Amgen secures $70m in biosimilar clash with Hospira
Amgen has secured $70 million in damages from a jury in a biosimilar dispute with Hospira.
On Friday, September 22, a jury at the US District Court for the District of Delaware found that Hospira had infringed US patent number 5,856,298.
The jury also found that Hospira had not infringed US patent number 5,756,349, also owned by Amgen.
The patents cover Amgen’s biological product Epogen (epoetin alfa), which 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.
In December 2014, Hospira filed its application with the Food and Drug Administration, seeking approval of an Epogen biosimilar.
A party may submit an “abbreviated” application under the statute for a biosimilar product based on an existing reference biologic product that is already approved.
In exchange for this abbreviated pathway, the applicant must fulfil certain obligations, including providing the sponsor with a copy of the application submitted under subsection (k), “and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application”.
Although Hospira provided a copy of its application to Amgen, it didn’t separately provide information concerning the manufacturing process (Hospira argued that such information was disclosed in its application).
Amgen, in a suit filed in September 2015, claimed that Hospira had violated the disclosure requirements under the Biologics Price Competition and Innovation Act, known as the ‘patent dance’.
Hospira had argued 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.
A spokesperson for Hospira said that the company will “continue to vigorously defend this case and will appeal this decision at the appropriate time”.
They added: “The company remains committed to making this important treatment option available to patients and physicians as quickly as possible.”
A spokesperson for Amgen said: “Enforcing our patents against infringement is critical to our mission of developing new therapeutics to treat serious illnesses for patients who need them.
“Our ability to discover and deliver new medicines that benefit patients and society depends on meaningful patent protection and enforcement because of the significant risks and investments faced in drug development and clinical trials.”
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