Hospira Ordered to Pay Amgen $70 Million Over Epoetin Alfa Patent Infringement

Biosimilar developer Hospira has been ordered to pay Amgen $70 million after a jury found that the drug maker infringed on Amgen’s US Patent Number 5,856,298 (the ‘298 patent), which covers erythropoietin.
The Center for Biosimilars Staff
September 26, 2017
Biosimilar developer Hospira has been ordered to pay Amgen $70 million after a jury found that the drug maker infringed on Amgen’s US Patent Number 5,856,298 (the ‘298 patent), which covers erythropoietin.

A federal jury found that Hospira infringed on one of Amgen’s patents for its innovator epoetin alfa (Epogen) when Hospira developed its proposed biosimilar. During the trial, Hospira had claimed that its development of the biosimilar was protected under safe harbor for pharmaceutical product development that would otherwise infringe on patents, but the jury did not find that Hospira had proven that the safe harbor defense applied to the manufacture of multiple batches of the biosimilar. It also found that Hospira had not proven that 2 of the claims of the ‘238 patent were obvious and therefore unpatentable.

The ruling represents yet another setback for Hospira, and parent company Pfizer, with respect to its epoetin biosimilar. In June, the FDA issued a second complete response letter (CRL) for the proposed drug. While the FDA’s first CRL, issued in 2015, indicated a need for additional data, the most recent CRL focused on Hospira’s manufacturing facility. The letter indicated that the agency had continuing concerns about Hospira’s plant in McPherson, Kansas, where the drug was slated to be manufactured. The rejection of the drug came as a surprise to many in the industry, as the FDA’s Oncologic Drugs Advisory Committee had voted 14 to 1 to recommend approval of the drug.

The European Medicines Agency, however, approved the drug for marketing under the brand name Retacrit. In the European Union, the drug is approved to treat anemia in patients who have chronic renal failure, anemia in patients receiving chemotherapy, to increase the amount of blood that patients with moderate anemia can self-donate prior to surgery, and to reduce the need for blood transfusions in patients with anemia who will undergo major bone surgery.

Epogen earned Amgen $1.28 billion in 2016, but steadily increasing competition from biosimilars like Retracrit in the European and international markets has led to declining profits for the innovator developer, which reported a 31% decline in its Epogen sales last year.

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