Judge Denies Hospira's Motions in Epoetin Alfa Biosimilar Case

In 2017, a federal jury found that Hospira infringed on Amgen’s US Patent Number 5,856,298 (the ’298 patent), which covers erythropoietin, in producing batches of biosimilar epoetin alfa. 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 claims is invalid), 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.

Yesterday, a judge for the district court of Delaware issued a memorandum opinion in the case that denied all of Hospira’s motions.

Read more about Amgen v Hospira.

According to the memorandum, infringement on patented inventions that is reasonably related to gaining FDA approval is covered by safe harbor, and Hospira contended that because it generated test data from each batch of the biosimilar that it produced—and it could have used that data to respond to FDA requests for information—each batch of the product was related to FDA approval. Amgen, however, argued—and the jury in the case agreed—that not all of the batches produced were reasonably related to seeking FDA approval.

The memorandum agrees with Amgen, concluding that only some of Hospira’s batches of the biosimilar are subject to safe harbor, and that substantial evidence supports the jury’s verdict. It also supported the jury’s verdict that Hospira infringed on the ’298 patent, again stating that substantial evidence, including testimony, supported the verdict. Additionally, the memorandum supports the jury’s $70 million lump-sum damages award.

Finally, the memorandum denied Hospira’s request for a new trial and also dismissed Amgen’s motion for a judgment of infringement of another patent, US Patent 5,756,349 (also covering erythropoietin), or a new trial.

A representative from Pfizer, parent company of Hospira, told The Center for Biosimilars^® in an email that “We are disappointed with the decision and are considering all of our legal options.”