Big Molecule Watch
December 16, 2019

BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa).

On September 25, 2017, a District of Delaware jury found that Hospira’s manufacture of 14 of the 21 batches of drug substance it manufactured in 2013-2015 infringed Amgen’s since-expired U.S. Patent No. 5,856,298, and was not protected activity under the § 271(e)(1) safe harbor, which shields otherwise infringing uses that are reasonably related to the development and submission of information to FDA in connection with the regulatory approval process.  The jury found that Hospira had not shown that the patent was invalid and awarded Amgen $70 million as a reasonable royalty for Hospira’s infringement.  Hospira challenged the jury’s verdict in post-trial motions, but in August 2018 the trial judge upheld the verdict, awarding Amgen $70 million in damages, plus about $10 million in pre-judgment interest, as well as post-judgment interest from September 25, 2017 until such date that Hospira satisfies the Final Judgment, computed daily and compounded annually at a rate of 1.31%.  Hospira appealed to the Federal Circuit regarding these unfavorable rulings, and Amgen cross-appealed regarding a finding of non-infringement with respect to a second, also-expired asserted patent, U.S. Patent No. 5,756,349.

In today’s opinion, the Federal Circuit panel affirmed the district court on all grounds in Hospira’s appeal and Amgen’s cross-appeal, thereby upholding the district court’s $70 million damages award, plus interest, in connection with Hospira’s infringement of the ’298 patent.

The patents Amgen asserted in the litigation expired several years ago, and Pfizer launched its biosimilar in the U.S. under the trade name RETACRIT in November 2018.

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