Amgen v. Hospira was decided on December 16, 2019 on appeal from the District of Delaware. Following the biosimilar trial, the jury found some patent claims (and not others) infringed and awarded plaintiff Amgen a reasonable royalty lump sum of $70 million. “Of the twenty-one accused drug substance batches, the jury found seven batches entitled to the Safe Harbor defense.” The district court then denied defendant Hospira’s motion for JMOL on noninfringement and invalidity, on Safe Harbor, and on damages, or in the alternative, for remittitur or a new trial. The district court also denied Amgen’s motion for JMOL for infringement of the claims found not infringed by the jury, or in the alternative, for a new trial. Both parties appealed.
The Federal Circuit affirmed the infringement and invalidity decisions, the Safe Harbor decision, and the damages.
The jury’s reasonable royalty is supported by the evidence. Amgen’s expert “determined what Hospira would have expected to gain from obtaining a license to manufacture the volume of batches needed to meet its expected product launch date in 2015, before expiration of the [asserted] patent, and appropriately concluded that the hypothetical negotiators would have been incentivized to obtain the license needed for Hospira’s pre-launch manufacture.” Moreover, Amgen’s expert “explained his reasoning for proposing a lump-sum structure for the royalties, including the fact that in this case, infringement is tied to manufacture and not directly to the sales of the product.” There was no reversible error, as Hospira was able to cross-examine Amgen’s expert and to present the testimony of its own damages expert. “Hospira was permitted to argue at trial that it had not yet received FDA approval, and that the amount of damages should be based on replacement cost because Hospira could simply remake the product.”
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Substantial evidence supports the jury royalty award of $70 million, which fell within the amounts of Amgen’s expert’s proposed royalty in the range of $154 and $170 million, and Hospira’s expert proposed royalty in the range of $4.1 to $4.6 million.