On June 12, the Supreme Court of the United States issued a unanimous (9-0) opinion in Sandoz v. Amgen (No. 15-1039), a highly anticipated case concerning key provisions of the Biologics Price Competition and Innovation Act (BPCIA), part of the larger Patient Protection and Affordable Care Act of 2009 (PPACA).
At the heart of the decision lay a fight between two major biopharmaceutical manufacturers over claims of patent infringement brought by Amgen Inc. against Sandoz Inc. on a blockbuster drug representing hundreds of millions in sales each year. Amgen has marketed filgrastim, a synthetically produced therapeutic protein, under the trade name Neupogen® since 1991, when it was approved for use by the Food and Drug Administration (FDA). In 2014, Sandoz sought FDA approval for a compound “biosimilar” to filgrastim, dubbed filgrastim-sndz, under the trade name Zarxio®.
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