On September 22, 2017, a District of Delaware jury in the matter Amgen v. Hospira, 15-cv-839-RGA (D. Del.) returned a verdict awarding Amgen $70 million for Hospira’s infringement of an Amgen patent covering the manufacture of Amgen’s erythropoetin product Epogen. That verdict is the first instance in which a patent owner has recovered significant infringement damages under the Biologics Price Competition and Innovation Act (BPCIA). It is also the first time a patent owner has recovered damages under the BPCIA for acts of infringement by a competitor conducted prior to the commercial marketing of the competitor’s biosimilar product.

In this lawsuit, Amgen accused Hospira under the BPCIA of having infringed Amgen’s U.S. Patents Nos. 5,756,349 (claiming vertebrate cells for the manufacture of erythropoetin) and 5,856,298 (claiming methods of preparing erythropoetin molecules having a certain number of sialic acids per molecule) by making 21 lots of erythropoetin active ingredient intended for use in Hospira’s biosimilar of Epogen. Amgen sought damages for Hospira’s manufacture of those 21 lots in the form of a reasonable royalty.

Hospira countered by asserting, among other things, that because Hospira had made those 21 lots for uses reasonably related to obtaining FDA approval of its biosimilar, they fell under the “safe harbor” of 35 U.S.C. § 271(e)(1), which states that “[i]t 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 its failure (thus far) to obtain FDA approval for its biosimilar weighed in favor of its “safe harbor” defense, and should also be considered as a factor in any reasonable-royalty damages calculation.

From September 18 to 22, 2017, the parties conducted a five-day jury trial before Judge Richard G. Andrews of the District of Delaware to resolve these and other issues. At trial, Amgen’s attorneys argued that Hospira’s 21 lots were manufactured for the purpose of stockpiling raw material in anticipation of the commercial approval and launch of Hospira’s biosimilar, thereby removing them from the ambit of the § 271(e)(1) safe harbor. Hospira’s attorneys, by contrast, characterized the lots as having been made for the purpose of validating Hospira’s manufacturing process, an activity Hospira’s attorneys asserted was “reasonably related” to obtaining FDA approval, and thus within the § 271(e)(1) safe harbor.

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 erythropoetin infringed the ’298 patent (but not the ’349 patent), that 14 of Hospira’s 21 lots of erythropoetin did not qualify for the protection of the § 271(e)(1) safe harbor; and that Amgen was entitled to damages in the amount of $70 million.

On September 25, 2017, Judge Andrews entered judgment in that amount for Amgen.