--Koios Pharmaceuticals LLC announced that it has filed
`a challenge to the validity of U.S. Patent 8,644,231, the sole Orange-Book listed patent protecting
`Rasuvo®—a methotrexate autoinjector product—from generic competition.
`
`Koios further announced that it has entered into a confidential development and commercialization
`partnership with a leading developer of sterile injectable pharmaceutical products to introduce a
`generic equivalent to Rasuvo.
`
`Rasuvo is 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.
`
`The ’231 patent would not expire until 2029.
`
`“We’re thrilled to have taken this first step toward our mission,” said Kayvan Noroozi, Koios’s
`President and CEO. “Methotrexate was developed by the famed pediatric pathologist Sidney Farber
`and has been used since the 1950s. Medac’s patent adds nothing new to the methotrexate molecule,
`and we strongly believe it does not make any inventive scientific contributions. The American public
`should have access to competitively priced methotrexate autoinjector products before the ’231 patent
`expires.”
`
`http://www.businesswire.com/news/home/20160720006500/en/Koios-Pharmaceuticals-Fi...
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`10/29/2016
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`Medac Exhibit 2009
`Koios v. Medac
`IPR2016-01370
`Page 00001
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`
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`Koios Pharmaceuticals Files Challenge to High-Cost Drug’s Patent | Business Wire
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`Page 2 of 2
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`Koios is represented by Scott Kamholz, M.D., Ph.D., and DeAnn Smith of Foley Hoag LLP. The
`challenge was filed as a petition for inter partes review before the U.S. Patent and Trademark Office
`under proceeding number IPR2016-01370.
`
`Contacts
`For Koios Pharmaceuticals LLC
`Nathaniel Hsieh, 310-975-7074
`nathaniel@noroozi.la
`
`http://www.businesswire.com/news/home/20160720006500/en/Koios-Pharmaceuticals-Fi...
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`10/29/2016
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`Page 00002
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