New Trials Sought Following Amgen v Hospira Ruling

October 25, 2017
The Center for Biosimilars Staff

Legal challenges to a recent jury verdict in Amgen v Hospira continue, with both parties in the case filing briefs asking for new trials over aspects of the ruling.

Legal challenges to a recent jury verdict in Amgen v Hospira continue, with both parties in the case filing briefs asking for new trials over aspects of the ruling.

Last month, a federal jury found that Hospira had infringed on Amgen’s US Patent Number 5,856,298 (the ‘298 patent), which covers erythropoietin, and ordered the biosimilar developer to pay Amgen, the maker of the reference epoetin alfa (Epogen), $70 million. Hospira had unsuccessfully argued during the trial that its development of a biosimilar product was protected under safe harbor.

In a motion filed this week, Hospira asked the court for a judgment that the manufacture of its batches of a biosimilar product are protected by safe harbor provisions, that Hospira did not infringe on the ‘298 patent (which is states is invalid), and that damages owed to Amgen must not exceed $1.5 million per batch of the drug (if those batches are then sold). In the alternative to such a finding, Hospira asked for a new trial in the case.

Amgen, too, filed a brief in response to the verdict, also asking for a new trial. The jury in Amgen v Hospira found that Hospira had not infringed on US Patent 5,756,349 patent (the ‘349 patent). Amgen claims that “no reasonable jury could have concluded that Hospira did not infringe” on its patent, which is directed toward cells that are capable of producing “large, specified amounts” of erythropoietin (EPO), and that Hospira’s documents that it submitted to the FDA—and presented to the court witness testimony during the trial—establish that its cells fell within the limitations set out in its ‘349 patent. “The jury was not free to disregard the only evidence presented at trial about the EPO production rate of Hospira’s cells,” according to Amgen’s brief.

Finally, Amgen took issue with Hospira’s closing arguments that appropriate data had not proven infringement on the ‘349 patent, saying that the argument had not had supporting testimony during the trial. Amgen seeks a new trial that will specifically address infringement of the ‘349 patent.


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