Introduction

On September 22 2017 a District of Delaware jury in Amgen v Hospira (15-cv-839-RGA (D Del)) awarded Amgen $70 million for Hospira's infringement of an Amgen patent covering the manufacture of Amgen's erythropoietin product Epogen. The verdict is the first instance in which a patent owner has recovered significant infringement damages under the Biologics Price Competition and Innovation Act. It is also the first time that a patent owner has recovered damages under the act for acts of infringement that a competitor carried out before the commercial marketing of the competitor's biosimilar product.

Facts

In this suit, Amgen accused Hospira under the act of having infringed Amgen's US Patents 5,756,349 (claiming vertebrate cells for the manufacture of erythropoietin) and 5,856,298 (claiming methods of preparing erythropoietin molecules having a certain number of sialic acids per molecule) by making 21 batches of the active ingredient erythropoietin intended for use in Hospira's biosimilar of Epogen. Amgen sought damages for Hospira's manufacture of those 21 batches in the form of a reasonable royalty. Hospira countered by asserting, among other things, that because it had made those 21 batches for uses reasonably related to obtaining Food and Drugs Administration (FDA) approval of its biosimilar, the batches fell under the safe harbour of 35 USC Section 271(e)(1), which states that:

"It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention… solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products."

Hospira further asserted that its failure thus far to obtain FDA approval for its biosimilar weighed in favour of its safe harbour defence, and should also be considered as a factor in any reasonable-royalty damages calculation.

Decision

From September 18 to 22 2017 the parties conducted a five-day jury trial before Judge Richard G Andrews of the District of Delaware in order to resolve these and other issues. At trial, Amgen's attorneys argued that Hospira's 21 batches had been manufactured for the purpose of stockpiling raw material in anticipation of the commercial approval and launch of Hospira's biosimilar, thereby disqualifying the batches from the Section 271(e)(1) safe harbour. Conversely, Hospira's attorneys argued that the batches had been made for the purpose of validating Hospira's manufacturing process, an activity that they asserted was reasonably related to obtaining FDA approval, and thus qualified for the Section 271(e)(1) safe harbour. The jury took a more nuanced approach to the issues. On September 22 2017 it returned a verdict in which it found that Amgen had proved, by a preponderance of evidence, that:

  • Hospira's manufacture of erythropoietin had infringed Patent 5,856,298 (but not Patent 5,756,349);
  • 14 of Hospira's 21 batches of erythropoietin did not qualify for the Section 271(e)(1) safe harbour; and
  • Amgen was entitled to damages in the amount of $70 million.

On September 25 2017 Andrews entered judgment in that amount for Amgen. On September 27 2017 Hospira challenged the jury's infringement and damages determinations in a motion for judgment as a matter of law. A decision on the motion is pending.

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For further information on this topic please contact Christopher Loh at Fitzpatrick, Cella, Harper & Scinto by telephone (+1 212 218 2100) or email (cloh@fchs.com). The Fitzpatrick, Cella, Harper & Scinto website can be accessed at www.fitzpatrickcella.com.