Hospira had 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.
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.”
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
Breaking Down Biosimilar Barriers: Payer and PBM Policies
November 13th 2024Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.