Patent Dance Takes Center Stage In Amgen V. Sandoz Appeal

Law360, New York (June 4, 2015, 1:49 PM EDT) -- On June 3, 2015, the Federal Circuit heard oral arguments in the closely watched Amgen Inc. v. Sandoz Inc. case, 2015-1499, where Amgen is appealing the Northern District of California’s determination that the “patent dance” provisions of the Biologics Price Competition and Innovation Act are optional, and that Sandoz was justified in providing notice of its intent to market a biosimilar at the time it filed its application at the U.S. Food and Drug Administration.

In ruling that the disclosure and notice provision of the BPCIA was not mandatory, the district court found that: (1) Sandoz was not required, but rather could elect...

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