Hospira appeals against $70m Amgen verdict
Hospira has appealed against a verdict which saw Amgen secure $70 million in damages over a biosimilar dispute between the two companies.
Last week, LSIPR reported that a jury at the US District Court for the District of Delaware found that Hospira had infringed Amgen’s US patent number 5,856,298.
At the same time, the jury found that Hospira had not infringed US patent number 5,756,349, also owned by Amgen.
Both of the patents cover Amgen’s biological product Epogen (epoetin alfa).
Epogen is used to treat anaemia caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions.
Hospira had submitted an application to the Food and Drug Administration in 2014, seeking approval for a biosimilar of Epogen.
The following year, in September 2015, Amgen filed a lawsuit which claimed that Hospira had violated the disclosure requirements under the Biologics Price Competition and Innovation Act, known as the ‘patent dance’.
Hospira claimed that it was covered by the safe harbour defence under 35 USC section 271(e)(1).
But the jury awarded Amgen damages of $70 million.
On Wednesday, September 27, Hospira submitted a filing that requested a judgment as a matter of law.
In the filing, Hospira claimed that it was protected under the safe harbour provisions, that there was no infringement, that two claims of the ‘298 patent are invalid, and that the damages awarded were excessive.
Hospira said that it had presented sufficient evidence to preclude a “reasonable” jury from finding that the company wasn’t entitled to safe harbour protection and from finding infringement and validity.
“Finally, if the jury were to find no safe harbour, infringement of both patents, and validity of the ‘298 patent, Amgen failed to present sufficient evidence at trial from which a reasonable jury could award damages within the range proffered by Amgen,” said the claim.
Hospira also argued that Amgen can’t prove infringement of the ‘298 patent because the patent expired on January 5, 2016.
Additionally, Hospira argued that the $70 million in damages was excessive, and that it had presented evidence that a reasonable jury would not return a damages verdict greater than $1.5 million per batch at the time of commercial sale (21 batches were created, so the maximum total would be $31.5 million).
A spokesperson for Hospira said: “Hospira will continue to vigorously defend this case. The company remains committed to making this important treatment option available to patients and physicians as quickly as possible.”
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