BPCIA At Fed. Circ.: Awaiting Guidance On Patent Dance

By Tasha Francis and Jenny Shmuel (October 12, 2017, 1:27 PM EDT) -- On Oct. 2, 2017, a Federal Circuit panel consisting of Judges Kathleen O'Malley, Alan Lourie and Richard Taranto heard arguments in Amgen v. Apotex (17-1010), which involved Apotex's Neulasta and Neupogen biosimilars that have yet to be approved by the U.S. Food and Drug Administration.

Filed October 2015 in the Southern District of Florida, Amgen v. Apotex was the first Biologics Price Competition and Innovation Act litigation to conclude on the merits (as opposed to settlement or jurisdictional rulings). The district court found that Apotex's biosimilar manufacturing processes did not infringe U.S. Patent 8,952,138, directed to a method of refolding proteins. In particular, Amgen...

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