Biosimilar Notice Rule Isn't Absolute, Apotex Tells Fed. Circ.

Law360, Washington (April 4, 2016, 5:10 PM EDT) -- Apotex urged a Federal Circuit panel to reverse a lower court's finding that biosimilar makers must always give 180-day advance notice of sales to brand-name rivals, arguing in a dispute over a proposed biosimilar for Amgen blockbuster Neulasta that the notice requirement only applies when they don't first exchange intellectual property information.

Rather than always ordering the notice, the Biologics Price Competition and Innovation Act only imposes the requirement on biosimilar makers that choose not to engage in the exchange of information, or “patent dance,” Apotex told the panel in an attempt to scrap a preliminary injunction against bringing their version to market....

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