Amgen Shows New Patents Can Affect Prior BPCIA Litigation

By Ashley Mays-Williams, Julia Kolibachuk and Maria Nunez (August 27, 2018, 4:14 PM EDT) -- On Aug. 7, 2018, Amgen and Amgen Manufacturing Limited (collectively, "Amgen") sued Apotex Inc. and Apotex Corp. (collectively, "Apotex") in a third lawsuit[1] over Apotex's pending biologics license applications, or BLAs, to make biosimilar versions of Amgen's pegfilgrastim and filgrastim products, Neulasta and Neupogen.[2] Notably, although the current patent-in-suit, U.S. Patent No. 9,856,287, claims priority to a patent asserted by Amgen in its two earlier actions against Apotex, the '287 patent did not issue until after the parties had already completed "patent dance" exchanges[3] pursuant to the Biologics Price Competition and Innovation Act in connection with the two earlier actions. Amgen's current action illustrates how owners of biologic drugs can use later-issued patents to extend biosimilar litigation after an initial BPCIA action has concluded....

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