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17 December 2019Big PharmaSaman Javed

Fed Circuit dismisses Hospira appeal, says it must pay Amgen $70m

A subsidiary of Pfizer, Hospira, infringed one of Amgen’s patents and must pay damages of $70 million, the US Court of Appeal for the Federal Circuit has affirmed.

In a decision handed down yesterday, December 16, the Federal Circuit upheld a ruling by the US District Court for the District of Delaware that Amgen’s patent is valid and infringed by Hospira.

The patent in dispute (US patent number 5,856,298) covers Amgen’s Epogen, a glycoprotein hormone that regulates red blood cell maturation and production and is used to treat anemia.

In 2014, Hospira applied for Food and Drug Administration approval for Retacrit, a biosimilar version of Epogen. It produced 21 batches of the drug.

Amgen then sued Hospira for infringement of the ‘298 patent and an additional patent (US patent number 5,756,349). Following a trial, a jury ruled that the ‘298 patent was valid and infringed. It found the ‘349 patent to be valid, but not infringed.

In its appeal to the Federal Circuit, Hospira asked the Federal Circuit for a new trial, arguing that the district court’s claim construction was erroneous, that Amgen did not sufficiently establish infringement and that Hospira’s batches of the biosimilar are protected under Safe Harbour Protection.

Safe Harbour Protection is a US statute, 35 U.S.C. § 271(e), which exempts drug development and approval from patent infringement.

In its ruling, the Federal Circuit rejected Hospira’s argument that all batches of its biosimilar were protected by Safe Harbor. Hospira had contested that all 21 batches were used for development and the submission of an application at the FDA.

But, the Federal Circuit agreed with the jury that only seven batches were protected under the Safe Harbor, two of which were used for qualifying Hospira’s process to make the drug, and five for mandatory inspection by the FDA.

It said the other fourteen batches were not protected.

“Substantial evidence supports the jury’s finding that the batches at issue were not manufactured solely for uses reasonably related to the development and submission of information to the FDA,” the Federal Circuit said.

Additionally, it said that a new trial is only granted where “a miscarriage of justice would result if the verdict were to stand”. It said Hospira’s arguments that the district court’s claim construction was erroneous was “unavailing”.

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