Taft Paves the Way for Generic Prostate Cancer Drug
Taft Pharmaceutical & Life Sciences attorneys Andrew Alul and Roshan Shrestha achieved a win for client Apotex in connection with Apotex's Abbreviated New Drug Application seeking approval from the U.S. Food and Drug Administration to market a lower-priced, generic alternative to the prostate cancer drug Jevtana® (cabazitaxel) Injection, currently exclusively marketed in the United States by the brand drug company Sanofi. In Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC et al., No. 3:14-cv-7869-MAS-LHG (D.N.J.) (consolidated), Sanofi sued Apotex and several other generic drug companies also seeking to market generic cabazitaxel products, alleging infringement of Sanofi's patents covering Jevtana®. After an eight-day bench trial in the United States District Court for the District of New Jersey, District Judge Michael Shipp found the asserted claims of Sanofi's later-expiring method of treatment patent, U.S. Patent No. 8,927,592, invalid, paving the way for early approval and market entry of Apotex's generic cabazitaxel product.
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