Court Denies Amgen Epogen Biosimilar Patent Appeal

The Court of Appeals for the Federal Circuit has denied an Amgen appeal of a lower court decision that rejected the company’s attempt to compel discovery from Hospira in a patent dispute over a biosimilar version of Amgen’s Epogen. Amgen claimed that Hospira did not live up to its “patent dance” information exchange obligations under the Biologics Price Competition and Innovation Act because it failed to provide complete information on the cell culture medium it used in manufacturing its biosimilar.

The district court rejected Amgen’s request for discovery because the cell culture medium was not at issue in any of the patents Amgen said were infringed. The appeals court said it lacked jurisdiction to hear the appeal because the district court ruling is not a final order, and said it could not justify hearing it under the collateral order doctrine or any other alternative theory proposed by Amgen.