Fed. Circ. Amgen Biosimilar Ruling Raises IP Damages Risk

Law360 (February 26, 2020, 4:53 PM EST) -- The U.S. Court of Appeals for the Federal Circuit recently affirmed a $70 million jury award for infringement of a manufacturing process patent for a biosimilar product without any infringing sales. The damages award in this case was particularly notable because the patentee did not practice the claimed technology.

This decision highlights a real risk facing drug companies developing a biosimilar product: The reference sponsor's patent portfolio may include dozens of patents that surround every step and variable in the manufacturing process, including alternatives that the reference sponsor itself does not use. This decision also highlights the benefits to innovator companies...

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