Federal Circuit Affirms Amgen's Win Against Hospira in Epoetin Alfa Litigation

December 18, 2019
The Center for Biosimilars Staff

This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.

This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.

This week’s development stems from the fact that, in 2017, a jury found that Hospira infringed on Amgen’s US Patent Number 5,856,298 (the ’298 patent), which covers erythropoietin, when Hospira produced batches of a biosimilar epoetin alfa that was eventually approved by the FDA and then launched in late 2018 under the name Retacrit.

The court at that time 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 batches of the drug were part of its FDA approval process, and that its development of a biosimilar product was protected under safe harbor.

Hospira then asked the court for a judgment that producing batches of a biosimilar product is an activity protected by safe harbor provisions, that Hospira did not infringe on the ’298 patent (which Hospira said was invalid, though the jury disagreed), and that damages owed to Amgen not exceed $1.5 million per batch of the drug if those batches were later sold. Alternatively, it sought a new trial in the case.

Hospira was denied those requests in 2018; a district court agreed with Amgen that not all of the batches of epoetin alfa that were produced by Hospira were reasonably related to seeking FDA approval, and so only some batches were subject to safe harbor. The memorandum also supported the jury’s $70 million lump-sum damages award.

The new opinion in the case, the court affirmed the prior ruling on all grounds, saying that the jury’s findings of that certain batches of the epoetin alfa biosimilar were not protected by safe harbor are supported by “substantial evidence,” and rejecting Hospira’s suggestion that “simply submitting information about a drug substance lot to the FDA brings the manufacture of that lot within the Safe Harbor.”

The court upheld the $70 million judgment with the addition of interest.

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